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Monday, July 6, 2020

Cellectis under pressure on safety signal in multiple myeloma study

Cellectis (NASDAQ:CLLS) is down 8% after hours after its Phase 1 MELANI-01 trial in multiple myeloma patients was placed on clinical hold by the FDA.
The agency suspended the study after one participant who received candidate UCARTCS1A experienced a fatal heart attack.
Clinical evaluation of the incident is ongoing. The company is working to address the required changes to the MELANI-01 clinical protocol aimed at enhancing patient safety.
UCARTCS1A is an allogeneic, off-the-shelf, gene-edited T-cell product candidate designed for CS1/SLAMF7-expressing blood cancers.

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