Archive for Healthcare

Heathcare and Biotech Updates

NCI Chooses Veterinary Biopharma as Select Manufacturing Contractor

By The Life Science Report

Source: Streetwise Reports   09/18/2019

The contract’s meaning, terms and benefits and the California firm’s near-term catalysts are discussed in an H.C. Wainwright & Co. report.

In a Sept. 12 research note, H.C. Wainwright & Co. analyst Swayampakula Ramakanth reported that Kindred Biosciences Inc. (KIN:NASDAQ) was chosen by the National Cancer Institute (NCI) as one of three Current Good Manufacturing Practice (cGMP) contractors for the PREVENT Cancer Preclinical Drug Development Program.

This means that as a select contractor for this NCI-supported program, Kindred, which modifies human therapies for cats, dogs and horses, may “provide manufacturing, formulation and analytical services needed for the preclinical development of innovative cancer prevention interventions and biomarkers” developed through PREVENT, explained Ramakanth. The maximum contract amount is $49.95 million; the term is four years. Also as a manufacturing pool member, Kindred may bid for future contracts.

Ramakanth highlighted that the benefits of this new development are twofold. One, having been chosen by “a leading institution for the development of novel therapies against cancer” validates Kindred’s expertise in cGMP manufacturing and project management of biologicals, which it executes on at its Burlingame, Calif., operation. Two, the biopharma could receive nondilutive cash flow from the contract.

Looking to H2/19 for its pipeline therapies, noted Ramakanth, Kindred intends to meet with the European Medicines Agency to discuss the regulatory path for Mirataz (mirtazapine transdermal ointment) in the European Union. It expects a decision in Q4/19 from the U.S. Food and Drug Administration on intravenous Zimeta (dipyrone).

Also, in H2/19, the biopharma expects to announce the results from the pilot effectiveness studies of two clinical molecules: the anti-L-4/IL-13 SINK molecule for atopic dermatitis in dogs and the anti-TNF antibody for inflammatory bowel disease in dogs.

H.C. Wainwright has a Buy rating and a $17.99 per share target price on Kindred Biosciences, whose stock is currently trading at around $7.09 per share.

Sign up for our FREE newsletter at: www.streetwisereports.com/get-news

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 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.

Disclosures from H.C. Wainwright & Co., Kindred Biosciences Inc., First Take, September 12, 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, Swayampakula Ramakanth, Ph.D., Sean Lee, Sean Kang and Arthur He, 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 Kindred
Biosciences, Inc. (including, without limitation, any option, right, warrant, future, long or short position).

As of August 31, 2019 neither the Firm nor its affiliates beneficially own 1% or more of any class of common equity securities of Kindred Biosciences, 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 Kindred Biosciences, Inc. for non-investment banking services in
the previous 12 months.

The Firm or its affiliates did receive compensation from Kindred Biosciences, 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.

The Firm does not make a market in Kindred Biosciences, Inc. as of the date of this research report.

( Companies Mentioned: KIN:NASDAQ,
)

Alder BioPharmaceuticals Shares Surge 80% on Acquisition News

By The Life Science Report

Source: Streetwise Reports   09/16/2019

Shares of migraine treatment research firm Alder BioPharmaceuticals opened 84% higher today after the company announced that it has agreed to be acquired by H. Lundbeck for $1.95 billion.

Early this morning, clinical-stage biopharmaceutical company Alder BioPharmaceuticals Inc. (ALDR:NASDAQ), which is developing migraine treatments, and Danish global pharmaceutical company H. Lundbeck A/S (HLUKF:OTC Pink sheets), which specializes in brain diseases, announced a definitive agreement for Alder to be acquired by Lundbeck.

Under the terms of the agreement, Lundbeck will commence a tender offer for all outstanding shares of Alder, whereby Alder stockholders will be offered an upfront payment for $18.00 per share in cash, along with one non-tradeable Contingent Value Right (CVR) of $2.00 per share. The upfront cash consideration represents a 79% premium to Alder’s shareholders based on the closing price on September 13, 2019, and an approximately 3% discount based on the 52-week high share price.

The non-tradeable CVR will be paid upon the approval by the European Commission of a Marketing Authorization Application in the European Union, through the centralized procedure. The terms of the CVR payment reflect the parties’ agreement over the sharing of potential economic upside benefits from such approval. There is no assurance such approval will occur or that any contingent payment will be made.

Alder’s Board of Directors unanimously approved the transaction, and the company will file a recommendation to shareholders recommending they tender their shares to Lundbeck. The transaction is expected to close in Q4/19 subject to customary closing conditions including the tender of more than 50% of all shares of Alder outstanding at the expiration of the offer and receipt of required regulatory clearances including a Hart-Scott-Rodino review in the U.S.

Alder is currently developing eptinezumab for the preventive treatment of migraine in adults. Migraine is a disabling neurological disease characterized by recurrent episodes of moderate to severe headache accompanied by nausea, vomiting and sensitivities to light and sound. More than 134 million people are estimated to experience migraine annually and it is estimated to be the second leading cause of years lived with disability among all diseases causing disability.

