USFDAAug 12, 2026, 09:47 PM
Belite Bio's tinlarebant NDA Accepted by FDA with Priority Review
AI Summary
Belite Bio announced that the U.S. FDA accepted its New Drug Application (NDA) for tinlarebant for the treatment of Stargardt disease type 1 (STGD1) with Priority Review, setting a PDUFA target action date of February 12, 2027. The company also presented additional positive secondary endpoint data from its Phase 3 DRAGON trial, showing a marked divergence in quantitative autofluorescence between treatment and placebo groups. For Q2 2026, Belite Bio reported a net loss of $28.4 million, with increased R&D and SG&A expenses reflecting pipeline advancement and commercialization preparations.
Key Highlights
- FDA accepted New Drug Application (NDA) for tinlarebant for Stargardt disease type 1 (STGD1) with Priority Review.
- PDUFA target action date for tinlarebant is February 12, 2027.
- Phase 3 DRAGON trial showed tinlarebant-treated subjects had stable/2% decreased qAF, while placebo had 20% increase.
- Cash and cash equivalents were $279.9 million as of June 30, 2026.
- Investments in U.S. treasuries increased to $500.1 million as of June 30, 2026.
- Q2 2026 R&D expenses increased to $18.2 million from $11.0 million in Q2 2025.
- Q2 2026 SG&A expenses increased to $16.7 million from $6.5 million in Q2 2025.
- Q2 2026 net loss was $28.4 million, compared to $16.3 million in Q2 2025.
Price Impact
More from BLTE