Supernus Provides Regulatory Update for SPN-830 [Yahoo! Finance]
Supernus Pharmaceuticals, Inc. (SUPN)
Last supernus pharmaceuticals, inc. earnings: 2/25 04:40 pm
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Source: Yahoo! Finance
and commercializing products for the treatment of central nervous system (CNS) diseases, today announced a regulatory update for SPN-830. SPN-830 is an investigational apomorphine infusion device for the continuous treatment of motor fluctuations (“off” episodes) in Parkinson's disease (PD) under U.S. Food and Drug Administration (FDA) review. The FDA has issued a Complete Response Letter (CRL) in response to the Company's New Drug Application (NDA) for SPN-830. The CRL indicates that the review cycle for the application is complete, but that the application is not ready for approval in its present form. The CRL mentions two areas that require additional review by the FDA or additional information to be provided to the FDA. The first area relates to product quality. The Company recently submitted additional product quality data to the FDA which it has not yet reviewed. The second relates to the master file for the infusion device which is proprietary to the device manufacturer. Th
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- SHAREHOLDER ALERT: Pomerantz Law Firm Investigates Claims on Behalf of Investors of Supernus Pharmaceuticals, Inc. - SUPNGlobeNewswire
- SHAREHOLDER ALERT: Pomerantz Law Firm Investigates Claims on Behalf of Investors of Supernus Pharmaceuticals, Inc. - SUPNPR Newswire
SUPN
Earnings
- 2/27/24 - Miss
SUPN
Sec Filings
- 4/29/24 - Form DEFA14A
- 4/29/24 - Form ARS
- 4/29/24 - Form DEF
- SUPN's page on the SEC website