FDA's Crowded November: Ivonescimab, Deramiocel and Povetacicept Face Verdicts
- Summit's ivonescimab for EGFR-mutated lung cancer after TKI therapy is due by November 14; it would be the first PD-1xVEGF bispecific cleared in the US. Capricor's DMD cell therapy deramiocel is due November 22 after a 9-3 negative advisory vote.
- Vertex's povetacicept in IgA nephropathy is due by November 30; rivals from Novartis and Vera are already approved. At least 11 action dates fall this month.
💡 Points Based on public reports
Ivonescimab is the cleanest read-through: a progression-free-survival win without a significant overall-survival result at filing, so approval would show how much the FDA discounts a later nominal survival signal. Capricor is the opposite, a negative panel and a prior rejection. Povetacicept is a late entrant, so label and pricing decide how fast it takes share.
Verdicts for Summit/Akeso, Capricor, Vertex mark FDA’s stacked November ↗