Belite Bio, Inc. announced positive developments regarding its lead drug candidate, Tinlarebant, for treating Stargardt disease (STGD1) and ongoing trials for geographic atrophy (GA). Following an interim analysis, an independent Data Safety Monitoring Board (DSMB) endorsed the continuation of the pivotal Phase 3 DRAGON trial without modifications and recommended submitting interim data for regulatory review. The trial is expected to complete by Q4 2025, with a three-month follow-up period. Additionally, Belite is conducting the Phase 3 PHOENIX trial for GA, currently with 464 enrolled subjects out of 500. The firm raised $15 million in funding and reported a net loss of $14.3 million for the first quarter of 2025. A conference call is scheduled for May 14, 2025, to discuss these results and provide further updates.
Following a pre-specified interim analysis, an independent Data Safety Monitoring Board (DSMB) recommended the pivotal Phase 3 trial (DRAGON) of Tinlarebant in adolescent Stargardt disease (STGD1) patients proceed without any modification; trial completion expected Q4 2025 (including a three-month follow-up period)
DSMB also recommended the Company submit the interim data for further regulatory review for drug approval
A pivotal global Phase 3 trial (PHOENIX) of Tinlarebant in geographic atrophy (GA) patients is ongoing with 464 of targeted 500 subjects enrolled
Raised $15 million in gross proceeds in a registered direct offering on February 5, 2025
Conference call and webcast on Wednesday, May 14, 2025, at 4:30 p.m. ET
Webcast Information
Belite Bio will host a webcast on Wednesday, May 14, 2025, at 4:30 p.m. Eastern Time to discuss the Company’s financial results and provide a business update. To join the webcast, please visit
https://events.q4inc.com/attendee/137642555
. A replay will be available for approximately 90 days following the event at the Company’s Investor Relations website at
https://investors.belitebio.com/presentations-events/events
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