Eptinezumab is an investigational monoclonal antibody (mAb) that is administered as a quarterly 30-minute IV infusion. Eptinezumab was designed for immediate and complete bioavailability with high specificity and strong binding for suppression of calcitonin gene-related peptide (CGRP), a neuropeptide believed to play a key role in mediating and initiating migraines. If approved by the U.S. Food and Drug Administration (FDA), it will be the first IV CGRP therapy for migraine prevention. Alder submitted a Biologics License Application (BLA) to the FDA for eptinezumab in February 2019 and the FDA has set a Prescription Drug User Fee Act (PDUFA) action date of February 21, 2020. Alder is also presently developing ALD1910, a mAb designed to inhibit pituitary adenylate cyclase-activating polypeptide (PACAP) for migraine prevention.

Lundbeck asserts that through this acquisition it will continue to expand the range of brain diseases for which the company brings its leading and best-in-class therapies to patients, and that by acquiring Alder, it will further enhance its capabilities to deliver future biological innovations in brain diseases. Eptinezumab, together with ALD1910, could help establish Lundbeck as an emerging leader in migraine and other pain syndromes.

Adler’s President and CEO Bob Azelby commented, “As a global leader in neuroscience research with products registered in more than 100 countries and a strong network of neurology specialists, Lundbeck is the ideal partner to advance Alder’s mission of changing the treatment paradigm for migraine prevention. We believe this positions eptinezumab for a successful launch both in and outside of the U.S…Importantly, today’s news provides Alder shareholders with significant and immediate cash value, as well as the ability to benefit further once eptinezumab is approved by the EMA. Looking ahead, we expect Lundbeck will leverage Alder’s expertise in antibody development to explore additional indications for eptinezumab and continue the development of ALD1910.”

Alder BioPharmaceuticals is headquartered in Bothell, Wash., and describes its business as a clinical-stage biopharmaceutical company focused on transforming migraine treatment through the discovery, development and commercialization of novel therapeutic antibodies.

H. Lundbeck is a global pharmaceutical company specialized in brain diseases based in Valby, Denmark. The company has operated for more than 70 years, and states that it has been at the forefront of neuroscience research. The firm employs approximately 5,500 employees in more than 50 countries. The firm generated revenue of $2.8 billion in 2018 and has research centers in Denmark and California and production facilities in Denmark, France and Italy.

Alder BioPharmaceuticals started the day with a market capitalization of about $841.4 million. The company has 83.64 million shares outstanding, and as of Friday, had a short interest of around 19.2%. The stock has a 52-week price range of $8.39–18.88/share. This morning, ALDR shares opened much higher at $18.48 (+$8.42, +83.70%) over Friday’s $10.06 closing price. The stock has traded on more than 40-times average volume today between $18.34-18.88/share and at present is trading at $18.56 (+$8.50, +84.49%).

Sign up for our FREE newsletter at: www.streetwisereports.com/get-news

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: ALDR:NASDAQ,
)

Fibrocell Science Shares Rise 60% on Acquisition News

By The Life Science Report

Source: Streetwise Reports   09/13/2019

Fibrocell Science’s shares are trading up 60% today after the company announced that it agreed to be acquired by Castle Creek Holdings for $63.3 million, or $3.00 per share.

Cell and gene therapy company Fibrocell Science Inc. (FCSC:NASDAQ), which focuses on transformational autologous cell-based therapies for skin and connective tissue diseases, announced it has reached an agreement to be acquired by Castle Creek Pharmaceutical Holdings Inc., the parent company of Castle Creek Pharmaceuticals LLC.

Under the terms of the agreement, Castle Creek will acquire Fibrocell for approximately $63.3 million, including repayment of debt and other financial instruments, in cash. Fibrocell common stockholders will receive all-cash consideration of $3.00 per share. Fibrocell reports that the offer represents a 63% premium to Fibrocell’s 30-day volume weighted average price as of September 11, 2019. The transaction has already been approved by the Boards of Directors of both companies and is expected to close in Q4/19 subject to customary closing conditions, including Fibrocell shareholder approval. Upon completion of the transaction, Fibrocell will become a privately held subsidiary of Castle Creek with Fibrocell’s employees continuing as employees of the combined company.

Fibrocell’s president and CEO John Maslowski commented on the sale, “We are incredibly pleased to announce this transaction, which we believe is in the best interests of both shareholders and patients…We believe that combining with Castle Creek has a strong strategic rationale, as they have the expertise and resources necessary to continue the development of both FCX-007 and FCX-013, potentially bringing these and additional novel products to patients in need.”

Greg Wujek, CEO of Castle Creek Pharmaceuticals, stated, “Following our licensing agreement to develop and commercialize FCX-007, our experience working together on rare dermatological conditions caused us to quickly realize that Castle Creek and Fibrocell could achieve even greater synergies by combining the companies into one…With Castle Creek’s resources, Fibrocell’s gene therapy platform can be advanced into additional areas of high, unmet need with the potential to develop multiple promising new therapies.”

