Supernus Provides Regulatory Update For SPN-830, FDA Has Issued A CRL In Response To The Co's NDA For Spn-830 Indicating That The Review Cycle For The Application Is Complete, But That The Application Is Not Ready For Approval In Its Present Form.
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Supernus Pharmaceuticals, Inc. (NASDAQ:SUPN) received a Complete Response Letter (CRL) from the FDA for its New Drug Application (NDA) for SPN-830, an investigational apomorphine infusion device for Parkinson's disease. The CRL indicates the application is not ready for approval due to issues related to product quality and the master file for the infusion device. Supernus plans to address these issues and resubmit the NDA. No clinical safety or efficacy issues were identified.
April 08, 2024 | 12:06 pm
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Supernus Pharmaceuticals received a CRL from the FDA for SPN-830, delaying its potential approval. The company plans to address the FDA's concerns and resubmit the NDA.
The issuance of a CRL by the FDA typically delays the approval process of a drug or device, potentially impacting the company's revenue projections and investor confidence in the short term. Although no clinical safety or efficacy issues were identified, the need to address product quality and device master file concerns could lead to delays in resubmission and approval, negatively affecting the stock price.
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