LONDON — Privately owned UK biotech company Daval International Limited (http://www.davalinternational.com) has been informed by Australia’s Therapeutic Goods Administration (TGA) that its innovative anti-inflammatory agent AIMSPRO(R) has been awarded Orphan Status for the treatment of Amyotrophic Lateral Sclerosis (ALS). ALS is the most common form of Motor Neuron Disease (MND),...
treatment News
MARIETTA, Ga. — Airway Therapeutics, Inc., a clinical-stage biopharmaceutical company developing novel biologic therapies for respiratory, inflammatory, and infectious diseases, today announced that the European Medicines Agency (EMA) Pediatric Committee (PDCO) has approved its Pediatric Investigation Plan (PIP) for its investigational biologic, zelpultide alfa, in its initial indication for the prevention...
NEW YORK & CAMBRIDGE, Mass. — Ajax Therapeutics, Inc., a biopharmaceutical company developing next generation JAK inhibitors for patients with myeloproliferative neoplasms (MPNs), today announced that it has received clearance for its Investigational New Drug (IND) application from the U.S. Food and Drug Administration (FDA) to initiate a Phase 1...
NEW YORK, NY and CAMBRIDGE, Mass. — Ajax Therapeutics, Inc., a biopharmaceutical company developing next generation JAK inhibitors for patients with myeloproliferative neoplasms (MPNs), today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to AJ1-11095 for the treatment of myelofibrosis, a debilitating blood cancer that...
TAMPA, Fla. and LONDON, UK — Akari Therapeutics, Plc (Nasdaq: AKTX), an oncology biotechnology company developing novel payload antibody drug conjugates (ADCs), today announced key preclinical data demonstrating the therapeutic potential of its novel ADC targeting Trop2, AKTX-101, in pancreatic cancer driven by K-Ras mutations, one of the deadliest and...
CAMBRIDGE, Mass. — Akebia Therapeutics, Inc. (Nasdaq: AKBA), a biopharmaceutical company with the purpose to better the lives of people impacted by kidney disease, today announced that the first patient has been dosed in a Phase 2 clinical trial of praliciguat, an oral, once-daily soluble guanylate cyclase (sGC) stimulator being evaluated...
SOUTH SAN FRANCISCO, Calif. — Akero Therapeutics, Inc. (Nasdaq: AKRO), a clinical-stage company developing transformational treatments for patients with serious metabolic diseases marked by high unmet medical need, today announced publication of 96-week results from the Phase 2b HARMONY trial in The Lancet. The publication reports final results from HARMONY,...
SOUTH SAN FRANCISCO, Calif. — Akero Therapeutics, Inc. (Nasdaq: AKRO), a clinical-stage company developing transformational treatments for patients with serious metabolic diseases marked by high unmet medical need, today released preliminary topline week 96 results from HARMONY, a Phase 2b study evaluating the efficacy and safety of its lead product...
HONG KONG — Akeso, Inc. (9926.HK) is excited to announce that the U.S. Food and Drug Administration (FDA) has approved its differentiated PD-1 monoclonal antibody, penpulimab-kcqx, in combination with cisplatin or carboplatin and gemcitabine for the first-line treatment of adult recurrent or metastatic non-keratinizing nasopharyngeal carcinoma (NPC). FDA also approved...
HONG KONG — Akeso, Inc. (9926.HK) (“Akeso” or the “Company”) announced that the first patient has been dosed in its global, multicenter, randomized Phase II registrational trial (COMPASSION-36/AK104-225). The trial will evaluate cadonilimab, Akeso’s first-in-class PD-1/CTLA-4 bispecific antibody, in combination with lenvatinib versus lenvatinib alone for the treatment of advanced hepatocellular...