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
Azenta (NASDAQ:AZTA) has signed a binding agreement to sell its B Medical Systems business to THELEMA S.À R.L. for $63 million, as the company moves to streamline operations and focus on its core capabilities.
Nvidia Corp. (NASDAQ:NVDA) has formally concluded its $5 billion purchase of Intel (NASDAQ:INTC) common stock, according to a regulatory filing released Monday.
Zevra Therapeutics (NASDAQ:ZVRA) announced Monday it has entered into an exclusive distribution agreement with Ireland-based Uniphar to broaden access to MIPLYFFA® (arimoclomol).
Unicycive Therapeutics (NASDAQ:UNCY) said it has resubmitted its 505(b)(2) New Drug Application to the U.S. Food and Drug Administration for oxylanthanum carbonate, a treatment for hyperphosphatemia in patients receiving dialysis.
