Shares of Neumora Therapeutics NMRA lost more than 80% on Thursday after reporting the failure of its lead pipeline drug, navacaprant, in a late-stage study for major depressive disorder (MDD).
The phase III KOASTAL-1 study evaluated the efficacy and safety of navacaprant against placebo in adults with moderate-to-severe MDD over a six-week treatment period. The study failed to achieve its primary endpoint – treatment with the drug failed to demonstrate a significant improvement over placebo in alleviating depression symptoms, as measured by the Montgomery-Asberg Depression Rating Scale (MADRS).
The study also failed to show statistically significant improvement in the reduction of anhedonia (the inability to feel pleasure), as assessed by the Snaith-Hamilton Pleasure Scale (SHAPS).
The KOASTAL-1 study is one of the three late-stage studies in the KOASTAL program evaluating navacaprant in the MDD indication. Despite the study's failure, Neumora intends to continue the other two studies. In the meantime, management continues to further analyze the study results, as management claimed that the drug showed an efficacy signal in female patients.
NMRA Stock Performance
Following the news, shares of Neumora hit an all-time low of $1.83. The latest announcement failed to impress investors, who had high hopes for navacaprant based on data from a previously conducted mid-stage study.
In the past year, Neumora Therapeutics’ shares have plummeted 87.5% compared with the industry’s 13.6% decline.
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More on NMRA’s KOASTAL-1 Study Results
A total of 383 study participants were enrolled in the KOASTAL-1 study, who were randomized into two equal groups – one receiving navacaprant and the other receiving placebo.
Data from the study revealed that patients in both groups achieved the same scores on the MADRS scale, which was an average 12.5-point decrease in depression symptoms. MADRS is a metric showing the improvement of depressive symptoms in MDD patients compared with placebo after the treatment period. A higher MADRS score reflects greater depression severity.
However, Neumora's reported results revealed a variation in response based on gender. Men who received navacaprant achieved an average 10.6-point decrease in depression symptoms, compared to an average 14-point decrease in women. When comparing these results against their respective placebo groups, the results favored the male patients – men who took the placebo experienced an average 13.8-point decrease compared to the average 11.4-point decrease observed in women.
Some investors also raised concerns about a lack of explanation on Neumora’s part as to why navacaprant would perform better in women than in men. The SHAPS scale, which measures a person's ability to feel pleasure, also favored men. A higher total SHAPS score indicates higher levels of the current state of anhedonia.
NMRA’s Zacks Rank
Neumora Therapeutics currently carries a Zacks Rank #3 (Hold).
Neumora Therapeutics, Inc. Price
Neumora Therapeutics, Inc. price | Neumora Therapeutics, Inc. Quote
Key Picks Among Biotech Stocks
Some better-ranked stocks from the sector are Castle Biosciences CSTL, CytomX Therapeutics CTMX and Spero Therapeutics SPRO. CSTL and SPRO sport a Zacks Rank #1 (Strong Buy) at present, and CTMX carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Bottom-line estimates for Castle Biosciences have improved from a loss of 59 cents per share to earnings of 34 cents for 2024 in the past 60 days. During the same timeframe, loss per share estimates for 2025 have narrowed from $2.15 to $1.84. In the past year, shares of Castle Biosciences have surged 34.9%.
CSTL’s earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 172.72%.
In the past 60 days, estimates for Spero Therapeutics’ 2024 loss per share have narrowed from $1.59 to $1.29. Estimates for 2025 loss per share have narrowed from $1.54 to 79 cents during the same timeframe. In the past year, Spero’s shares have lost 26.5%.
SPRO’s earnings beat estimates in two of the trailing four quarters and missed the mark in the other two, delivering an average surprise of 94.42%.
In the past 60 days, estimates for CytomX Therapeutics’ 2024 loss per share have narrowed from 29 cents to 5 cents. Estimates for 2025 loss per share have narrowed from 56 cents to 35 cents during the same timeframe. CTMX’s shares have lost 34.9% in the past year.
CytomX’s earnings beat estimates in two of the trailing four quarters and missed the mark in the other two, delivering an average surprise of 115.70%.
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