JNJ Halts Development of Depression Drug Over Efficacy Concerns

Johnson & Johnson (JNJ Quick QuoteJNJ – Free Report) decided to discontinue the Phase 3 VENTURA development program, which is evaluating aticaprant as an adjunctive treatment for major depressive disorder (MDD).

Though data from the VENTURA program did confirm that the J&J drug was safe and well-tolerated in study participants, the decision to stop developing it for MDD indication is due to ‘insufficient efficacy in the target patient population.’ However, the pharma giant still intends to explore aticaprant’s potential ‘in other areas of high unmet need.’

J&J is currently undergoing full analyses of data from the VENTURA program and intends to share the same at a future medical meeting.

This comes as a setback to J&J, which had high expectations for aticaprant in the MDD indication. The company has forecasted generating annual peak sales in the range of $1-$5 billion from the drug in the now-abandoned indication.

J&J Reiterates Long-Term View for Innovative Medicine Biz

Despite the above setback, J&J still maintained its vision to become the #1 neuroscience company by 2030 and also reiterated its Innovative Medicine business to grow at a CAGR between 5% and 7% from 2025 to 2030.

We believe that the company could make up for this shortfall with the recently announced acquisition of Intra-Cellular Therapies (ITCI Quick QuoteITCI – Free Report) , which is expected to be completed later this year. In January, J&J announced an offer to buy ITCI for about $14.6 billion.

Once the above transaction is completed, J&J will acquire Intra-Cellular Therapies’ sole marketed drug, Caplyta, which is currently approved for two indications — schizophrenia and bipolar depression. A regulatory filing was submitted to the FDA in December seeking label expansion for this oral therapy in the MDD indication.

JNJ Stock Performance

Year to date, J&J’s shares have gained nearly 15% compared with the industry’s 12% growth.

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J&J Not the First to Face MDD Setback This Year

The setback with aticaprant comes just a couple of months after Neumora Therapeutics (NMRA Quick QuoteNMRA – Free Report) reported the failure of its lead pipeline drug, navacaprant, in the phase III KOASTAL-1 study for patients with MDD. Like aticaprant, the NMRA drug is a kappa opioid receptor (KOR) antagonist — a class of drugs designed to block a specific brain receptor linked to negative emotions and stress.

The KOASTAL-1 study failed to achieve its primary endpoint — treatment with Neumora’s drug failed to demonstrate a significant improvement over placebo in alleviating depression symptoms. The study also failed to show statistically significant improvement in the reduction of anhedonia (the inability to feel pleasure) following treatment with navacaprant.

Based on the above setback, Neumora announced that it is making changes in the two ongoing late-stage studies, KOASTAL-2 and KOASTAL-3, which are also evaluating navacaprant in the MDD indication. NMRA is making multiple changes to these studies across site selection, medical monitoring and screening tools. Until these changes come into effect, Neumora has decided to ‘pause’ both studies. It expects to resume the studies by the end of this month.

JNJ’s Zacks Rank

J&J currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.