Fibrocell’s portfolio includes FCX-007 and FCX-013. FCX-007 is an investigational, late-stage stage gene therapy product candidate for the treatment of recessive dystrophic epidermolysis bullosa (RDEB), a congenital and progressive orphan skin disease caused by the deficiency of the protein COL7. A Phase 3 trial was initiated recently, and if successful, a Biologics License Application (BLA) filing is expected in 2021. The company states that FCX-007 has been granted Orphan Drug designation, Rare Pediatric Disease designation, Fast Track designation and Regenerative Medicine Advanced Therapy (RMAT) designation by the FDA. FCX-013 is described as an investigational, gene therapy candidate for the treatment of moderate to severe localized scleroderma. FCX-013 is an autologous fibroblast genetically modified using lentivirus and encoded for matrix metalloproteinase 1 (MMP-1), a protein responsible for breaking down collagen. FCX-013 is currently enrolling for the Phase 1 portion of a Phase 1/2 clinical trial. The firm advises that the FDA has granted Orphan Drug designation, Rare Pediatric Disease designation and Fast Track designation to FCX-013.

These product candidates are expected to augment Castle Creek Pharmaceuticals’ CCP-020, an investigational, late-stage topical ointment under development for the treatment of epidermolysis bullosa simplex, further strengthening Castle Creek Pharmaceuticals as a leader in dermatology.

Castle Creek Pharmaceutical Holdings is a privately held holding company that holds and invests in companies in the orphan dermatology space. It s subsidiary Castle Creek Pharmaceuticals is a biopharmaceutical company developing innovative therapies for patients with rare, serious or debilitating dermatologic conditions. The firm states that it is dedicated to developing and bringing novel therapies to those living with epidermolysis bullosa.

Fibrocell notes that it is a cell and gene therapy company focused on improving the lives of people with rare diseases of the skin and connective tissue by utilizing its proprietary autologous fibroblast technology to develop personalized biologics that target the underlying cause of disease.

FCSC shares opened much higher today at $2.92 (+$1.09, +59.56%) over yesterday close of $1.83. Since the open shares have traded on high volume in a very narrow trading range of $2.92–2.95/share and are currently trading at $2.92 (+$1.09 +59.56%).

Sign up for our FREE newsletter at: www.streetwisereports.com/get-news

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 professional for medical advice.

( Companies Mentioned: FCSC:NASDAQ,
)

Moderna Shares Rise on the Release of Positive Results from Two mRNA Phase 1 Programs

By The Life Science Report

Source: Streetwise Reports   09/12/2019

Shares of Moderna Inc. traded up double-digits today as the firm announced results from its Phase 1 CMV Vaccine Study as well as its Phase 1 data for mRNA-1944 encoding for antibody against the chikungunya virus.

This morning clinical-stage biotechnology company Moderna Inc. (MRNA:NASDAQ), which states it is pioneering messenger RNA (mRNA) therapeutics and vaccines to create a new generation of transformative medicines, announced positive data from the three-month interim analysis of safety and immunogenicity of the Phase 1 study of its investigational cytomegalovirus (CMV) vaccine (mRNA-1647).

Based on these data, the firm advised that it is advancing mRNA-1647 to a dose-confirmation Phase 2 study in the near term. Preparation has also begun for a pivotal Phase 3 study designed to evaluate the efficacy of mRNA-1647 against primary CMV infection. The firm indicates that mRNA-1647 is a vaccine combining six mRNAs in a single vial, which encode for two antigens on the surface of CMV: five mRNAs encoding the subunits that form the membrane-bound pentamer complex and one mRNA encoding the full-length membrane-bound glycoprotein B (gB).

Tal Zaks, M.D., Ph.D., chief medical officer at Moderna commented, “I am very encouraged by the ability of mRNA-1647 to induce high levels of durable immune responses that can reach or exceed the levels generated by natural CMV infection…We recognize there is an urgent need for a preventative vaccine against congenital CMV and will be advancing mRNA-1647 into a Phase 2 study in the near term to confirm the appropriate dose, while we plan for a pivotal Phase 3 study.”

Sallie Permar, M.D., Ph.D., associate dean of physician scientist development and professor of pediatrics, immunology, and molecular genetics and microbiology at Duke Medical School, added, “Cytomegalovirus is the leading infectious cause of birth defects, and there is a great need for a vaccine that blocks transmission of the virus from the mother to the fetus…These interim data are exciting because mRNA-1647 has shown the ability to induce immune responses in seronegative individuals that are greater than what is seen in those naturally infected with CMV, which is important in that natural immunity is not completely protective against congenital CMV transmission.”

The Phase 1 study, which has completed enrollment, is evaluating the safety and immunogenicity of mRNA-1647 in 169 healthy adult volunteers. The study population includes those who were naïve to CMV infection (CMV-seronegative) and those who had previously been infected by CMV (CMV-seropositive). A safety analysis indicated that the vaccine was generally well tolerated and there were no vaccine-related serious adverse events.

