VALENCIA, Spain — ARTHEx Biotech S.L., a clinical-stage biotechnology company focused on developing innovative medicines through the modulation of microRNAs, announced that the U.S. Food and Drug Administration (FDA) cleared the Company to initiate the Phase I-IIa ArthemiR™ study of ATX-01 for the treatment of Myotonic Dystrophy Type 1 (DM1)....
treatment News
Cardiac amyloidosis is a rare disease characterized by the accumulation of plaques of the amyloid protein in the heart, making it hard (which is why it is also called stiff heart syndrome) and may require a pacemaker or be the cause of death. It has some treatments, but they are...
SAN DIEGO, Calif. — Artiva Biotherapeutics, Inc., a clinical stage company whose mission is to deliver highly effective, off-the-shelf, allogeneic natural killer (NK) cell-based therapies, announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to Artiva’s lead program AlloNK® (also known as AB-101) for...
NEW HAVEN, Conn. — Arvinas Inc., (Nasdaq: ARVN), a clinical-stage biotechnology company creating a new class of drugs based on targeted protein degradation, today announced that the first subject was dosed in its Phase 1 clinical trial of ARV-102, the Company’s first oral PROTAC® (PROteolysis-TArgeting Chimera) protein degrader in development...
MILPITAS, Calif. – ASC Therapeutics, a privately-held biopharmaceutical company pioneering the development of transformative in-vivo gene replacement, gene editing and allogeneic cell therapies for hematologic and other rare disorders today announced that the U.S. Food & Drug Administration (FDA) has cleared an Investigational New Drug (IND) application for ASC618, an...
COPENHAGEN, Denmark — Ascendis Pharma A/S (Nasdaq: ASND) today announced that YORVIPATH® (palopegteriparatide, developed as TransCon PTH), a parathyroid hormone (PTH) replacement therapy indicated for the treatment of adults with chronic hypoparathyroidism, is now available in Germany and Austria. YORVIPATH is the second product developed with Ascendis Pharma’s TransCon technology...
SUZHOU, China and ROCKVILLE, Md. — Ascentage Pharma a global biopharmaceutical company engaged in developing novel therapies for cancer, chronic hepatitis B (CHB), and age-related diseases, announced today that Prof. Xiaoyuan Gong of the Institute of Hematology and Blood Diseases Hospital, the Chinese Academy of Medical Sciences, has presented the preliminary results from...
SUZHOU, China, and ROCKVILLE, Md. — Ascentage Pharma (6855.HK), a global biopharmaceutical company engaged in developing novel therapies for cancer, chronic hepatitis B (CHB), and age-related diseases, announced today that results from three clinical studies of lisaftoclax (APG-2575), a key candidate drug in the Company’s pipeline, have been selected for...
BOSTON, Mass. –Ascidian Therapeutics, a biotechnology company aspiring to treat human diseases by rewriting RNA, today announced that the U.S. Food and Drug Administration (FDA) has cleared its investigational new drug (IND) application and granted Fast Track designation for ACDN-01. ACDN-01 is the first-ever clinical-stage RNA exon editor and...
HANGZHOU and SHAOXING, China — Ascletis Pharma Inc. (HKEX: 1672, “Ascletis”) today announces late-breaking abstract poster presentation of interim results from Phase IIb expansion cohort of ASC22 (Envafolimab) for functional cure of chronic hepatitis B (CHB), and abstract poster presentation of Phase I study results of ASC41 for treatment of...