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The U.K. Medicines and Health Care Products Regulatory Agency posted a draft guidance on the use of real-world evidence to serve as a control arm for clinical trials.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.
The morning’s negative stock reaction to Tourmaline Bio Inc.’s phase II news with heart drug pacibekitug had some onlookers scratching their heads, even as analysts congratulated the company on results from the ongoing study – a good-news dataset to which the market gradually caught on as the day progressed.
Mirroring results reported in a phase IIb study, Apnimed Inc.’s first of two pivotal trials testing AD-109 as an oral therapy in obstructive sleep apnea hit primary and secondary endpoints. Should similar findings emerge from a second phase III trial, expected to read out in a couple of months, the privately held firm anticipates a U.S. NDA filing in early 2026.
Rebrain SAS's Optimmri platform received European Medical Device Regulation CE mark certification to enable surgeons to identify areas of interest in the brain during deep brain stimulation procedures for Parkinson's disease and essential tremor.
Just two months after Inozyme Pharma Inc. cut its workforce by 25% and prioritized activities to focus on a BLA filing for INZ-701 for ENPP1 deficiency, interim phase III data from its Energy 3 trial showed consistent safety and immunogenicity and increased phosphate levels in patients treated with the rare disease enzyme replacement therapy.
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