Investor hopes rose sharply for Merus NV’s phase III trials – data should roll out next year – with bispecific antibody petosemtamab after mid-stage results impressed Wall Street in head and neck squamous cell carcinoma. Shares of Utrecht, the Netherlands-based Merus (NASDAQ:MRUS) jumped, too, closing May 23 at $55.14, up $13.54, or 33%, on interim data as of the Feb. 27 cutoff date.
Data from the first-in-human study of Tricares SAS Topaz transcatheter tricuspid valve replacement (TTVR) system, showed it significantly reduced tricuspid regurgitation (TR) in patients treated with the device. The early clinical data at 30 days demonstrated that all patients implanted with Topaz were at a TR grade ‘none’ (0+) or ‘mild’ (1+) following the procedure.
Annji Pharmaceutical Co. Ltd.’s rosolutamide (AJ-201, JM-17) achieved positive results in a phase I/II trial in adults with spinal and bulbar muscular atrophy, also known as Kennedy’s disease.
Medtronic plc revealed data at the EuroPCR conference which showed there was a significant, safe and sustained blood pressure reduction in patients treated with its Spyral renal denervation system who meet European recommended guidelines criteria over a three-year period.
Three-year data from Elixir Medical Corp.’s Bioadaptor randomized controlled trial showed that patients with coronary artery disease treated with its Dynamx coronary drug-eluting bioadaptor system continued to see lower adverse events rates compared to those treated with Medtronic plc’s Resolute Onyx drug-eluting stent .
The U.K. Medicines and Health Care Products Regulatory Agency posted a draft guidance on the use of real-world evidence to serve as a control arm for clinical trials.
Anti-aging specialist Juvenescence Ltd. reached the first close of its series B-1 at $76 million and said it is on course to close the round at $150 million in the third quarter of 2025. “The reason for the first close and not waiting for the very end is just so we can start to move the pipeline forward,” said Richard Marshall, CEO. “We’ve got molecules in and waiting to go, so the sooner we can get going on those, the better,” he told BioWorld.
A drug that failed in a phase III trial in 2019 is being brought back to the clinic by Repronovo SA, a fertility and women’s health startup that has raised $65 million in a series A. The money will fund a phase II study of nolasiban in improving success rates in assisted reproductive technology, the same indication as the previous phase III failure.
Shockwave Medical Inc., a unit of Johnson & Johnson Medtech, reported positive 30-day results from the EMPOWER CAD trial, which used its intravascular lithotripsy system in women with complex, calcified coronary artery disease. The results from the first prospective, real-world percutaneous coronary intervention study in female patients confirmed the benefit of coronary patients as seen in other retrospective analyses.
The credibility gap in psychedelic drug development continues to narrow with positive top-line data from a Beckley Psytech Ltd. phase IIa study in depression. The results keep the treatment into a tight race with GH Research plc, which also has an inhalable drug in development.