Jul. 3 at 1:47 PM
For those of you tracking PDUFA resubmissions,
$REGN received news on their resubmission for Lynozyfic (linvoseltamab-gcpt) for the treatment of relapsed/refarctory multiple myeloma.
REGN's Lynozyfic BLA resubmission was accepted in Feb & granted a PDUFA date of July 10. REGN announced the approval today, 1 week ahead of PDUFA.
https://investor.regeneron.com/news-releases/news-release-details/lynozyfictm-linvoseltamab-gcpt-receives-fda-accelerated-approval
$OTLK has a PDUFA deadline of 27 Aug for their resubmission of LYTENAVA (ONS-5010).
$OMER has a PDUFA deadline of 25 Sept for their resubmission of narsoplimab.