Tonix Pharmaceuticals (NASDAQ:TNXP) said it is advancing development plans for TNX-4800, a long-acting human monoclonal antibody designed for the prevention of seasonal Lyme disease, as the company prepares for regulatory discussions on potential late-stage clinical pathways.
GATX Corp. (NYSE:GATX) said it and Brookfield Infrastructure Partners L.P. (NYSE:BIP) have received all required regulatory approvals to complete their previously announced transaction to acquire Wells Fargo’s rail operating lease portfolio
Adlai Nortye (NASDAQ:ANL) said it has entered into an exclusive licensing agreement with ASK Pharm for the development and commercialization of its proprietary pan-RAS (ON) inhibitor, AN9025, in Greater China.
Praxis Precision Medicines (NASDAQ:PRAX) said the U.S. Food and Drug Administration has granted Breakthrough Therapy Designation to ulixacaltamide, a selective T-type calcium channel inhibitor being developed for the treatment of essential tremor, accelerating the regulatory path for the experimental therapy.
INOVIO (NASDAQ:INO) said the U.S. Food and Drug Administration has accepted for review its Biologics License Application for INO-3107, a DNA medicine being developed as a potential treatment for adults with recurrent respiratory papillomatosis, a rare disease caused by human papillomavirus.
Verisk (NASDAQ:VRSK) has terminated its definitive agreement to acquire AccuLynx after the Federal Trade Commission failed to complete its review of the transaction by the Dec. 26, 2025 termination date specified in the merger agreement.
Mereo BioPharma (NASDAQ:MREO) said Phase 3 trials of setrusumab (UX143) in osteogenesis imperfecta failed to meet their primary endpoints, dealing a setback to the late-stage program as the company moves to cut spending and reassess priorities.
SELLAS Life Sciences (NYSE:SLS) said it is approaching the final analysis milestone in its pivotal Phase 3 REGAL trial evaluating galinpepimut-S (GPS) in acute myeloid leukemia, following an aggregate event count update from its contract research organization.
Ultragenyx Pharmaceutical (NASDAQ:RARE) Phase 3 trials of setrusumab (UX143) in osteogenesis imperfecta failed to meet their primary endpoints, prompting the company to plan significant expense reductions while it evaluates next steps for the program.
Genmab (NASDAQ:GMAB) said it will discontinue further clinical development of acasunlimab, as the company sharpens its focus on the most value-creating opportunities in its late-stage portfolio amid an increasingly competitive landscape.
Theriva Biologics (NYSE:TOVX) said it has received Scientific Advice from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) on the design of a proposed Phase 3 trial evaluating VCN-01 in combination with gemcitabine and nab-paclitaxel for first-line treatment of metastatic pancreatic ductal adenocarcinoma.
Johnson & Johnson (NYSE:JNJ) said it has completed its acquisition of Halda Therapeutics OpCo in an all-cash transaction valued at $3.05 billion, strengthening the company’s oncology pipeline with a novel targeted-therapy platform
