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Immunovant shares mid-stage Graves’ disease data; FDA lifts Rezolute’s hold

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Plus, news about Xencor, Bambusa Therapeutics, Grin Therapeutics and Vaxcyte:

Immunovant reports Phase 2a Graves’ disease data: Patients taking batoclimab for 12 weeks saw a 76% response rate and an average 77% reduction in IgG levels. Plus, 56% of patients came off treatment with antithyroid drugs during that period. After another 12 weeks, during which patients took a lower dose of batoclimab, the average IgG reduction was 65%, and response rate was 68%. Its stock $IMVT was down about 4% on Monday morning. — Max Gelman

FDA lifts Rezolute’s partial clinical hold for RZ358: The company can now move forward with a Phase 3 trial for hypoglycemia caused by congenital hyperinsulinism. Enrollment is expected to begin in early 2025, with topline data coming in the second half of next year. Rezolute’s shares $RZLT rallied about 16% on Monday. — Max Gelman

Xencor’s autoimmune plans: The company expects to put two T cell engagers into trials for autoimmune disease next year. That includes plamotamab, a CD20xCD3 bispecific antibody that Xencor plans to test in multi-drug resistant rheumatoid arthritis; and XmAb657, which targets CD19 and CD3. Xencor’s stock $XNCR jumped about 14% in trading on Monday morning. — Lei Lei Wu

Bambusa Therapeutics raises $15M for I&I: The Boston-based biotech is working on bispecific antibodies for immunological and inflammatory disorders, which have become a booming area of interest for drugmakers. BVF Partners and KKR’s Dawn Biopharma co-led the seed round. Bambusa is run by Shanshan Xu, a former BioNTech exec. — Kyle LaHucik

Grin’s neurodevelopmental drug passes Phase 1 test: The New York biotech’s NR2B modulator, called radiprodil, achieved an 86% reduction in the frequency of countable motor seizures when added to background therapy in people with disorders driven by variants in the GRIN genes. The company plans to advance the program into a Phase 3 trial pending discussions with regulators. — Ayisha Sharma

Vaxcyte closes $1.5B offering: The raise came on the heels of Phase 1/2 data for its 31-valent pneumococcal vaccine. Vaxcyte had originally sought $1 billion, but all the options were exercised. — Max Gelman


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