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Iovance Biotherapeutics Shares Rise 12% on Updated Phase 2 Melanoma Study Results

By The Life Science Report

Source: Streetwise Reports   11/08/2019

Shares of Iovance Biotherapeutics traded 12% higher today after the firm reported updated clinical data from its phase 2 lifileucel metastatic melanoma trial.

Just a few days after reporting third quarter 2019 earnings, late-stage biotechnology company Iovance Biotherapeutics Inc. (IOVA:NASDAQ), which develops novel T cell-based cancer immunotherapies, today announced that new data from Cohort 2 of the ongoing Phase 2 lifileucel metastatic melanoma study (C-144-01) were presented Friday, Nov. 8, 2019, at the Society for Immunotherapy of Cancer (SITC) 34th Annual Meeting in National Harbor, Maryland.

The company advised that new data from the second Cohort in the ongoing C-144-01 study includes consecutively dosed post-PD-1 patients with Stage IIIC/IV unresectable melanoma who also have received BRAF/MEK therapy if clinically indicated. In the presentation to the SITC, the firm highlighted that the study’s “Cohort 2 objective response rate (ORR) as determined by independent review committee (IRC) was 35 percent, which aligns well with the investigator assessed ORR of 36 percent”.

Maria Fardis, Ph.D., MBA, President and CEO of Iovance Biotherapeutics commented, “We are pleased to see continued evidence of durability with lifileucel therapy as patients are evaluated with longer term follow-up… Concordance between IRC assessment and investigator reported results is highly favorable in this metastatic disease setting as compared with the published literature. These results continue to show that lifileucel offers a potential therapeutic option for the metastatic melanoma patients enrolled in this study. We continue to enroll patients in the pivotal cohort of the study, Cohort 4, which is expected to serve as the basis for an expected Biologics License Application (BLA) submission for lifileucel in late 2020.”

Earlier this week the company reported earnings for the third quarter ended September 30, 2019. Being a clinical stage company the company did not recognize any revenue for the quarter or year-to-date. For Q3/19, the company reported a Net loss of $49.5 million, or $0.40 per share, compared to a net loss of $33.8 million, or $0.36 per share in Q3/18. Research and development expenses increased $13.7 million in the same period to $41.6 million, up from $27.9 in Q3/18, which according to the company was primarily due to higher manufacturing costs resulting from increased capacity added to support enrollment in the pivotal and other clinical trials. General and administrative expenses increased by $2.9 million to $10.0 million in Q3/19, compared to $7.1 million in Q3/18 mostly due to adding employees and increased legal fees in order to support the growing patent portfolio.

In the earnings release CEO Maria Fardis stated, “We continue making great progress in developing tumor infiltrating lymphocyte (TIL) therapy, which could become the first approved cell therapy product for solid tumor indications…Our pivotal studies in metastatic melanoma and advanced cervical cancer are on track to complete enrollment in early 2020. We expect to submit for regulatory approval for TIL therapies lifileucel and LN-145 in late 2020…We are very pleased to have a new IND active in order to investigate the polyclonal blood-based T cell, or PBL therapy (IOV-2001), in chronic lymphocytic leukemia (CLL). This candidate was developed based on Iovance research efforts focused on the generation of novel cell therapy products. We anticipate the initiation of IOV-CLL-01, an Iovance-sponsored trial with IOV-2001 PBL product, before the end of 2019.”

Iovance Biotherapeutics is a clinical-stage biopharmaceutical company based in San Carlos, Calif. The company states that it “intends to improve patient care by making T cell-based immunotherapies broadly accessible for the treatment of patients with solid tumors and blood cancers. Tumor infiltrating lymphocyte (TIL) therapy uses a patient’s own immune cells to attack cancer.” The company’s TIL therapies are being investigated for the treatment of patients with locally advanced, recurrent or metastatic cancers including head and neck and non-small cell lung cancer. In addition, clinical studies of T cell therapy for peripheral blood lymphocyte (PBL) blood cancers therapy are being planned.

Iovance began the day with a market capitalization of approximately $2.6 billion with about 12.62 million shares outstanding, along with a 11.3% short interest. IOVA shares opened today at $22.27 (+$1.60, +7.74%) over yesterday’s $20.67 closing price. The stock has traded today between $21.78 to $23.75 per share and currently is trading at $23.04 (+$2.38 +11.52%).

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Disclosure:
1) Stephen Hytha compiled this article for Streetwise Reports LLC and provides services to Streetwise Reports as an independent contractor. He or members of his household own securities of the following companies mentioned in the article: None. He or members of his household are paid by the following companies mentioned in this article: None.
2) The following companies mentioned in this article are billboard sponsors of Streetwise Reports: None. Click here for important disclosures about sponsor fees.
3) Comments and opinions expressed are those of the specific experts and not of Streetwise Reports or its officers. The information provided above is for informational purposes only and is not a recommendation to buy or sell any security.
4) The article does not constitute investment advice. Each reader is encouraged to consult with his or her individual financial professional and any action a reader takes as a result of information presented here is his or her own responsibility. By opening this page, each reader accepts and agrees to Streetwise Reports’ terms of use and full legal disclaimer. This article is not a solicitation for investment. Streetwise Reports does not render general or specific investment advice and the information on Streetwise Reports should not be considered a recommendation to buy or sell any security. Streetwise Reports does not endorse or recommend the business, products, services or securities of any company mentioned on Streetwise Reports.
5) From time to time, Streetwise Reports LLC and its directors, officers, employees or members of their families, as well as persons interviewed for articles and interviews on the site, may have a long or short position in securities mentioned. Directors, officers, employees or members of their immediate families are prohibited from making purchases and/or sales of those securities in the open market or otherwise from the time of the interview or the decision to write an article until three business days after the publication of the interview or article. The foregoing prohibition does not apply to articles that in substance only restate previously published company releases.
6) This article does not constitute medical advice. Officers, employees and contributors to Streetwise Reports are not licensed medical professionals. Readers should always contact their healthcare professionals for medical advice.

( Companies Mentioned: IOVA:NASDAQ,
)

Dexcom Posts 49% YoY Revenue Growth, Sending Shares to 52-Week High

By The Life Science Report

Source: Streetwise Reports   11/07/2019

Glucose monitoring systems developer Dexcom’s shares traded 30% higher today after releasing Q3/19 earnings and raising full-year 2019 guidance.

Glucose monitoring systems maker Dexcom Inc. (DXCM:NASDAQ) yesterday announced financial results for its third quarter ended September 30, 2019.

In the report the company reported that worldwide revenue in Q3/19 grew by 49% to $396.3 million, compared to $266.7 million in Q3/18. The firm indicated that volume growth together with strong new patient additions continues to be the primary revenue growth driver. Dexcom further advised that U.S. revenue increased by 53% and international revenue increased by 36% in the corresponding period.

The firm indicated that GAAP operating income in Q3/19 was $56.0 million compared to $13.9 million in Q3/18. For Q3/19, the company posted GAAP net income of $45.8 million, or $0.50 per diluted share, compared to $46.6 million, or $0.52 per diluted share in Q3/18.

Regarding the effectiveness of the company’s monitoring devices, the firm noted “the 3-Year COMISAIR study results continued to demonstrate the value proposition of Dexcom’s real-time CGM resulting in significant improvements to A1C and time in range for Dexcom CGM subgroups regardless of one’s method of insulin delivery.”