CMV is a common pathogen and member of the herpesvirus family. Congenital CMV infection results when infected mothers transmit the virus to their unborn child, and it is the leading infectious cause of birth defects in the U.S., with approximately 25,000 newborns in the U.S. infected every year. There is currently no approved vaccine for the prevention of CMV infection.

The company also today announced positive data in the first analysis of safety and activity in its Phase 1 study evaluating escalating doses of mRNA-1944 administered via intravenous infusion in healthy adults. mRNA-1944 encodes for an antibody (CHKV-24) with activity against chikungunya virus.

The data from the study shows that at all three dose levels, the administration of mRNA-1944 led to detectable levels of CHKV-24 antibody in all participants, ranging from 1 µg/mL to 14 µg/mL. The firm states that these results mark the first systemic mRNA therapeutic to show production of a secreted protein in humans. mRNA-1944 is being developed with financial support from the Defense Advanced Research Projects Agency (DARPA), an agency of the U.S. Department of Defense. mRNA-1944 is the first development candidate from the company’s systemic therapeutics modality to start clinical testing and utilizes the same lipid nanoparticle (LNP) formulation as the company’s rare disease program for methylmalonic acidemia (mRNA-3704). A total of 22 healthy adults have been enrolled in the study to date.

Dr. Zaks advised, “These Phase 1 data represent a significant scientific breakthrough: this study shows for the first time the ability to generate therapeutic levels of a complex protein in humans through systemic administration of an mRNA, essentially instructing the body to make its own medicines.”

Moderna’s CEO Stéphane Bancel stated, “These data represent another critical milestone for the validation of Moderna’s mRNA platform in humans…This is the fifth modality for which we have shown translation from preclinical research to humans and the first demonstration of mRNA as a systemic therapeutic capable of creating high levels of protein at a well-tolerated dose. We believe these results further validate our approach, the scientific platform we have built and the potential of mRNA to become a new class of medicines. We look forward to learning from the ongoing Phase 1/2 study of mRNA-3704 for methylmalonic acidemia, the first of our rare disease programs to enter the clinic, as it utilizes the same technology demonstrated in this chikungunya study.”

Chikungunya is a mosquito-borne virus that poses a significant public health problem in tropical and subtropical regions. The disease is characterized by an acute onset of fever, rash, muscle pain and sometimes debilitating pain in multiple joints. There are no vaccines approved to prevent chikungunya infection or disease.

Moderna Inc. is a clinical stage biotechnology company headquartered in Cambridge, Mass., engaged in transformative medicines based on messenger ribonucleic acid (mRNA). It is pursuing mRNA science to minimize the undesirable activation of the immune system by mRNA and to maximize the potency of mRNA once in the target cells. The company has a diverse development pipeline of 22 programs with multiple clinical studies underway. Its therapeutics and vaccine development programs span infectious diseases, oncology, cardiovascular diseases and rare genetic diseases. The company currently has strategic alliances for development programs with AstraZeneca, Plc. and Merck, Inc. and the Defense Advanced Research Projects Agency.

MRNA share opened today at $17.34 (+$1.42, +8.92%) over yesterday’s $15.92 closing price. The stock has traded today between $16.23 and $18.46/share and at present is trading at $16.84 (+$0.92, +5.78%).

Sign up for our FREE newsletter at: www.streetwisereports.com/get-news

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 professional for medical advice.

( Companies Mentioned: MRNA:NASDAQ,
)

T2 Biosystems Receives BARDA Contract to Fight Antimicrobial Resistance, Shares Up More than 88%

By The Life Science Report

Source: Streetwise Reports   09/11/2019

This healthcare diagnostics stock rose more than 88% on Wednesday following the award of a BARDA contract that could be worth up to $69 million.

On Wednesday morning, T2 BioSystems Inc. (TTOO:NASDAQ) announced receipt of funding from the U.S. Department of Health and Human Service’s Biomedical Advanced Research and Development Authority (BARDA) to advance technology for diagnosis and treatment of bloodstream infections.

The initial phase of the milestone-based contract is worth $6 million, with a potential value of up to $69 million if all contract options are exercised.

The goal of the contract is to, “enable a significant expansion of the company’s current portfolio of diagnostics for sepsis-causing pathogens and antibiotic-resistance genes,” and to “reduce the growing threat of antimicrobial resistance.”

The Massachusetts-based medical diagnostics company uses a unique T2 Magnetic Resonance detection technology to identify sepsis-causing pathogens as quickly as possible to enable faster treatment. T2 Biosystems states that its “blood tests provide actionable results in just 3-5 hours. The only other way to identify the species-specific diagnosis requires a blood culture, which can take 1-5 days or more.”

Shares reached $2.69 during Wednesday trading, up more than 88% from the prior day’s close of $1.43.

Sign up for our FREE newsletter at: www.streetwisereports.com/get-news

Disclosure:
1) Kevin Jaillet compiled this article for Streetwise Reports LLC and is an employee of Streetwise Reports. 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. The information provided above is for informational purposes only and is not a recommendation to buy or sell any security.
3) Comments and opinions expressed are those of the specific experts and not of Streetwise Reports or its officers.
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 professional for medical advice.

