Belite Bio: Tinlarebant NDA submission remains on track to complete in 2Q

研报英文原文证据摘录

Belite Bio: Tinlarebant NDA submission remains on track to complete in 2Q

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Belite Bio

Tinlarebant NDA submission remains on

track to complete in 2Q

Reiterate Rating: BUY | PO: 200.00 USD | Price: 143.36 USD

Management focused on US filing for STGD 20 May 2026

Belite Bio (BLTE) emphasized they remain on track to complete the rolling new drug Equity

application (NDA) submission for tinlarebant for Stargardt disease (STGD) in 2Q. They

also reiterated the DRAGON II trial, which enrolled patients in the US, Japan and the UK

Key Changesand will facilitate filing in Japan, has completed enrollment. They underscored the high

unmet need in STGD with no approved therapies, giving them confidence in the large (US$) Previous Current

commercial opportunity. Management commented that they are focusing on the US 2026E EPS -3.08 -3.17

filing and approval but expect global submissions to follow. We remain bullish on the 2027E EPS -2.15 -2.22

large commercial opportunity for tinlarebant given the high unmet need and positive 2028E EPS 2.05 1.68

data supporting its clinical benefit in STGD. In our DCF, we roll the quarter and update

for 1Q results, cash and share count. We reiterate our Buy rating with $200 PO. Tazeen Ahmad

Research Analyst

BofAS

+1 646 855 4236Commercial preparedness efforts are underway tazeen.ahmad@bofa.com

The company highlighted they have started hiring the key commercial leadership and are

Daniel Giraldo

working on building out the commercial infrastructure in preparation for the expected Research Analyst

US approval. BLTE noted high focus on improving disease and treatment awareness, BofAS daniel.giraldoperez@bofa.com

which they think will be key for the launch. They highlighted efforts to increase genetic Jeremiah Lorentz