Vigil Neuroscience, Inc. Has Received A Response Letter From The FDA Regarding The Partial Clinical Hold On Its Drug VG-3927, Stating That Additional Non-Clinical Data Is Needed To Exceed The Maximum Exposure Limit In The Phase 1 Trial
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Vigil Neuroscience, Inc. has received a response from the FDA regarding the partial clinical hold on its drug VG-3927. The FDA has requested additional non-clinical data to exceed the maximum exposure limit in the Phase 1 trial. The company is working on obtaining the required data and will work with the FDA to address the hold. The company's statements about its TREM2 agonist program remain unchanged.
October 12, 2023 | 8:15 pm
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Vigil Neuroscience's drug VG-3927 is under partial clinical hold by the FDA, which has requested additional non-clinical data. The company is working to provide the required data and address the hold.
The FDA's request for additional non-clinical data and the partial clinical hold on VG-3927 could delay the drug's development and approval process, potentially impacting Vigil Neuroscience's stock negatively in the short term.
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