Thinly traded micro cap Acer Therapeutics (NASDAQ:ACER) is poised for a significant down move this morning on the news that it received a Complete Response Letter (CRL) from the FDA regarding its marketing application for EDSIVO (celiprolol) for the treatment of vascular Ehlers-Danlos syndrome (vEDS), an inherited collagen disorder characterized by thin, translucent easily bruised skin.
The CRL cites the need for a new clinical trial to assess celiprolol’s effect on reducing the risk of clinical events in vEDS patients.
Shares, currently halted, will resume trading at 9:00 am ET.
Update: Shares are down 76% premarket on increased volume.
No comments:
Post a Comment
Note: Only a member of this blog may post a comment.