Neumora shares plummet as FDA halts NMRA-266 Phase 1 trial over safety

WATERTOWN, Mass. - Neumora Therapeutics, Inc. (NASDAQ:NMRA), a clinical-stage biopharmaceutical company, announced today that its Phase 1 trial of NMRA-266, an investigational brain disease treatment, has been placed on clinical hold by the U.S. Food and Drug Administration (FDA). The decision follows new pre-clinical data indicating convulsions in rabbits.

Neumora shares dropped 17% in premarket trading on Monday.

NMRA-266, a positive allosteric modulator of the M4 muscarinic receptor, is part of Neumora's efforts to develop treatments for brain diseases. The clinical hold has paused the Phase 1 single ascending dose / multiple ascending dose study of NMRA-266. To date, approximately 30 participants have been dosed, with no convulsions observed in any participant.

The company is actively engaging with the FDA to address the clinical hold. As a result of this development, Neumora's previous guidance on NMRA-266 is no longer applicable, and an update will be provided once more information is available.

Neumora's M4 franchise includes several novel compounds, each with unique properties and chemical composition, which have shown promise in preclinical efficacy models. The company is continuing pre-clinical safety and toxicology work on these compounds and aims to submit an Investigational New Drug (IND) application in 2025.

Henry Gosebruch, Neumora's president and Chief Executive Officer, expressed disappointment with the safety findings but affirmed the company's commitment to advancing its broader portfolio. Neumora anticipates key milestones, including Phase 3 data in major depressive disorder and the start of a Phase 2 study in bipolar depression with navacaprant, as well as a Phase 1b study in agitation in Alzheimer’s disease with NMRA-511.

Neumora Therapeutics is focused on redefining neuroscience drug development with a pipeline of seven clinical and preclinical programs targeting a range of neuropsychiatric disorders and neurodegenerative diseases. The company's approach integrates translational, clinical, and computational tools to support the development of precision medicine.

The information in this article is based on a press release statement from Neumora Therapeutics, Inc.

As Neumora Therapeutics, Inc. (NASDAQ:NMRA) navigates the recent FDA clinical hold on its NMRA-266 trial, investors and stakeholders are closely monitoring the company's financial health and market performance. According to InvestingPro, Neumora Therapeutics currently holds a market capitalization of $2.15 billion. Despite the challenges faced in the clinical trial, NMRA has experienced a significant price uptick with a 48.34% increase over the last six months. This could be indicative of investor confidence in the company's long-term prospects or its broader portfolio of clinical programs.

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While the company does not pay a dividend, which might deter income-focused investors, it is noteworthy that Neumora holds more cash than debt on its balance sheet, a InvestingPro Tip that suggests a strong financial position to weather potential setbacks. Additionally, Neumora's liquid assets exceed its short-term obligations, further indicating financial stability.

However, investors should be aware of certain concerns. The company has not been profitable over the last twelve months, and analysts do not anticipate profitability this year. Neumora's gross profit margins are also considered weak, which could impact its ability to generate income from its operations. These factors are crucial for potential investors to consider as they assess the company's future in a highly volatile biopharmaceutical market.

To gain deeper insights into Neumora Therapeutics and access additional InvestingPro Tips, interested parties can visit InvestingPro. There are currently 3 more tips available to help investors make informed decisions. For those looking to subscribe to InvestingPro, use coupon code PRONEWS24 to get an additional 10% off a yearly or biyearly Pro and Pro+ subscription.

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