Argenx NV’s Vyvgart (efgartigimod), approved late Friday by the FDA for treating generalized myasthenia gravis, became the first FcRn antagonist to cross the finish line. But the best news may be the drug’s broad label, which company executives highlighted during an investor call.
Following initial approvals for rheumatic diseases, Bristol Myers Squibb Co.'s Orencia (abatacept) has become the first FDA-approved drug for the prevention of acute graft-vs.-host disease (aGVHD), in combination with calcineurin inhibitors and methotrexate, both types of immunosuppressants.
Life sciences VC Apple Tree Partners has launched its first U.K.-based portfolio company, providing $53 million in series A funding for immunology specialist Adendra Therapeutics Ltd.
Odyssey Therapeutics Inc. launched with a whopping $218 million series A round, the year’s second-largest, to fuel work by almost 100 employees recruited in the past few months, mostly from big pharma firms.
Beigene Ltd. has received approval from China’s NMPA to market Sylvant (siltuximab) for the treatment of patients with multicentric Castleman disease, including HIV-negative and human herpes virus-8-negative disease. The green light comes at a good time as the Beijing-headquartered company is preparing for a $3.5 billion listing on Shanghai’s STAR Market, its third listing. The monoclonal antibody siltuximab previously received regulatory approval in the U.S. and Europe.
Kezar Life Sciences Inc. shares (NASDAQ:KZR) rose 37%, or $3.18, to close Nov. 16 at $11.59 on interim results from the phase II part of the study called Mission, testing KZR-616, a first-in-class selective immunoproteasome inhibitor, in patients with active, proliferative lupus nephritis (LN).
LONDON – There’s not yet proof of the pudding, but Omass Therapeutics Ltd.’s new structure-based technology has passed a key test, in enabling the discovery of orally available small molecules aimed at intractable and poorly drugged membrane and complex-bound protein targets. The targets, including G protein-coupled receptors (GPCRs), intracellular protein complexes and solute carriers, are relevant to immunology indications and rare diseases with high unmet need.
Merck & Co. Inc. has signed a potential $1 billion research tie-up with Synthekine Inc. to develop engineered cytokines to fight autoimmune diseases, as its $11.5 billion merger with Acceleron Pharma Inc. hit a regulatory speed bump.
Mozart Therapeutics Inc. CEO Katie Fanning said the firm’s $55 million series A financing will allow the filing of an IND, probably in early 2024, for a prospect in celiac disease. Founded in July 2020, Seattle-based Mozart is based on research into the CD8 T-cell regulatory network, which has been found to play an important role in surveillance, recognition and elimination of inappropriately activated autoreactive and pathogenic immune cells.
When James Peyer, Cambrian Biopharma Inc.’s CEO, watched his grandfather fail every cancer treatment and eventually pass away, he came to a realization that now forms the backbone of his company. “The more I learned about cancer, the more convinced I became that we were approaching cancer as a disease in the wrong way,” Peyer told BioWorld. “We were waiting until people were sick and only then doing something about it.” Cambrian just closed on an oversubscribed series C that brought in $100 million to develop a pipeline of therapies designed to treat and prevent age-related diseases.
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