FDA clears SkinStylus for periorbital wrinkles across all skin types; accepts Biofrontera's sNDA for Ameluz PDT in superficial BCC with a September 2026 PDUFA date; Belite Bio completes rolling NDA submission for tinlarebant in Stargardt disease.
Belite Bio has begun a rolling NDA submission for tinlarebant, an oral therapy for Stargardt disease type 1. The drug has Breakthrough Therapy Designation, and the company expects to complete the submission in Q2 2026.
Belite Bio announced preliminary Q4 2025 results and plans to submit an NDA for tinlarebant in Q2 2026 following positive Phase 3 trial results. BioArctic reported record financial results with operating profit exceeding SEK 1.2 billion for 2025. Recordati delivered strong preliminary full-year 2025 results despite FX headwinds.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT05244304 |
Phase 3, Randomized, Placebo-Controlled Study of Tinlarebant to Explore Safety and Efficacy in Adolescent Stargardt Disease |
COMPLETED | PHASE3 |
