Emmaus Sickle Cell NDA Facing FDA Concerns About Clinical Meaningfulness
PGLG's application only has one Phase III trial, and Emmaus is hoping statistical re-analyses can address FDA skepticism about clinical meaningfulness of the primary endpoint data.
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The latest drug development news and highlights from our FDA Performance Tracker.
The first IPO for a pharmaceutical company nurtured by Karolinska Development is expected to involve Modus Therapeutics, which has changed its name from Dilaforette and is pursuing the development of a Phase II potential sickle cell therapy.
Shares in Mast Therapeutics dropped by more than 80% upon news that a Phase III trial of its lead product vepoloxamer in sickle cell disease had failed.