Belite Bio Initiates Rolling Submission of New Drug Application to the U.S. Food and Drug Administration for Tinlarebant for the Treatment of Stargardt Disease
Belite Bio, Inc - American Depositary Shares (BLTE)
Company Research
Source: GlobeNewswire
Belite expects to complete the new drug application submission in the second quarter of 2026Rolling submission initiated under Breakthrough Therapy Designation SAN DIEGO, April 21, 2026 (GLOBE NEWSWIRE) -- Belite Bio, Inc (NASDAQ: BLTE) (“Belite Bio” or the “Company”), a clinical-stage drug development company focused on advancing novel therapeutics targeting degenerative retinal diseases that have significant unmet medical needs, today announced that it has initiated a rolling submission of an New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for tinlarebant, an investigational novel oral therapy for the treatment of Stargardt disease type 1 (STGD1), a rare, inherited retinal disorder caused by mutations in the ABCA4 gene. Tinlarebant has previously been granted Breakthrough Therapy Designation (BTD) by the FDA for STGD1, and the FDA has previously granted Belite approval for the rolling submission of the NDA. The Company expects to complete the NDA rollin
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News
- Foundation Fighting Blindness to Host United in Vision 2026 Conference in Partnership with Retina International World CongressPR Newswire
- Belite Bio (BLTE) had its "buy" rating reaffirmed by HC Wainwright. They now have a $200.00 price target on the stock.MarketBeat
- Belite Bio (BLTE) had its "sell (d-)" rating reaffirmed by <a style="font-weight:bold" href="https://weissratings.com/">Weiss Ratings</a>.MarketBeat
- Belite Bio (BLTE) was upgraded by <a style="font-weight:bold" href="https://www.wallstreetzen.com/newsletters/zen-ratings?ticker=BLTE&utm_campaign=getratings&utm_medium=online&utm_source=MarketBeat">Wall Street Zen</a> from "sell" to "holMarketBeat
- Belite Bio reports FY results [Seeking Alpha]Seeking Alpha
BLTE
Earnings
- 3/2/26 - Beat
BLTE
Sec Filings
- 4/21/26 - Form 4
- 4/21/26 - Form 6-K
- 4/20/26 - Form 4
- BLTE's page on the SEC website