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Belite Bio, Inc, a clinical-stage biopharmaceutical drug development company, engages in the research and development of novel therapeutics targeting atrophic age-related macular degeneration and autosomal recessive stargardt diseases. Its lead product candidate is LBS-008, an oral once-a-day treatment that can reduce and maintain the delivery of vitamin A to the eye to reduce the accumulation of toxic vitamin A by-products in ocular tissue that is in phase 3 clinical trial. The company is also developing LBS-009, an anti-retinol binding protein 4 oral therapy targeting liver disease, including non-alcoholic fatty liver disease, nonalcoholic steatohepatitis, and type 2 diabetes, which is in the preclinical development phase. Belite Bio, Inc was founded in 2016 and is based in San Diego, California. Belite Bio, Inc operates as a subsidiary of Lin Bioscience International Ltd.

Belite Bio, Inc

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SAN DIEGO, SEPT. 08, 2026 (GLOBE NEWSWIRE) -- -BELITE BIO, INC (NASDAQ: BLTE) (BELITE BIO OR THE COMPANY), A CLINICAL-STAGE DRUG DEVELOPMENT COMPANY FOCUSED ON ADVANCING NOVEL THERAPEUTICS TARGETING DEGENERATIVE RETINAL DISEASES THAT HAVE SIGNIFICANT UNMET MEDICAL NEEDS, TODAY ANNOUNCED THE SUBMISSION OF A NEW DRUG APPLICATION (NDA) TO THE MINISTRY OF HEALTH, LABOUR, AND WELFARE (MHLW) IN JAPAN FOR TINLAREBANT IN STARGARDT DISEASE TYPE 1 (STGD1). TINLAREBANT IS AN INVESTIGATIONAL, ONCE-DAILY ORAL THERAPY FOR THE TREATMENT OF STGD1, A RARE, INHERITED RETINAL DISEASE CAUSED BY MUTATIONS IN THE ABCA4 GENE THAT LEADS TO PROGRESSIVE AND IRREVERSIBLE VISION LOSS. STGD1 AFFECTS AN ESTIMATED 9,500 PEOPLE IN JAPAN ALONE, AND THERE ARE CURRENTLY NO APPROVED TREATMENT OPTIONS FOR THE DISEASE.

BELITE BIO ANNOUNCES SUBMISSION OF NEW DRUG APPLICATION TO THE MINISTRY OF HEALTH, LABOUR, AND WELFARE IN JAPAN UNDER THE SAKIGAKE DESIGNATION SYSTEM FOR TINLAREBANT FOR THE TREATMENT OF STARGARDT DISEASE TYPE 1

SAN DIEGO, SEPT. 01, 2026 (GLOBE NEWSWIRE) -- BELITE BIO, INC (NASDAQ: BLTE) (BELITE BIO OR THE COMPANY), A CLINICAL-STAGE DRUG DEVELOPMENT COMPANY FOCUSED ON ADVANCING NOVEL THERAPEUTICS TARGETING DEGENERATIVE RETINAL DISEASES THAT HAVE SIGNIFICANT UNMET MEDICAL NEEDS, TODAY ANNOUNCED THAT THE COMPANY WILL PARTICIPATE IN FOUR UPCOMING INVESTOR CONFERENCES. DETAILS OF THE PRESENTATIONS ARE AS FOLLOWS:

BELITE BIO TO PARTICIPATE IN FOUR UPCOMING INVESTOR CONFERENCES

SAN DIEGO, AUG. 24, 2026 (GLOBE NEWSWIRE) -- BELITE BIO, INC (NASDAQ: BLTE) (BELITE BIO OR THE COMPANY), A CLINICAL-STAGE DRUG DEVELOPMENT COMPANY FOCUSED ON ADVANCING NOVEL THERAPEUTICS TARGETING DEGENERATIVE RETINAL DISEASES THAT HAVE SIGNIFICANT UNMET MEDICAL NEEDS, TODAY ANNOUNCED THAT IT WILL HOST A VIRTUAL COMMERCIAL DAY ON WEDNESDAY, SEPTEMBER 2, 2026, FROM 8:00  9:30 A.M. ET.

