SEC Form 8-K filed by Neumora Therapeutics Inc.
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Item 8.01. Other Events
On April 15, 2024, Neumora Therapeutics, Inc. (the “Company”) announced that its Phase 1 trial of NMRA-266 has been placed on clinical hold by the U.S. Food and Drug Administration (“FDA”). NMRA-266 is a positive allosteric modulator (PAM) of the M4 muscarinic receptor and is part of the Company’s M4 PAM franchise. The clinical hold determination follows recently available pre-clinical data showing convulsions in rabbits. Following this action, the Phase 1 single ascending dose / multiple ascending dose study with NMRA-266 has been paused. Approximately 30 participants have been dosed in the Phase 1 study, with no evidence of convulsions observed in any participant. The Company is working with the FDA to evaluate the potential to resolve the clinical hold. While these discussions with the FDA are ongoing, the Company’s prior guidance regarding NMRA-266 is no longer applicable. The Company will provide an update on NMRA-266 when available.
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| NEUMORA THERAPEUTICS, INC. | ||||||
| Date: April 15, 2024 | By: | /s/ Joshua Pinto | ||||
| Joshua Pinto | ||||||
| Chief Financial Officer | ||||||