PTC Therapeutics Inc. will be launching its oral phenylketonuria therapy, Sephience (sepiapterin) in both the U.S. and Europe this summer, following the U.S. FDA approval just ahead of its July 29 PDUFA date. Sephience previously gained marketing authorization by the European Commission, roughly three months after a thumbs up from the EMA’s Committee for Medicinal Products for Human Use.
Work at Libra Therapeutics Inc. has led to the identification of new mucolipin-1 (MCOLN1; TRPML1) activators reported to be useful for the treatment of metabolic diseases, infections, hematologic diseases, inflammation, cardiovascular, eye, neurological and renal disorders, among others.
Nextcure Inc. has unveiled new preclinical data supporting the therapeutic potential of NC-605, a new anti-Siglec-15 antibody, in treating osteogenesis imperfecta, a rare genetic disorder characterized by fragile bones and frequent fractures.
Albireo Ltd. has patented new benzothia(di)azepine compounds acting as ileal sodium/bile acid cotransporter (SLC10A2; IBAT; ASBT) and/or sodium-bile acid cotransporter (SLC10A1; NTCP) inhibitors reported to be useful for the treatment of diabetes, cardiovascular, gastrointestinal, liver and renal disorders.
CSPC Baike (Shandong) Biopharmaceutical Co. Ltd. has patented new polycyclic compounds acting as glucagon-like peptide 1 receptor (GLP-1R) agonists reported to be useful for the treatment of Alzheimer’s disease, obesity, type 2 diabetes and nonalcoholic fatty liver disease (NAFLD; MASLD).
Superluminal Medicines Inc. has commenced IND-enabling studies for its lead program, an orally administered, highly selective, biased melanocortin MC4 receptor (MC4R) agonist initially targeting rare genetic forms of obesity and hypothalamic obesity, with potential as a treatment for general obesity in combination with GLP-1 drugs. IND submission is expected in the second half of 2026.
A glucagon-like peptide-1 and glucose-dependent insulinotropic polypeptide receptor dual agonist developed by Jiangsu Hengrui Pharmaceuticals Co. Ltd. and licensed by Kailera Therapeutics Inc. has shown a mean weight loss of 19.2% at the 6-mg dose with no plateau over 48 weeks in a phase III trial conducted in China.
SML Biopharm Co. Ltd. is harnessing mRNA technology to develop novel immunotherapy-based cancer vaccines, including two candidates for cervical and head and neck cancers caused by human papillomavirus (HPV) infection.
The U.S. FDA on July 15 cleared Biocon Biologics Ltd.’s Kirsty (insulin aspart-xjhz) as the first and only interchangeable biosimilar product referencing Novo Nordisk A/S’ Novolog (insulin aspart), a rapid-acting diabetes medication.
SML Biopharm Co. Ltd. is harnessing mRNA technology to develop novel immunotherapy-based cancer vaccines, including two candidates for cervical and head and neck cancers caused by human papillomavirus (HPV) infection.
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