Future of BMS’ Cobenfy Still in Limbo After Phase III Fail

Bristol Myers Squibb tested Cobenfy as an adjunctive treatment with atypical antipsychotics for schizophrenia in the Phase III ARISE study, which earlier this year failed to demonstrate significant symptom improvement.

When Bristol Myers Squibb’s schizophrenia drug Cobenfy failed in the Phase III ARISE study in April, the pharma said it would talk with regulatory authorities to determine the drug’s future adjunctive uses.

On Thursday during the company’s second quarter earnings call, however, chief medical officer Samit Hirawat said that those discussions have yet to happen. “No conversations have occurred from the health authority perspective,” he said. BMS is still digging into ARISE’s data and will share its findings in the future.

ARISE was testing Cobenfy as an adjunctive therapy for schizophrenia, alongside atypical antipsychotics. Topline findings in April showed that the drug was unable to significantly improve overall positive and negative symptoms, nor was it able to boost social and personal performance. Reacting to the late-stage fail, Leerink analysts wrote in an April 22 note that Cobenfy could have “far less potential than we originally anticipated.”

During Thursday’s earnings call, management fielded questions regarding Cobenfy’s development for Alzheimer’s disease psychosis, for which a readout from the Phase III ADEPT-2 trial is expected later this year. The study, which has enrolled some 400 patients, compares Cobenfy against placebo and is looking at the drug’s effects on hallucinations and delusions.

ADEPT-2 is one of three studies that BMS is running for Cobenfy in Alzheimer’s psychosis, Hirawat explained on Thursday, noting that the other two trials—ADAPT-1 and ADAPT-4—are scheduled to read out next year. “Two of the three studies need to be positive for us to be engaging authorities for a filing,” he said.

BMS brought in $12.27 billion in Q2. While this represents a largely flat year-on-year change, it still comes 8% ahead of consensus forecasts, according to an investor note from Leerink on Thursday morning. The blood thinner Eliquis remained the pharma’s top-selling drug, bringing in $3.68 billion in Q2, an 8% increase versus the same period last year and outpacing the consensus by 5%. Opdivo, a PD-1 inhibitor indicated for various cancers, jumped 7% year-on-year and beat estimates by 6% to earn $2.56 billion.

Cobenfy, which BMS acquired when it bought Karuna Therapeutics in December 2023 for $14 billion, made $35 million. Sales of the drug came ahead of analyst expectations by 9%, according to Leerink.

Notably, BMS had a handful of products that saw strong growth in Q2, chief amongst them being the CAR-T therapy Breyanzi, which surged 125% and hit sales of $344 million for the quarter. Camzyos, for symptomatic obstructive hypertrophic cardiomyopathy, made $260 million in the quarter, an 87% increase from the same period in 2024.

Buoyed by its strong Q2 performance, BMS on Thursday also lifted its full-year 2025 guidance: From $45.8 billion to $46.8 billion in April, the pharma now expects revenues to hit $46.5 billion to $47.5 billion.

Tristan is an independent science writer based in Metro Manila, with more than eight years of experience writing about medicine, biotech and science. He can be reached at tristan.manalac@biospace.com, tristan@tristanmanalac.com or on LinkedIn.
MORE ON THIS TOPIC