( Companies Mentioned: TTOO:NASDAQ,
)

Biopharma Makes Licensing Deal for Therapeutic Rights in Japan

By The Life Science Report

Source: Streetwise Reports   09/11/2019

The company’s reasons for the transaction and expected short-term, stock-moving events are provided in a ROTH Capital Partners report.

In a Sept. 9 research note, ROTH Capital Partners analyst Yasmeen Rahimi reported that Eidos Therapeutics Inc. (EIDX:NASDAQ) agreed to give Alexion Pharmaceuticals exclusive rights in Japan to its clinical stage therapeutic AG10 for $50 million.

AG10 is a small molecule designed to potently stabilize transthyretin (TTR), thereby halting the progression of amyloidosis and other ATTR diseases.

Rahimi discussed Eidos’ rationale behind the deal and “why it makes sense now.”

One, the transaction provides an easier way for Eidos to enter the Japanese market. By itself, Eidos would have had to conduct another pivotal study just for that.

Two, the deal is a “tack-on development that adds more to the Eidos coffers without changing existing AG10 commercial strategy,” Rahimi noted.

Three, the arrangement also serves as an initial instance of Eidos being vigorously vetted by big pharma “and emerging as an even shinier, validated diamond for others to see,” wrote Rahimi.

About the deal in general, Rahimi commented, “Taking a bird’s eye view of the ATTR-cardiomyopathy landscape, we view this as a significantly hot indicator of the number of strategics knocking on Eidos’ door for a space at the AG10 table.”

Rahimi indicated that the next two months for the San Francisco-headquartered biopharma look “rosy” with potential significant upside regardless of whether its acquisition by BridgeBio Pharma goes through. Closing would be a “significant win” for Eidos, “completing a fourfold increase in share price from about $10 lows in October 2018,” the analyst added. However, not closing would not hamper the working relationship between the two firms.

Another upcoming catalyst for Eidos is its scheduled presentation at the 2019 American Heart Association Scientific Sessions meeting in November, during which the biopharma will review the long-term safety and pharmacokinetic/pharmacodynamic results from its Phase 2 open-label extension study.

ROTH has a Buy rating and a $51 per share price target on Eidos, whose stock is currently trading at around $43.43 per share.

Sign up for our FREE newsletter at: www.streetwisereports.com/get-news

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 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.

Disclosures from ROTH Capital Partners, Eidos Therapeutics Inc., Flash Note, September 9, 2019

Regulation Analyst Certification (“Reg AC”): The research analyst primarily responsible for the content of this report certifies the following under Reg AC: I hereby certify that all views expressed in this report accurately reflect my personal views about the subject company or companies and its or their securities. I also certify that no part of my compensation was, is or will be, directly or indirectly, related to the specific recommendations or views expressed in this report.

ROTH makes a market in shares of Eidos Therapeutics, Inc. and as such, buys and sells from customers on a principal basis.

ROTH Capital Partners, LLC expects to receive or intends to seek compensation for investment banking or other business relationships with the covered companies mentioned in this report in the next three months.

( Companies Mentioned: EIDX:NASDAQ,
)

Sanofi Pays Lexicon Pharma $260 Million to Settle Diabetes Drug Dispute

By The Life Science Report

Source: Streetwise Reports   09/11/2019

Lexicon Pharmaceuticals shares traded higher by more than 30% today after the company announced termination of its alliance with Sanofi SA and a $260 million settlement over its diabetes drug Zynquista.

Yesterday afternoon, The Woodlands, Tex.-based Lexicon Pharmaceuticals Inc. (LXRX:NASDAQ) announced the termination of its alliance with Sanofi SA (SNY:NASDAQ ADR) for the development and commercialization of Zynquista (sotagliflozin) and the settlement of its related disputes with Sanofi, each effective September 9, 2019.

Under the terms of the alliance termination, Lexicon will regain all rights to Zynquista and assume full responsibility for its worldwide development and commercialization in both type 1 and type 2 diabetes. Under the terms of the settlement, Sanofi will pay Lexicon $260 million, of which $208 million is payable upfront, with the remaining $52 million payable within 12 months, and Sanofi will coordinate with Lexicon in the transition of responsibility for ongoing clinical studies and other activities.

Lonnel Coats, president and CEO of Lexicon Pharmaceuticals, commented, “Our four-year alliance with Sanofi has been a productive one, with Zynquista receiving marketing approval in Europe in type 1 diabetes and advancing into late-stage studies in type 2 diabetes…Regaining worldwide rights allows us to advance our efforts to realize the full value of the Zynquista program as we prepare for regulatory filings in the U.S. and in Europe in type 2 diabetes, with data coming over the next few months from the remainder of the core Phase 3 studies and over the longer term from two outcomes studies with potential for demonstrating cardiovascular and renal benefits. We believe that this potential, along with a European approval in type 1 diabetes, offers an attractive opportunity for potential collaborators as we work to maximize the global potential for Zynquista and to achieve greater operational flexibility.”