The company’s Chairman, President and CEO Kevin Sayer commented, “Dexcom maintained its robust revenue growth momentum in the third quarter, leading to another significant increase to our full year revenue outlook…Our team is working hard to meet demand and ensure an exceptional experience for our customers, and we look forward to a strong close to 2019.”

The company updated and mostly raised its estimates for full-year 2019. The firm now expects FY/19 Revenue of $1.425–1.450 billion (38–41% annual growth). This compares to previous expectations of $1.325–1.375 billion (28–33% yearly growth). The firm advised that it anticipates a 63% gross profit margin compared to previous expectations of 64–65%. Additionally, the company indicated that it expects non-GAAP operating margin of approximately 9% up from the previously projected 7%, and non-GAAP adjusted EBITDA margin of approximately 19.5% compared to previous expectations of 18.5%.

Dexcom is a medical device company headquartered in San Diego, Calif., that designs, develops and markets continuous glucose monitoring (CGM) systems for use by people with diabetes and by healthcare providers.

Dexcom started the day with a market capitalization of around $14 billion with approximately 91.19 million shares outstanding, and about a 6% short interest. DXCM shares opened nearly 21% higher today at $185.20 (+$32.08, +20.95%) over yesterday’s closing price of $153.12. The stock has traded today between $183.15-200.80 per share and currently is trading at $198.50 (+$45.38 +29.64%).

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Disclosure:
1) Stephen Hytha compiled this article for Streetwise Reports LLC and provides services to Streetwise Reports as an independent contractor. He or members of his household own securities of the following companies mentioned in the article: None. He or members of his household are paid by the following companies mentioned in this article: None.
2) The following companies mentioned in this article are billboard sponsors of Streetwise Reports: None. Click here for important disclosures about sponsor fees.
3) Comments and opinions expressed are those of the specific experts and not of Streetwise Reports or its officers. The information provided above is for informational purposes only and is not a recommendation to buy or sell any security.
4) The article does not constitute investment advice. Each reader is encouraged to consult with his or her individual financial professional and any action a reader takes as a result of information presented here is his or her own responsibility. By opening this page, each reader accepts and agrees to Streetwise Reports’ terms of use and full legal disclaimer. This article is not a solicitation for investment. Streetwise Reports does not render general or specific investment advice and the information on Streetwise Reports should not be considered a recommendation to buy or sell any security. Streetwise Reports does not endorse or recommend the business, products, services or securities of any company mentioned on Streetwise Reports.
5) From time to time, Streetwise Reports LLC and its directors, officers, employees or members of their families, as well as persons interviewed for articles and interviews on the site, may have a long or short position in securities mentioned. Directors, officers, employees or members of their immediate families are prohibited from making purchases and/or sales of those securities in the open market or otherwise from the time of the interview or the decision to write an article until three business days after the publication of the interview or article. The foregoing prohibition does not apply to articles that in substance only restate previously published company releases.
6) This article does not constitute medical advice. Officers, employees and contributors to Streetwise Reports are not licensed medical professionals. Readers should always contact their healthcare professionals for medical advice.

( Companies Mentioned: DXCM:NASDAQ,
)

Could There Finally Be an Effective Treatment for Alzheimer’s Disease?

By The Life Science Report

Source: Streetwise Reports   11/06/2019

ProMIS’ preclinical treatment could possibly outshine Biogen’s candidate.

Finding an effective treatment for Alzheimer’s disease has been elusive as many seemingly promising avenues of research did not prove out in clinical trials. Biogen Inc. (BIIB:NASDAQ) appeared to be going down the same path after it pulled the plug on its phase 3 aducanumab trials in March. But, in a stunning reversal, Biogen recently announced that, after looking at a more complete set of phase 3 data that included patients receiving the highest dosage, it has concluded the treatment was effective after all.

A small-cap firm, ProMIS Neurosciences Inc. (PMN:TSX; ARFXF:OTCQB), believes its Alzheimer’s treatment currently in development, PMN310, will run circles around Biogen’s, and is developing treatments for Parkinson’s, ALS and other neurodegenerative diseases, all of which are caused by the progressive death of nerve cells.

Noble Capital Markets has seconded this view. Analyst Cosme Ordonez, in an October 24 report, wrote, “We believe ProMIS’ PMN310 is a superior drug. . .Although PMN310 is still in preclinical development, we believe it has the potential to become the preferred antibody for the treatment of Alzheimer’s.”

“In our opinion, ProMIS’ preclinical results validate the hypothesis that PMN310 has the potential to become an efficacious drug for the treatment of Alzheimer’s disease. Despite recent setbacks in the Alzheimer’s area, we believe that ProMIS will be successful as the company has developed a unique, distinctive therapeutic approach,” Ordonez concluded.

Today no effective treatment that attacks the root cause of the disease is available for chronic neurodegenerative diseases; the treatments that do exist merely temporarily slow down symptoms without any effect on disease progression.

“When Biogen stopped its aducanumab trial in March,” ProMIS CEO Elliot Goldstein, MD, told Streetwise Reports, “it got tremendous negative attention; people felt that the science must be wrong, that targeting amyloid beta wasn’t the right thing to do. Investors left the sector in droves.”

“But I believe Biogen was targeting the wrong kind of amyloid beta; it comes in several forms and most are harmless,” Goldstein explained. “The target is the small clumps of amyloid beta called oligomers that when they misfold are highly toxic and kill neurons. Most of the failed studies were using compounds designed to mainly knock out plaque or other normal, non-toxic forms of amyloid, and while these treatments can have some effect on the toxic form, they weren’t selective and specific for it.”

When Biogen received more data from its study, “especially from patients who had been receiving the highest dosage, it turns out that the EMERGE study was unequivocally positive. At the highest dose of 10 milligrams per kilogram body weight aducanumab was blocking enough of the toxic form of amyloid beta to make a significant difference. But the dosage can’t be increased further because of toxic side effects, most notably swelling of the brain, also called edema. About 35% of the patients in Biogen’s trials had this dose limiting side effect,” Goldstein noted.

“We like to say that aducanumab is approvable but certainly improvable; it’s not selective enough for the toxic oligomers that are the root cause of Alzheimer’s. If a lot of the treatment goes to bust harmless plaques, you are wasting a lot of the ammunition on the wrong target,” Goldstein stated.

It’s not easy to develop antibodies against these toxic oligomers because they are “shape shifters,” Goldstein said. “Misfolded oligomers have unstructured regions, so you can’t isolate them using the usual physical techniques for making antibodies. To solve this challenge, we used our proprietary thermodynamic algorithms that run on supercomputers to compute exactly where they’re misfolding, and the shape of the misfolding, and then we create, test and validate antibodies that work selectively against that specific toxic form.”

That one antibody targeting toxic oligomers of amyloid will work only against the misfolded protein that leads to Alzheimer’s, but the principle is the same for some of the other neurodegenerative diseases. Small misfolded clumps of the protein called alpha-synuclein are a root cause of Parkinson’s disease. When the protein called TDP-43 forms misfolded toxic clumps, it leads to amyotrophic lateral sclerosis (ALS). ProMIS has candidate antibody therapies for all three diseases.

“Selectivity for the toxic oligomer is very important,” Goldstein stressed. “You want to aim at the right target so that you don’t waste ammunition and cause damage and side effects. By avoiding side effects, you can raise the dosage so that it can be more effective.”

