After delaying a June PDUFA date, the U.S. FDA has approved Kalvista Pharmaceuticals Inc.’s Ekterly (sebetralstat) for hereditary angioedema (HAE) in those aged 12 and older. The plasma kallikrein inhibitor now joins a market with previously approved drugs for the rare, genetic, life-threatening condition, as well as other companies with HAE drugs in development. Ekterly is the first orally-delivered on-demand treatment, as all others in the U.S. are intravenously or subcutaneously administered.

Torrent Pharmaceutical Ltd. will buy J. B. Chemicals and Pharmaceuticals Ltd. (JB Pharma) from private equity firm KKR & Co. Inc. at an equity valuation of ₹256.89 billion (US$3 billion), which will then merge into one entity under Torrent Pharma.

Innovent Biologics Inc. announced June 27 that it gained National Medical Products Administration’s (NMPA) approval of mazdutide as a new weight loss therapy for obese or overweight patients in China. Mazdutide is a dual glucagon/glucagon-like peptide-1 (GCG/GLP-1) receptor agonist originally discovered by Eli Lilly and Co., of Indianapolis.

An experimental drug for treating diabetes and obesity has been shown to lower blood sugar levels and increase fat burning. It is a β2-adrenergic receptor (β2AR) agonist that mimics the effects of physical exercise by activating skeletal muscle metabolism. Unlike GLP-1-based treatments such as semaglutide and tirzepatide, this new compound, developed by researchers at the Karolinska Institute, Stockholm University, and the biotech company Atrogi AB, does not suppress appetite or cause muscle loss. 

Shanghai Yao Yuan Biotechnology Ltd., also known as Drug Farm, is advancing a portfolio of immune-modulating therapies for various indications including hepatitis B virus, hepatocellular cancer and a relatively new rare genetic disease called ROSAH, an acronym for retinal dystrophy, optic nerve edema, splenomegaly, anhidrosis, and headache.

With plenty of GLP-1 money to spend, Eli Lilly and Co. is buying Verve Therapeutics Inc. and its gene-editing program for about $1.3 billion. Two of Verve’s one-time treatments are in the clinic. Lead candidate VERVE-102, a gene-editing treatment targeting PCSK9, is in a phase Ib study to reduce cholesterol levels.

The 23andme Holding Co.’s saga came full circle with founder Anne Wojcicki regaining control of the bankrupt genetic testing company in a bidding battle against Regeneron Pharmaceuticals Inc.

CSPC Pharmaceutical Group Ltd. announced June 13 that it struck a potential $5.33 billion deal with Astrazeneca plc to develop novel preclinical small-molecule candidates using CSPC’s AI-driven drug development platform.

Four biotech companies from South Korea announced new or planned financings mid-June, including GC Genome Corp. Rznomics Inc., G2Gbio Inc. and Mezzion Pharma Co. Ltd. Six major mid-June deals included R&D pacts between Y-Biologics Inc. and Crosspoint Therapeutics, Daewoong Pharmaceutical Co. Ltd. and Salipro Biotech AB, Next & Bio Inc. and GC Cell Corp., Galux Inc. and Hanall Biopharma Co. Ltd., Celltrion Inc. and Onconic Therapeutics Inc., and SK Plasma Co. Ltd. and Aimedbio Inc.

Deep Apple Therapeutics Inc. could bring in as much as $812 million in a new collaboration and license deal with Novo Nordisk A/S. The total includes an unspecified up-front payment, research costs and milestones. The two plan to develop and commercialize oral small molecules for non-incretin G-protein coupled receptor targets for treating cardiometabolic diseases, including obesity, a core specialty for Novo Nordisk.