The U.S. FDA has cleared Tessera Therapeutics Inc.’s IND application for TSRA-196, its lead in vivo gene editing therapy for α-1 antitrypsin deficiency (AATD). The Australian Human Research Ethics Committee (HREC) has also granted approval for the company to begin the phase I/II clinical study.
Askbio Inc., a subsidiary of Bayer AG, has received IND clearance from the FDA for AB-1009, an AAV gene therapy being developed for the treatment of late-onset Pompe disease.
Incregen Therapeutics LLC has advanced INC-118, a glucose-dependent insulinotropic polypeptide (GIP) ligand antagonist designed to address long-term obesity management, into IND-enabling studies.
Amylyx Pharmaceuticals Inc. has nominated AMX-0318, a long-acting glucagon-like peptide-1 (GLP-1) receptor antagonist, as a development candidate for post-bariatric hypoglycemia and other rare diseases.
Kallyope Inc. has outlined plans to initiate phase I studies this year with K-554, a non-incretin peptide candidate offering a new mechanism of action in obesity.
Genprex Inc. has released preliminary in vivo proof-of-concept data for GPX-002, the company’s diabetes gene therapy drug candidate, in a nonhuman primate (NHP) model of type 2 diabetes and in a mouse model of type 2 diabetes. GPX-002 is being developed for the potential long-term control of both type 1 and type 2 diabetes.
Hyloris Pharmaceuticals SA has entered into a license agreement with Arbormed Co. Ltd. for exclusive rights in Europe and Turkey to Arbormed’s novel injectable product candidate for Wilson’s disease.
A review of 2025's noteworthy advances in medical research, including GLP-1 receptor agonists as anti-aging drugs, tumor-agnostic therapies and xenotransplants.
CSPC Pharmaceutical Group Ltd. has obtained approval from the National Medical Products Administration (NMPA) in China to conduct clinical trials of SYH-2072 (tablets), a highly selective and potent aldosterone synthase inhibitor. It is being investigated as a potential treatment for uncontrolled hypertension and primary aldosteronism.
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