Nested Therapeutics Inc. has obtained FDA clearance of its IND application for NST-628 for the treatment of patients with advanced solid tumors harboring genetic alterations in the RAS-MAPK pathway.
Beam Therapeutics Inc. has received clearance of its clinical trial authorization (CTA) application by the U.K.’s Medicines and Healthcare Products Regulatory Agency for BEAM-302, an in vivo base editor, as a potential treatment for patients with α1-antitrypsin deficiency (AATD).
Atamyo Therapeutics SAS has received clinical trial application (CTA) authorizations in Italy and France for ATA-200, its gene therapy for the treatment of γ-sarcoglycan related limb-girdle muscular dystrophy type 2C/R5 (LGMD2C/R5).
Cinfina Pharma Inc. has obtained FDA clearance of its IND application for CIN-110, a PYY3-36 analogue, allowing it to initiate a first in-human study in otherwise healthy subjects with obesity. CIN-110 is a stable and long-acting analogue of PYY3-36 being developed both as a monotherapy and for co-administration for obesity.
Aptamer Sciences Inc. has filed an IND application with the Korean Ministry of Food and Drug Safety seeking clearance to conduct a phase I trial of AST-201 in patients with GPC3-positive advanced solid tumors.
Vertex Pharmaceuticals Inc. has obtained IND clearance from the FDA for VX-407, an investigational first-in-class small-molecule corrector that targets the underlying cause of autosomal dominant polycystic kidney disease (ADPKD) in patients with a subset of PKD1 genetic variants.
CSPC Pharmaceutical Group Ltd. has obtained clearance by China’s National Medical Products Administration (NMPA) to conduct clinical trials in China with SYS-6023 for advanced solid tumors.
CSPC Pharmaceutical Group Ltd. has received clearance from China’s National Medical Products Administration (NMPA) to conduct clinical trials in China with SYH-2039, a highly selective methionine adenosyltransferase 2A (MAT2A) inhibitor, for advanced malignant tumors.
Xgene Pharmaceutical Pty Ltd., a subsidiary of Xgene Pharmaceutical Co. Ltd., has received approval in Australia to initiate a phase I trial of the selective TRPM8 blocker XG-2002 (RQ-00434739).
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