COMPANY |
Neumora Therapeutics, Inc. |
COURT |
United States District Court for the Southern District of New York |
CASE NUMBER |
1:25-cv-01072 |
JUDGE |
The Hon. John P. Cronan |
CLASS PERIOD |
September 15, 2023 through February 6, 2025 |
SECURITY TYPE |
Common Stock |
LEAD PLAINTIFF DEADLINE IS APRIL 7, 2025.
If you have suffered losses and would like to discuss your rights, please fill out this form or you may contact Jonathan Naji, Esq. at (484) 270-1453 or via e-mail at info@ktmc.com.
Case Background:
A class action lawsuit alleging violations of the federal securities laws has been filed on behalf of those who purchased or otherwise acquired Neumora Therapeutics, Inc. (“Neumora”) (NASDAQ: NMRA) common stock pursuant and/or traceable to Neumora’s prospectus and registration statement (collectively, the “Offering Documents”) issued in connection with Neumora’s initial public offering (“IPO”) on or around September 15, 2023, inclusive (the “Class Period”).
Neumora is a clinical-stage biopharmaceutical company that engages in developing therapeutic treatments for brain diseases, neuropsychiatric disorders, and neurodegenerative diseases. In September 2020, Neumora acquired Navacaprant, Neumora’s flagship therapeutic candidate, through its acquisition of BlackThorn Therapeutics, Inc. (“BlackThorn”).
Before the BlackThorn acquisition, BlackThorn had already begun a phase two clinical trial—which was double-blinded, randomized, and placebo controlled—to test Navacaprant as a monotherapy for the treatment of mild to moderate major depressive disorder (“MDD”) (the “Phase Two Trial”). Subsequently, Neumora decided to amend the Phase Two Trial inclusion criteria to include patients with moderate to severe MDD as this was the patient population the company planned to focus on in its later phase three trials. Neumora also included a “prespecified analysis to the Phase 2 statistical analysis plan focused on the moderate to severe MDD population.”
In June 2023, as described in the Offering Documents, Neumora completed its “End-of-Phase 2” meeting with 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”). The Phase Three Program’s purpose was to further evaluate Navacaprant as monotherapy for moderate to severe MDD.
The Class Period begins on or around September 15, 2023, when Neumora conducted its IPO, selling 14.71 million shares of common stock priced at $17.00 per share and raising over $250 million in proceeds for the shares of Neumora common stock offered to the public. In other words, the IPO was a great success for Neumora because the proceeds generated from the IPO could be deployed to fund its ongoing Phase Three Program related to Navacaprant.
On January 2, 2025, Neumora issued a press release announcing the results from the KOASTAL-1 study of Navacaprant for the treatment of moderate to severe MDD. 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-Åsberg Depression Rating Scale (‘MADRS') total score at Week 6 or the key secondary endpoint of a change from baseline in the Snaith-Hamilton Pleasure Scale (‘SHAPS') scale." In that same press release, Neumora’s Executive Vice President stated that "[w]e are disappointed by the results from KOASTAL-1 as they were not consistent with the body of evidence supporting this mechanism" and 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."
Since the IPO, the value of Neumora common stock shares has declined substantially from the IPO price of $17.00 per share, to a closing price of $1.91 per share on February 5, 2025 (an 88.7% decline from the IPO price).
The complaint alleges that, in the Offering Documents, Defendants made materially 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, Neumora 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.
What is a Lead Plaintiff?
A lead plaintiff is a representative party that acts on behalf of other class members in directing the litigation. In order to be appointed lead plaintiff, the Court must determine that the class member’s claim is typical of the claims of other class members, and that the class member will adequately represent the class. Your ability to share in any recovery is not, however, affected by the decision whether or not to serve as a lead plaintiff. Filling out the online form above or communicating with any counsel is not necessary to participate or share in any recovery achieved in this case. Any member of the purported class may move the court to serve as a lead plaintiff through counsel of his/her choice, or may choose to do nothing and remain an inactive class member.