Supernus Pharmaceuticals Faces Second FDA Rejection For Investigational Device For Parkinson's Disease
Portfolio Pulse from Vandana Singh
Supernus Pharmaceuticals Inc. (NASDAQ:SUPN) received a second Complete Response Letter (CRL) from the FDA for its investigational device, SPN-830, aimed at treating Parkinson's disease. The FDA's concerns relate to product quality and the master file for the infusion device. Despite no clinical safety or efficacy issues being identified, the FDA requires additional information for approval. Supernus plans to work with the device manufacturer to address these issues. SUPN stock dropped 9% in premarket trading and closed down 1.61% at $33.01.
April 08, 2024 | 2:11 pm
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Supernus Pharmaceuticals Inc. received a second FDA rejection for SPN-830, causing a 9% drop in premarket trading and a 1.61% decrease at close.
The second FDA rejection of SPN-830, particularly without identifying clinical safety or efficacy issues, suggests regulatory hurdles that are significant but potentially addressable. The immediate negative market reaction reflects investor concerns over the delay in approval and potential additional costs for compliance. However, the company's intention to work with the device manufacturer to address the FDA's concerns could mitigate long-term impacts if they successfully resubmit and obtain approval.
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