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...
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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...
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...
MILAN – Italian pharmaceutical group Recordati (RECI.MI) has signed an agreement to buy UK-headquartered EUSA Pharma for an enterprise value of 750 million euros ($847 million) to boost its rare disease products portfolio, it said in a statement on Friday. EUSA Pharma, founded in 2015 and controlled by funds managed by...
SALT LAKE CITY, Utah — Recursion, a leading clinical stage TechBio company decoding biology to industrialize drug discovery, today announced it has signed an agreement with Bayer AG to in-license a new chemical entity that emerged from the companies’ fibrosis research collaboration. The compound represents a novel approach to treating...
SALT LAKE CITY, Utah — Recursion (Nasdaq: RXRX), a clinical-stage TechBio company decoding biology to radically improve lives, today announced positive Phase 1b/2 data from the ongoing TUPELO trial of REC-4881, an investigational allosteric MEK1/2 inhibitor for familial adenomatous polyposis (FAP). Through an unbiased phenotypic screen of thousands of compounds, the...
TEL-AVIV, Israel and RALEIGH, N.C. — RedHill Biopharma Ltd. a specialty biopharmaceutical company, today announced that its two novel, oral host-directed investigational drugs, opaganib and RHB-107 (upamostat) demonstrated robust synergistic effect when combined individually with remdesivir (Veklury), significantly improving viral inhibition while maintaining cell viability, in a new U.S. Army-funded...