By Josh Nathan-Kazis
Shares of the biotech Neumora Therapeutics began the first trading day of 2025 with a loss of more than 80% after the company said that its experimental depression drug failed in a key trial.
Patients who received the drug, called navacaprant, showed no more improvement in depressive symptoms than people who received a placebo. The Phase 3 trial was the first of three that were intended to pave the way for the drug's approval as a treatment for major depressive disorder.
That approval is now looking increasingly unlikely.
But there is still hope for Neumora, which has no approved drug in its portfolio. Navacaprant could perform better in the two continuing Phase 3 trials. And while navacaprant is Neumora's lead pipeline asset, the company has a handful of other drugs in earlier phases of testing.
Neumora said Thursday that it has enough cash on hand to operate through the middle of 2026.
Neumora went public in September of 2023 with an opening price of $16.50 per share. The stock ended 2024 at $10.60, and was down 81% at $2.06 shortly after the open on Thursday.
While there are many medicines available to treat major depressive disorder, including cheap generics, navacaprant works differently than existing drugs. Based on the results of earlier trials, Neumora had hoped that navacaprant's new mechanism would allow it to treat anhedonia, an inability to feel pleasure, a common symptom that current depression drugs aren't always able to treat.
The results of the Phase 3 trial weren't encouraging.
Neumora said that after six weeks, patients on navacaprant saw a 12.5-point reduction in depression on a metric called the Montgomery-Åsberg Depression Rating Scale. Patients on a placebo saw the exact same reduction.
Ahead of the results, William Blair analyst Myles Minter had written that a two-point difference between the navacaprant group and the placebo group was the minimum required to be seen as clinically significant, or enough to make a real-world difference.
On a separate assessment meant to measure the ability to feel pleasure, called the Snaith-Hamilton Pleasure Scale, patients on navacaprant saw a 5.8 point reduction, while patients on the placebo saw a 5.5 point production.
The company said that the study "did not demonstrate statistically significant improvement on primary endpoint of reduction in depressive symptoms."
Neumora said in its press release that there was an "efficacy signal" in female participants in the trial, and that it would further analyze those results. On the MADRS measure, female participants on navacaprant saw a 14-point reduction, better than the 11.4-point reduction for female participants on the placebo.
For male participants, however, the drug appeared to work worse than the placebo. Male participants saw a 10.6-point reduction on navacaprant, and a 13.8-point reduction on the placebo.
Write to Josh Nathan-Kazis at josh.nathan-kazis@barrons.com
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January 02, 2025 09:59 ET (14:59 GMT)
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