Belite Bio, Inc BLTE
Belite Bio, Inc (Nasdaq: BLTE) is an ophthalmology drug developer. Its lead program, Tinlarebant (LBS-008), oral RBP4 antagonist, is in Phase 3 for Stargardt disease type 1 (STGD1). Its next catalyst on record is Tinlarebant (STGD1): FDA PDUFA target action date (NDA with Priority Review) (February 12, 2027).
Upcoming catalysts
- February 12, 2027Tinlarebant (STGD1) — FDA PDUFA target action date (NDA with Priority Review)
U.S. Food and Drug Administration (FDA) accepted the New Drug Application (NDA) with Priority Review for tinlarebant for the treatment of Stargardt disease type 1 (STGD1); Prescription Drug User Fee Act (PDUFA) target action date of February 12, 2027
Next further out: Tinlarebant (STGD1) — Japan MHLW review of NDA submitted under Sakigake designation (date not stated). 2 catalysts on record beyond the next 30 days; subscribers see each with its filing sentence.
Pipeline
| Program | Indication | Modality | Stage |
|---|---|---|---|
| Tinlarebant (LBS-008) - STGD1 (US NDA under FDA priority review; Japan NDA submitted under Sakigake) | Stargardt disease type 1 | small molecule | Phase 3 |
| Tinlarebant - DRAGON II (Phase 1b/2/3 in Japan/US/UK) | STGD1 | small molecule | Phase 3 |
| Tinlarebant - PHOENIX (pivotal Phase 3, enrollment complete, 530 subjects) | Geographic atrophy (advanced dry AMD) | small molecule | Phase 3 |
| LBS-009 (anti-RBP4) | Retinal disease / metabolic | small molecule | Pre-clinical |
Recent results and decisions
- Aug 12, 2026positive Secondary qAF data at ASRS: at month 25 qAF stable to slightly decreased (about 2%) with tinlarebant vs about 20% increase with placebo.
at month 25, qAF values in tinlarebant-treated subjects remained stable to slightly decreased from baseline (approximately 2%), whereas placebo-treated subjects showed an approximate 20% increase from baseline
Filing - Aug 11, 2026accepted FDA accepted the NDA with Priority Review; PDUFA target action date February 12, 2027.
The FDA has set a Prescription Drug User Fee Act (PDUFA) date of February 12, 2027.
Filing - Apr 21, 2026submitted Initiated rolling NDA submission to FDA under Breakthrough Therapy Designation; completion expected Q2 2026.
The Company expects to complete the NDA rolling submission in the second quarter of 2026.
Filing
3 more on record.
For subscribers
- Cash runway against each catalyst, with the company's own runway statement
- Track record: every Phase 3 readout, FDA decision and guidance slip since 2014
- Expected move for each dated catalyst, from comparable past events
- Phase 2 evidence behind each Phase 3 readout
- Companies on the same target or class
- Full catalyst list with filing sentences, deals, registered trials, Excel export
Other phase 3 ophthalmology companies
The free Monday brief
Last week's readouts and FDA decisions and the dated catalysts in the week ahead, each with its filing sentence.