BioCentury
ARTICLE | Company News

FDA hold muddies Ipsen’s timeline for palovarotene in rare bone disease

December 6, 2019 9:25 PM UTC
Updated on Dec 7, 2019 at 1:44 AM UTC

A partial clinical hold on four studies of palovarotene that shaved $1.1 billion from Ipsen’s market cap on Friday could slow the biopharma’s timeline for a planned NDA to treat rare bone disease fibrodysplasia ossificans progressiva.

Spokesperson Christian Marcoux told BioCentury the company still intends to submit the palovarotene NDA “as quickly as possible,” but the timeline is now “subject to ongoing conversations with FDA including clarification of all questions” pertaining to the hold. Ipsen Group (Euronext:IPN; Pink:IPSEY) had intended to submit the application next quarter. ...

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