Canaccord initiated BLTE with a Buy rating and a $303 target, citing tinlarebant's STGD1 potential and international upside. The FDA accepted the marketing application with Priority Review and a February 12, 2027 PDUFA date, backing a 2027 U.S. launch and overseas expansion, while GA data in 2027 could add another catalyst.
BLTE's Tinlarebant trial showed significant efficacy in STGD1 patients. 35.7% lesion growth reduction confirmed compared to placebo in the trial. Company plans New Drug Application submission for Tinlarebant in 2026. BLTE stock rose 11.3% following the trial results announcement. RBP4 levels reduced by 80% at the trial's 5 mg daily dose.