Sanofi begins countdown for FDA isatuximab review; Cirrhosis-focused biotech presents another mini IPO
→ Sanofi has a milestone to celebrate today with its top late-stage prospect isatuximab as the FDA accepts the BLA for review. Positioned as a blockbuster rival to Darzalex from J&J and Genmab, isatuximab is an anti-CD38 drug that’s scored positive data in treating relapsed/refractory multiple myeloma. The EMA is also evaluating a marketing application as Sanofi and its entrenched competitors both continue to test their respective drugs in earlier settings.
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