BELITE BIO TO HOST VIRTUAL COMMERCIAL DAY ON SEPTEMBER 2, 2026

SAN DIEGO, AUG. 21, 2026 (GLOBE NEWSWIRE) -- BELITE BIO, INC (NASDAQ: BLTE) (BELITE BIO OR THE COMPANY), A CLINICAL-STAGE DRUG DEVELOPMENT COMPANY FOCUSED ON ADVANCING NOVEL THERAPEUTICS TARGETING DEGENERATIVE RETINAL DISEASES THAT HAVE SIGNIFICANT UNMET MEDICAL NEEDS, TODAY ANNOUNCED THAT ITS DATA WILL BE PRESENTED AT THE SCHWEIZERISCHE OPHTHALMOLOGISCHE GESELLSCHAFT (SOG) ANNUAL CONGRESS BEING HELD ON AUGUST 26-28, 2026, IN LAUSANNE, SWITZERLAND AND THE 19TH ASIA-PACIFIC VITREO-RETINA SOCIETY (APVRS) CONGRESS BEING HELD ON AUGUST 28-30, 2026, IN GOLD COAST, AUSTRALIA.

BELITE BIO ANNOUNCES ORAL PRESENTATIONS AT TWO UPCOMING MEDICAL CONFERENCES

SAN DIEGO, AUG. 12, 2026 (GLOBE NEWSWIRE) -- BELITE BIO, INC (NASDAQ: BLTE) (BELITE BIO OR THE COMPANY), A CLINICAL-STAGE DRUG DEVELOPMENT COMPANY FOCUSED ON ADVANCING NOVEL THERAPEUTICS TARGETING DEGENERATIVE RETINAL DISEASES THAT HAVE SIGNIFICANT UNMET MEDICAL NEEDS, TODAY ANNOUNCED ITS FINANCIAL RESULTS FOR THE SECOND QUARTER ENDED JUNE 30, 2026, AND PROVIDED A BUSINESS UPDATE.

BELITE BIO REPORTS UNAUDITED SECOND QUARTER 2026 FINANCIAL RESULTS AND PROVIDES A CORPORATE UPDATE

SAN DIEGO, AUG. 11, 2026 (GLOBE NEWSWIRE) -- BELITE BIO, INC (NASDAQ: BLTE) (BELITE BIO OR THE COMPANY), A CLINICAL-STAGE DRUG DEVELOPMENT COMPANY FOCUSED ON ADVANCING NOVEL THERAPEUTICS TARGETING DEGENERATIVE RETINAL DISEASES THAT HAVE SIGNIFICANT UNMET MEDICAL NEEDS, TODAY ANNOUNCED THAT THE U.S. FOOD AND DRUG ADMINISTRATION (FDA) HAS ACCEPTED AND GRANTED PRIORITY REVIEW DESIGNATION OF THE NEW DRUG APPLICATION (NDA) FOR TINLAREBANT FOR THE TREATMENT OF STARGARDT DISEASE TYPE 1 (STGD1). THE FDA HAS SET A PRESCRIPTION DRUG USER FEE ACT (PDUFA) DATE OF FEBRUARY 12, 2027.

BELITE BIO ANNOUNCES U.S. FOOD AND DRUG ADMINISTRATION ACCEPTANCE AND PRIORITY REVIEW OF NEW DRUG APPLICATION FOR TINLAREBANT FOR THE TREATMENT OF STARGARDT DISEASE TYPE 1

SAN DIEGO, AUG. 06, 2026 (GLOBE NEWSWIRE) -- BELITE BIO, INC (NASDAQ: BLTE) (BELITE BIO OR THE COMPANY), A CLINICAL-STAGE DRUG DEVELOPMENT COMPANY FOCUSED ON ADVANCING NOVEL THERAPEUTICS TARGETING DEGENERATIVE RETINAL DISEASES THAT HAVE SIGNIFICANT UNMET MEDICAL NEEDS, TODAY ANNOUNCED THAT IT WILL HOST A WEBCAST ON THURSDAY, AUGUST 13, 2026, AT 4:30 P.M. EASTERN TIME TO DISCUSS THE COMPANY'S FINANCIAL RESULTS AND PROVIDE A BUSINESS UPDATE FOR THE SECOND QUARTER ENDED JUNE 30, 2026.

