H.C. Wainwright Reiterates Buy Rating on Belite Bio, Inc, ADR (BLTE)

Wed, 22 Jul 2026 06:51:55 -0400

H.C. Wainwright analyst Yi Chen reiterated a Buy rating and $200.00 price target on Belite Bio, Inc, ADR (NASDAQ: BLTE).

The analyst commented: "Belite Bio recently presented additional positive secondary endpoint data from the Phase 3 DRAGON trial of tinlarebant in Stargardt disease type 1 (STGD1) at the American Society of Retina Specialists (ASRS) 2026 meeting in Montréal, Canada. Of note, quantitative autofluorescence (qAF) is a marker of toxic bisretinoid accumulation and it showed a marked divergence between treatment arms. At Month 25, qAF in tinlarebant-treated subjects remained stable to slightly decreased from baseline (approximately 2%), while the placebo arm had

Belite Bio reports Phase 3 tinlarebant data at ASRS meeting

Mon, 20 Jul 2026 08:00:41 -0400

Belite Bio, Inc. (NASDAQ: BLTE) reported additional secondary endpoint data from its Phase 3 DRAGON trial of tinlarebant in Stargardt disease type 1 (STGD1) at the American Society of Retina Specialists 2026 Annual Meeting on July 18, 2026, in Montréal, Canada.

According to the company's press release, quantitative autofluorescence (qAF), a marker of toxic bisretinoid accumulation, showed divergence between treatment groups at month 25. Subjects treated with tinlarebant had qAF values that remained stable to slightly decreased from baseline by approximately 2%, while placebo-treated subjects showed an approximately 20% increase in qAF from baseline.

The Phase 3 DRAGON trial enrolled 104 subjects

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

Mon, 20 Jul 2026 08:00:00 -0400

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

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

Mon, 20 Jul 2026 08:00:00 -0400

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

Belite Bio to Participate in the H.C. Wainwright 6th Annual Ophthalmology Virtual Conference

Wed, 15 Jul 2026 08:00:00 -0400

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.

Webcast Link Instructions
A webcast of the panel can be accessed under "Events" in the investor relations section of the Belite Bio website at:

Belite Bio to Participate in the H.C. Wainwright 6th Annual Ophthalmology Virtual Conference

Wed, 15 Jul 2026 08:00:00 -0400

Webcast Link Instructions
A webcast of the panel can be accessed under "Events" in the investor relations section of the Belite Bio website at:

Belite Bio to Participate in the Piper Sandler Virtual Ophthalmology Investor Symposium

Mon, 06 Jul 2026 08:00:00 -0400

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.

Webcast Link Instructions
A webcast of the presentation can be accessed under "Events" in the investor relations section of the Belite Bio website at:

Belite Bio to Participate in the Piper Sandler Virtual Ophthalmology Investor Symposium

Mon, 06 Jul 2026 08:00:00 -0400

Webcast Link Instructions
A webcast of the presentation can be accessed under "Events" in the investor relations section of the Belite Bio website at:

Belite Bio Announces Oral Presentations at Two Upcoming Medical Conferences

Mon, 06 Jul 2026 07:00:00 -0400

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 Belite data will be presented at the 63rd Annual Symposium of the International Society for Clinical Electrophysiology of Vision (ISCEV) being held on July 6-11, 2026, in Sydney, Australia, and the American Society of Retina Specialists (ASRS) 2026 Annual Meeting being held on July 15-18, 2026, in Montréal, Canada.

Presentation Details
Session: Session

Belite Bio Announces Oral Presentations at Two Upcoming Medical Conferences

Mon, 06 Jul 2026 07:00:00 -0400

Presentation Details
Session: Session

Form 4 BELITE BIO, INC For: Jun 18 Filed by: Scholl Hendrik Peter

Mon, 22 Jun 2026 06:06:00 -0400

si-local-file:///var/storage/secattach/20260622/26669413.html

Form 4 BELITE BIO, INC For: Jun 18 Filed by: Scholl Hendrik Peter

Mon, 22 Jun 2026 06:06:00 -0400

si-local-file:///var/storage/secattach/20260622/26669413.html

Form 144 BELITE BIO, INC Filed by: Scholl Hendrik Peter

Thu, 18 Jun 2026 16:27:00 -0400

si-local-file:///var/storage/secattach/20260618/26666481.html

Form 144 BELITE BIO, INC Filed by: Scholl Hendrik Peter

Thu, 18 Jun 2026 16:27:00 -0400

si-local-file:///var/storage/secattach/20260618/26666481.html

Form 4 BELITE BIO, INC For: Jun 16 Filed by: Scholl Hendrik Peter

Wed, 17 Jun 2026 06:04:00 -0400

si-local-file:///var/storage/secattach/20260617/26656448.html

Form 4 BELITE BIO, INC For: Jun 16 Filed by: Scholl Hendrik Peter

Wed, 17 Jun 2026 06:04:00 -0400

si-local-file:///var/storage/secattach/20260617/26656448.html

Form 144 BELITE BIO, INC Filed by: Scholl Hendrik Peter

Tue, 16 Jun 2026 19:11:00 -0400

si-local-file:///var/storage/secattach/20260616/26655659.html

Form 144 BELITE BIO, INC Filed by: Scholl Hendrik Peter

Tue, 16 Jun 2026 19:11:00 -0400

si-local-file:///var/storage/secattach/20260616/26655659.html

H.C. Wainwright Reiterates Buy Rating on Belite Bio, Inc, ADR (BLTE)

Tue, 16 Jun 2026 06:44:25 -0400

H.C. Wainwright analyst Yi Chen reiterated a Buy rating and $200.00 price target on Belite Bio, Inc, ADR (NASDAQ: BLTE).

