Biotech Stock Roundup: CELG's Inrebic Gets FDA Nod, SRPT Suffers Setback & More
Zacks Investment Research | Aug 20, 2019 11:00PM ET
It was a busy week for the sector with updates from quite a few big biotechs. While Celgene (NASDAQ:CELG) won the FDA approval for its bone marrow cancer drug, Gilead’s (NASDAQ:GILD) marketing authorization application (MAA) for filgotinib for rheumatoid arthritis and Vertex’s (NASDAQ:VRTX) new drug application (NDA) for the triple combination regimen of VX-445 (elexacaftor), tezacaftor and ivacaftor have been accepted by the European Medicines Agency (EMA) and the FDA, respectively. Meanwhile, Sarepta (NASDAQ:SRPT) plummeted as the FDA rejected its muscular dystrophy treatment.
Recap of the Week’s Most Important Stories:
Celgene Gets FDA Approval for Bone Marrow Cancer Drug: Celgene Corporation plunged significantly after the FDA rejected the application for the approval of its exon 53 skipping candidate, golodirsen. The company had filed an NDA in December last year, seeking accelerated approval for the candidate as a potential treatment for Duchenne muscular dystrophy (DMD). The FDA issued a CRL against the NDA for golodirsen, citing two concerns — the risk of infections related to intravenous infusion ports and renal toxicity seen in pre-clinical models. Sarepta stated that renal toxicity in pre-clinical models was observed in doses ten times the dose used in clinical studies. The renal toxicity issue raised in the CRL was not observed in the clinical trial — Study 4053-101 — which formed the basis for the golodirsen NDA.
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Biotech Stock Roundup: Amgen’s Enbrel Patent Win, AMRN’s Setback & More )
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