Goldstein is pleased with Biogen’s success. “First, we believe Biogen has a strong likelihood of receiving FDA approval for aducanumab, and that means hope at the end of the tunnel for Alzheimer’s patients and their caregivers.”

For ProMIS, Goldstein sees his company’s PMN310 antibody becoming the next generation, best-in-class treatment for Alzheimer’s. “We have preclinical evidence that PMN310 selectively targets and neutralizes the neurotoxicity without binding to normal, non-toxic forms of amyloid, such as plaque.”

PMN310 is in the late preclinical stage of development. Final steps to an IND file include completing the scale up manufacturing of PMN310, followed by start of the clinical trial program.

To raise the funds to proceed, ProMIS is in discussion with “more than five and less than 10” pharmaceutical companies, some at the term sheet stage, Goldstein stressed. “Because we have distinct antibody programs running simultaneously for Alzheimer’s, Parkinson’s, ALS and frontotemporal dementia (FTD), there could potentially be more than one deal in the offing in the next three to twelve months.”

ProMIS has approximately 261 million shares outstanding, and around 25% are owned by insiders. The company plans to uplist to the NASDAQ when conditions become favorable.

Noble Capital Markets opined on October 24, “We believe ProMIS’s currently deflated share price does not reflect the potential of its lead drug PMN310 and unique mechanism of action targeting the true culprit of Alzheimer’s disease, which makes it potentially superior to aducanumab. We are reiterating our Outperform rating and $1.00 target price on the stock.” The stock is currently trading at CA$0.16.

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Disclosure:
1) Patrice Fusillo compiled this article for Streetwise Reports LLC and provides services to Streetwise Reports as an employee. She or members of her household own securities of the following companies mentioned in the article: None. She or members of her household are paid by the following companies mentioned in this article: None.
2) The following companies mentioned in this article are billboard sponsors of Streetwise Reports: None. Click here for important disclosures about sponsor fees.

3) Comments and opinions expressed are those of the specific experts and not of Streetwise Reports or its officers. The information provided above is for informational purposes only and is not a recommendation to buy or sell any security.
4) The article does not constitute investment advice. Each reader is encouraged to consult with his or her individual financial professional and any action a reader takes as a result of information presented here is his or her own responsibility. By opening this page, each reader accepts and agrees to Streetwise Reports’ terms of use and full legal disclaimer. This article is not a solicitation for investment. Streetwise Reports does not render general or specific investment advice and the information on Streetwise Reports should not be considered a recommendation to buy or sell any security. Streetwise Reports does not endorse or recommend the business, products, services or securities of any company mentioned on Streetwise Reports.
5) From time to time, Streetwise Reports LLC and its directors, officers, employees or members of their families, as well as persons interviewed for articles and interviews on the site, may have a long or short position in securities mentioned. Directors, officers, employees or members of their immediate families are prohibited from making purchases and/or sales of those securities in the open market or otherwise from the time of the interview or the decision to write an article until three business days after the publication of the interview or article. The foregoing prohibition does not apply to articles that in substance only restate previously published company releases. As of the date of this article, officers and/or employees of Streetwise Reports LLC (including members of their household) own securities of ProMIS, a company mentioned in this article.
6) This article does not constitute medical advice. Officers, employees and contributors to Streetwise Reports are not licensed medical professionals. Readers should always contact their healthcare professionals for medical advice.

( Companies Mentioned: PMN:TSX; ARFXF:OTCQB,
)

Aquestive Therapeutics Shares Up on Pipeline Update and Raised Full-Year 2019 Guidance

By The Life Science Report

Source: Streetwise Reports   11/06/2019

Aquestive Therapeutics shares traded 20% higher today after the firm reported Q3/19 earnings and raised its FY/19 guidance. The firm states it expects to complete its NDA for Libervant buccal film near the end of this month.

Yesterday afternoon, specialty pharmaceutical company Aquestive Therapeutics Inc. (AQST:NASDAQ), which focuses on the development and commercialization of differentiated products in order to meet unmet patient needs and solve therapeutic problems, reported third quarter financial results for the period ending September 30, 2019. In the release, the company also provided an update on recent business and pipeline developments.

Aquestive’s CEO Keith J. Kendall commented, “The third quarter was an important one in our evolution. We successfully completed the crossover study requested by the U.S. Food and Drug Administration (FDA) for Libervant compared to the reference listed rectal gel. We also completed our proof-of-concept study for epinephrine, AQST-108, for the treatment of allergic reactions including anaphylaxis, and requested a pre-IND meeting with the FDA. In addition, we advanced the commercialization of Sympazan with more than 50% growth of shipments to retailers since the end of the second quarter.”

In the report the company stated that it is “building a portfolio of differentiated medicines that can offer physicians and patients, who have difficulty using currently available treatment options, improved clinical and usability features based on the Company’s PharmFilm technology.”

The firm advised that “Aquestive is expected to complete its rolling NDA submission for Libervant (diazepam) Buccal Film around the end of November 2019, after having filed the CMC portion in September 2019. Libervant has the potential to be the first oral therapy approved by the FDA for the management of seizure clusters in the population of 1.2 million refractory epilepsy patients and the first diazepam based treatment usable by and delivering a consistent predictable dose to virtually all patients to whom it is prescribed.”

The company further noted that “positive data reported from Phase 1 dose escalation proof-of-concept study in healthy subjects for AQST-108, a “first in class” oral sublingual film formulation of epinephrine, demonstrated the ability to deliver systemic epinephrine using Aquestive’s proprietary PharmFilm formulation.”

In addition, the firm pointed out that the “adoption of Sympazan (clobazam) oral film for the treatment of seizures associated with Lennox-Gastaut syndrome (LGS) continues to grow, with shipments to retailers increasing over 50% as compared to the quarter ended in June.”

The company reported that total revenues were $12.4 million in Q3/19, compared to $13.3 million in Q2/18. The firm advised that as expected the year-over-year decrease reflected lower license and royalty revenue in 2019.

Aquestive’s reported a net loss for Q3/19 of $18.4 million, or $0.74 loss per share compared to a net loss of $15.0 million, or $0.64 loss per share in Q3/18. The firm advised that “the year-over-year change in net loss was driven primarily by higher investments in 2019 in the commercialization of Sympazan, and in the development of Libervant and AQST-108.” The company listed that as of Cash and cash equivalents as of September 30, 2019 were $20.9 million.

The company noted that it is raising its full-year 2019 revenue and earnings guidance and updating its financial outlook for 2019. Aquestive indicated that for FY/19, it expects “total revenues of $45-47 million; Non-GAAP gross margins of 67-69%; Non-GAAP adjusted EBITDA loss of $49-50 million; and Cash burn of approximately $60-65 million.”

Aquestive Therapeutics is headquartered in Warren, N.J., and is a specialty pharmaceutical company focused on the development of treatments for diseases related to the central nervous system (CNS). The firm’s CNS product pipeline includes Libervant, a buccal soluble film formulation of diazepam for the treatment of recurrent epileptic seizures, and Sympazan, an oral soluble film formulation of clobazam for the treatment of seizures associated with a rare, intractable form of epilepsy known as Lennox-Gastaut Syndrome. The company also has complex molecule programs used in the treatment of anaphylaxis and neuroendocrine tumors, and the firm also has a pipeline of products under partner programs for treatment of opioid dependence and Parkinson’s disease.

