Biotech Stock Roundup: Vertex, AMAG Drugs Get FDA Nod, Conatus Study Fails & More
Zacks Investment Research | Jun 26, 2019 08:37AM ET
It was a busy week for the biotech sector with drug approvals, collaborations and pipeline updates. Vertex Pharmaceuticals Incorporated (NASDAQ:VRTX) and AMAG Pharmaceuticals, Inc. (NASDAQ:AMAG) obtained FDA approvals for the treatment of Symdeko in children and Vyleesi in premenopausal women, respectively. Meanwhile, Conatus (NASDAQ:CNAT) crashed on failure of yet another study on NASH candidate. The FDA also accepted Alexion’s (NASDAQ:ALXN) application for label expansion of Ultomiris.
Recap of the Week’s Top Stories:
Vertex Gets FDA Nod for Symdeko in Children: Vertex Pharmaceuticals Incorporated announced that the FDA has accepted its supplemental biologics license application (sBLA) for its long-acting C5 complement inhibitor, Ultomiris (ravulizumab-cwvz), under a priority review for the treatment of patients with atypical hemolytic uremic syndrome (aHUS) to inhibit complement-mediated thrombotic microangiopathy (TMA). The regulatory body has set an action date of Oct 19, 2019. This sBLA was based on data from the phase III study on Ultomiris, conducted in complement inhibitor-naive patients with aHUS, which met its primary objective of complete TMA response. The drug is already approved in the United States for treating adult patients with paroxysmal nocturnal hemoglobinuria (PNH) to be administered every eight weeks.
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