BMS registers Phase 2 depression trial for BMS-986511; adds Alzheimer's PK study for BMS-986446

Bristol-Myers Squibb posted two new interventional study records this week alongside items carried over from last week.

• A new Phase 2 trial will test BMS-986511 (evifacotrep) against placebo in adults with major depressive disorder, titled "A Phase 2, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Monotherapy, Multicenter Study to Evaluate the Efficacy and Safety of BMS-986511 in Two Sequential Parts in Participants With Major Depressive Disorder."¹ The study is not yet recruiting, with an estimated enrollment of 200 participants and an estimated start date of October 30, 2026.¹
• A new Phase 1 study will evaluate BMS-986446 (also known as PRX005 or moponetug) for pharmacokinetics, bioavailability, safety, tolerability, and immunogenicity, with single-dose IV and subcutaneous administration in healthy adults and multiple doses in participants with early Alzheimer's disease. The trial is recruiting, with an estimated enrollment of 84 participants and an actual start date of August 21, 2026.²
• The FDA approved a labeling supplement for BARACLUDE tablets (entecavir, NDA021797), with a label document dated August 20, 2026.³
• A parallel labeling supplement was approved for the BARACLUDE oral solution formulation (entecavir 0.05mg/mL, NDA021798), with a label document also dated August 20, 2026.⁴
• A Phase 1 study of [14C]Navlimetostat (BMS-986504) will evaluate mass balance, metabolism, excretion, and pharmacokinetics at steady state in healthy female participants⁵, enrolling 6 participants (estimated)⁵ and not yet recruiting⁵, with an estimated start of September 16, 2026.
• A non-interventional cohort study will use CIBMTR registry data to assess the long-term safety and effectiveness of lisocabtagene maraleucel in participants with relapsed/refractory marginal zone lymphoma.⁶ The study is estimated to enroll 300 participants (estimated)⁶ and is currently active not recruiting.⁶