Bristol-Myers Squibb stock holds Buy rating at Truist despite trial delay

Investing.com - Bristol-Myers Squibb Co. (NYSE:BMY) will enroll additional patients in its ADEPT-2 clinical trial after excluding some study sites due to "clinical trial execution irregularities," the company announced Wednesday. The pharmaceutical giant, which boasts a market capitalization of $104.5 billion and maintains an impressive "GREAT" overall financial health score according to InvestingPro, continues to advance its clinical pipeline despite these setbacks.

The enrollment changes will delay the ADEPT-2 trial readout to the end of 2026, aligning it with the expected readouts of the ADEPT-1 and ADEPT-4 trials. The ADEPT-2 study is one of four trials evaluating Cobenfy for Alzheimer’s disease psychosis.

Following a third-party interim analysis of a subset of enrolled patients, the FDA was informed of the efficacy and safety results and recommended continuing the study. The company remains blinded to the actual trial data, according to Truist Securities.

Truist Securities maintained its Buy rating and $65.00 price target on Bristol-Myers Squibb, noting that the trial continuation suggests no safety issues were identified that required changes to the study protocol.

The investment firm also highlighted that the decision to continue the trial after excluding certain sites indicates the efficacy data reviewed by the Data Monitoring Committee and FDA was potentially favorable, though this does not guarantee the trial will ultimately succeed.

In other recent news, Bristol Myers Squibb announced the continuation of its ADEPT-2 Phase 3 study for Alzheimer’s disease-related psychosis after identifying irregularities at certain study sites. The company chose to exclude data from these sites to maintain the study’s integrity. Additionally, a U.S. judge ruled that a $6.7 billion lawsuit against Bristol Myers Squibb, related to the delayed approval of three drugs, including Breyanzi, could proceed with certain claims. On the regulatory front, the European Commission approved Breyanzi for treating relapsed mantle cell lymphoma, following impressive results from the TRANSCEND NHL 001 trial. This approval highlights Breyanzi’s significant response rates in patients who had undergone multiple lines of therapy. Meanwhile, Bristol Myers Squibb maintained its Neutral rating from Guggenheim, despite positive trial results from competitor Bayer in stroke prevention. These developments come amid broader industry discussions, such as Bernstein’s analysis of the Inflation Reduction Act’s limited impact on drug pricing for companies like Abbvie and Amgen.

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