Neumora Therapeutics Inc. (NMRA)

Neumora Therapeutics (NMRA) stock fell by 17.48% following the announcement of a clinical hold by the FDA on the company's Phase 1 trial of NMRA-266. This clinical hold was imposed due to safety concerns raised by preclinical data showing convulsions in rabbits.

• Impact on NMRA-266 Development: NMRA-266, a positive allosteric modulator (PAM) of the M4 muscarinic receptor, is a key component of Neumora's M4 PAM franchise. The clinical hold has led to the pause of the Phase 1 single ascending dose / multiple ascending dose study involving NMRA-266. Despite approximately 30 participants being dosed with no observed convulsions, further development of NMRA-266 is currently on hold as Neumora works with the FDA to resolve the clinical hold.
• Next Steps and Future Outlook: Neumora is actively engaged with the FDA to address the safety concerns and explore potential solutions. Consequently, the company's prior guidance regarding NMRA-266 is no longer valid, and updates on the drug's development will be provided as new information becomes available.
• Diversified Pipeline and Other Compounds: Beyond NMRA-266, Neumora's M4 franchise includes several other compounds with different chemical compositions and properties. These compounds have demonstrated promising activity in preclinical efficacy models, high selectivity for the M4 receptor subtype, and the potential for oral once-daily dosing. Neumora is advancing preclinical safety and toxicology work with these compounds and aims to submit an IND for them in 2025.

Neumora Therapeutics Stock (NMRA) dropped by 6.45% from $11.94 to $11.17 in the trading on Tuesday October 10, 2023. The reason why NMRA stock down today is due to the change in organization structure. Neumora reported the appointment of Robert Lenz, M.D., Ph.D., as executive vice president, head of research and development.

Shares of Neumora Therapeutics (NMRA) dropped by 21.97% from $14.11 to $11.01 in the trading on Monday October 2, 2023. The reasons why stock NMRA is down today includes:

• Market Conditions: The broader stock market experienced a mixed situation on October 2, 2023. This can be attributed to concerns such as inflation, rising interest rates, and the ongoing conflict in Ukraine.
• NMRA-Specific News: On September 29, 2023, the FDA issued a Complete Response Letter (CRL) for Nemerix™, NMRA's drug for wet age-related macular degeneration, which required additional clinical data and delayed its potential launch. This led to the decline of NMRA stock price.