Successful Dosing of Adults in XLRS LIGHTHOUSE Trial
Preliminary adult data from Atsena’s LIGHTHOUSE trial continue to show structural and functional improvement signals in X‑linked retinoschisis alongside...
Seres Therapeutics Implements Cost Cuts After FDA Feedback
Seres’ SER-155 previously showed a 77% relative reduction in bloodstream infections versus placebo in a Phase 1b allo-HSCT study,...
BPL-003 Trial Shows Victory for Treatment-Resistant Depression
In an open-label Phase 2a study of 13 patients with treatment-resistant depression, intranasal mebufotenin benzoate (BPL-003) delivered a mean...
Actuate Gives FDA Updated Clinical Data for EMA Interactions
Actuate’s randomized Phase 2 (n=286) in first-line metastatic pancreatic adenocarcinoma reported a statistically significant improvement in median overall survival...
Cytisinicline Shows Potential for Smoking Cessation in COPD
Cytisinicline increased continuous smoking abstinence versus placebo with statistical significance in both COPD and non-COPD subgroups across the Phase...
New Hope for Neuropathic Corneal Pain: A Urcosimod Trial
In a randomized, double-masked, placebo-controlled Phase 2 proof-of-concept study of 17 patients with neuropathic corneal pain (NCP), 75% of...
New Vitiligo Therapy Shows Unprecedented Response Rates
A 251-patient, multicenter randomized controlled trial in adults with localized non-segmental vitiligo reported that combining a 308 nm excimer...
Cerevance to Present Phase 2 Data on Solengepras in Parkinson’s
Phase 2 data from the ASCEND trial of solengepras signaled potential benefit on functional and non-motor measures in early...
Adverum Finishes Screening for Pivotal ARTEMIS Wet AMD Trial
Screening for Adverum’s first Phase 3 trial of its intravitreal gene therapy for wet AMD will close by September...
FDA’s National Priority Voucher Program Is Just a Modular PMA Rebrand, With Risks
In June 2025, FDA announced its new Commissioner’s National Priority Voucher (CNPV) program, a headline-grabbing reform that promises to...