Zenas Biopharma LLC launched on March 23 as a U.S. funded cross-border biotech company targeting autoimmune diseases in China. The company, headquartered in Miromar Lakes, Fla., is founded and funded by Tellus Bioventures LLC and Fairmount Funds Management LLC.
Less than a month after informing the market of a slowdown caused by pandemic-related site closures in phase II studies with neonatal Fc receptor (FcRn)-targeting IMVT-1401, Immunovant Inc. said it’s voluntarily pausing dosing with the compound in thyroid eye disease (TED) in the study called Ascend Go-2 because of a worrisome physiological signal. The New York-based firm plans to investigate and, after seeking the FDA’s go-ahead on tweaks to the program, forge onward with development.
Miragen Therapeutics Inc. gained ground lost on Wall Street earlier this month and then some, with shares (NASDAQ:MGEN) closing at $1.26, up 74 cents or 142% after the company disclosed plans to take over Viridian Therapeutics Inc., conducting at the same time a private placement that will raise $91 million.
New York-based Immunovant Inc.’s phase IIa results with neonatal Fc receptor (FcRn)-targeting IMVT-1401 in thyroid eye disease (TED), also known as Graves’ ophthalmopathy, prompted renewed speculation about the space, hot since the approval on Jan. 21 of Tepezza (teprotumumab-trbw) from Horizon Therapeutics plc, of Dublin.
About a month-and-a-half earlier than expected, Horizon Therapeutics plc has won FDA approval for teprotumumab in thyroid eye disease (TED), a progressive autoimmune condition that disproportionately affects women.
As expected, Horizon Pharma plc sailed through the meeting of the FDA’s Dermatologic and Ophthalmic Drugs Advisory Committee regarding the BLA for teprotumumab in thyroid eye disease (TED) with few surprises but much discussion.
Hitches for Horizon Pharma plc seem unlikely in the upcoming FDA advisory panel to mull the BLA for teprotumumab in thyroid eye disease (TED), though regulators did take issue with the clinical activity score (CAS) as calculated by the company.
