BMY Delays Cobenfy ADEPT and Milvexian Readouts to 2027

Update August 24, 2026: The iberdomide PDUFA resolved on August 13 — the FDA granted accelerated approval to Zenbexus (iberdomide) for relapsed/refractory multiple myeloma, four days ahead of the August 17 PDUFA date. BMY closed at $67.01 on August 21 (Polygon). See our Zenbexus approval coverage. The approval extends the CELMoD franchise; mezigdomide follows on May 13, 2027. The Cobenfy ADEPT and milvexian LIBREXIA-AF delays to 2027 remain unchanged below.

Bristol Myers Squibb (BMY) pushed two Phase 3 readouts into 2027 on its Q2 earnings call Thursday, delaying the Cobenfy ADEPT program in Alzheimer’s disease psychosis and the milvexian LIBREXIA-AF trial in atrial fibrillation. BMY closed at $64.86.

CEO Chris Boerner said ADEPT data will now arrive beginning in early 2027 and be “spread across the year.” The delay stems from slower enrollment in ADEPT-2 and ADEPT-4, plus slower relapse event accrual in ADEPT-1. CMO Cristian Massacesi confirmed the delays are not related to study conduct issues and noted that slower relapse accrual in ADEPT-1 could signal Cobenfy is working, though the trial remains blinded.

This is the second postponement for the Alzheimer’s psychosis program. BMS first delayed ADEPT in December 2025 after identifying enrollment irregularities at a small number of sites, pushing the readout from late 2025 to late 2026. Now 2027 is the new late 2026, as BMO analyst Evan Seigerman put it.

Cobenfy (xanomeline-trospium) is the key asset from BMY’s $14 billion Karuna Therapeutics acquisition. The schizophrenia launch has been muted: $63 million in Q2 revenue, missing consensus by about 4%. Chief commercial officer Adam Lenkowsky pointed to two challenges: accelerating new patient starts and improving repeat prescribing in a disease state where physician behavior is deeply entrenched.

The Alzheimer’s psychosis expansion was supposed to be Cobenfy’s next growth driver. Roughly 7 million Americans have Alzheimer’s, and an estimated 25 to 50 percent experience associated psychosis. With the ADEPT readout now in 2027, that expansion is on hold.

BMY plans to share open-label safety and efficacy data from the ADEPT-1 lead-in portion and a rollover study later this year, which could offer a directional signal. But registrational data is what moves the stock, and that is now a 2027 event.

The milvexian delay compounds the setback. LIBREXIA-AF, the Phase 3 trial of milvexian versus apixaban for stroke prevention in atrial fibrillation, moved from 2026 to Q1 2027 on slower event accrual. Massacesi suggested the slower pace could be favorable for the trial’s noninferiority and superiority endpoints, but the delay follows the November 2025 discontinuation of LIBREXIA-ACS for futility. Milvexian, partnered with Johnson & Johnson (JNJ), now has one remaining 2026 readout: LIBREXIA-STROKE, still expected by year-end.

With both ADEPT and LIBREXIA-AF pushed out, BMY’s near-term pipeline narrative shifts to the CELMoD platform. Iberdomide (Zenbexus) was approved August 13, 2026 for relapsed refractory multiple myeloma — four days ahead of its August 17 PDUFA. Mezigdomide follows on May 13, 2027. The BMY Q2 earnings analysis noted the Growth Portfolio hit 58 percent of revenue at 15 percent growth, but the catalyst calendar now leans entirely on CELMoD approvals through mid-2027.

The competitive picture adds pressure. MapLight Therapeutics is advancing ML-007 in schizophrenia Phase 2, and the muscarinic agonist class is getting crowded. BMY’s ADEPT delay gives competitors time to close the gap.

What to watch next: the iberdomide PDUFA resolved August 13 with accelerated approval of Zenbexus for relapsed/refractory multiple myeloma — see our Zenbexus approval coverage. The next CELMoD catalyst is mezigdomide on May 13, 2027. Cobenfy ADEPT and milvexian LIBREXIA-AF remain pushed to 2027.

Risk: BMY’s pipeline depth is now concentrated in two CELMoD approvals. A delay or rejection of iberdomide would compound the ADEPT and LIBREXIA-AF setbacks and leave the stock without a catalyst for roughly nine months.

Source: Bristol Myers Squibb Q2 2026 earnings press release