4DMT Molecular Therapeutics Inc. is looking ahead to phase III as positive data continue to roll out for gene therapy candidate 4D-150 in wet age-related macular degeneration (AMD), with the results from the phase II portion of the phase I/II Prism trial showing the single-shot treatment significantly reduced the need for chronic anti-VEGF injections. Presented over the weekend at the Angiogenesis, Exudation, and Degeneration 2024 Conference, results from the 24-week dose-expansion cohort, which comprised wet AMD patients with severe disease and high treatment burdens, showed patients receiving the high dose (3E10 vg/eye) had a 90% reduction in annualized anti-VEGF injection rates. Read More
In August 2020, Johnson & Johnson paid $6.5 billion cash to acquire Momenta Pharmaceuticals Inc. That strengthened J&J’s immune-mediated disease portfolio and grew its interest in autoantibody-driven disease therapies by bringing nipocalimab into the fold. Now the investment is paying off with top-line results of phase II and III studies that hit their primary endpoints using the fully human glycosylated monoclonal antibody targeting the human neonatal Fc receptor. The studies were in treating generalized myasthenia gravis and in Sjögren’s disease. Read More
As the company’s phase II study in idiopathic pulmonary fibrosis continues, Pliant Therapeutics Inc.’s investors looked hard at 12-week interim data from the 320-mg dose group of Integris-PSC, a multinational, randomized, double-blind, placebo-controlled phase II trial testing bexotegrast in primary sclerosing cholangitis and suspected moderate to severe liver fibrosis. Read More
Court rulings favoring biopharma companies that have challenged the U.S. Department of Health and Human Services’ efforts to force them to unconditionally offer 340B prescription drug discounts to an unlimited number of contract pharmacies could become moot in the future if a bipartisan draft bill becomes law. Read More
Armed with strong phase III safety data in Japanese patients, Palo Alto, Calif.-based Bridgebio Pharma Inc. is planning to file for Japan approval of its investigational drug acoramidis for a rare heart disorder. Read More
As Novo Nordisk A/S has struggled with supply of its GLP-1 drug Wegovy (semaglutide), its controlling shareholder, Novo Holdings A/S, has agreed to acquire global contract development and manufacturing organization Catalent Inc. and its more than 50 global sites for $63.50 per share in cash, about $16.5 billion. Read More
A partnership between Gate Neurosciences Inc. and Beacon Biosignals Inc. promises to advance the field of precision psychiatry by using electroencephalogram (EEG) biomarkers to diagnose depression and rapidly assess response to medications. The collaboration will first use Beacon’s U.S. FDA-cleared Dreem 3S headband device and neurobiomarker platform to conduct EEGs in participants in Gate’s phase II trial of zelquistinel, a small-molecule NMDA receptor modulator under development as an antidepressant. Read More
Biopharmas raising money in public or private financings, including: Adverum, Biosenic, Coherus, Corbus, Metagenomi, Neximmune, Silence, Vaxcyte. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Avicanna, DMK, DRI Healthcare, Eli Lilly, Omeros, Rayner Surgical, Rbio, Valneva, Zuellig. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abivax, Cabaletta, Genmab, Junshi, Pfizer, Regeneron, Revance, Tyra. Read More