NEW YORK--(BUSINESS WIRE)-- The law firm of Kirby McInerney LLP reminds investors that a class action lawsuit has been filed in the U.S. District Court for the Southern District of New York on behalf of those who acquired Neumora Therapeutics, Inc. (“Neumora” or the “Company”) (NASDAQ:NMRA): (a) common stock pursuant and/or traceable to the registration statement and prospectus (collectively, the “Offering Documents”) issued in connection with the Company’s September 2023, initial public offering (“IPO” or the “Offering”). Investors have until April 7, 2025, to apply to the Court to be appointed as lead plaintiff in the lawsuit.

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Neumora’s flagship therapeutic candidate is Navacaprant, a one-daily oral kappa opioid receptor antagonist aimed at treating major depressive disorder (“MDD”).

In June 2023, as described in the Offering Documents, Neumora completed its “End-of-Phase 2” meeting with the U.S. Food & Drug Administration (the “FDA”), which purportedly showed Navacaprant to be an effective monotherapy in treating moderate to severe MDD, providing statistically significant improvements in depressive symptoms. Due to the Phase Two Trial results, Neumora initiated its “pivotal” phase three program, which included three efficacy studies: KOASTAL-1, KOASTAL-2, and KOASTAL-3 (collectively referred to as the “Phase Three Program”).

On or about September 15, 2023, Neumora conducted the IPO and raised more than $250 million from the investing public. The lawsuit alleges that, unbeknownst to investors, Neumora’s KOASTAL-1 study, was riddled with risks and uncertainties that were well known by the Company at the time of the IPO.

Before the markets opened on January 2, 2025, Neumora issued a press release announcing the results from the KOASTAL 1 study. The press release revealed that the KOASTAL-1 study failed to “demonstrate a statistically significant improvement on the primary endpoint of change from baseline in the Montgomery-Asberg Depression Rating Scale total score at Week 6 or the key secondary endpoint of a change from baseline in the Snaith-Hamilton Please Scale. Essentially, there was no significant difference between the Navacaprant and placebo. In that same press release, Executive Vice President Rob Lenz stated that there is “a lot to investigate from this study” due to the “contrast in drug and placebo responses in depressed mood and anhedonia in female compared to male participants.” On this news, Neumora shares fell by $8.63 per share, or approximately 81%, from $10.60 per share on December 31, 2024, to close at $1.97 on January 2, 2025.

After markets closed on January 14, 2025, Neumora presented at the 43^rd Annual J.P. Morgan Healthcare Conference. During the conference, Lenz explained that the percentage of men in the KOASTAL-1 study’s patient population was “one aspect of the trial we did not anticipate at the beginning of the trial,” while also acknowledging that the KOASTAL-1 study “did not meet statistical significance” on its primary and secondary endpoints. When asked by an analysist regarding prior data gathered in the Phase Two trial, CEO Henry Gosebruch explained that the patient population size may had been too small to foresee the stark difference in improvement of symptoms between the sexes.

Since the IPO, the value of Neumora’s common stock has declined substantially from the IPO price of $17 per share to a closing price of $1.95 per share on February 6, 2025, a decline of more than 88%.

The complaint alleges that the Offering Documents contained false and/or misleading statements and/or failed to disclose that: (1) in order for Neumora to justify conducting its Phase Three Program, Neumora was forced to amend BlackThorn’s original Phase Two Trial inclusion criteria to include a patient population with moderate to severe MDD to show that Navacaprant offered a statistically significant improvement in treating MDD; (2) and to that same end, the Company also added a prespecified analysis to the Phase Two statistical analysis plan, focusing on patients suffering from moderate to severe MDD; and (3) the Phase Two Trials lacked adequate data, particularly in regards to the patient population size and the ratio of male to female patients within the patient population, to be able to accurately predict the results of the KOASTAL-1 study.

If you purchased or otherwise acquired Neumora securities, have information, or would like to learn more about this investigation, please contact Thomas W. Elrod of Kirby McInerney LLP by email at investigations@kmllp.com or fill out the form below, to discuss your rights or interests with respect to these matters without any cost to you.

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Kirby McInerney LLP is a New York-based plaintiffs’ law firm concentrating in securities, antitrust, whistleblower, and consumer litigation. The firm’s efforts on behalf of shareholders in securities litigation have resulted in recoveries totaling billions of dollars. Additional information about the firm can be found at Kirby McInerney LLP’s website.

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