The company explains in the release that Zynquista (sotagliflozin) as an oral dual inhibitor of two proteins responsible for glucose regulation known as sodium-glucose co-transporter types 1 and 2 (SGLT1 and SGLT2). SGLT1 is responsible for glucose absorption in the gastrointestinal tract, and SGLT2 is responsible for glucose reabsorption by the kidneys. The firm indicates that Zynquista is approved in the European Union (EU) for use as an adjunct to insulin therapy to improve blood sugar (glycemic) control in adults with type 1 diabetes with a body mass index ≥27 kg/m2, who could not achieve adequate glycemic control despite optimal insulin therapy. Outside of such approval, Zynquista is investigational and has not been approved by any other regulatory authority for type 1 or type 2 diabetes.

Lexicon describes itself as a fully integrated biopharmaceutical company with a mission of pioneering medicines that transform patients’ lives. Through its Genome5000 program, Lexicon scientists studied the role and function of nearly 5,000 genes and identified more than 100 protein targets with significant therapeutic potential in a range of diseases. In addition to its first commercial product, XERMELO, Lexicon states that it has a pipeline of promising drug candidates in clinical and preclinical development in diabetes and metabolism, oncology and neuropathic pain.

Sanofi, based in Paris, France, is a $108.6 billion market cap global healthcare company involved in research, development, manufacture and marketing of therapeutic solutions. The company’s Pharmaceuticals segment comprises the commercial operations of various franchises, including Diabetes and Cardiovascular, Specialty Care (Rare Diseases, Multiple Sclerosis, and Oncology), Established Prescription Products, and Consumer Healthcare and Generics. The Vaccines segment is dedicated to vaccines and includes the commercial operations of the company’s vaccines division, Sanofi Pasteur.

Lexicon Pharmaceuticals began the day with a market capitalization of about $182.8 million. The company has 106.31 million shares outstanding, and as of yesterday had a short interest of around 7.3%. The stock has a 52-week price range of $1.125–11.51/share. This morning, LXRX shares opened at $2.36 (+$0.64, +37.21%) over yesterday’s $1.72 closing price. The stock has traded on more than 10-times higher than average volume today between $2.17 and $2.71/share and at present is trading at $2.22 (+$0.50, +29.07%).

Sign up for our FREE newsletter at: www.streetwisereports.com/get-news

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 professional for medical advice.

( Companies Mentioned: LXRX:NASDAQ,
)

Mallinckrodt Shares Up 60% as It Announces Sale of Unit

By The Life Science Report

Source: Streetwise Reports   09/10/2019

Shares of Mallinckrodt Plc are trading more than 60% higher today on news that the company is selling its CDMO subsidiary BioVectra Inc. to H.I.G. Capital for $250 million.

Global biopharmaceutical company Mallinckrodt Plc (MNK:NYSE) announced today that it has entered into a definitive agreement to sell its wholly owned subsidiary BioVectra Inc. to an affiliate of H.I.G. Capital, a leading global private equity investment firm, for approximately $250 million. The terms of the sale include fixed consideration of $175 million composed of an upfront payment of $135 million, a long-term note for $40 million and contingent payments of up to $75 million that will enable Mallinckrodt to capture future BioVectra growth potential.

The transaction is expected to close in Q4/19, subject to customary closing conditions, and the notice states that it is not anticipated that the sale will have any material tax impact for Mallinckrodt. The company indicates that it intends to use the proceeds from this divestiture consistent with its previously disclosed capital allocation priorities, and asserts that the transaction continues to advance its strategic focus on branded biopharmaceuticals by monetizing a non-core business.

The release identifies BioVectra as a contract development and manufacturing organization (CDMO) whose global client base includes many of the top biopharmaceutical companies in the world. BioVectra has over 45 years of experience specializing in cGMP microbial fermentation, complex chemistry – high potency APIs, biologics and formulation development. After the sale, BioVectra will continue to supply an active pharmaceutical ingredient supporting Mallinckrodt’s specialty brands business under a long-term arrangement.

President and CEO of Mallinckrodt Mark Trudeau stated, “This transaction continues to advance Mallinckrodt’s strategic focus on branded, high-growth biopharmaceuticals by monetizing a non-core business…While we recognize the longer-term growth potential for BioVectra, we believe that the structure of this deal enables us to participate in the future success of the business, and therefore we see this sale as the best option for both Mallinckrodt and BioVectra moving forward.”

Mike Gallagher, managing director at H.I.G. Capital commented, “We are excited to support BioVectra’s exceptional leadership and highly dedicated employees…BioVectra demonstrates a tremendous ability to generate robust organic growth and utilizes a broad set of technical capabilities to deliver outstanding service and quality. They are completing major capital expenditure programs to significantly expand capacity and the company is well positioned to capitalize on growing demand for their services.”

Mallinckrodt reports that it is a global business consisting of multiple wholly owned subsidiaries that develop, manufacture, market and distribute specialty pharmaceutical products and therapies. The company’s Specialty Brands reportable segment’s areas of focus include autoimmune and rare diseases in specialty areas like neurology, rheumatology, nephrology, pulmonology and ophthalmology; immunotherapy and neonatal respiratory critical care therapies; analgesics; and gastrointestinal products. Its Specialty Generics reportable segment includes specialty generic drugs and active pharmaceutical ingredients.

