New York, NY – In people with pulmonary arterial hypertension (PAH), adding Winrevair (sotatercept-csrk) to standard therapy was linked to longer survival, fewer safety events, and a lower need for lung transplant compared with standard therapy alone, according to new real-world data. “These findings extend clinical trial evidence, suggesting sotatercept [Winrevair] offers meaningful...
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OSAKA, Japan & CAMBRIDGE, Mass. – VPRIV (velaglucerase alfa), an approved enzyme replacement therapy (ERT) for Gaucher disease, appears to be safe and effective in children under 4—a population not included in the clinical trials that supported its approval. A recent U.S. real-world study evaluated VPRIV in a small group...
NORFOLK, Va. — ReAlta Life Sciences, Inc., a mid-stage clinical biotech company dedicated to saving lives by rebalancing the inflammatory response to address life-threatening diseases, today announced enrollment of the first patient in a Phase 2 clinical trial evaluating the safety and efficacy of RLS-0071, an investigational new drug based...
NORFOLK, Va. — ReAlta Life Sciences, Inc. (“ReAlta” or the “Company”), a clinical-stage biopharmaceutical company dedicated to saving lives by rebalancing the inflammatory response to address rare and acute inflammatory diseases, today announced that the European Medicines Agency (EMA) has granted Orphan Drug Designation to RLS-0071 (pegtarazimod) for the treatment of...
PLANO, Texas – Reata Pharmaceuticals, Inc. (Nasdaq: RETA) (“Reata,” the “Company,” or “we”), a clinical-stage biopharmaceutical company, today announced that it received a communication from the Division of Neurology Products 1 (“Division”) of the U.S. Food and Drug Administration (“FDA”) stating that, after a preliminary review of briefing materials for...
PLANO, Texas – Reata Pharmaceuticals, Inc. (Nasdaq: RETA) (“Reata,” the “Company,” or “we”), a clinical-stage biopharmaceutical company, today announced that it has submitted a New Drug Application (“NDA”) for bardoxolone methyl (“bardoxolone”) for the treatment of chronic kidney disease (“CKD”) caused by Alport syndrome to the U.S. Food and Drug...
Shares of Reata Pharmaceuticals Inc (RETA.O) tripled in value on Wednesday after the U.S. Food and Drug Administration (FDA) approved its rare disease drug, ending years of uncertainty over its future.
MENLO PARK, Calif. — ReCode Therapeutics, a clinical-stage genetic medicines company using tissue-specific delivery to power the next wave of mRNA and gene correction therapeutics, today announced that the U.S. Food and Drug Administration (FDA) has granted clearance for the initiation of Part 3 of its ongoing Phase 2 clinical...
Milan, Italy – Recordati today announced that it has entered into a collaboration and license agreement with Moderna to develop and commercialize worldwide mRNA-3927, an investigational product for the treatment of propionic acidemia (PA). Under the terms of the agreement, Moderna will continue to lead the development of mRNA-3927, in...
BRIDGEWATER, N.J. — Recordati Rare Diseases Inc. today announced the presentation of new data detailing advances in the understanding of Castleman disease (CD), a group of rare immune system disorders characterized by abnormal lymph node enlargement and systemic inflammatory symptoms that can be potentially life-threatening. In a series of poster presentations...