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.
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.
Bluejay Diagnostics (NASDAQ:BJDX) said it has completed commercial-scale production of both polyclonal and monoclonal antibodies targeting interleukin-6 (IL-6) for its Symphony™ cartridge program, marking a development milestone for the diagnostic platform.
HUTCHMED (NASDAQ:HCM) announced Monday that the China National Medical Products Administration (NMPA) has accepted its New Drug Application for fanregratinib and granted it priority review status.
Cango (NYSE:CANG) entered into a definitive investment agreement on Dec. 29, 2025, with Enduring Wealth Capital Limited (EWCL) for the private placement of 7 million Class B ordinary shares.
Omeros Corporation (NASDAQ:OMER) said the U.S. Food and Drug Administration approved YARTEMLEA (narsoplimab-wuug) to treat hematopoietic stem cell transplant-associated thrombotic microangiopathy, marking the first authorized therapy for the life-threatening condition.
