RES’ DOSE PREDICTIONS APPROVED BY THE FDA
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FDA approval of IND application for Solid Bio’s SGT-212, a gene therapy to treat Friedreich’s Ataxia. January 7, 2025.
FDA approval of IND application for Astria’s STAR-0310, a monoclonal antibody OX40 antagonist for the treatment of atopic dermatitis. December 10, 2024.
FDA approval of IND application for Be Biopharma’s BE-101, engineered B cell medicine for the treatment of Hemophilia B. May 28, 2024.
FDA approval for Phase 1b/2 trial of Astria’s Navenibart (STAR-0215), a monoclonal antibody inhibitor of plasma kallikrein for the treatment of hereditary angioedema. December 11, 2024.
FDA approval for Phase 3 trial of Takeda’s TAK-861, a small molecule inhibitor therapy for treatment of narcolepsy. June 3, 2024.
FDA approval of IND application for Solid Bio’s SGT-003, a gene therapy for Duchenne Muscular Dystrophy. November 14, 2023.
FDA approval of Takeda’s ADZYNMA (ADAMTS13, recombinant-krhn), the first and only FDA-approved recombinant protein designed to address an unmet medical need in people with cTTP by replacing the deficient ADAMTS13 enzyme. November 9, 2023.
FDA approval of Phase I trial for EMD Serono’s M9140, an anti-CEACAM5 Antibody Drug Conjugate for the treatment of advanced solid tumors. 2022.
FDA approval for Phase 1a trial of Astria’s STAR-0215, a monoclonal antibody inhibitor of plasma kallikrein for treatment of hereditary angioedema. August 4, 2022.
FDA approval of Vertex’s INCIVEK (telaprevir), antiviral therapy for treatment of HCV. May 23, 2011.
