Belite Bio (BLTE) catalysts

Upcoming FDA decisions and readouts we track for Belite Bio, each with the filing that announced it.

Listed on — Nasdaq Catalysts tracked — 1 Rows last checked — 11 Sep 2026

FreeBioList tracks 1 upcoming catalyst for Belite Bio (BLTE, listed on Nasdaq). It concerns Tinlarebant (Stargardt disease type 1).

First on the list: the PDUFA date for Tinlarebant (Stargardt disease type 1), dated 12 Feb 2027.

The row links to an SEC filing (8-K or 6-K). It has been verified by a person reading the filing itself, most recently on 11 Sep 2026. The methodology page explains each status.

Background reading: What a PDUFA date is, and why the FDA doesn't publish them.

Ticker: BLTE
Next catalyst: 12 Feb 2027
Type: PDUFA date
Listed options: No

Company ▾	Drug ▾	Effect / indication	Next catalyst ▾	Phase / type ▾	Status ▾	Source	Options
Belite Bio BLTE · Nasdaq	Tinlarebant	Stargardt disease type 1	12 Feb 2027 in 128d	PDUFA date	Verified	6-K exhibit 99.1 ↗	No
Notes — Filing states a "Prescription Drug User Fee Act target action date of February 12, 2027." Source: 6-K exhibit 99.1, filed 08 Sep 2026 · verified 11 Sep 2026

Companies working on related conditions

Ocugen (OCGN)Stargardt disease (modifier gene therapy); Retinitis pigmentosa (modifier gene therapy); Stargardt disease; Retinitis pigmentosa

Also due in Q1 2027

Arcutis Biotherapeutics (ARQT)PDUFA date for ZORYVE (roflumilast) cream 0.05%, 23 Feb 2027
Intellia Therapeutics (NTLA)PDUFA date for Lonvoguran ziclumeran (lonvo-z), 10 Mar 2027
Apnimed (APMD)PDUFA date for AD109 (Oxnimbi), 28 Feb 2027
ImmunityBio (IBRX)PDUFA date for ANKTIVA (nogapendekin alfa) plus BCG, 06 Jan 2027
Cullinan Therapeutics (CGEM)PDUFA date for Zipalertinib, 27 Feb 2027
Dyne Therapeutics (DYN)PDUFA date for z-rostudirsen (DYNE-251), 21 Jan 2027