Zevra Therapeutics Resubmits Its New Drug Application For Arimoclomol For Niemann-pick Disease Type C To FDA. Zevra Expects The Application To Be Classified As A Class II Submission Which Would Be Subject To A Review Period By FDA Within Six Months
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Zevra Therapeutics has resubmitted its New Drug Application (NDA) for Arimoclomol, a treatment for Niemann-Pick disease type C, to the FDA. The company anticipates that the application will be considered a Class II submission, which would lead to a six-month review period by the FDA.
December 27, 2023 | 12:33 pm
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Zevra Therapeutics has resubmitted its NDA for Arimoclomol, potentially advancing the drug's approval process with a six-month FDA review.
The resubmission of the NDA for Arimoclomol is a critical regulatory step for Zevra Therapeutics, as it could lead to the approval of the drug. If classified as a Class II submission, the six-month review period is a positive development, indicating a potentially faster path to market. This news is likely to be viewed positively by investors, as it demonstrates progress in the drug's development and could lead to future revenue for the company if approved.
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