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.
Antag Therapeutics ApS has received IND clearance from the FDA for lead molecule, AT-7687. A phase I trial will evaluate AT-7687 in healthy lean and healthy obese subjects, including as monotherapy and in combination with semaglutide in the healthy obese individuals.
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.
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.
Cascade Pharmaceuticals Inc. has synthesized benzoheterocyclic compounds acting as free fatty acid FFA1 receptor (GPR40) agonists reported to be useful for the treatment of diabetes.
The melanocortin MC4 receptor (MC4R), expressed in all brain regions, plays a relevant role in metabolism regulation and in the control of hunger and satiety. MC4R-specific agonist ligands such as setmelanotide have shown potential as antiobesity therapeutics, although reported off-target effects highlight the need for more specific compounds.
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.
RSS
