The FDA Has Extended The Review Period For GSK's New Drug Application For Momelotinib By Three Months To Provide Time To Review Recently Submitted Data, Extended Action Date Is 16 September 2023
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The FDA has extended the review period for GSK's new drug application for Momelotinib by three months to provide time to review recently submitted data. The extended action date is now set for 16 September 2023.
June 16, 2023 | 10:51 am
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GSK's new drug application for Momelotinib has its review period extended by the FDA by three months to review recently submitted data, with a new action date of 16 September 2023.
The FDA's extension of the review period for GSK's Momelotinib drug application is a neutral event for the company's stock price in the short term. While it may cause some uncertainty among investors, it is not an outright rejection or approval of the drug. The extension allows the FDA to review additional data, which could potentially lead to a more favorable outcome for GSK. However, the impact on the stock price will depend on the final decision by the FDA, which is now expected on 16 September 2023.
CONFIDENCE 90
IMPORTANCE 75
RELEVANCE 100