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...
treatment News
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...
HONG KONG — Akeso, Inc. (9926.HK) announced that its supplemental New Drug Application (sNDA) for gumokimab (AK111), a novel humanized anti-IL-17A monoclonal antibody for the treatment of active ankylosing spondylitis (AS), has been accepted for review by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA). There are...
HONG KONG — Akeso, Inc. today announced that the Company presented the promising phase II results of cadonilimab (a tetravalent PD-1/CTLA-4 bispecific antibody) and Lenvatinib (Len) combined with TACE for the treatment of mid- and advanced-stage hepatocellular carcinoma (HCC) in a poster at the 2024 American Society of Clinical Oncology...
HONG KONG — Akeso published two phase Ib clinical results of its innovative CD47 monoclonal antibody ligufalimab (AK117) in combination with azacitidine in patients with newly diagnosed higher-risk myelodysplastic syndrome (HR-MDS) and treatment-naïve acute myeloid leukemia (AML) at the 65th American Society of Hematology (ASH) Annual Meeting. HR-MDS Anemia...
ZURICH, Switzerland — AL-S Pharma today announced positive topline results from the Phase 2 clinical study evaluating AP-101, a potential first-in-class, disease-modifying treatment for amyotrophic lateral sclerosis (ALS). AP-101 is a monoclonal antibody targeting misfolded SOD1, a key pathology in both sporadic ALS and mutant SOD1-ALS.1 AP-101, in addition to standard of...
NEWTON, Mass. – Alcresta Therapeutics, Inc., a leading commercial-stage company focused on developing and commercializing novel enzyme-based products, today announced publication of a position paper by the North American Society for Pediatric Gastroenterology, Hepatology, and Nutrition (NASPGHAN) Pancreas Committee recommending the use of RELiZORB® (immobilized lipase cartridge), a first-of-its-kind digestive...
LEXINGTON, Mass. — Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra) today announced that the European Medicines Agency (EMA) has granted Orphan Designation for ADX-2191 (methotrexate intravitreal injection, USP) for the treatment of primary large B-Cell lymphomas of immune-privileged sites, including primary vitreoretinal lymphoma. There is currently no approved treatment for patients with...
LEXINGTON, Mass. – Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra) today announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to the company for ADX-2191 (methotrexate for intravitreal injection) for the treatment of primary vitreoretinal lymphoma (PVRL). There are no approved treatments for PVRL, a rare, aggressive,...