Supernus Pharmaceuticals Resubmits NDA For SPN-830 Apomorphine Infusion Device
Portfolio Pulse from Benzinga Newsdesk
Supernus Pharmaceuticals has resubmitted its New Drug Application (NDA) for the SPN-830 Apomorphine Infusion Device to the U.S. Food and Drug Administration (FDA). This comes after the company believes it has addressed the FDA's questions related to a Complete Response Letter (CRL) issued in October 2022.
October 09, 2023 | 8:47 pm
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POSITIVE IMPACT
Supernus Pharmaceuticals' resubmission of the NDA for SPN-830 could potentially lead to FDA approval, which would be a positive development for the company.
The resubmission of the NDA indicates that Supernus Pharmaceuticals has addressed the FDA's concerns, which could potentially lead to the approval of the SPN-830 Apomorphine Infusion Device. This would be a positive development for the company and could have a positive impact on its stock price in the short term.
CONFIDENCE 85
IMPORTANCE 80
RELEVANCE 100