Positive top-line data from phase II and III studies of lorundrostat for treating uncontrolled or resistant hypertension propelled Mineralys Therapeutics Inc.’s stock sharply upward on March 10. The phase III Launch-HTN study hit its primary endpoint in reducing systolic blood pressure and the phase II Advance-HTN study also met its primary endpoint of a clinically meaningful reduction in blood pressure. Oral lorundrostat targets dysregulated mineralcorticoid aldosterone as a selective aldosterone synthase inhibitor. Mineralys estimated there to be about 15- to 20-million patients with uncontrolled hypertension in the U.S. On March 10, the Radnor, Pa.-based company’s shares (NASDAQ:MLYS) closed 42% upward at $14.96 each. Read More
Several drugs already selected for Medicare price negotiations, including Novo Nordisk A/S’ mega-blockbuster diabetes/weight-loss franchise, could see up to a three-year reprieve if a bipartisan bill recently introduced in the U.S. House and Senate becomes law. Read More
While the U.S. has historically led the global pharmaceutical industry by pursuing both continual innovation and high quality, those strengths could become areas of weakness in times of political uncertainty, according to PA Consulting expert Andy Prinz. Read More
The recent series A financing by Bambusa Therapeutics Inc. to fund bispecific antibodies for immunological and inflammatory disorders proved investor faith in the new approach with a proven mechanism. Read More
Three public health experts have voiced concerns that the uncertainties sparked by the Trump administration’s moves to reduce federal spending could limit the U.S. CDC’s ability to track and respond to infectious disease outbreaks and will undermine the public health support system in the U.S. Read More
George Demos, former vice president of drug safety and pharmacovigilance at Acadia Pharmaceuticals Inc., is the latest biopharma executive to plead guilty to insider trading charges. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Astrazeneca, Avacta, Atyr, Biocon, Eli Lilly, Sun, Torqur. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Kancera, Novakand, Orgenesis, Recardio, Virpax. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Alk-Abello, Bavarian, BMS, Ferring, Scpharmaceuticals. Read More
