The U.S. FDA has issued yet another complete response letter (CRL) for dasiglucagon, a glucagon receptor agonist, being developed by Zealand Pharma A/S for treating congenital hyperinsulinism, an ultra-rare disease that is also being targeted by at least two other companies. This CRL is pegged to the timing of a third-party manufacturing facility reinspection that was done in August and September. The agency also wants some additional clinical analysis from the phase III study.
Judo Bio Inc. emerged from stealth mode and rolled out data showing the value of using megalin receptors for intracellular delivery of ligand-small interfering RNA (siRNA) therapeutics to the kidney as a way of reducing expression of the targeted genes.
Danish pharma giant Novo Nordisk A/S is set to launch its blockbuster glucagon-like peptide-1 therapy, Wegovy (semaglutide), in South Korea’s growing obesity therapeutics market next week, a company official confirmed to BioWorld.
Taiwan’s Caliway Biopharmaceuticals Co. Ltd. raised NT$6.4 billion (US$206 million) in its IPO on the Taipei Stock Exchange, making it the largest IPO in Taiwan’s biotech industry history and valuing the company at nearly $3 billion following the listing.
South San Francisco-based Septerna Inc. filed an S-1 with the U.S. SEC to conduct an IPO on Nasdaq about two years and eight months after launching operations with a $100 million series A led by Third Rock Ventures. The company is focused on G protein-coupled receptor oral small molecules derived from its Native Complex Platform, aimed at treating diseases within the endocrinology, immunology and inflammation, and metabolic diseases realms.
Neurobo Pharmaceuticals Inc., of Cambridge, Mass., reported top-line phase Ia study results of its obesity drug candidate, DA-1726, Sept. 30, causing the company’s shares to lose 11.7% of their value over two days.
In one of the top series A financings in biopharma history, new company Kailera Therapeutics Inc. emerged with $400 million raised and a pipeline of next-generation assets to treat obesity and type 2 diabetes.
Akeso Pharmaceuticals Inc. scored two approvals from China’s National Medical Products Administration on Sept. 30 before the long Labor Day holiday – one for its PCSK9 inhibitor, ebronucimab, and the second to expand use of PD-1/CTLA4 bispecific antibody cadonilimab in unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma, marking the second indication for cadonilimab in China.
The U.S. FDA has lifted the full clinical hold it imposed in June on Biomea Fusion Inc.’ s phase I/II studies of BMF-219 in types 1 and 2 diabetes. A safety review of the phase IIb expansion study was encouraging and none of the elevated lab values confirmed serious liver injury or impairment, said Biomea’s CEO, Thomas Butler.
Breakthrough – or even better, revolutionary breakthrough – is perhaps the most overused term in drug development. But the discovery and development of GLP-1 receptor agonists (GLP-1RAs), which was honored with the 2024 Lasker-DeBakey Clinical Medical Research Award just last week, is one of the rare innovations that is deserving of the title.
RSS
