Cell and gene therapy companies are the beneficiaries of positive changes along the regulatory path that the U.S. FDA is paving for them, according to a panel of executives who spoke at the BioFuture 2024 conference in New York. The agency is trying to set up cell and gene companies for success and that’s a very different agency than what it was years ago, said Paul Bresge, CEO of Ray Therapeutics Inc. Read More
Shares of Tharimmune Inc. shot up more than 100% in early trading Oct. 30 as the firm disclosed regulatory backing to launch a phase II trial this quarter testing TH-104, a transdermal buccal film version of nalmefene, to treat pruritus that is associated with primary biliary cholangitis. Read More
The prospect of a gene therapy for Alzheimer’s disease has kept Wall Street steadily interested in Lexeo Therapeutics Inc., and another increment of intrigue was added when the New York-based firm offered positive interim results from the 52-week, 15-subject phase I/II study of LX-1001 for the treatment of the condition when APOE4-associated. Read More
Two days after Monte Rosa Therapeutics Inc. signed a molecular glue degrader deal with Novartis AG, two other companies, Biogen Inc. and Neomorph Inc., are moving forward in the same space in a partnership worth up to $1.45 billion. Cambridge, Mass.-based Biogen and San Diego-based Neomorph will develop molecular glue degraders (MGDs) for priority targets in Alzheimer’s, rare neurological and immunological diseases, using Neomorph’s MGD platform to identify and validate novel small-molecule protein degraders. Read More
Synox Therapeutics Ltd. extended its series B by a further $17 million as it announced the first patients have been dosed in a phase III study of emactuzumab in the treatment of tenosynovial giant cell tumor, a rare condition in which benign tumors grow in the soft tissue lining of joints and tendons. Read More
Phase III Scorpio-PEP study results showed Shionogi & Co. Ltd.’s oral antiviral ensitrelvir fumaric acid (Xocova) reduced risk of symptomatic COVID-19 infection in subjects who were exposed to the virus by infected household members. Read More
Biopharmas raising money in public or private financings, including: Aprinoia, Biora, Biovie, Curis, Eledon, Maia, Monopar, Pathos, Vaxinano. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Cantargia, Clover, Coya, Eledon, Gemvax, Glycomimetics, Innovent, Invivyd, Kind, Nektar, Nkgen, Purdue, Regeneration, Zai Lab. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Aion, Chimagen, Dr. Falk, Fina, GC Biopharma, GSK, Hopo, Kynos, Ncage, Nvolety, Ryvu, Tikkunlev, Valanx, Vaxxas. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abeona, Allogene, Protega, Remegen, Shorla. Read More