Aquestive Therapeutics has a market capitalization of around $105.9 million with approximately 25 million shares outstanding. AQST shares opened slightly higher today at $4.33 (+$0.10, +2.36%) over yesterday’s $4.23 closing price. The stock has traded today between $4.33 and $5.74/share and is currently trading at $5.10 (+$0.87, +20.57%).

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Disclosure:
1) Stephen Hytha compiled this article for Streetwise Reports LLC and provides services to Streetwise Reports as an independent contractor. He or members of his household own securities of the following companies mentioned in the article: None. He or members of his household are paid by the following companies mentioned in this article: None.
2) The following companies mentioned in this article are billboard sponsors of Streetwise Reports: None. Click here for important disclosures about sponsor fees.
3) Comments and opinions expressed are those of the specific experts and not of Streetwise Reports or its officers. The information provided above is for informational purposes only and is not a recommendation to buy or sell any security.
4) The article does not constitute investment advice. Each reader is encouraged to consult with his or her individual financial professional and any action a reader takes as a result of information presented here is his or her own responsibility. By opening this page, each reader accepts and agrees to Streetwise Reports’ terms of use and full legal disclaimer. This article is not a solicitation for investment. Streetwise Reports does not render general or specific investment advice and the information on Streetwise Reports should not be considered a recommendation to buy or sell any security. Streetwise Reports does not endorse or recommend the business, products, services or securities of any company mentioned on Streetwise Reports.
5) From time to time, Streetwise Reports LLC and its directors, officers, employees or members of their families, as well as persons interviewed for articles and interviews on the site, may have a long or short position in securities mentioned. Directors, officers, employees or members of their immediate families are prohibited from making purchases and/or sales of those securities in the open market or otherwise from the time of the interview or the decision to write an article until three business days after the publication of the interview or article. The foregoing prohibition does not apply to articles that in substance only restate previously published company releases.
6) This article does not constitute medical advice. Officers, employees and contributors to Streetwise Reports are not licensed medical professionals. Readers should always contact their healthcare professionals for medical advice.

( Companies Mentioned: AQST:NASDAQ,
)

Fulgent Genetics Hits 52-Week High After Posting 84% Q3 Revenue Increase

By The Life Science Report

Source: Streetwise Reports   11/05/2019

Fulgent Genetics shares traded more than 40% higher today after the company reported record revenue in Q3/19. The firm noted that it completed a record 20,697 billable tests in Q3/19, up 272% over the same period last year.

After U.S. markets closed yesterday, Temple City, Calif. based provider of comprehensive genetic testing and Next Generation Sequencing (NGS) solutions Fulgent Genetics Inc. (FLGT:NASDAQ), announced third quarter financial results for the period ending September 30, 2019.

In the report the company advised that revenue in Q3/19 increased 84% to a record $10.3 million, compared to $5.6 million in Q3/18. The revenue increase was driven by record billable tests completed, which grew by 272% year-over-year to 20,697.

During Q3/19 the firm indicated that gross margin improved by 8.9 percentage points to 62.45% up from 53.56% in Q3/18, and the cost per test performed improved 60% year-over-year and 15% sequentially.

The company stated that GAAP income for the Q3/19 was $1.5 million, or $0.08 per share, and non-GAAP income was $2.6 million, or $0.14 per share. The firm advised that in Q3/19 Adjusted EBITDA increased 950% to $3.0 million, compared to $281,000 in Q3/18.

The company’s Chairman and CEO Ming Hsieh commented, “We continued to build on our momentum in the third quarter and once again posted very strong results. Revenue and billable test volume reached new record highs in the third quarter, while cost per test continued to improve. Our strong top line results have been driven by the growing traction with our oncology and reproductive health businesses, as well as our sequencing-as-service offering. Our established strategic investments and partnerships are contributing to our ongoing momentum, and we have been successful in meeting the growing demand from our new commercial genomic customers. We believe our superior test capabilities, extensive and flexible test menu, along with our competitive pricing will continue to drive strong growth across our business.”

Paul Kim, CFO at Fulgent Genetics, added, “We once again achieved record results in the third quarter, exceeding our expectations for test volume, revenue and profit. At the same time, we have seen increasing efficiencies across our business which have resulted in ongoing improvements in gross and operating margins. These efficiencies coupled with our increasing scale resulted in meaningful EBITDA, net income and cash flow generation in the quarter. We expect to see continued progress as we close out the year.”

Fulgent Genetics describes itself as a technology company focused on offering comprehensive genetic testing in order to provide physicians with clinically actionable diagnostic information they can use to improve the quality of patient care. The company states that “it has developed a proprietary technology platform which allows it to offer a broad and flexible test menu and continually expand and improve its proprietary genetic reference library, while maintaining accessible pricing, high accuracy and competitive turnaround times. The company believes its test menu offers more genes for testing than its competitors in today’s market.”

Fulgent Genetics began the day with a market cap of about $173.8 million with approximately 18.49 million shares outstanding. FLGT shares opened more than 22% higher today at $11.50 (+$2.10, +22.34%) over yesterday’s closing price of $9.40. The stock has traded today between $10.90 and $13.59/share and reached a 52-week intraday high price in morning trading. At present, the stock is trading at $13.25 (+3.85, +40.96%).

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Disclosure:
1) Stephen Hytha compiled this article for Streetwise Reports LLC and provides services to Streetwise Reports as an independent contractor. He or members of his household own securities of the following companies mentioned in the article: None. He or members of his household are paid by the following companies mentioned in this article: None.
2) The following companies mentioned in this article are billboard sponsors of Streetwise Reports: None. Click here for important disclosures about sponsor fees.
3) Comments and opinions expressed are those of the specific experts and not of Streetwise Reports or its officers. The information provided above is for informational purposes only and is not a recommendation to buy or sell any security.
4) The article does not constitute investment advice. Each reader is encouraged to consult with his or her individual financial professional and any action a reader takes as a result of information presented here is his or her own responsibility. By opening this page, each reader accepts and agrees to Streetwise Reports’ terms of use and full legal disclaimer. This article is not a solicitation for investment. Streetwise Reports does not render general or specific investment advice and the information on Streetwise Reports should not be considered a recommendation to buy or sell any security. Streetwise Reports does not endorse or recommend the business, products, services or securities of any company mentioned on Streetwise Reports.
5) From time to time, Streetwise Reports LLC and its directors, officers, employees or members of their families, as well as persons interviewed for articles and interviews on the site, may have a long or short position in securities mentioned. Directors, officers, employees or members of their immediate families are prohibited from making purchases and/or sales of those securities in the open market or otherwise from the time of the interview or the decision to write an article until three business days after the publication of the interview or article. The foregoing prohibition does not apply to articles that in substance only restate previously published company releases.
6) This article does not constitute medical advice. Officers, employees and contributors to Streetwise Reports are not licensed medical professionals. Readers should always contact their healthcare professionals for medical advice.

( Companies Mentioned: FLGT:NASDAQ,
)

RedHill Biopharma Shares Rise 10% After Receiving FDA Approval for H. Pylori Treatment Drug Talicia

By The Life Science Report

Source: Streetwise Reports   11/04/2019

Shares of RedHill Biopharma Ltd. traded more than 10% higher today after the firm announced that the FDA has approved its Talicia delayed-release capsules for the treatment of H. pylori infection in adults. The firm plans to commence distribution by its U.S. sales force in Q1/20.

