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.
The proinflammatory cytokine macrophage migration inhibitory factor has been demonstrated to drive the induction and progression of spondyloarthritis in mice and to be associated with human disease, according to the findings of an international study led by researchers at the University of Toronto in Ontario, Canada.
Pacira Biosciences Inc. will add to its core non-opioid-based therapies business by buying Flexion Therapeutics Inc. for $427 million. That brings into the company’s fold Zilretta (triamcinolone acetonide extended-release injectable suspension) for treating osteoarthritis knee pain, an injectable non-opioid that’s already FDA approved in addition to being in a phase II study for treating shoulder osteoarthritis.
Less than two weeks after Japan’s MHLW became the first regulatory agency to clear avacopan for anti-neutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis, the FDA has followed suit. It cleared the oral, small-molecule C5aR antagonist for use as an adjunct therapy for adults with the two main forms of the rare autoimmune renal disease, granulomatosis with polyangiitis and microscopic polyangiitis, in combination with standard therapy.
The U.K.’s Medicines and Healthcare Products Regulatory Agency (MHRA) joined the JAK inhibitor pile-on Oct. 6 with new measures to reduce the risk of major heart problems and malignancies in people taking Pfizer Inc.’s Xeljanz (tofacitinib).