Bristol Myers Squibb Faces Setback as Cobenfy Falls Short in Schizophrenia Trial.

Bristol Myers Squibb (BMS) has suffered another significant clinical blow after its schizophrenia drug Cobenfy did not achieve the primary goal in the Phase III ARISE trial. The setback arrives just a week after the failure of Camzyos in a different late-stage trial, raising concerns over the company's pipeline performance.

In the ARISE trial, Cobenfy was evaluated as an adjunctive treatment to standard atypical antipsychotics in patients with schizophrenia. According to the topline results released Tuesday, while the drug showed numerical improvement in symptom severity scores compared to placebo, the benefit did not reach statistical significance. The study also failed to meet several key secondary endpoints, including measures of personal and social functioning.

Analysts at Leerink Partners responded to the data with concern, noting that the findings suggest Cobenfy’s therapeutic effect is “modest.” As a result, Leerink slashed its long-term sales forecast for the drug, lowering projections to $2.6 billion by 2030—a sharp drop from its previous estimate of $5.8 billion.

BMO Capital Markets labeled the latest development as “Strike 2?” in reference to BMS’ recent streak of Phase III disappointments. The firm highlighted that just last week, the company announced that Camzyos had failed to improve oxygen use and clinical burden in patients with non-obstructive hypertrophic cardiomyopathy. “From a clinical perspective, the story for Bristol continues to be challenging following back-to-back [Phase III] whiffs from ODYSSEY-HCM and ARISE,” BMO stated.

The market responded swiftly to the ARISE trial outcome, with BMS shares falling 5.9% in premarket trading on Wednesday.

Despite the negative results, some analysts remain hopeful about Cobenfy’s future. William Blair acknowledged the short-term challenges but maintained a more optimistic outlook, estimating the drug’s peak global sales potential at $3.7 billion. They emphasized that although the trial missed statistical significance, Cobenfy might still hold value in a treatment area with limited alternatives, possibly enabling some off-label use.

Cobenfy is a muscarinic receptor-targeting antipsychotic developed by Karuna Therapeutics, which BMS acquired in December 2023 for $14 billion. The drug modulates M1 and M4 muscarinic acetylcholine receptors and was approved by the FDA in September 2024 as the first novel schizophrenia therapy in over 30 years.

During BMS’ Q4 earnings call in February, Chief Commercial Officer Adam Lenkowsky highlighted a robust initial market reception, noting strong Medicare and Medicaid coverage with uptake rates of 80% and 90%, respectively.

While the ARISE results have introduced uncertainty around Cobenfy’s growth trajectory, the drug remains a cornerstone of BMS' neuropsychiatry ambitions. The company now faces the challenge of reaffirming confidence in its pipeline after consecutive high-profile trial failures.

Source:https://www.biospace.com/drug-development/strike-2-bms-stumbles-again-as-cobenfy-disappoints-in-schizophrenia

This is non-financial/medical advice and made using AI so could be wrong.