Neuroscience company Neumora Therapeutics (NMRA-81.13%) announced today that its experimental treatment for depression, Navacaprant, fell short of expectations in a late-stage clinical trial, disappointing Wall Street.
Navacaprant failed to show meaningful improvements in depression scores compared to a placebo in its KOASTAL-1 trial. After six weeks, both the treatment group and the placebo group experienced an average 12.5-point reduction on the Montgomery-Åsberg Depression Rating Scale (MADRS). The drug also fell short in improving participants’ ability to experience pleasure, showing no statistically significant difference compared to the placebo.
The company’s stock (NMRA) plummeted over 80% following the announcement, hitting an all-time low of under $2 per share on the NASDAQ.
“We will not waver on our mission to make a difference for people living with brain diseases, which our broad pipeline of novel programs has the potential to address. The outcome of KOASTAL-1 is not what we expected, but there are encouraging trends in the data that we are analyzing,” said Neumora CEO Henry Gosebruch in a statement. 383 people participated in the trial.
He added that the company’s coffers, including a cash balance of $342 million at the end of the third quarter, provides a runway through mid-2026.
This was the first of three planned phase-3 trials of the drug.
Neumora aims to offer a new way of treating depression. Unlike most common antidepressants that work by boosting serotonin levels in the brain, navacaprant targets kappa opioid receptors, which are involved in regulating mood, pain, and stress.
“There is a lot to investigate from this study, in particular the contrast in drug and placebo responses in depressed mood and anhedonia in female participants compared to male participants,” said Rob Lenz, who leads research and development at Neumora.
Female participants taking navacaprant reported an average 14-point reduction on the MADRS, outpacing the placebo group by several points. Meanwhile, male participants in the treatment group showed a smaller average reduction of 10.6 points.
A previous, smaller study of the drug found statistically significant and clinically meaningful improvements in symptoms of depression in patients with moderate-to-severe depression.
At the time, Neumora co-founder Paul L. Burns called the drug “truly novel” and said it may be able to help manage ahedonia, the reduced ability to experience joy and pleasure.
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Neumora Therapeutics’ stock has plummeted over 80% following the failure of its experimental depression drug, navacaprant, in a Phase 3 trial. Barron’s
The trial, known as Koastal-1, involved 383 adults and aimed to assess the drug’s efficacy in treating major depressive disorder (MDD). Unfortunately, navacaprant did not demonstrate a statistically significant improvement in depressive symptoms compared to a placebo, as measured by the Montgomery-Åsberg Depression Rating Scale (MADRS). Additionally, it showed minimal impact on anhedonia, the inability to feel pleasure, assessed by the Snaith-Hamilton Pleasure Scale (SHAPS). MarketWatch
Analysts expressed surprise at these negative results, especially given prior promising data. Brian Abrahams of RBC Capital Markets noted higher placebo responses in this study, which may have contributed to the outcome. Subgroup analyses suggested a potential differential effect based on gender, with hints of better performance in female participants; however, the effect was not significant enough to inspire confidence for future trials. Barron’s
Despite this setback, Neumora maintains a robust financial position, with a cash balance of $342 million, ensuring operational stability until mid-2026. The company plans to continue evaluating navacaprant in other disorders, such as bipolar depression and Alzheimer’s-related agitation. MarketWatch
Neumora Therapeutics went public in September 2023 at $16.50 per share. Following the recent announcement, the stock has fallen to approximately $2.06, marking a significant decline. Barron’s
