STAT+: Pharmalittle: We’re reading about an FDA delay forcing a biotech to close, a Neurocrine deal, and more
Why it matters: The FDA's delay directly caused Kezar Life Sciences to wind down, impacting its autoimmune hepatitis treatment.
- Kezar Life Sciences was forced to close after an unexplained four-month delay by the FDA in scheduling a critical clinical trial design meeting for its autoimmune hepatitis treatment (STAT+).
- Novo Nordisk's Wegovy pill and Eli Lilly's Foundayo are competing in a rapidly growing oral weight-loss drug market, with doctors reporting high demand for these more convenient and affordable options (Reuters).
- Neurocrine Biosciences is set to acquire Soleno Therapeutics in a $2.9 billion deal, further illustrating significant M&A activity within the biotech sector (STAT News).
A critical four-month delay by the FDA in scheduling a meeting for Kezar Life Sciences' autoimmune hepatitis treatment led to the small biotech's closure, highlighting regulatory hurdles in drug development. Meanwhile, the market for oral weight-loss drugs is expanding rapidly, with Novo Nordisk's Wegovy and Eli Lilly's Foundayo competing for new patients seeking lower costs and greater convenience, as noted by Reuters and STAT.