This morning Tel Aviv-based specialty biopharmaceutical company RedHill Biopharma Ltd. (RDHL:NASDAQ), which is focused on the development and commercialization of proprietary drugs for the treatment of gastrointestinal diseases, announced that “the U.S. Food and Drug Administration (FDA) has approved Talicia® (omeprazole magnesium, amoxicillin and rifabutin) delayed-release capsules 10 mg/250 mg/12.5 mg for the treatment of Helicobacter pylori (H. pylori) infection in adults.” The company stated its sales force expects to launch Talicia in the U.S. in Q1/20.

The firm advised in the release “Talicia is the only rifabutin-based therapy approved for the treatment of H. pylori infection and is designed to address the high resistance of H. pylori bacteria to current clarithromycin-based standard-of-care therapies. It is estimated that H. pylori resistance to clarithromycin more than doubled between 2009-2013.”

RedHill Biopharma’s CEO Dror Ben-Asher commented, “The FDA’s approval of Talicia demonstrates our unwavering dedication to patients suffering from gastrointestinal diseases…We are working to expand our sales force to approximately 140 representatives who will promote Talicia, Aemcolo and other gastrointestinal-focused products in our basket.”

Lead investigator of the Talicia Phase 3 studies, David Y. Graham, MD, MACG, professor of medicine, molecular virology and microbiology at Baylor College of Medicine in Houston, stated, “Talicia offers patients a much-needed new treatment option for H. pylori with an excellent safety and efficacy profile that is not compromised by clarithromycin or metronidazole resistance. The clinical studies for Talicia demonstrated high efficacy in eradication of H. pylori. Studies with Talicia found zero resistance to rifabutin and showed 17% resistance to clarithromycin, a current standard-of-care macrolide antibiotic, consistent with current data showing that clarithromycin-containing therapies fail in approximately 25-40% of cases.”

In addition, Colin W. Howden, MD, AGAF, FACG, Hyman Professor of Medicine & chief of the Division of Gastroenterology at the University of Tennessee Health Science Center, added, “H. pylori is a major cause of peptic ulcer and gastritis. It is also carcinogenic and is the leading cause of gastric cancer. Treatment of H. pylori infection has become increasingly difficult due to growing bacterial resistance and the lack of advances in treatment options over the past decade. Talicia offers a new effective treatment option to overcome bacterial resistance and provide optimal efficacy and I believe it could become a recommended first-line standard-of-care treatment for H. pylori infection.”

The company advises in the report that H. pylori bacterial infection is classified as a Group I carcinogen by the International Agency for Research on Cancer that affects over 50% of the population worldwide and approximately 35%, or over 100 million people, in the U.S., with an estimated 2.5 million patients treated annually in the U.S.

The firm further explains in the release that “Talicia is a three-drug combination of omeprazole, a proton pump inhibitor, amoxicillin, a penicillin-class antibacterial, and rifabutin, a rifamycin antibacterial­­, indicated for the treatment of Helicobacter pylori infection in adults.”

RedHill Biopharma is a specialty biopharmaceutical company focused on the development and commercialization of late clinical-stage, proprietary, orally administered, small molecule drugs for the treatment of gastrointestinal and inflammatory diseases and cancer. The company commercializes and promotes several gastrointestinal products in the U.S., including Donnatal, EnteraGam and Mytesi, and plans to also launch Aemcolo and Talicia in the U.S.

RDHL ADR shares opened higher today at $8.43 (+$1.51, +21.82%) over Friday’s $6.92 closing price. The stock has traded today between $7.28 to $8.55 per share and is currently trading at $7.65 (+0.83, +11.99%).

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Disclosure:
1) Stephen Hytha compiled this article for Streetwise Reports LLC and provides services to Streetwise Reports as an independent contractor. He or members of his household own securities of the following companies mentioned in the article: None. He or members of his household are paid by the following companies mentioned in this article: None.
2) The following companies mentioned in this article are billboard sponsors of Streetwise Reports: None. Click here for important disclosures about sponsor fees.
3) Comments and opinions expressed are those of the specific experts and not of Streetwise Reports or its officers. The information provided above is for informational purposes only and is not a recommendation to buy or sell any security.
4) The article does not constitute investment advice. Each reader is encouraged to consult with his or her individual financial professional and any action a reader takes as a result of information presented here is his or her own responsibility. By opening this page, each reader accepts and agrees to Streetwise Reports’ terms of use and full legal disclaimer. This article is not a solicitation for investment. Streetwise Reports does not render general or specific investment advice and the information on Streetwise Reports should not be considered a recommendation to buy or sell any security. Streetwise Reports does not endorse or recommend the business, products, services or securities of any company mentioned on Streetwise Reports.
5) From time to time, Streetwise Reports LLC and its directors, officers, employees or members of their families, as well as persons interviewed for articles and interviews on the site, may have a long or short position in securities mentioned. Directors, officers, employees or members of their immediate families are prohibited from making purchases and/or sales of those securities in the open market or otherwise from the time of the interview or the decision to write an article until three business days after the publication of the interview or article. The foregoing prohibition does not apply to articles that in substance only restate previously published company releases.
6) This article does not constitute medical advice. Officers, employees and contributors to Streetwise Reports are not licensed medical professionals. Readers should always contact their healthcare professionals for medical advice.

( Companies Mentioned: RDHL:NASDAQ,
)

BeiGene Shares Up 35% on Amgen’s $2.7 Billion Investment and China Partnership

By The Life Science Report

Source: Streetwise Reports   11/01/2019

Shares of BeiGene Ltd. traded 35% higher today to a new a 52-week intraday high after announcing a commercialization agreement for of XGEVA (denosumab), KYPROLIS (carfilzomib), and BLINCYTO (blinatumomab) with Amgen Inc. in China. As part of the partnership, Amgen will invest $2.7 billion in BeiGene for 20.5% equity ownership.

Late yesterday afternoon Chinese biotechnology firm BeiGene Ltd. (BGNE:NASDAQ; 06160:HKEX) and Amgen Inc. (AMGN:NASDAQ) announced a “global strategic oncology collaboration for the commercialization and development in China of Amgen’s XGEVA (denosumab), KYPROLIS (carfilzomib), and BLINCYTO (blinatumomab), and the joint global development of 20 oncology assets in Amgen’s pipeline, with BeiGene responsible for development and commercialization in China. In connection with the collaboration, Amgen will purchase a 20.5% stake in BeiGene for approximately $2.7 billion in cash at $174.85 per American Depositary Share (ADS).”

The price represents a 36% premium to BeiGene’s 30-day volume-weighted average share price as of October 30, 2019. Amgen will receive one seat on BeiGene’s Board of Directors as part of the terms of the agreement.

The report advised that the transactions have been approved by the boards of directors of both companies and are expected to close in Q1/20, subject to BeiGene’s shareholder majority approval and Hong Kong Stock Exchange and regulatory requirements and other customary closing conditions. BeiGene claims it has already received commitments from shareholders holding approximately 40% of its outstanding shares to vote in favor of the transactions.

