Supernus down as FDA declines nod to its Parkinson's disease drug-device combo

Supernus Pharmaceuticals

08/04/2024 13:29

** Shares of Supernus Pharmaceuticals  SUPN.O  fall 10.6% to
$30 premarket
    ** Co says U.S. FDA has declined to approve its application
for its experimental apomorphine infusion device for the
continuous treatment of motor fluctuations in Parkinson's
disease
    ** FDA's letter says the application is not ready for
approval in its present form
     ** FDA has mentioned two areas requiring additional review
or information
    ** SUPN recently submitted additional product quality data
to FDA which it has not yet reviewed
    ** Second area relates to the master file for infusion
device which is proprietary to device manufacturer
    ** Co plans to discuss with manufacturer the requested
information and steps required for resubmission 
    ** No clinical safety or efficacy issues were identified as
a requirement for approval - SUPN
    ** Up to last close, stock up ~16% YTD

 (Reporting by Sriparna Roy in Bengaluru)
 ((Sriparna.Roy@thomsonreuters.com;))