H.I.G. Capital was founded in 1993 and is a large global private equity and alternative assets investment firm with more than $34 billion of equity capital under management. The firm is based in Miami, with offices in New York, Boston, Chicago, Dallas, Los Angeles, San Francisco and Atlanta in the U.S., as well as international affiliate offices in London, Hamburg, Madrid, Milan, Paris, Bogotá, Rio de Janeiro and São Paulo. H.I.G. specializes in providing debt and equity capital to small and mid-sized companies. The firm’s current portfolio includes more than 100 companies with combined sales in excess of $30 billion.

Mallinckrodt started today with a market capitalization of about $176.4 million. The company has 84.01 million shares outstanding, and as of yesterday had a short interest of around 50.9%. The stock has a 52-week price range of $1.43–34.10/share. MNK shares opened today at $2.27 (+$0.27, +8.10%) compared to yesterday’s closing price of $2.10. The stock has traded on higher than average volume today between $2.23 and $3.57/share and currently is trading at $3.40 (+$1.30, +61.90%).

Sign up for our FREE newsletter at: www.streetwisereports.com/get-news

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 professional for medical advice.

( Companies Mentioned: MNK:NYSE,
)

ACADIA Pharma’s Shares Open 75% Higher on Positive Anti-Psychosis Drug Phase 3 Results

By The Life Science Report

Source: Streetwise Reports   09/09/2019

Shares of ACADIA Pharmaceuticals opened up 75% higher today after the company announced that its Phase 3 Study of pimavanserin for the treatment of dementia-related psychosis met its primary endpoint.

San Diego, Calif.-based biopharmaceutical company ACADIA Pharmaceuticals Inc. (ACAD:NASDAQ) today announced that its Phase 3 HARMONY study evaluating pimavanserin for the treatment of dementia-related psychosis met its primary endpoint, demonstrating a highly statistically significant longer time to relapse of psychosis with pimavanserin compared to placebo in a planned interim efficacy analysis. The firm further reported that upon the recommendation of the study’s independent data monitoring committee, which met to review the data from the planned interim efficacy analysis, the study will now be stopped early based on pre-specified stopping criteria requiring a one-sided p-value less than 0.0033 on the study’s primary endpoint.

The company plans to meet with the U.S. Food and Drug Administration (FDA) regarding a supplemental New Drug Application (NDA) submission in 2020, and the results from the HARMONY study will be submitted for presentation at upcoming medical meetings. The FDA previously granted Breakthrough Therapy Designation for pimavanserin for the treatment of dementia-related psychosis. No drug is approved by the FDA for the treatment of dementia-related psychosis.

Jeffrey Cummings, M.D., Sc.D., Director Emeritus of Cleveland Clinic Lou Ruvo Center for Brain Health in Las Vegas, commented, “Psychosis adds dramatically to the marked burden that dementia patients already carry and is one of the most challenging-to-manage aspects of the disease for caregivers…With no approved treatment options available today for dementia-related psychosis, the pimavanserin study results represent a meaningful advance that will potentially bring us a much needed therapy for this debilitating disease.”

ACADIA’s President Serge Stankovic, M.D., M.S.P.H., stated, “We are very excited that today’s results bring us one step closer to the potential of offering patients with dementia-related psychosis a critically needed treatment option…We look forward to speaking with the FDA about a supplemental new drug application (NDA) to support pimavanserin for the treatment of dementia-related psychosis. I want to thank all of the patients, their families, and the investigators for their participation in this important study.”

The firm indicates that pimavanserin is a selective serotonin inverse agonist and antagonist preferentially targeting 5-HT2A receptors. These receptors are thought to play an important role in psychosis, schizophrenia, depression and other neuropsychiatric disorders.

The HARMONY Study is a Phase 3 study double-blind, placebo-controlled relapse prevention trial designed to evaluate the efficacy and safety of pimavanserin for the treatment of delusions and hallucinations associated with dementia-related psychosis across a broad population of patients with the most common subtypes of dementia including: Alzheimer’s disease, dementia with Lewy bodies, Parkinson’s disease dementia, vascular dementia, and frontotemporal dementia spectrum disorders. The study included a 12-week open-label stabilization period during which patients with dementia-related psychosis were treated with pimavanserin 34 mg once daily. Dose reduction to 20 mg once daily was allowed if clinically justified within the first four weeks.

The company advised in the release that around 8 million people in the United States are living with dementia and studies suggest that approximately 30% of dementia patients, or 2.4 million people, have psychosis, commonly consisting of delusions and hallucinations. Serious consequences have been associated with severe or persistent psychosis in patients with dementia such as repeated hospital admissions, increased likelihood of nursing home placement, progression of dementia, and increased risk of morbidity and mortality.

