Good morning. Elizabeth Cooney here again, pinch-hitting for Ed Silverman. Although he sometimes makes his colleagues wonder if he ever sleeps, he does indeed take a vacation. Here are some news items to have with your morning coffee (choose your own adventure) on a holiday-shortened week this side of the pond (as Ed would say). …
The drug industry is experiencing one of the longest market downturns it has ever seen, and the effects are now reverberating down to privately held startups, leading to fear and fraught conversations between executives and venture capitalists and translating into real-world consequences, investors told STAT. Private companies that had been hoping to launch an IPO in a year or two are getting more desperate for financing.
Amylyx Pharmaceuticals said the U.S. Food and Drug Administration is bringing together a panel of outside experts for a second time to review new data on the company’s experimental treatment for ALS, STAT says. The FDA’s decision to schedule a second advisory panel for the Amylyx drug, called AMX0035, is unusual, particularly during the same review period. The expert panel will meet on Sept. 7, Amylyx said. The move suggests FDA officials are still debating whether to grant accelerated approval to AMX0035 now, with the requirement that Amylyx confirm the treatment’s benefit for patients with results from an ongoing Phase 3 study expected in 2024.
About the Author Reprints
Exciting news! STAT has moved its comment section to our subscriber-only app, STAT+ Connect. Subscribe to STAT+ today to join the conversation or join us on Twitter, Facebook, LinkedIn, and Threads. Let's stay connected!
To submit a correction request, please visit our Contact Us page.