This page aggregates BLTE's FDA catalysts from pdufa.bio's own calendar and decision archive. Each item links to its source page. Facts and dates only; verify against primary FDA / SEC / company filings.
February 12, 2027. The next catalyst for Belite Bio, Inc is Tinlarebant - Stargardt disease type 1 (PDUFA). That date is a confirmed date. One further catalyst is scheduled after it. Dates are taken from FDA notices, company filings or ClinicalTrials.gov, and we do not publish a specific day when the source only gives a month or a quarter.
We have no measured history for BLTE itself. Across the whole study of 1,883 FDA decisions, the median stock rose 18.0% at its best point in the 120 trading days before the decision, but was only 2.4% higher the day before it. Most of the move happened before the answer arrived and was largely given back.
FDA publications, company filings with the SEC, company press releases and ClinicalTrials.gov, with share prices measured from daily closing data. Every date and outcome links the document it came from. Where an outcome was inferred from the price reaction rather than read from a filing, the page says so on its face.