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.
Boehringer Ingelheim GmbH terminated its second metabolic dysfunction-associated steatohepatitis (MASH) alliance on March 6, ending an $870 million license agreement inked with Yuhan Corp. for dual GLP-1/FGF21 agonist, BI-3006337 (YH-25724). Yuhan said March 7 that Boehringer, of Ingelheim, Germany, returned rights to YH-25724, a dual-acting glucagon-like peptide-1 and fibroblast growth factor 21 receptor agonist, based on the counterparty’s “strategic judgement” on developing MASH therapeutics.
Rusfertide could become a blockbuster therapy for polycythemia vera, H.C. Wainwright analyst Douglas Tsao wrote March 4 after the injectable hepcidin mimetic peptide hit its primary endpoint and all four key secondary endpoints in the ongoing phase III Verify study.
Persica Pharmaceuticals Ltd. has delivered positive 12-month follow-up data from its phase Ib study of PP-353, an injectable antibiotic for treating chronic lower back pain, and is now looking for a partner and further financing to take the product into phase III development.
The march toward better drugs in Parkinson’s disease suffered a setback as Irlab Therapeutics AB rolled out top-line results from the phase IIb study with pirepemat called React-PD.
As U.S. regulatory uncertainty swirls around the vaccine space and health care in general, Vaxcyte Inc. stands poised for a readout of phase II infant data by the end of this quarter with VAX-24, the 24-valent pneumococcal conjugate vaccine (PCV). The San Carlos, Calif.-based firm will offer top-line safety, tolerability, and immunogenicity data, to be followed by top-line data with the booster dose by the end of this year.
For executives of Lexicon Pharmaceuticals Inc., the missed primary endpoint in the phase IIb Progress study testing pilavapadin, its non-opioid candidate, in adults with moderate to severe diabetic peripheral neuropathic pain seemed merely a footnote for what CEO Mike Exton called an “exciting and long-awaited day for the Lexicon team, collaborators and patients.”
In January 2025, BioWorld tracked 171 phase I-III clinical trial updates, down from 212 in December. The month delivered 12 successful phase III outcomes, six of those in cancer, while two trials ended in failure.
After Study 1’s independent data monitoring committee said the experiment will likely fall short of its primary endpoint with ulixacaltamide in essential tremor, Praxis Precision Medicines Inc. plans to wait for full data from Study 1 as well as Study 2 in the Essential 3 phase III program before deciding on regulatory moves.
Astrazeneca plc’s good news with its oral selective estrogen receptor degrader (SERD) and estrogen receptor antagonist, camizestrant, when used as part of a combo in breast cancer raised optimism for the approach, which has caught on in various biopharma quarters.
RSS
