BioCentury
ARTICLE | Product Development

Complete response for Sanofi’s rare anemia candidate; plus Sumitovant-Urovant, C4-Roche, IN8bio and Synendos 

November 14, 2020 4:19 AM UTC

Setback for Sanofi rare anemia therapy
Sanofi (Euronext:SAN; NASDAQ:SNY) said late Friday that FDA issued a complete response letter to a BLA for anti-C1s mAb sutimlimab to treat hemolysis in adults with cold agglutinin disease, a rare anemia. The French pharma said the letter cited deficiencies identified during a prelicense inspection of a third-party manufacturing facility, and that it is in contact with FDA and the manufacturer to resolve the problem quickly.

Sumitovant to acquire remainder of Urovant
Sumitovant Biopharma Inc. will acquire the remaining 28% of Urovant Sciences  Ltd.(NASDAQ:UROV) it does not already own for $16.25 per share in cash, which values Urovant at $681 million and represents a 96% premium to Urovant’s closing price of $8.28 on Thursday. ...

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