MW Neumora Therapeutics' stock craters after trial of major depressive disorder fails to meet main goals

By Ciara Linnane

News is a setback for the clinical-stage biotech and a drug that proved successful in earlier trials

Neumora Therapeutics Inc.'s stock tumbled 80% Thursday, after the clinical-stage biotech said a late-stage trial of a treatment for major depressive disorder failed to meet its main goals.

The Watertown, Mass.-based company $(NMRA)$ said the Phase 3 trial of navacaprant failed to demonstrate statistically significant improvement on the primary endpoint of reduction in depressive symptom compared to placebo at week 6.

Navacaprant is the company's main product candidate, and was measured using the Montgomery-Åsberg Depression Rating Scale, or MADRS, a 10-question diagnostic questionnaire used by mental-health professionals to measure the severity of depressive symptoms.

The treatment also failed to meet a secondary endpoint of change from baseline in the Snaith-Hamilton Pleasure Scale, or SHAPS, which measures anhedonia, the inability to experience pleasure.

"We are disappointed by the results from KOASTAL-1 as they were not consistent with the body of evidence supporting this mechanism in MDD," said Rob Lenz, executive vice president and head of R&D at Neumora in prepared remarks.

The treatment did show an efficacy signal in women, however and the company will further analyze the data, he said.

"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," he said.

In the meantime, the company has a strong financial foundation with a cash balance of $342 million as of the end of the third quarter, offering it runway into 2026, said Henry Gosebruch, president and chief executive.

The study involved 383 adult patients suffering from MDD. The study is one of three Phase 3 trials being conducted under the Koastal banner. Navacaprant was safe and well tolerated with no serious adverse effects.

Neumora is also conducting trials evaluating navacaprant as a treatment for other central nervous system disorders, including bipolar depression, Alzheimer's disease agitation, schizophrenia and Parkinson's disease.

MMD is a chronic psychiatric condition that affects more than 21 million people in the U.S.. Women are nearly twice as likely as men to develop the disease, according to the National Alliance on Mental Illness.

Nearly 70% of MDD patients fail to achieve remission with first-line treatment, which can cause side effects such as weight gain, sexual dysfunction, drowsiness, nausea and insomnia.

Navacaprant is a novel kappa opioid receptor antagonist, where kappa opioid receptors are targets for anhedonia that are expressed in brain circuits regulating reward, motivation, stress, and anxiety.

The drug proved effective in a Phase 2 trial and did not demonstrate any of the unpleasant side-effects, such as weight gain or sexual dysfunction, that other depression treatments can cause, leading patients to stop taking them.

Mizuho analysts were bullish on Neumora's stock before Thursday's release, noting that it's been 30 years since a novel mechanism of action for MDD was approved, creating a high unmet need.

-Ciara Linnane

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January 02, 2025 10:27 ET (15:27 GMT)

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