Top-line data from the Reveal-2 phase III trial of elegrobart to treat chronic thyroid eye disease (TED) drove Viridian Therapeutics Inc.’s stock up by 33.6%, positioning the company for a BLA filing in the first quarter of 2027. The trial met both primary endpoints at week 24: proptosis responder rate, as measured by exophthalmometry, required for a filing with the U.S. FDA; and the overall responder rate, required for an EMA filing. Doses every four weeks or every eight weeks achieved 50% and 54% PRR, respectively, compared to 15% for placebo. The doses also achieved 47% and 54% ORR vs. 15% for placebo. ORR included those with both proptosis and Clinical Activity Score response, defined as no worsening from baseline in the study eye, without deterioration in the fellow eye. Read More

Thanks to a trial design that, according to Evercore ISI analyst Cory Kasimov, “played out exactly as drawn up,” Cytokinetics Inc. hit both of the phase III co-primary endpoints with aficamten in symptomatic non-obstructive hypertrophic cardiomyopathy (nHCM). Read More

Medical Microinstruments Inc.’s (MMI) Symani surgical system was used to treat a patient with Alzheimer’s disease as part of a study evaluating robotic-enabled microsurgery for the condition. The procedure investigated whether restoring lymphatic drainage pathways in the deep cervical lymph nodes could improve the clearance of harmful neurotoxins believed to contribute to the progression of Alzheimer’s. Read More

Amid calls for transparency on the most-favored nation (MFN) pricing deals U.S. President Donald Trump has reached with 17 biopharma companies, the White House Council of Economic Advisers released a report May 5 detailing how the volunteer MFN policy works and touting the $530 billion-plus in savings it’s projected to deliver over the next 10 years. Read More

Next-generation T-cell engager (TCE) specialist Cytospire Therapeutics Ltd. has raised £61 million (US$82.7 million) in a series A round, equipping it to advance the lead program CYT-X300 to the clinic in the treatment of EGFR-positive solid tumors. The company’s pan gamma delta (γδ) TCEs are designed to overcome problems with cytokine release syndrome, on-target effects on healthy cells, and the excessive activation of CD3 that have occurred with earlier bispecific antibodies that bind to the CD3 receptor on T cells. Read More

Three years after Johnson & Johnson handed back rights to an siRNA candidate targeting a genetic driver of metabolic dysfunction-associated steatohepatitis (MASH), Arrowhead Pharmaceuticals Inc. found a new partner in Madrigal Pharmaceuticals Inc., a firm that markets the first U.S. FDA-approved MASH drug, Rezdiffra (resmetirom), and has been building a pipeline in the space. Read More

New hires and promotions in the biopharma and med-tech industries, including: Aura, Confluent, Eupraxia, Kyverna, Legend, Medcura, Pasithea, Spruce, Tenax. Read More

Biopharma and med-tech companies raising money in public or private financings, including: Aura, Avalyn, Cabaletta, CNS, Latus, Mobia Medical, Odyssey, Windward. Read More

Clinical updates for biopharma and med tech, including data readouts and publications: Alto, Cairn, Celcuity, Dr. Falk, Edwards, J&J, Mirum, Neurocrine, Renexxion, Rezolute, Rhythm, Takeda. Read More

Biopharma and med-tech happenings, including deals and partnerships, and other news in brief: Amgen, Biocryst, Cullgen, Endorobotics, Gyre, Macrogenics, Neopharmed, Olympus. Read More

Regulatory snapshots for biopharma and med tech, including global submissions and approvals, and other regulatory decisions and designations: Adma, Applied Biocode, Arvinas, Atossa, Clene, E-scopics, Incyte, Lanexa, Pfizer, Satellite, Specialised, Sunshine, Zeta. Read More