Sakigake designation was established by MHLW to accelerate drug approval process in Japan for innovative drugs with prominent effectiveness targeting serious diseases, in order to make them available to patients in Japan ahead of the rest of the world, by providing (a) prioritized consultation, (b) pre-application consultation, (c) prioritized review, (d) assignment of a review partner, and (e) extension of re-examination period. Stargardt Disease (STGD1) SAN DIEGO, June 12, 2024 (GLOBE NEWSWIRE) -- Belite ...

Tinlarebant is Belite Bio's orally administered tablet intended to slow disease progression in patients affected with Stargardt Disease (STGD1) and Geographic Atrophy (GA) in advanced Dry Age-related Macular Degeneration (Dry AMD) Data from a 24-month Phase 2 trial in adolescent STGD1 subjects showed a sustained lower atrophic lesion growth in Tinlarebant-treated subjects compared to ProgStar participants possessing similar baseline characteristics (aged ≤18 years) (p<0.001) In the Phase 2 trial, 5 of 12 su ...

| --- | --- | --- | |-------|-----------------------------------------------------------------------------------|-----------------------------------------------| | | | | | | Q1 2024 Financial Results Conference Call May 14, 2024, 4:30 p.m. ET Nasdaq: BLTE | | | | | For more info please visit: www.belitebio.com | This presentation (including any oral briefing and any question-and-answer in connection with it) is not intended to, and does not constitute, represent or form part of any offer, invitation or soli ...

Hao-Yuan Chuang On G&A expenses in Q1 2024, G&A expenses was $1.6 million compared to $1.2 million in Q1 2023. The increase was primarily due to increasing share-based compensation granted in the third quarter of 2023. In addition, we raised additional $25 million from our registered rent offering in April. We expect cash runway beyond 2026. Thank you. Back to you, Tom. Thanks, Hao. I would like to conclude with the key milestones to expect for this year. We are still making good progress in the Phase 3 in ...

Tinlarebant is Belite Bio's orally administered tablet intended to slow disease progression in patients affected with Stargardt Disease (STGD1) and Geographic Atrophy (GA) in advanced Dry Age-related Macular Degeneration (Dry AMD) Data from a 24-month Phase 2 trial in adolescent STGD1 subjects showed a sustained lower atrophic lesion growth in Tinlarebant-treated subjects compared to ProgStar participants possessing similar baseline characteristics (aged ≤18 years) (p<0.001) In the Phase 2 trial, 5 of 12 su ...

Webinar, moderated by Cantor Fitzgerald, will be held on Monday, May 13, 2024, at 2:00 p.m. ET Discussion will feature Dr. Michel Michaelides, leading expert in the field of inherited eye disease in adults and children SAN DIEGO, May 06, 2024 (GLOBE NEWSWIRE) -- Belite Bio, Inc. (NASDAQ:BLTE), a clinical-stage biopharmaceutical drug development company focused on advancing novel therapeutics targeting degenerative retinal diseases that have significant unmet medical needs, today announced that the executive ...

Additional analysis of visual acuity loss, genotypic profiles, and retinal imaging data from a 24-month Phase 2 trial of Tinlarebant in adolescent Stargardt disease patients provides further support for the potential of Tinlarebant to slow and potentially halt lesion growthIn 5 of 12 subjects (42%) with known pathogenic ABCA4 mutations, no incident atrophic (DDAF) lesions were formed during the 24-month treatment period and no change in QDAF was observedA novel lesion size quantification method that can bet ...

Tinlarebant is Belite Bio's orally administered tablet intended to slow disease progression in patients affected with Stargardt Disease (STGD1) and Geographic Atrophy (GA) in advanced Dry Age-related Macular Degeneration (Dry AMD)Data from a 24-month Phase 2 trial in adolescent STGD1 subjects showed a sustained lower atrophic lesion growth in Tinlarebant-treated subjects compared to ProgStar participants possessing similar baseline characteristics (aged ≤18 years) (p<0.001)In the Phase 2 trial, 42% of Tinla ...

SAN DIEGO, April 25, 2024 (GLOBE NEWSWIRE) -- Belite Bio, Inc (NASDAQ:BLTE) ("Belite Bio" or the "Company"), a clinical-stage biopharmaceutical drug development company focused on advancing novel therapeutics targeting degenerative retinal diseases that have significant unmet medical needs, today announced that it has entered into a securities purchase agreement with an institutional investor, for the purchase and sale of up to an aggregate of 651,380 American Depositary Shares of the Company ("ADSs"), each ...

Shares of Belite Bio, Inc. Sponsored ADR (BLTE) have gained 2.5% over the past four weeks to close the last trading session at $40.03, but there could still be a solid upside left in the stock if short-term price targets of Wall Street analysts are any indication. Going by the price targets, the mean estimate of $56.50 indicates a potential upside of 41.1%.The average comprises four short-term price targets ranging from a low of $50 to a high of $60, with a standard deviation of $4.51. While the lowest esti ...