The following are some of today’s top gainers in the healthcare sector.
1. Hepion Pharmaceuticals Inc. (HEPA)
Hepion Pharma, formerly ContraVir Pharmaceuticals, is a clinical-stage biopharmaceutical company developing targeted therapies for liver disease arising from non-alcoholic steatohepatitis (NASH) and chronic hepatitis virus infection (HBV, HCV, HDV). The lead drug candidate is CRV431 for NASH and HBV and HCV, in early stage of clinical development.
Gained 43.20% to close Thursday’s (Oct.17) trading at $3.58.
News: The peer-reviewed Journal of Pharmacology and Experimental Therapeutics has published data highlighting CRV431’s potential as a treatment for chronic liver diseases.
In July of this year, the Company received the go-ahead from the FDA to proceed with its planned Investigational New Drug application (IND) opening study. The study will recruit 24 patients consisting of eight with mild, eight with moderate, and eight with severe hepatic impairment, based on established Child-Pugh scores. The control group will accommodate up to an additional 24 healthy subjects.
2. Assembly Biosciences Inc. (ASMB)
Assembly Biosciences is a clinical-stage biotechnology company developing innovative therapeutics targeting the hepatitis B virus (HBV) and diseases associated with the microbiome.
Gained 21.98% to close Thursday’s trading at $15.51. This is the second straight day of double-digit gain for the stock.
News: No news
Clinical Trials & Near-term Catalysts:
— The Company announced encouraging final data from its long-term Phase 2a trial combining ABI-H0731 a potent core inhibitor, for the treatment of HBV, with Nuc (Nucleos(t)Ide therapy, yesterday, sending the stock up over 36%.
— Data from phase 1b trial of ABI-H2158 in HBV-infected subjects are expected in Q1 2020. Interim data from this study, reported yesterday, demonstrated potent antiviral activity as a monotherapy over 14 days of treatment.
— A phase 1a trial of ABI-H3733, an HBV drug candidate, is expected to be initiated in Q1 2020.
— A phase 1b trial of ABI-M201 in patients with mildly to moderately active ulcerative colitis is underway.
3. Assertio Therapeutics Inc. (ASRT)
Assertio Therapeutics, formerly known as Depomed Inc., currently markets three FDA-approved products, and its core areas of focus include neurology, orphan, and specialty medicines.
Gained 19.71% to close Thursday’s trading at $1.24.
News: No news
The FDA decision on the Company’s injectable formulation of long-acting Cosyntropin depot is expected on October 19, 2019. The product is proposed as a diagnostic drug in the screening of patients presumed to have adrenocortical insufficiency.
Adrenal insufficiency, also called adrenocortical insufficiency or hypocortisolism, is a rare disorder in which the adrenal glands don’t produce enough hormones like cortisol and aldosterone.
4. Endo International plc (ENDP)
Endo International is a generics and specialty branded pharmaceutical company.
Gained 16.11% to close Thursday’s trading at $4.83.
News: No news
— On September 6, 2019, the Company submitted a Biologics License Application to the FDA for collagenase clostridium histolyticum (CCH) for the treatment of cellulite in the buttocks.
The FDA has a 60-day filing review period to determine whether the BLA is complete and acceptable for filing.
— On September 5, 2019, the Company executed a definitive Settlement Agreement and Release in connection with the lawsuit brought by Cuyahoga and Summit counties in Ohio against opioid makers and distributors, including Endo International.
As part of the settlement, Endo will pay a total sum of $10 million and will provide up to $1 million of its Vasostrict and Adrenalin products free of charge, to be initially allocated by and between the two plaintiff counties as follows: Cuyahoga County will receive $6.2 million in cash and up to $620,000 of Vasostrict and/or Adrenalin, and Summit County will receive $3.8 million in cash and up to $380,000 of Vasostrict and/or Adrenalin.
More than 2,000 lawsuits have been filed by state and local governments against major drugmakers, alleging that the companies aggressively marketed the painkillers despite knowing the risk of addiction and that they are liable for the nation’s opioid crisis.
— On August 20, 2019, the Company reached a settlement in principle with two Ohio counties – the County of Cuyahoga, Ohio, the County of Summit, Ohio and certain related persons to resolve Track 1 opioid cases.
As part of the settlement, Endo will pay a total sum of $10 million and will provide up to $1 million of its Vasostrict and Adrenalin products free of charge to the two Ohio counties to be used in their sole discretion.
The Company is slated to announce its third-quarter 2019 financial results on November 5, 2019.
5. Clovis Oncology Inc. (CLVS)
Clovis Oncology is a commercial-stage biotechnology company focused on acquiring, developing and commercializing cancer treatments in the United States, Europe, and other international markets. The Company has 1 marketed drug, Rubraca, for ovarian cancer.
Gained 14.37% to close Thursday’s trading at $3.66.
News: No news
The Company is slated to report third-quarter financial results on October 29, 2019.
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