John V. Oyler, Co-Founder, CEO, and Chairman of BeiGene commented, “Through this collaboration, Amgen, a true biotech pioneer and leader in our industry, has recognized the transformative potential of BeiGene’s unique clinical development capabilities to accelerate global drug development. We are thrilled to join forces with Amgen to realize the development and commercialization of this broad oncology pipeline with the aim of benefitting patients around the world…In addition, this alliance expands the portfolio available to our market-leading China commercial team, led by Dr. Xiaobin Wu, with the potential to bring as many as eight internally discovered and in-licensed innovative treatments to cancer patients by the end of 2020.”

Amgen’s Chairman and CEO Robert A. Bradway added, “This strategic collaboration with BeiGene will enable Amgen to serve significantly more patients by expanding our reach in the world’s most populous country. We’ve chosen an innovative strategic collaborator that can offer commercial and clinical reach with global quality standards…Cancer is a leading cause of death in China and will only become a more pressing public health issue as the Chinese population ages. We look forward to working with BeiGene to make a meaningful difference in the lives of millions of cancer patients in China and around the world.”

The report outlined that under the agreement, BeiGene will commercialize XGEVA, KYPROLIS and BLINCYTO in China for five or seven years, during which time the parties will equally share profits and losses. Following the commercialization period, BeiGene will have the right to retain one product and will be entitled to receive royalties on sales in China for an additional five years on the products not retained.

The release further indicated that BeiGene has agreed to jointly develop 20 Amgen oncology pipeline assets globally, which include targeted small-molecule agents such as AMG 510, a first-in-class investigational KRAS G12C inhibitor, as well as BiTE (Bispecific T cell Engager) antibodies, for solid and hematologic malignancies. The agreement further stipulates that for each pipeline asset that is approved in China, BeiGene will receive commercial rights for seven years from approval, during which time the parties will share equally in profits and losses.

BeiGene was established in Beijing, China in 2010. The company employs 3,000 people in China, the U.S., Australia and Europe and also has corporate offices in the Cayman Islands. The firm describes its business as a “global, commercial-stage, research-based biotechnology company focused on molecularly-targeted and immuno-oncology cancer therapeutics that is advancing a pipeline consisting of novel oral small molecules and monoclonal antibodies for cancer.” The Company’s main products include Zanubrutinib (BGB-3111), Tislelizumab (BGB-A317) and Pamiparib (BGB-290). The firm also markets several pharmaceutical products in China licensed from Celgene Corp. including ABRAXANE, REVLIMID and VIDAZA.

Amgen is headquartered in Thousand Oaks, Calif. and is one of the world’s largest biotechnology firms with a market cap of around $126.6 billion. The company states that it is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. The firm claims that it uses tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology. Some of the firms largest patented medicines include Enbrel, Prolia, XGEVA, Neulasta and Aranesp.

BeiGene started the day with a market capitalization of approximately $8.3 billion with about 60.35 million ADR shares outstanding. The stock has a 52-week price range of $108.00-187.56. BGNE shares opened much higher today at $170.00 (+$31.66, +22.89%) over yesterday’s $138.34 closing price. The stock set a new 52-week high intraday price in early morning trading and has traded today between $170.00 to $187.56/share. At present, BGNE’s shares are trading at $187.27 (+$48.93, +35.37%).

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Disclosure:
1) Stephen Hytha compiled this article for Streetwise Reports LLC and provides services to Streetwise Reports as an independent contractor. He or members of his household own securities of the following companies mentioned in the article: None. He or members of his household are paid by the following companies mentioned in this article: None.
2) The following companies mentioned in this article are billboard sponsors of Streetwise Reports: None. Click here for important disclosures about sponsor fees.
3) Comments and opinions expressed are those of the specific experts and not of Streetwise Reports or its officers. The information provided above is for informational purposes only and is not a recommendation to buy or sell any security.
4) The article does not constitute investment advice. Each reader is encouraged to consult with his or her individual financial professional and any action a reader takes as a result of information presented here is his or her own responsibility. By opening this page, each reader accepts and agrees to Streetwise Reports’ terms of use and full legal disclaimer. This article is not a solicitation for investment. Streetwise Reports does not render general or specific investment advice and the information on Streetwise Reports should not be considered a recommendation to buy or sell any security. Streetwise Reports does not endorse or recommend the business, products, services or securities of any company mentioned on Streetwise Reports.
5) From time to time, Streetwise Reports LLC and its directors, officers, employees or members of their families, as well as persons interviewed for articles and interviews on the site, may have a long or short position in securities mentioned. Directors, officers, employees or members of their immediate families are prohibited from making purchases and/or sales of those securities in the open market or otherwise from the time of the interview or the decision to write an article until three business days after the publication of the interview or article. The foregoing prohibition does not apply to articles that in substance only restate previously published company releases.
6) This article does not constitute medical advice. Officers, employees and contributors to Streetwise Reports are not licensed medical professionals. Readers should always contact their healthcare professionals for medical advice.

( Companies Mentioned:
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Navidea Shares Jump 60% on Phase 2b Rheumatoid Arthritis Trial Results

By The Life Science Report

Source: Streetwise Reports   10/29/2019

Shares of Navidea Biopharmaceuticals traded 60% higher today on extremely high relative volume after the firm released data from its Phase 2b Rheumatoid Arthritis Tc 99m Tilmanocept Planar Imaging study.

Developer of precision immunodiagnostic agents and immunotherapeutics Navidea Biopharmaceuticals Inc. (NAVB:AMEX), today announced positive results from the company’s first interim analysis of its ongoing NAV3-31 Phase 2B study. The company advised in the report that the “Analysis demonstrates that these interim data support Navidea’s hypotheses that Tc 99m Tilmanocept imaging can provide robust, quantitative imaging in healthy controls and in patients with active rheumatoid arthritis (RA) and that this imaging is stable, reproducible, and can define joints with and without RA-involved inflammation.”

The firm’s NAV3-31 Phase 2B trial which included 30 patient subjects is titled “Evaluation of the Precision and Sensitivity of Tilmanocept Uptake Value (TUV) on Tc 99m Tilmanocept Planar Imaging”. The study included three arms that included healthy subjects, patients with active, moderate-to-severe rheumatoid arthritis (RA) who are on stable therapy, and a pilot arm of the upcoming Phase 3 trial of Tc 99m tilmanocept as an early indicator of efficacy of anti-TNF alpha treatment in RA patients. The company advised that the whole body and hand/wrist image sets acquired on the same day at multiple time points demonstrated quantitative repeatability and stability of signal, noting that images from patients with active RA show the same localization patterns on images taken a week apart.

The company advised that the data demonstrated quantitative repeatability and stability of signal and it is now continuing to enroll subjects as planned to complete the Phase 2b study and preparing for the upcoming Phase 3 trial.

The company’s Chief Medical Officer Michael Rosol commented, “These results support our hypotheses for Arms 1 and 2 of this trial and are key for the path forward to the Phase 3. The demonstration that Tc 99m tilmanocept imaging is stable and has low variability enables us to proceed with confidence in testing our hypothesis that this can be an early indicator of therapeutic efficacy in these patients…With these exciting results in hand, we continue to enroll subjects as planned to complete this Phase 2B and prepare for the upcoming Phase 3.”

Navidea’s CEO Jed Latkin added, “I am very pleased that the results of this interim analysis are so encouraging. It reaffirms that we are heading in the right direction with our clinical trial pipeline in rheumatoid arthritis. I look forward to continuing this momentum into the Phase 3.”