ACADIA Pharmaceuticals states that its vision is to become the leading pharmaceutical company dedicated to the advancement of innovative medicines that improve the lives of patients with central nervous system (CNS) disorders. The company received FDA approval for NUPLAZID (pimavanserin) in April 2016, the first and only medicine approved for the treatment of hallucinations and delusions associated with Parkinson’s disease psychosis. The firm also has ongoing clinical development efforts in additional areas with significant unmet need, including dementia-related psychosis, schizophrenia, major depressive disorder, and Rett syndrome.

ACADIA shares opened much higher today at $41.79 (+$17.99, +75.59%), compared to Friday’s $23.80 closing price. The stock has traded today between $36.62 and $43.98/share and at present is trading at $39.21 (+$15.41, +64.75%).

Sign up for our FREE newsletter at: www.streetwisereports.com/get-news

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 professional for medical advice.

( Companies Mentioned: ACAD:NASDAQ,
)

Neon Therapeutics Shares Are Flashing Brightly after Reporting Predictive Cancer Breakthrough

By The Life Science Report

Source: Streetwise Reports   09/06/2019

After announcing publication in the scientific journal Immunity that it had created a 61-fold improvement process for predicting cancer-specific antigens, Neon Therapeutics’ stock has traded wildly today, up more than 46% at times on nearly 100-times average daily volume, but has since pulled back greatly.

Shares of clinical-stage immuno-oncology firm Neon Therapeutics Inc. (NTGN:NASDAQ) are trading up today on enormous relative volume after the company announced publication in the scientific journal Immunity of a breakthrough process for predicting which neoantigens will be presented by MHC class II molecules in the tumor microenvironment.

The company notes that predicting the relevant cancer-specific antigens is a crucial precursor to developing immunotherapies that effectively train T cells to traffic to the tumor and destroy malignant cells. In the paper titled “Defining HLA-II ligand processing and binding rules with mass spectrometry enhances cancer epitope prediction,” Neon’s proprietary mono-allelic profiling technology called MAPTAC facilitated the development of convolutional neural network-based predictors. These algorithms achieved up to a 61-fold improvement in predicting MHC class II peptides compared to publicly available tools.

The company advised that MHC class II prediction technology will be integrated into Neon’s RECON bioinformatics platform and is expected to improve the efficacy of immunotherapies developed by Neon by predicting recruitment of CD4+ T cells, which are believed to be important in controlling tumor growth.

Richard Gaynor, M.D., Neon’s president of research and development, commented, “The publication of this work represents an extensive research initiative to significantly improve the recruitment of CD4+ T cell responses. We believe this novel technology and prediction approach significantly advances the neoantigen field by setting a new benchmark for understanding the MHC class II pathway. These new insights may enable the development of improved immunotherapies, as well as therapies for other areas, including autoimmune disorders”.

Associate Director, Proteomics at Neon and lead author of the paper Jennifer Abelin, Ph.D added, “Until recently, neoantigen-directed therapies have been focused primarily on eliciting CD8+ T cell responses toward ligands presented on MHC class I molecules. It has been historically difficult to predict the antigens that will be presented through class II due to inaccurate peptide binding prediction and unsolved complexities of the class II pathway. Through the research published today in Immunity, we have integrated novel proteomics and genomics strategies to build a more accurate tool for defining and understanding the rules of the class II pathway, leading to algorithms that have been shown to significantly outperform currently available prediction tools.”

The company claims that the findings in the Immunity publication demonstrate that Neon’s proprietary class II prediction algorithms substantially outperform NetMHCIIpan, the current benchmark for class II prediction. Key findings in the research include the development of novel proteomic strategies that resolve over 40 MHC class II motifs and the observation that intra-tumoral MHC class II presentation is dominated by professional antigen presenting cells (APCs) rather than tumor cells. Tracking which tumor epitopes are most readily phagocytosed and presented by APCs further enhances the ability to pinpoint therapeutically relevant epitopes.

Neon Therapeutics lists that its clear mission is “to build a breakthrough oncology company creating neoantigen-based therapeutics that significantly improve the lives of patients.”The firm states that it is a leader in the field of neoantigen-targeted therapies, dedicated to transforming the treatment of cancer by directing the immune system towards neoantigens. The firm is using its neoantigen platform to develop both vaccine and T cell therapies, including NEO-PV-01, a clinical-stage neoantigen vaccine for the treatment of metastatic melanoma, non-small cell lung cancer, and bladder cancer; NEO-PTC-01, a neoantigen T cell therapy for the treatment of solid tumors; and NEO-SV-01, a neoantigen vaccine for the treatment of a subset of hormone receptor-positive (HR+) breast cancer.

Neon Therapeutics started today with a market capitalization of about $82.6 million. The company has 28.38 million shares outstanding and typically trades 145,000 to 195,000 shares per day. Today in early trading, volume has already exceeded 18 million shares. NTGN shares opened today at $3.58 (+$0.67, +23.02%) compared to yesterday’s $2.91 closing price. The stock has traded today between $3.22 and $4.25/share and at present is trading at $3.36 (+$0.45, +15.46%).

Sign up for our FREE newsletter at: www.streetwisereports.com/get-news

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.

( Companies Mentioned: NTGN:NASDAQ,
)