Research analysts who have asked questions during BELITE BIO earnings calls.
Jennifer Kim
Cantor Fitzgerald
4 questions for BLTE
Also covers: CPRX, EYPT, INSM +1 more
Michael Okunewitch
Maxim Group
4 questions for BLTE
Also covers: BLFS, BNGO, BRTX +11 more
YC
Yi Chen
H.C. Wainwright & Co.
4 questions for BLTE
Also covers: ANGO, APDN, BLFS +22 more
BR
Basma Radwan Ibrahim
Leerink Partners
3 questions for BLTE
Also covers: ACAD, AMLX, RLMD +2 more
Bruce Jackson
The Benchmark Company LLC
3 questions for BLTE
Also covers: BFRI, BSEM, CV +8 more
BP
Boris Peaker
Titan Partners
1 question for BLTE
Also covers: ACOG, GLYC, OCGN +1 more
MG
Marc Goodman
Leerink Partners
1 question for BLTE
Also covers: ACAD, ALDX, ALKS +14 more
Recent press releases and 8-K filings for BLTE.
Belite Bio Completes Enrollment in DRAGON II Clinical Trial
BLTE
New Projects/Investments
Product Launch
- Belite Bio, Inc. announced the completion of enrollment for its Phase 2/3 DRAGON II clinical trial evaluating tinlarebant for the treatment of Stargardt disease type 1 (STGD1).
- The DRAGON II trial successfully enrolled 60 adolescent STGD1 subjects across Japan, the United States, and the United Kingdom.
- Tinlarebant previously demonstrated clinical efficacy in the pivotal Phase 3 DRAGON trial, achieving a 36% reduction in lesion growth.
- The company plans to submit a New Drug Application (NDA) to the U.S. FDA in the first half of 2026.
Jan 27, 2026, 1:00 PM
Belite Bio Completes Enrollment for DRAGON II Clinical Trial
BLTE
New Projects/Investments
Product Launch
- Belite Bio has completed enrollment of 60 adolescent subjects in its Phase 2/3 DRAGON II clinical trial evaluating tinlarebant for the treatment of Stargardt disease type 1 (STGD1).
- The company plans to file a New Drug Application (NDA) with the U.S. FDA for tinlarebant in the first half of 2026.
- Tinlarebant previously met the primary endpoint in the pivotal Phase 3 DRAGON trial, showing a 36% reduction in lesion growth.
Jan 27, 2026, 1:00 PM
Belite Bio Prices $350.0 Million Public Offering of American Depositary Shares
BLTE
New Projects/Investments
- Belite Bio, Inc. announced the pricing of an underwritten public offering of 2,272,727 American Depositary Shares (ADSs) at $154.00 per ADS.
- The offering is expected to generate approximately $350.0 million in gross proceeds for the company.
- The underwriters have a 30-day option to purchase up to 340,909 additional ADSs.
- Net proceeds will be used for commercialization preparation, pipeline development and expansion, and working capital and general corporate purposes.
- The offering is anticipated to close on or about December 3, 2025.
Dec 2, 2025, 9:00 PM
BELITE BIO, INC Reports Q3 2025 Balance Sheet
BLTE
- Cash and cash equivalents for BELITE BIO, INC significantly increased from $31,677 thousand as of December 31, 2024, to $157,034 thousand as of September 30, 2025.
- Total current assets rose from $147,073 thousand at December 31, 2024, to $277,213 thousand at September 30, 2025.
- The company's total shareholders' equity increased from $145,821 thousand as of December 31, 2024, to $274,082 thousand as of September 30, 2025.
- The accumulated deficit grew from $(107,647) thousand at December 31, 2024, to $(159,934) thousand at September 30, 2025.
Dec 1, 2025, 9:52 PM
Belite Bio Announces Proposed Underwritten Public Offering of ADSs
BLTE
New Projects/Investments
- Belite Bio, Inc. announced on December 1, 2025, that it has commenced an underwritten public offering of American Depositary Shares (ADSs), with each ADS representing one of its ordinary shares.
- All of the securities in the offering are to be sold by Belite Bio, and the company intends to grant the underwriters a 30-day option to purchase additional ADSs.
- The net proceeds from the offering are intended to be used for commercialization preparation, development and expansion of pipelines, and working capital and other general corporate purposes.
- The offering is subject to market conditions, and there is no assurance as to whether or when it may be completed, or its actual size or terms.
