Roivant Sciences Ltd.’s Immunovant Inc. unit unveiled phase II data in Graves’ disease with batoclimab, whetting appetites on Wall Street for the results with next-generation prospect IMVT-1402 from two potentially registrational trials that are enrolling now.
Remegen Co. Ltd. emerged as a surprise challenger in the generalized myasthenia gravis space, unveiling positive phase III data of its China-approved lupus drug, telitacicept (RCT-18; Tai’ai), in the rare autoimmune neuromuscular disorder at the 2025 American Academy of Neurology conference.
Remegen Co. Ltd. emerged as a surprise challenger in the generalized myasthenia gravis space, unveiling positive phase III data of its China-approved lupus drug, telitacicept (RCT-18; Tai’ai), in the rare autoimmune neuromuscular disorder at the 2025 American Academy of Neurology conference.
Roivant Sciences Ltd. CEO Matt Cline said the firm’s unit Immunovant Inc. with FcRn blocker batoclimab has established “frankly a new bar” in myasthenia gravis (MG) as the New York-based firm reported top-line results from its phase III study and first data from period 1 of the phase IIb study with the same drug in chronic inflammatory demyelinating polyneuropathy. The data look promising, and Immunovant intends to use the findings to help advance second-generation FcRn prospect IMVT-1402 in both indications. Potentially registrational trials are planned. The U.S. FDA has granted IND clearance.
Immunovant Inc. is seeking a $450 million windfall on the back of the “best-in-class potential” of its early stage monoclonal antibody for IgG-mediated autoimmune diseases, IMVT-1402, which a phase I readout demonstrated could supersede the firm’s lead, batoclimab.
Argenx SE’s top-line results from the phase II Adhere study with Vyvgart Hytrulo (efgartigimod alfa plus hyaluronidase-qvfc) in chronic inflammatory demyelinating polyneuropathy (CIDP) sparked buzz about other developers in the space with similar mechanisms of action to Vyvgart Hytrulo, such as Immunovant Inc.
Hanall Biopharma Co. Ltd. has clarified that the new FcRn inhibitor IMVT-1402, unveiled by its licensed partner Immunovant Inc. as a new development program for autoimmune diseases, is a compound discovered and developed by Hanall, HL-161ANS.
Immunovant Inc. has announced a next-generation anti-FcRn, IMVT-1402, for autoimmune diseases. In animal studies, IMVT-1402 has shown deep IgG lowering, similar to the company's lead asset batoclimab, with no or minimal impact on albumin and low-density lipoprotein (LDL).
A prolific builder of biopharma and health technology companies, Roivant Sciences Ltd. is poised to join Nasdaq through a newly proposed merger with a special purpose acquisition company (SPAC) sponsored by Patient Square Capital LLC. The deal, which values Roivant at $5 billion, includes $611 million of new money, composed of $411 million held in trust by the SPAC, Montes Archimedes Acquisition Corp., plus $200 million from a committed PIPE financing. The transaction, expected to peg Roivant's initial market cap at $7.3 billion, follows a September 2019 deal in which Roivant sold interests in five biopharmas to Sumitomo Dainippon Pharma Co. Ltd. (SDP) for $3 billion cash.
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.
