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.
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.
Proteinqure Inc. has received regulatory clearances from the U.FDA and Health Canada to initiate a phase I trial of lead candidate, PQ-203. The trial will begin in Canada and expand to U.S. sites later in 2025. The FDA also granted PQ-203 fast track designation for triple-negative breast cancer (TNBC).
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.
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.
Spine Biopharma Inc. cited an “inconsistent sham control response” among some of the sites in its phase III study testing SB-01 as an intradiscal treatment for patients with chronic low back pain associated with degenerative disc disease. The study, dubbed MODEL, fell short of statistical significance on pain intensity and pain-related function, despite showing numerical and clinically meaningful improvements.
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.
Soligenix Inc.’s phase IIa study of SGX-945 (dusquetide) for treating oral ulcers in those with Behçet's disease showed biological efficacy in the proof-of-concept study. The positive results propelled the company’s stock (NASDAQ:SNGX) a hefty 134% higher on July 31, with shares closing at $2.93 each.
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%.
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