U.S. FDA Approves Bristol Myers Squibb's Breyanzi as the First CAR T Cell Therapy for Adults with Relapsed or Refractory Marginal Zone Lymphoma (MZL)

William Blair analyst Matthew Phipps notes Bristol Myers today announced that its ADEPT-2 study evaluating Cobenfy in Alzheimer's disease psychosis will now read out by the end of 2026, versus prior timing for a readout by year-end 2025. The delay is due to the need for additional patient enrollment in the study given that irregularities were identified at several clinical trial sites, the analyst tells investors in a research note. Blair says that while a delay due to site irregularities typically raises concerns with investors, there is potentially a positive read-through in the Independent Data Monitoring Committee and Food and Drug Administration recommending continuation of the trial with more patients. This suggests positive trends are being observed, according to Blair. The firm thinks "any non-failure could be good news" given the selloff in Bristol Myers shares year-to-date. It has a Market Perform rating on the name. The stock in morning trading is up 5% to $50.76.

After Bristol Myers announced that it is delaying the readout of the ADEPT-2 study of Cobenfy in Alzheimer's Psychosis as it adds more patients to the trial due to irregularities at some clinical trial sites, JPMorgan said the firm is "not completely surprised by this update" and sees it as an incremental positive. Expectations were low on ADEPT-2, the additional patient-adds enhances the chances of a successful study and this does not impact the timing of the FDA filing based on the remaining ADEPT study readouts, according to the analyst, who maintain an Overweight rating on the shares.

Leerink analyst David Risinger notes that Bristol Myers announced that it will enroll additional patients in the ADEPT-2 study. The firm views it as positive news that the Data Monitoring Committee recommended enrolling additional patients in Cobenfy's ADEPT-2 trial in Alzheimer's disease psychosis patients. Recall that the company disclosed in early August that it was scrutinizing Cobenfy trial conduct, and Leerink and consensus feared the trial could fail. The firm keeps an Outperform rating on the shares.

Goldman Sachs raised the firm's price target on Bristol Myers to $57 from $51 and keeps a Neutral rating on the shares.