Clover’s 420-patient Phase 2 trial found strong antibody responses to RSV, hMPV and PIV3 with no apparent immune interference, supporting further development of its multi-virus vaccines for older adults.
HoneyNaps has developed a four-patch wireless polysomnography platform capturing EEG, EOG, ECG, EMG, airflow and oxygen data while connecting with its FDA-cleared SOMNUM AI software.
A 120-patient multicenter study of the FDA-cleared SinglePass Kronos biopsy-tract electrocautery device reported 100% technical success and no clinically significant bleeding through 30 days.
FDA feedback supports major elements of Matricelf’s proposed first-in-human NewRal study in chronic complete thoracic spinal cord injury while requesting additional IND information.
Pulnovo’s randomized PADN-HF-PH study found a 51% reduction in clinical worsening with pulmonary artery denervation plus medical therapy, with results published in NEJM.
Novartis and Ionis say pelacarsen substantially reduced lipoprotein(a) but failed to reduce major cardiovascular events in the 8,323-patient Phase 3 Lp(a)HORIZON trial.
A 587-patient matched real-world analysis found severe bleeding in 21.8% of CytoSorb-treated urgent CABG patients versus 34.5% of controls, strengthening CytoSorbents’ planned DrugSorb-ATR De Novo resubmission.
Medibyt has received FDA 510(k) clearance for CPETWise, a software platform designed to standardize cardiopulmonary exercise test analysis while preserving clinician access to underlying physiological data.
Kali Therapeutics has received FDA IND clearance for KT501, a CD19xBCMAxCD3 trispecific T-cell engager designed to produce deep B-cell and plasma-cell depletion in autoimmune disease.
Mabwell’s 80-patient Phase 1b/2a COPD trial showed an 81% numerical reduction in moderate-to-severe exacerbations at the highest 9MW1911 dose, supporting Phase 2b and planned Phase 3 development.