CLAIM #12198 · Bristol-Myers Squibb Company (BMY) · 2025Q3 earnings call · Oct 30, 2025 · due Dec 31, 2026
“We plan to initiate pivotal studies in autism spectrum irritability in next year.”
Cristian Massacesi · Chief Medical Officer
How to check this claim
Look at: Initiation of pivotal study/studies in autism spectrum irritability for Cobenfy
It came true if: At least one pivotal study in autism spectrum irritability is initiated (dosing first patient or listed as active/recruiting) between 2026-01-01 and 2026-12-31
Where: Company press releases, clinical trial registry (ClinicalTrials.gov), or management commentary on quarterly earnings calls
In context
“e that we deliver these studies with the highest [ PTS ] and on time. We're obviously excited to have Cristian on board to bring a fresh perspective to that. So net-net, I feel good about where we are in terms of working through the broader development programs and ensuring that we're executing appropriately. But Cristian, I don't know if you want to add anything. Cristian Massacesi: Thanks, Chris. Yes, let me try to, first of all, reassure that the Cobenfy development program is progressing at really a rapid pace. We currently have in the development plan, 14 studies that are ongoing or in the process to be activated. 10 of those studies are pivotal studies. We actually posted and maybe you have seen a third pivotal study in bipolar mania, BALSAM-4. We are also expanding the indications. We plan to initiate pivotal studies in autism spectrum irritability in next year. So the program is moving at pace. I think, Chris, you answered very well the reason to believe. I want to add -- part of your question was some differences. Just to clarify, ADEPT-4 is very similar to ADEPT-2 is the sister or the brother study. So we are doing ADEPT-4 exactly in the same patient population with the same primary endpoint than ADEPT-2. The readout, as you know, is projected next year. ADEPT-1 is slightly different because it's a relapse prevention design. This is a trial in which patients are enrolled into Cobenfy for 12 weeks. And then at the end of that period, based on the response on the psychosis metrics and CGI, the patient is randomized to Cobenfy and placebo. So different approach, but same setting. Operator: The next question comes from Geoff Meacham with Citi. Geo”
Verify independently
SEC filings for BMY ↗ · Claim quote is verbatim from the 2025Q3 earnings call.