BELITE BIO TO HOST WEBCAST ON AUGUST 13, 2026, TO DISCUSS SECOND QUARTER 2026 FINANCIAL RESULTS

TINLAREBANT IS THE FIRST THERAPEUTIC CANDIDATE TO DEMONSTRATE CLINICAL EFFICACY IN STARGARDT DISEASE TYPE 1, HAVING MET THE PRIMARY EFFICACY ENDPOINT, REDUCTION IN LESION GROWTH PRESENTATION TO INCLUDE POSITIVE UPDATE ON SECONDARY ENDPOINTS, WITH QUANTITATIVE AUTOFLUORESCENCE SHOWING A MARKED DIVERGENCE BETWEEN TREATMENT GROUPS NEW DRUG APPLICATION TO THE U.S. FOOD AND DRUG ADMINISTRATION FOR TINLAREBANT COMPLETED SAN DIEGO, JULY 20, 2026 (GLOBE NEWSWIRE) -- BELITE BIO, INC (NASDAQ: BLTE) (BELITE BIO OR THE COMPANY), A CLINICAL-STAGE DRUG DEVELOPMENT COMPANY FOCUSED ON ADVANCING NOVEL THERAPEUTICS TARGETING DEGENERATIVE RETINAL DISEASES THAT HAVE SIGNIFICANT UNMET MEDICAL NEEDS, TODAY ANNOUNCED ADDITIONAL, POSITIVE SECONDARY ENDPOINT DATA FROM ITS PHASE 3 DRAGON TRIAL OF TINLAREBANT IN STARGARDT DISEASE TYPE 1 (STGD1). THE FINDINGS, ALONG WITH PREVIOUSLY REPORTED TOPLINE DATA, WERE DELIVERED IN AN ORAL PRESENTATION AT THE AMERICAN SOCIETY OF RETINA SPECIALISTS (ASRS) 2026 ANNUAL MEETING ON JULY 18, 2026, IN MONTRAL, CANADA.

BELITE BIO ANNOUNCES ORAL PRESENTATION AT THE ASRS ANNUAL MEETING FEATURING ADDITIONAL POSITIVE SECONDARY ENDPOINT DATA FROM THE PHASE 3 TRIAL OF TINLAREBANT IN STARGARDT DISEASE TYPE 1

SAN DIEGO, JULY 15, 2026 (GLOBE NEWSWIRE) -- BELITE BIO, INC (NASDAQ: BLTE) (BELITE BIO OR THE COMPANY), A CLINICAL-STAGE DRUG DEVELOPMENT COMPANY FOCUSED ON ADVANCING NOVEL THERAPEUTICS TARGETING DEGENERATIVE RETINAL DISEASES THAT HAVE SIGNIFICANT UNMET MEDICAL NEEDS, TODAY ANNOUNCED THAT THE COMPANY WILL PARTICIPATE IN A PANEL DISCUSSION AT THE H.C. WAINWRIGHT 6TH ANNUAL OPHTHALMOLOGY VIRTUAL CONFERENCE ON WEDNESDAY, JULY 22, 2026, AT 3:00 PM ET.

BELITE BIO TO PARTICIPATE IN THE H.C. WAINWRIGHT 6TH ANNUAL OPHTHALMOLOGY VIRTUAL CONFERENCE

SAN DIEGO, JULY 06, 2026 (GLOBE NEWSWIRE) -- BELITE BIO, INC (NASDAQ: BLTE) (BELITE BIO OR THE COMPANY), A CLINICAL-STAGE DRUG DEVELOPMENT COMPANY FOCUSED ON ADVANCING NOVEL THERAPEUTICS TARGETING DEGENERATIVE RETINAL DISEASES THAT HAVE SIGNIFICANT UNMET MEDICAL NEEDS, TODAY ANNOUNCED THAT THE COMPANY WILL PARTICIPATE IN A FIRESIDE CHAT AT THE PIPER SANDLER VIRTUAL OPHTHALMOLOGY INVESTOR SYMPOSIUM ON THURSDAY, JULY 9, 2026, AT 12:30 PM ET.

Belite Bio, Inc

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Belite Bio, Inc

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