Dec 1, 2025, 9:28 PM
Belite Bio Announces Positive Phase Three DRAGON Study Results for Tinlarebant
BLTE
Product Launch
New Projects/Investments
- Belite Bio reported positive top-line results from its two-year phase three DRAGON study of Tinlarebant for Stargardt disease.
- The study met its primary endpoint, demonstrating a statistically significant and clinically meaningful 36% reduction in the annualized rate of DDAF lesion growth compared to placebo.
- Tinlarebant, an orally administered small molecule, maintained an excellent safety and tolerability profile over the two-year treatment period.
- This represents the first-ever oral therapy in a retinal degenerative disease to demonstrate a clinically meaningful slowdown of neurodegeneration, addressing a significant unmet medical need.
- Belite Bio plans to file the full data package with regulatory agencies in the first half of next year, anticipating a clear path toward potential approval.
Dec 1, 2025, 1:00 PM
Belite Bio Announces Positive Phase III DRAGON Study Results for Tinlarebant
BLTE
New Projects/Investments
- Belite Bio reported positive top-line results from its two-year phase III DRAGON trial of Tinlarebant for Stargardt disease, demonstrating statistically significant and clinically meaningful outcomes.
- The study's primary endpoint showed a 36% reduction in the annualized rate of DDAF lesion growth compared to placebo, with a p-value of 0.0033.
- Tinlarebant, an orally administered small molecule, was safe and well tolerated over the two-year treatment period, with a zero rate of serious treatment emergent adverse events.
- This marks the first-ever oral therapy in a retinal degenerative disease to demonstrate a clinically meaningful slowdown of neurodegeneration, addressing a significant unmet medical need.
- Belite Bio has received "green lights" for submission from regulatory authorities including the MHRA, China NMPA, and Japan, with discussions ongoing with the FDA.
Dec 1, 2025, 1:00 PM
Belite Bio Reports Positive Phase Three DRAGON Topline Results for Tinlarebant
BLTE
- Belite Bio announced positive topline results from its two-year phase three DRAGON study for Tinlarebant, an oral therapy for Stargardt disease.
- The study met its primary endpoint, demonstrating a statistically significant and clinically meaningful 36% slowing in DDAF lesion growth in patients treated with Tinlarebant compared to placebo.
- Tinlarebant maintained an excellent safety and tolerability profile over the two-year treatment period, with no serious treatment-related adverse events reported.
- This represents the first-ever oral therapy in a retinal degenerative disease to achieve a clinically meaningful slowdown of neurodegeneration, addressing a significant unmet medical need.
- Belite Bio anticipates a clear path toward regulatory approval, believing the robust findings from this single study may be sufficient for market authorization.
Dec 1, 2025, 1:00 PM
Belite Bio Announces Positive Phase 3 DRAGON Trial Results for Tinlarebant
BLTE
New Projects/Investments
- Belite Bio announced positive topline results from its pivotal global Phase 3 DRAGON trial of Tinlarebant for adolescents with Stargardt disease, marking the first successful pivotal trial for this condition.
- Tinlarebant met its primary efficacy endpoint, demonstrating a statistically significant 36% reduction in the growth rate of retinal lesions compared to placebo (p-value = 0.0033).
- The drug was well tolerated throughout the 24-month trial, with a favorable safety profile and only four treatment-related discontinuations.
- Belite Bio intends to file a New Drug Application (NDA) with the US FDA in the first half of 2026.
Dec 1, 2025, 11:01 AM
Belite Bio Announces Positive Phase 3 DRAGON Trial Results for Tinlarebant in Stargardt Disease
BLTE
- Belite Bio announced positive topline results on December 1, 2025, from the global Phase 3 DRAGON trial for Tinlarebant in adolescents with Stargardt disease type 1 (STGD1).
- Tinlarebant met its primary efficacy endpoint, demonstrating a statistically significant 36% reduction in the growth rate of retinal lesions compared to placebo (p-value = 0.0033).
- This marks the first successful pivotal trial for STGD1, a condition that currently has no approved treatment worldwide.
- The company plans to file a New Drug Application (NDA) with the US FDA in 1H 2026.
- Tinlarebant was well tolerated throughout the trial, with only four treatment-related discontinuations.
Dec 1, 2025, 11:00 AM
Quarterly earnings call transcripts for BELITE BIO.
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