Neumora Therapeutics

J&J Discontinues Depression Trials for Aticaprant After Insufficient Efficacy Results

3 months ago

• Johnson & Johnson has terminated Phase III VENTURA trials for aticaprant as an add-on therapy for major depressive disorder due to insufficient efficacy, despite previous projections of $1-5 billion in peak annual sales. • The setback impacts J&J's goal of becoming the top neuroscience company by 2030, though the company remains committed to exploring aticaprant's potential in other therapeutic areas with high unmet needs. • The failure raises doubts about kappa opioid receptor antagonists in depression treatment, affecting other companies like Neumora Therapeutics, whose similar drug navacaprant also failed in Phase III trials earlier this year.

Neumora's Depression Drug Navacaprant Fails Phase III Trial, Triggering Stock Plunge and Legal Investigation

4 months ago

• Neumora Therapeutics' experimental depression treatment navacaprant failed to show efficacy in the Phase III Koastal-1 trial, demonstrating no significant difference from placebo. • The company's stock price suffered a dramatic 81% decline, falling to $1.97 per share following the announcement on January 2, 2025. • Law firm Levi & Korsinsky has launched an investigation into potential federal securities law violations by Neumora Therapeutics in response to the trial failure.

Neumora's Navacaprant Fails Phase 3 Trial for Major Depressive Disorder

5 months ago

• Neumora Therapeutics' navacaprant failed to meet the primary endpoint in its Phase 3 KOASTAL-1 study for major depressive disorder (MDD). • The trial did not demonstrate a statistically significant improvement in depressive symptoms compared to placebo, as measured by the MADRS scale. • An efficacy signal was observed in female participants, warranting further investigation into gender-specific responses. • Despite the setback, Neumora has a strong cash balance and will continue to analyze the data and provide updates at the J.P. Morgan Healthcare Conference.

Ziftomenib Shows Promise in AML: Kura Oncology and Kyowa Kirin Advance to Phase 3 Trials

6 months ago

• Kura Oncology and Kyowa Kirin's ziftomenib demonstrates statistically significant efficacy in Phase 2 trial for relapsed/refractory NPM1-mutant acute myeloid leukemia (AML). • The companies plan to submit a New Drug Application (NDA) to the FDA in the second quarter of 2025, seeking approval for ziftomenib in R/R NPM1-m AML. • Phase 3 trials are set to begin in the second half of 2025, evaluating ziftomenib in combination with intensive and non-intensive chemotherapy regimens for newly diagnosed AML. • FDA feedback supports potential accelerated approval pathways in both intensive and non-intensive treatment settings, based on MRD negative CR and CR endpoints.