Bristol Myers Squibb (BMY) announced Wednesday it's hitting the reset button on a closely watched Alzheimer's study, but here's the twist: this might actually be good news.
The pharmaceutical giant revealed it will enroll additional patients in its ADEPT-2 Phase 3 study after discovering irregularities at some trial sites. ADEPT-2 is testing whether Cobenfy, currently approved for schizophrenia in adults, can help people dealing with psychosis linked to Alzheimer's disease dementia.
The study is a multicenter, randomized, double-blind, placebo-controlled trial designed to measure changes in the Neuropsychiatric Inventory-Clinician (NPI-C) Hallucinations and Delusions score as the primary endpoint, plus Clinical Global Impression-Severity (CGI-S) as a key secondary measure. It's also assessing safety and tolerability compared to placebo.
What Went Wrong, and What Went Right
During a thorough blinded review of the study data, Bristol Myers spotted execution problems at a small number of sites. Before locking the database, the company decided to exclude patient data from those questionable sites from the primary analysis.
Here's where it gets interesting. Bristol Myers consulted with the U.S. Food and Drug Administration, and together they arranged for an independent party to conduct an interim analysis of both efficacy and safety data. An independent Data Monitoring Committee (DMC) reviewed the results.
The DMC's recommendation? Keep going. Enroll more patients to hit the original target population. Based on that guidance, Bristol Myers will continue enrollment and advance the program. The company remains blinded to the actual study data, which is standard practice.
Why Analysts Think This Could Be Positive
William Blair weighed in Wednesday, noting that "The ADEPT-2 study was highly anticipated by investors given the size of the market opportunity, need for momentum in the Cobenfy clinical trial launch, and recent setbacks with other late-stage programs at Bristol Myers."
Analyst Matt Phipps makes a smart observation: normally, delays tied to site issues would spook investors. But the fact that both the independent DMC and the FDA supported continued enrollment suggests there might be encouraging early signals in the data. You don't typically get that kind of backing if things look hopeless.
Phipps also notes that given the pressure on Bristol Myers shares lately, "any non-failure could be good news." That's a low bar, but it's an honest assessment of where expectations stand.
The timeline has shifted, though. Results from the full ADEPT program in Alzheimer's-related psychosis, including ADEPT-2, ADEPT-1, and ADEPT-4, are now expected by the end of 2026 instead of the previously anticipated end of 2025.
Context: Bristol Myers Needs a Win
This news arrives at a moment when Bristol Myers could really use some positive momentum. Back in November, the company and Johnson & Johnson (JNJ) pulled the plug on the Phase 3 Librexia ACS trial of milvexian, which was being tested alongside standard antiplatelet therapy for patients after an acute coronary syndrome event.
That decision followed a preplanned interim analysis by an independent committee, which determined the trial was unlikely to hit its primary efficacy endpoint. Another late-stage disappointment.
Against that backdrop, Wednesday's announcement that regulators and independent monitors see enough promise in Cobenfy to keep the Alzheimer's study running represents a meaningful shift in tone.
BMY Price Action: Bristol Myers Squibb shares jumped 5.77% to $51.03 at the time of publication Wednesday.
