Biotech Stock Roundup: EPZM Drug Gets FDA Nod, XLRN & HEPA Surge On Study Data
Zacks Investment Research | Jan 28, 2020 09:59PM ET
This week, quite a few biotech companies came out with pipeline and regulatory updates. Epizyme (NASDAQ:EPZM) got a significant boost with the FDA approval of its lead drug. Both Acceleron Pharma Inc. (NASDAQ:XLRN) and Hepion Pharmaceuticals, Inc. (NASDAQ:HEPA) surged on positive pipeline updates. Incyte (NASDAQ:INCY) too came out with positive results from a late-stage study on ruxolitinib cream, while Gilead Sciences (NASDAQ:GILD) and Regeneron (NASDAQ:REGN) provided regulatory updates on their candidates.
Recap of the Week’s Most Important Stories:
Epziyme Wins FDA Nod for Tazverik: The FDA the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here .
Regeneron, Sanofi’s sBLA for Dupixent Accepted: Regeneron Pharmaceuticals, Inc. and partner Sanofi (NASDAQ:SNY) announced that the FDA has accepted for Priority Review the supplemental Biologics License Application (sBLA) for Dupixent (dupilumab). Both companies are seeking the approval of the drug as an add-on maintenance treatment for children aged 6-11 years with moderate-to-severe atopic dermatitis, whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. The FDA has set a target action date of May 26, 2020. The drug is already approved in the United States to treat patients aged 12 years or older with moderate-to-severe atopic dermatitis.
Hepion Surges on Positive Study Data: Shares of Hepion Pharmaceuticals, Inc. surged after it announced positive data from an expanded study with human precision cut liver slices (PCLS). Hepion's drug candidate, CRV431, prevented experimentally induced liver fibrosis to a larger extent than four other leading non-alcoholic steatohepatitis (NASH) drug candidates — obeticholic acid, elafibranor, resmetirom and Aramchol — in this specialized experimental model using human liver tissue. Hepion is evaluating CRV431 for NASH, fibrosis and other liver diseases. A phase I, single ascending dose study previously showed CRV431 to be safe and well tolerated in humans. The candidate is currently being administered to humans in a 28-day multiple ascending dose study.
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