GT Biopharma's GTB-5550 Secures FDA IND Clearance For Multiple Myeloma; Stock Down

GT Biopharma, a clinical-stage immuno-oncology company using its TriKE natural killer cell engager platform, said AI tools rolled out internally have improved discovery and drug engineering productivity. The company plans to advance lead programs GTB-3650 and GTB-5550 through Phase 1 studies this year and use AI for candidate selection, molecular design, and structural modeling. Shares were up 0.38% to $0.48 premarket, per Benzinga Pro.

Pfizer (PFE) and Valneva (VALN) announced the EMA has started reviewing their Lyme disease vaccine candidate, PF-07307405, based on Phase 3 trial data showing over 70% efficacy. The trial met one statistical criterion but not the primary endpoint. Pfizer will commercialize the vaccine if approved, while Valneva benefits as a development partner.

Abbott Laboratories (ABT) will pay $384 million to resolve U.S. Justice Department allegations regarding infant formula production. The settlement addresses civil claims and closes the criminal investigation, but litigation risks persist. Abbott's Q2 2026 sales were $12.6 billion, with adjusted EPS guidance of $5.45-$5.60. The company aims to refocus on broader growth despite ongoing reputational and legal concerns.

Ocular Therapeutix (OCUL) completed a Pre-NDA meeting with the FDA for AXPAXLI, its wet AMD treatment. The meeting confirmed the NDA submission plan for Q4 2026, supported by Phase 3 trial data. AXPAXLI is also in trials for diabetic retinal disease. OCUL stock is up 2.19% to $10.72.

Rocket Pharmaceuticals (RCKT) received FDA alignment to continue its Phase 2 trial for RP-A501 in Danon disease, with a recalibrated dose and modified protocol. The trial will include 12 male patients, with dosing expected to complete by mid-2027. The FDA reviewed safety data from the first three patients, finding no adverse events. RCKT's stock rose 2.39% to $3.43 on Monday.

Kimberly-Clark (KMB) is selling assets to address EU antitrust concerns over its $40B Kenvue acquisition, aiming for approval by September 29. The deal, expected to create a $32B revenue company, faces similar scrutiny in Australia. KMB anticipates $1.9B in annual cost synergies but may need to divest assets to secure approval.