UNITED STATES
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CURRENT REPORT
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| Item 8.01 | Other Events. |
On Thursday, October 12, 2023, Vigil Neuroscience, Inc. (the “Company”) provided an update on the Company’s small molecule TREM2 agonist, VG-3927. The Company announced that it received the 30-day response letter (“Letter”) from the U.S. Food and Drug Administration (“FDA”) regarding the previously communicated partial clinical hold on its Investigational New Drug application for VG-3927. The Letter states that additional non-clinical data will need to be provided in order to exceed the maximum exposure limit in the Phase 1 trial evaluating VG-3927 in healthy volunteers. The Company is in the process of obtaining additional pharmacokinetic data and will work with the FDA to address the partial clinical hold.
The Company stated that the Letter otherwise does not alter its prior statements concerning its small molecule TREM2 agonist program.
The disclosure under this Item 8.01 contains “forward-looking statements” of the Company that are made pursuant to the safe harbor provisions of the federal securities laws, including, without limitation, express or implied statements regarding the Company’s ability to work with the FDA to address the partial clinical hold. Factors that could cause actual results to differ include the risks inherent in working with the FDA and the Company’s ability to provide additional pharmacokinetic data to the FDA; as well as the risks and uncertainties identified in the Company’s filings with the Securities and Exchange Commission (SEC), including Vigil’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2023 and in any subsequent filings it may make with the SEC. Forward-looking statements contained in this announcement are made as of this date, and Vigil undertakes no duty to update such information except as required under applicable law. All disclosure under this Item 8.01 is as of the date of this Form 8-K, and the Company undertakes no duty to update this information unless required by law.
SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| Vigil Neuroscience, Inc. | ||||||
| Date: October 12, 2023 | By: | /s/ Ivana Magovčević-Liebisch | ||||
| Ivana Magovčević-Liebisch | ||||||
| President and Chief Executive Officer | ||||||