Cobenfy’s late-stage flop is BMS’ second high-profile failure in as many weeks. The pharma announced last week that Camzyos was unable to improve disease burden in non-obstructive hypertrophic cardiomyopathy.
Bristol Myers Squibb’s schizophrenia drug Cobenfy failed to significantly ease symptom severity when used alongside atypical antipsychotics in patients with schizophrenia, according to a topline readout from the Phase III ARISE trial on Tuesday.
Analysts at Leerink Partners, writing to investors on Tuesday evening, noted that this late-stage failure “demonstrates that Cobenfy’s efficacy is modest,” adding that the drug may have “far less potential than we originally anticipated.” Leerink “significantly” lowered its long-term forecasts for Cobenfy based on the ARISE readout to about $2.6 billion by 2030 from a prior projection of $5.8 billion—a 55% crash.
Meanwhile, BMO Capital Markets called the news “Strike 2?” and zoomed out to situate the Phase III failure in the broader context of BMS’ pipeline story. Last week, BMS announced a late-stage failure for its myosin inhibitor Camzyos, which was unable to improve clinical burden and oxygen consumption 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 said.
Shares of BMS fell 5.9% in premarket trading Wednesday following the Cobenfy failure.
“Recent clinical missteps . . . continue to give us pause,” they said of BMS’ clinical execution. “The numerical benefit demonstrated in today’s study [is] likely not enough to drive transformational uptake in the adjunctive setting,” though the lack of options in this space could translate to “some” off-label use for Cobenfy.
William Blair, on the other hand, appeared more optimistic. ARISE’s failure “may reduce the likelihood of upside to near-term numbers,” the analysts wrote, however adding that “we still believe the peak opportunity for Cobenfy is significant.” William Blair estimates peak global sales of $3.7 billion for the drug in schizophrenia.
As per Tuesday’s readout, adjunctive Cobenfy improved scores on a rating scale for gauging schizophrenia symptoms, the study’s primary outcome, compared with placebo. This effect fell short of statistical significance. Patients in both treatment arms were given antipsychotic agents as background treatment.
Cobenfy likewise missed important secondary outcomes, including improvements in personal and social performance.
Cobenfy, the centerpiece of BMS’ $14 billion acquisition of Karuna Therapeutics in December 2023, is a muscarinic antipsychotic that works by targeting the M1 and M4 muscarinic acetylcholine receptors. In September 2024, Cobenfy won the FDA’s nod for schizophrenia, becoming the first novel therapy for schizophrenia in more than three decades.
During the company’s fourth-quarter business report in February, chief commercial officer Adam Lenkowsky said Cobenfy’s launch “is really off to a strong start,” noting 80% and 90% uptake in Medicare and Medicaid, respectively.
