With the U.S. FDA clearance of the sNDA for Wegovy (semaglutide) from Novo Nordisk A/S to treat noncirrhotic metabolic dysfunction-associated steatohepatitis (MASH), Wall Street speculation deepened as to the consequences for Madrigal Pharmaceuticals Inc.’s Rezdiffra (resmetirom), a thyroid hormone receptor-beta (THR-beta) agonist that won the MASH go-ahead last year.
Superluminal Medicines Inc. and Eli Lilly and Co. are collaborating in a deal to develop cardiometabolic disease and obesity therapies by aiming at undisclosed G protein-coupled receptor targets. The deal could bring Superluminal as much as $1.3 billion, including up-front and near-term investments, an equity investment, development and commercial milestones, plus tiered royalties on net sales.
Doing his version of the Texas Two-Step, Texas Attorney General (AG) Ken Paxton is again shuffling Eli Lilly and Co. into a state courtroom – this time for allegedly overstepping the anti-kickback line.
A federal appeals court opened the door Aug. 6 for an amended class-action lawsuit alleging that Astrazeneca plc, Eli Lilly and Co., Novo Nordisk A/S and Sanofi SA engaged in a horizontal price-fixing conspiracy involving insulin products and GLP-1 drugs indicated in diabetes when they each adopted similar policies in 2020 to impose restrictions on 340B discounts to an unlimited number of contract pharmacies.
Innogen Pharmaceutical Group announced an $86 million IPO on the Hong Kong Stock Exchange that will see the company advance its lead product, Diabegone (efsubaglutide alfa), an ultra-long-acting glucagon-like peptide-1 receptor agonist into new global markets for type 2 diabetes as well as other metabolic diseases.
The fibroblast growth factor 21 (FGF21) analogue space took another turn as Novo Nordisk A/S said during its second-quarter financial update that work with zalfermin (NNC0194-0499) will be discontinued. A phase II study testing the compound in combination with glucagon-like peptide-1 therapy failed to hit the primary endpoint related to liver fibrosis in metabolic dysfunction-associated steatohepatitis (MASH), without MASH worsening.
Deep learning tools for protein design can also be used to create molecules that bind to them. Certain peptides, such as intrinsically disordered proteins (IDPs), are challenging to target due to their variable nature. However, scientists from the lab of Nobel laureate David Baker have developed a method to generate binders for IDPs by searching the world’s largest protein database with their AI-powered tool RFdiffusion.
Madrigal Pharmaceuticals Inc.’s long-awaited business development pact became reality by way of an exclusive global license agreement that could be worth more than $2 billion with CSPC Pharmaceutical Group Ltd., of Shijiazhuang, China, for SYH-2086. The candidate is a preclinical oral, small-molecule glucagon-like peptide-1 (GLP-1) receptor agonist and orforglipron derivative.
With reduced sales and operating expectations for the rest of the year, Novo Nordisk A/S is on the receiving end of a huge stock drop. For a big pharma, where the stock drops are usually more modest, the shares (NASDAQ:NVO) fell off a cliff on July 29, closing 21.8% downward to $53.93 each, the lowest price per share in the past 12 months. Lower U.S. sales of semaglutide blockbusters Wegovy and Ozempic for treating obesity and diabetes are at the heart of the plunge. In May, the Danish company had expected 13% to 21% sales growth but now is looking at only 8% to 14%.
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.
RSS
