Autoimmune Disorders

Ligand OmniAb® Partner Immunovant Announced Positive Topline Results from Phase 2a Trial of IMVT-1401 in Myasthenia Gravis

SAN DIEGO–(BUSINESS WIRE)–Ligand Pharmaceuticals Incorporated (NASDAQ: LGND) OmniAb® partner Immunovant, Inc. (NASDAQ: IMVT) announced positive topline results from ASCEND MG, a Phase 2a study of OmniAb-derived IMVT-1401 in patients with myasthenia gravis (MG). Immunovant is a clinical-stage biopharmaceutical company focused on enabling normal lives for patients with autoimmune diseases. Highlights of …

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FDA Approves Genentech’s Enspryng for Treatment of Neuromyelitis Optica Spectrum Disorder

SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the U.S. Food and Drug Administration (FDA) has approved Enspryng™ (satralizumab-mwge) as the first and only subcutaneous treatment for adults living with anti-aquaporin-4 (AQP4) antibody positive neuromyelitis optica spectrum disorder (NMOSD). NMOSD …

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CymaBay Announces Positive Topline Results from Phase 3 Study of Seladelpar in Patients with Primary Biliary Cholangitis

NEWARK, Calif., Aug. 03, 2020 (GLOBE NEWSWIRE) — CymaBay Therapeutics, Inc. (NASDAQ: CBAY) today announced positive topline results from ENHANCE, a placebo-controlled, randomized, Phase 3 study evaluating the safety and efficacy of seladelpar for the treatment of primary biliary cholangitis (PBC). Seladelpar is a potent and selective peroxisome proliferator-activated receptor …

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New Topline Tepezza Data Underscore its Efficacy in Longer Disease Duration, Long-Term Durability and Potential for Retreatment in Patients with Thyroid Eye Disease

DUBLIN–(BUSINESS WIRE)–Horizon Therapeutics plc (Nasdaq: HZNP) today announced positive topline data from two clinical trials that add to the growing body of evidence supporting the efficacy and safety of TEPEZZA® (teprotumumab-trbw) for the treatment of Thyroid Eye Disease (TED). TEPEZZA is the first and only medicine approved by the U.S. Food …

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FDA Accepts and Grants Priority Review to Aurinia’s NDA for Voclosporin for the Treatment of Lupus Nephritis

VICTORIA, British Columbia & ROCKVILLE, Md.–(BUSINESS WIRE)–Aurinia Pharmaceuticals Inc. (Nasdaq:AUPH / TSX:AUP) (“Aurinia” or the “Company”), a late-stage clinical biopharmaceutical company focused on advancing voclosporin across multiple indications, today announced that the U.S. Food and Drug Administration (FDA) has accepted the filing of its New Drug Application (NDA) for voclosporin, …

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Rinvoq Monotherapy Meets All Primary and Secondary Endpoints in Second Phase 3 Study for Atopic Dermatitis

NORTH CHICAGO, Ill., July 21, 2020 /PRNewswire/ — AbbVie (NYSE: ABBV) today announced upadacitinib (15 mg and 30 mg, once daily) monotherapy met both primary and all secondary endpoints in Measure Up 2, the second Phase 3 study in individuals with moderate to severe atopic dermatitis.1 The co-primary endpoints were at least a …

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FDA Grants Breakthrough Therapy Designation to Concert’s CTP-543 for Treatment of Alopecia Areata

LEXINGTON, Mass.–(BUSINESS WIRE)–Concert Pharmaceuticals, Inc. (NASDAQ: CNCE) today announced that the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation for the Company’s oral Janus kinase inhibitor, CTP-543, for the treatment of adult patients with moderate-to-severe alopecia areata. There are currently no drugs approved by the FDA for the treatment …

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Janssen Discontinues Phase 3 Study Evaluating Ustekinumab in Systemic Lupus Erythematosus

SPRING HOUSE, Pa., June 26, 2020 — The Janssen Pharmaceutical Companies of Johnson & Johnson announced today its decision to discontinue the Phase 3 LOTUS study of STELARA® (ustekinumab) in Systemic Lupus Erythematosus (SLE) due to lack of efficacy in SLE. The decision is based on data from a pre-planned interim efficacy analysis. Interim …

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FDA Approves Viela Bio’s Uplizna for the Treatment of Neuromyelitis Optica Spectrum Disorder

GAITHERSBURG, Md., June 11, 2020 (GLOBE NEWSWIRE) — Viela Bio (Nasdaq:VIE) today announced that the U.S. Food and Drug Administration (FDA) has approved UPLIZNATM (inebilizumab-cdon) for the treatment of adult patients with neuromyelitis optica spectrum disorder (NMOSD) who are anti-AQP4 antibody positive as a twice-a-year maintenance regimen following initial doses. Approximately 80%1 of …

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Innovent and Roche Collaborate to Discover and Develop Multiple Products Including Cellular Therapies and Bispecific Antibodies

SUZHOU, China, June 8, 2020 /PRNewswire/ — Innovent Biologics, Inc. (“Innovent”) (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines for the treatment of cancer, metabolic, autoimmune and other major diseases, today announced a strategic research and development collaboration with Roche covering multiple cell therapies …

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