Introducing STAT’s Biotech Q4 Scorecard: Ten companies with important clinical trial and FDA milestones scheduled to read out over the next three months. We’ll use emojis to track the winners and losers as the outcomes are announced. Scroll down for a short explanation of each company and its pivotal readout.
Axovant Sciences (AXON) and Sage Therapeutics (SAGE): Two holdovers from our September scorecard are seeking redemption after humbling failures of their lead drugs in pivotal clinical trials. Data are coming on a mid-stage study of Axovant’s intepirdine in patients with Lewy Body dementia. That’s the backup indication after the drug’s failure in Alzheimer’s. Sage is conducting a phase 3 study of brexanolone in postpartum depression following the drug’s failure to reduce seizures in patients with a severe form of epilepsy.
Are you considering the KITE/GILEAD axi-cel approval on/about November 29 FDA PDUFA date a forgone conclusion? It won’t exactly “break” Gilead with a CRL (Complete Response Letter) but if that happens, don’t you think it would result in a huge drop in the stock price?
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