The company explains in the report that “RA is a chronic disease affecting over 1.3 million Americans and as much as 1% of the worldwide population. If the product is successfully developed, Navidea would expect to play a major role in the management of RA patients worldwide.”

Navidea Biopharmaceuticals is based in Dublin, Ohio and has more than 50 employees worldwide. The firm states that it is a “biopharmaceutical company focused on the development of precision immunodiagnostic agents and immunotherapeutics, and is developing multiple precision-targeted products based on its Manocept platform to enhance patient care by identifying the sites and pathways of disease and enable better diagnostic accuracy, clinical decision-making, and targeted treatment. Navidea’s Manocept platform is predicated on the ability to specifically target the CD206 mannose receptor expressed on activated macrophages.”

Navidea began the day with a market capitalization of about $14 million with 18.06 million shares outstanding. The stock has a 52-week price range of $0.49-5.32. NAVB shares opened much higher today at $1.24 (+$0.4625, +59.49%) over yesterday’s $0.7775 closing price. The stock has traded more than 21 million shares today between $1.09-1.39/share and is currently trading at $1.26 (+$0.4825, +62.06%).

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Disclosure:
1) Stephen Hytha compiled this article for Streetwise Reports LLC and provides services to Streetwise Reports as an independent contractor. He or members of his household own securities of the following companies mentioned in the article: None. He or members of his household are paid by the following companies mentioned in this article: None.
2) The following companies mentioned in this article are billboard sponsors of Streetwise Reports: None. Click here for important disclosures about sponsor fees.
3) Comments and opinions expressed are those of the specific experts and not of Streetwise Reports or its officers. The information provided above is for informational purposes only and is not a recommendation to buy or sell any security.
4) The article does not constitute investment advice. Each reader is encouraged to consult with his or her individual financial professional and any action a reader takes as a result of information presented here is his or her own responsibility. By opening this page, each reader accepts and agrees to Streetwise Reports’ terms of use and full legal disclaimer. This article is not a solicitation for investment. Streetwise Reports does not render general or specific investment advice and the information on Streetwise Reports should not be considered a recommendation to buy or sell any security. Streetwise Reports does not endorse or recommend the business, products, services or securities of any company mentioned on Streetwise Reports.
5) From time to time, Streetwise Reports LLC and its directors, officers, employees or members of their families, as well as persons interviewed for articles and interviews on the site, may have a long or short position in securities mentioned. Directors, officers, employees or members of their immediate families are prohibited from making purchases and/or sales of those securities in the open market or otherwise from the time of the interview or the decision to write an article until three business days after the publication of the interview or article. The foregoing prohibition does not apply to articles that in substance only restate previously published company releases.
6) This article does not constitute medical advice. Officers, employees and contributors to Streetwise Reports are not licensed medical professionals. Readers should always contact their healthcare professionals for medical advice.

( Companies Mentioned: NAVB:NYSE,
)

New Data Could Drive Use of Pancreatic Cancer Early Detection Test

By The Life Science Report

Source: Streetwise Reports   10/29/2019

The recent results and their implications are provided in an H.C. Wainwright & Co. report.

In an Oct. 25 research note, H.C. Wainwright & Co. analyst Yi Chen reported that newly compiled data support the clinical utility of Interpace Diagnostics Group Inc.’s (IDXG:NASDAQ) PancraGEN and could help drive market adoption of it.

The diagnostic test is used for early detection of cancer in indeterminate pancreatic cysts and pancreatobiliary solid lesions.

Chen reviewed and commented on the new data. They are from a retrospective records review of 2,167 patients who had two or more endoscopic ultrasound-guided fine needle aspirations (EUS-FNAs) of their pancreatic cyst and were tested with PancraGEN between April 2002 and March 2019. Interpace presented these study results recently at the annual meeting of the American College of Gastroenterology.

“The data demonstrate that examining molecular progression and regression of pancreatic cysts over time using PancraGEN can lead to a better understanding of their natural history, which can help guide the frequency of surveillance,” Chen noted.

Specifically, findings showed that 86% of patients initially had a low risk PancraGEN result. Among those, at follow-up EUS-FNA, PancraGEN showed 92% to still be low risk and 8% to now be moderate or high risk. About 99% of diagnostic progression was only to moderate risk.

Of the 14% who initially had a moderate or high risk PancraGEN result, 21% remained moderate or high risk at follow-up whereas 79% regressed to low risk. More than 99% of the cases of diagnostic regression was from moderate risk.

Chen reported, too, that last month, Interpace contracted with three independent Blue Cross Blue Shield (BCBS) plans, equating to 5 million covered lives across Alabama, Arkansas and Arizona. This development means these insurers’ subscribers now have in-network access to the biotech’s ThyGeNEXT and ThyraMIR tests, which are used to evaluate indeterminate thyroid biopsies.

These and previously announced similar contracts boost the positioning of Interpace’s thyroid diagnostics in the market and ensure reimbursement for their use, Chen pointed out. “We believe the company’s continuous expansion in contracts with commercial payors should increase market adoption and test volume growth in the coming quarters,” he added.

H.C. Wainwright has a Buy rating and a $2 per share target price on Interpace, whose stock is now trading at around $0.78 per share.

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Disclosure:
1) Doresa Banning compiled this article for Streetwise Reports LLC and provides services to Streetwise Reports as an independent contractor. She or members of her household own securities of the following companies mentioned in the article: None. She or members of her household are paid by the following None. Click here for important disclosures about sponsor fees.
3) Comments and opinions expressed are those of the specific experts and not of Streetwise Reports or its officers. The information provided above is for informational purposes only and is not a recommendation to buy or sell any security.
4) The article does not constitute investment advice. Each reader is encouraged to consult with his or her individual financial professional and any action a reader takes as a result of information presented here is his or her own responsibility. By opening this page, each reader accepts and agrees to Streetwise Reports’ terms of use and full legal disclaimer. This article is not a solicitation for investment. Streetwise Reports does not render general or specific investment advice and the information on Streetwise Reports should not be considered a recommendation to buy or sell any security. Streetwise Reports does not endorse or recommend the business, products, services or securities of any company mentioned on Streetwise Reports.
5) From time to time, Streetwise Reports LLC and its directors, officers, employees or members of their families, as well as persons interviewed for articles and interviews on the site, may have a long or short position in securities mentioned. Directors, officers, employees or members of their immediate families are prohibited from making purchases and/or sales of those securities in the open market or otherwise from the time of the interview or the decision to write an article until three business days after the publication of the interview or article. The foregoing prohibition does not apply to articles that in substance only restate previously published company releases.

6) This article does not constitute medical advice. Officers, employees and contributors to Streetwise Reports are not licensed medical professionals. Readers should always contact their healthcare professionals for medical advice.

Disclosures from H.C. Wainwright & Co., Interpace Diagnostics Group Inc., Company Update, October 25, 2019

Investment Banking Services include, but are not limited to, acting as a manager/co-manager in the underwriting or placement of securities, acting as financial advisor, and/or providing corporate finance or capital markets-related services to a company or one of its affiliates or subsidiaries within the past 12 months.

I, Yi Chen, Ph.D. CFA and Raghuram Selvaraju, Ph.D., certify that 1) all of the views expressed in this report accurately reflect my personal views about any and all subject securities or issuers discussed; and 2) no part of my compensation was, is, or will be directly or indirectly related to the specific recommendation or views expressed in this research report; and 3) neither myself nor any members of my household is an officer, director or advisory board member of these companies.

