Supernus falls after FDA rejects infusion device for Parkinson's disease

Supernus Pharmaceuticals

10/10/2022 14:04

** Shares of Supernus Pharmaceuticals Inc  SUPN.O  drop ~10%
to $29.80 premarket
    ** Co says the U.S. Food and Drug Administration has
declined to approve its experimental apomorphine infusion
device, SPN-830, for continuous treatment of motor fluctuations
in Parkinson's disease  urn:newsml:reuters.com:*:nGNX5ZsH5y
    ** Co says FDA's complete response letter (CRL) requires
additional information and analysis related to device and drug
product across several areas 
    ** FDA mentions that marketing approval of the device
requires inspections that could not be completed in a timely
manner due to COVID-19 travel restrictions - SUPN 
    ** SUPN adds that the FDA does not seek additional efficacy
and safety clinical studies
    ** Co says it will continue to work with the regulator, and
when possible, provide clarity regarding potential timing of
resubmission of the application 
    ** As of last close, stock up ~14% YTD
 (Reporting by Raghav Mahobe)
 ((Raghav.Mahobe@thomsonreuters.com;))