Lexicon Pharmaceuticals Inc. is counting on the Oct. 31 meeting of the U.S. FDA’s Endocrinologic and Metabolic Drugs Advisory Committee to help it break through the type 1 diabetes (T1D) door with Zynquista (sotagliflozin), proposed as an adjunct to insulin to improve glycemic control in people with T1D and mild to moderate chronic kidney disease.
While phase II results of Coya Therapeutics Inc.’s low-dose IL-2 drug, COYA-301, showed promise in Alzheimer’s disease patients when dosed every four weeks, it was the more frequent dosing of every two weeks that led to exhausted regulatory T cells and no benefits, driving down the company’s stock by nearly 28%.
With another failure of E-selectin antagonist uproleselan on the books, Glycomimetics Inc. signed an acquisition agreement with privately held, solid tumor-focused Crescent Biopharma Inc., and a syndicate of investors has put up $200 million to make the merger possible. The combined firm will operate under Crescent’s name after the deal closes in the second quarter of 2025, subject to shareholders’ go-ahead.
Semaglutide, the glucagon-like peptide 1 receptor agonist from Novo Nordisk A/S, which has seemingly improved every disease it’s been tested on, was a focus at Kidney Week 2024, where researchers presented data from multiple clinical studies in patients with kidney diseases.
Some studies suggest a need for cardiologists to rethink their approach to device implant. However, the TAVR UNLOAD study failed to demonstrate a statistically significant difference between device implant and medical management for patients with aortic stenosis and low left ventricular ejection fraction.
The U.S. FDA’s approval of the Abbott Laboratories Triclip was predicated on a data set comprised of 350 patients, but an additional bolus of data seems to reinforce the rationale for the FDA approval, including improvements in quality of life.
A major increase in the popularity of weight loss drugs, particularly GLP-1s, has created a rivalry with traditional device orientated approaches, but a new technology aims to navigate the space between them.
Shockwave Medical, a unit of New Brunswick, N.J.-based Johnson & Johnson Medtech, completed enrollment in the first prospective all-female study of percutaneous coronary intervention in complex disease. The real-world, all-comers trial will evaluate the benefits of coronary intravascular lithotripsy in female patients with calcified lesions.
An old target that found new life at Monte Rosa Therapeutics Inc. has become the subject of a sizeable deal between the company and Novartis AG, as the pair set about developing molecular glue degraders (MGDs). Shares of Monte Rosa (NASDAQ:GLUE) closed Oct. 28 at $9.48, up $4.59, or 93.9%, on word of the Boston-based firm’s deal with Novartis to advance VAV1 MGDs, including MRT-6160, a prospect undergoing a phase I single ascending dose/multiple ascending dose study in healthy volunteers for immune-mediated conditions.
Although more and more gene therapies are getting the FDA stamp of approval, concerns persist about their potential long-term risks. U.S. lawmakers have proposed several pieces of legislation over the past few years to address some of the uncertainties. Now the Congressional Research Service (CRS) is suggesting other requirements Congress may want to consider to improve the regulatory landscape for gene therapies, especially those intended to treat blood disorders.
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