None of the research analysts or the research analyst’s household has a financial interest in the securities of Interpace
Diagnostics Group, Inc. (including, without limitation, any option, right, warrant, future, long or short position).

As of September 30, 2019 neither the Firm nor its affiliates beneficially own 1% or more of any class of common equity securities of Co-Diagnostics, Inc.

Neither the research analyst nor the Firm has any material conflict of interest in of which the research analyst knows or has reason to know at the time of publication of this research report.

The research analyst principally responsible for preparation of the report does not receive compensation that is based upon any specific investment banking services or transaction but is compensated based on factors including total revenue and profitability of the Firm, a substantial portion of which is derived from investment banking services.

The firm or its affiliates received compensation from Interpace Diagnostics Group, Inc. for non-investment banking services
in the previous 12 months.

The Firm or its affiliates did receive compensation from Interpace Diagnostics Group, Inc. for investment banking services
within twelve months before, and will seek compensation from the companies mentioned in this report for investment banking
services within three months following publication of the research report.

H.C. Wainwright & Co., LLC managed or co-managed a public offering of securities for Interpace Diagnostics Group, Inc. during the past 12 months.

The Firm does not make a market in Interpace Diagnostics Group, Inc. as of the date of this research report.

H.C. Wainwright & Co., LLC and its affiliates, officers, directors, and employees, excluding its analysts, will from time to time have long or short positions in, act as principal in, and buy or sell, the securities or derivatives (including options and warrants) thereof of covered companies referred to in this research report.

( Companies Mentioned: IDXG:NASDAQ,
)

IVERIC bio Shares Double After Announcing Phase 2b AMD Topline Data

By The Life Science Report

Source: Streetwise Reports   10/28/2019

Shares of IVERIC bio opened nearly 100% higher today after reporting that it successfully met its primary endpoint in its Phase 2b age-related macular degeneration study for Zimura.

Early this morning, gene therapy focused biopharmaceutical company IVERIC bio Inc. (ISEE:NASDAQ), which focuses on the discovery and development of novel treatment options for orphan inherited retinal diseases, announced initial topline data confirming that “Zimura (avacincaptad pegol), the firm’s complement factor C5 inhibitor, met its prespecified primary endpoint in reducing the rate of geographic atrophy (GA) growth in patients with dry age-related macular degeneration (AMD) in a randomized, controlled Phase 2b clinical trial.”

The study enrolled 286 patients in order to assess the safety and efficacy of various doses of Zimura in patients with GA secondary to dry AMD. The company reported a reduction in the mean rate of GA growth over 12 months and noted that the overall data suggest a dose response relationship across all treatment groups. The company further advised that Zimura was generally well tolerated after 12 months of administration with no Zimura-related inflammation, nor were there any ocular serious adverse events and no cases of endophthalmitis reported in the study eye in this ongoing clinical trial.

Marco A. Zarbin, M.D., Ph.D., FACS, Professor and Chair, Institute of Ophthalmology and Visual Science, Rutgers-New Jersey Medical School, Newark, NJ stated, “IVERIC bio’s unwavering commitment to science has resulted in compelling Phase 2b data in GA secondary to dry AMD, a major public health problem that has devastating effects on our patients…As a retina specialist, Zimura’s impressive efficacy results and favorable safety profile observed to date in this trial indicate its potential as a future treatment for this growing patient population, which represents an urgent unmet medical need.”

IVERIC bio’s CEO and President Glenn P. Sblendorio commented, “This is a major milestone for IVERIC bio and a potentially significant advancement for patients with GA secondary to dry AMD who currently have no treatment options…Based on these data, we intend to explore all options for the future development of Zimura, including the possibility for collaboration opportunities, licensing and / or potentially further internal development.”

IVERIC bio’s Chief Medical Officer Kourous A. Rezaei, M.D., added, “Zimura’s efficacy data in this clinical trial supports the potential role of C5 inhibition in GA secondary to dry AMD…C5 activation may lead to retinal cell degeneration and ultimately cell death. We believe that the combination of statistically significant efficacy results for both Zimura 2 mg and 4 mg groups compared to their respective sham controls, with the lack of Zimura induced inflammation, zero rate of endophthalmitis and observed CNV conversion rate as compared to sham in this trial may potentially differentiate Zimura. We are encouraged by these exciting results, which we look forward to presenting in more detail at upcoming medical meetings in the near future.”

The company explains that “dry AMD is where thinning of the retinal pigment epithelial cells in the central portion of the retina, or the macula, develops, along with other age-related changes to the adjacent retinal and choroidal tissue layers…it is a significant cause of moderate and severe loss of central vision in older adults, affecting both eyes in the majority of patients…Geographic atrophy, the advanced stage of dry AMD, is a disease characterized by degeneration of retinal tissue leading to further loss of vision.” IVERVIC points out that presently there are no U.S. FDA or European Medicines Agency approved therapies to treat dry AMD.

IVERIC bio is headquartered in New York, NY and is a gene therapy focused biopharmaceutical company focused on the discovery and development of novel treatment options for orphan inherited retinal diseases with significant unmet medical needs. The firm proclaims that “Vision is Our Mission”.

IVERIC started off today with a market capitalization of about $38.7 million with approximately 41.56 million shares outstanding. ISEE shares opened nearly 100% higher today on the news at $1.85 (+$0.92, +98.92%) compared to Friday’s $0.93 closing price. The stock typically trades 75,000 to 150,000 shares per day, but today has already traded more than 22 million shares between $1.58 to $1.99 per share and is presently trading at $1.87 (+$0.94, +101.08%).

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Disclosure:
1) Stephen Hytha compiled this article for Streetwise Reports LLC and provides services to Streetwise Reports as an independent contractor. He or members of his household own securities of the following companies mentioned in the article: None. He or members of his household are paid by the following companies mentioned in this article: None.
2) The following companies mentioned in this article are billboard sponsors of Streetwise Reports: None. Click here for important disclosures about sponsor fees.
3) Comments and opinions expressed are those of the specific experts and not of Streetwise Reports or its officers. The information provided above is for informational purposes only and is not a recommendation to buy or sell any security.
4) The article does not constitute investment advice. Each reader is encouraged to consult with his or her individual financial professional and any action a reader takes as a result of information presented here is his or her own responsibility. By opening this page, each reader accepts and agrees to Streetwise Reports’ terms of use and full legal disclaimer. This article is not a solicitation for investment. Streetwise Reports does not render general or specific investment advice and the information on Streetwise Reports should not be considered a recommendation to buy or sell any security. Streetwise Reports does not endorse or recommend the business, products, services or securities of any company mentioned on Streetwise Reports.
5) From time to time, Streetwise Reports LLC and its directors, officers, employees or members of their families, as well as persons interviewed for articles and interviews on the site, may have a long or short position in securities mentioned. Directors, officers, employees or members of their immediate families are prohibited from making purchases and/or sales of those securities in the open market or otherwise from the time of the interview or the decision to write an article until three business days after the publication of the interview or article. The foregoing prohibition does not apply to articles that in substance only restate previously published company releases.
6) This article does not constitute medical advice. Officers, employees and contributors to Streetwise Reports are not licensed medical professionals. Readers should always contact their healthcare professionals for medical advice.

( Companies Mentioned: ISEE,
)