The analyst commented: "Last Friday, Belite Bio announced the completion of its rolling submission of a New Drug Application (NDA) to the U.S. FDA for tinlarebant as a once-daily oral therapy for the treatment of Stargardt disease type 1 (STGD1) caused by mutations in the ABCA4 gene. As a reminder, the rolling NDA was initiated in April 2026 and was submitted under Breakthrough Therapy designation. Management noted that the completed application will undergo the 60-day review period, and if accepted by

Form 6-K BELITE BIO, INC For: Jun 12

Mon, 15 Jun 2026 06:07:00 -0400

si-local-file:///var/storage/secattach/20260615/26643681.html

Form 6-K BELITE BIO, INC For: Jun 12

Mon, 15 Jun 2026 06:07:00 -0400

si-local-file:///var/storage/secattach/20260615/26643681.html

Belite Bio completes FDA drug application for rare eye disease treatment

Mon, 15 Jun 2026 03:02:57 -0400

Belite Bio Inc (NASDAQ: BLTE) completed its rolling submission of a New Drug Application to the U.S. Food and Drug Administration for tinlarebant, an oral therapy for Stargardt disease type 1, according to a company statement.

The submission, initiated in April 2026, was filed under Breakthrough Therapy Designation. Stargardt disease type 1 is a rare inherited retinal disease caused by mutations in the ABCA4 gene that leads to progressive vision loss. The condition affects an estimated 53,000 people in the U.S., with no currently approved treatments available.

The completed application will undergo a 60-day FDA review period. If accepted, the agency will

Belite Bio completes FDA drug application for rare eye disease treatment

Mon, 15 Jun 2026 03:02:57 -0400

The completed application will undergo a 60-day FDA review period. If accepted, the agency will

Belite Bio Completes Rolling Submission of New Drug Application to U.S. Food and Drug Administration for Tinlarebant for the Treatment of Stargardt Disease Type 1

Fri, 12 Jun 2026 21:30:00 -0400

SAN DIEGO, June 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 the completion of its rolling submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for tinlarebant. Tinlarebant is an investigational, once-daily oral therapy for the treatment of Stargardt disease type 1 (STGD1), a rare, inherited retinal disease caused by mutations in the ABCA4 gene that leads to progressive

Belite Bio Completes Rolling Submission of New Drug Application to U.S. Food and Drug Administration for Tinlarebant for the Treatment of Stargardt Disease Type 1

Fri, 12 Jun 2026 21:30:00 -0400

StreetInsider.com News Articles

H.C. Wainwright Reiterates Buy Rating on Belite Bio, Inc, ADR (BLTE)

Belite Bio reports Phase 3 tinlarebant data at ASRS meeting

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

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

Belite Bio to Participate in the H.C. Wainwright 6th Annual Ophthalmology Virtual Conference

Belite Bio to Participate in the H.C. Wainwright 6th Annual Ophthalmology Virtual Conference

Belite Bio to Participate in the Piper Sandler Virtual Ophthalmology Investor Symposium

Belite Bio to Participate in the Piper Sandler Virtual Ophthalmology Investor Symposium

Belite Bio Announces Oral Presentations at Two Upcoming Medical Conferences

Belite Bio Announces Oral Presentations at Two Upcoming Medical Conferences

Form 4 BELITE BIO, INC For: Jun 18 Filed by: Scholl Hendrik Peter

Form 4 BELITE BIO, INC For: Jun 18 Filed by: Scholl Hendrik Peter

Form 144 BELITE BIO, INC Filed by: Scholl Hendrik Peter

Form 144 BELITE BIO, INC Filed by: Scholl Hendrik Peter

Form 4 BELITE BIO, INC For: Jun 16 Filed by: Scholl Hendrik Peter

Form 4 BELITE BIO, INC For: Jun 16 Filed by: Scholl Hendrik Peter

Form 144 BELITE BIO, INC Filed by: Scholl Hendrik Peter

Form 144 BELITE BIO, INC Filed by: Scholl Hendrik Peter

H.C. Wainwright Reiterates Buy Rating on Belite Bio, Inc, ADR (BLTE)

Form 6-K BELITE BIO, INC For: Jun 12

Form 6-K BELITE BIO, INC For: Jun 12

Belite Bio completes FDA drug application for rare eye disease treatment

Belite Bio completes FDA drug application for rare eye disease treatment

Belite Bio Completes Rolling Submission of New Drug Application to U.S. Food and Drug Administration for Tinlarebant for the Treatment of Stargardt Disease Type 1

Belite Bio Completes Rolling Submission of New Drug Application to U.S. Food and Drug Administration for Tinlarebant for the Treatment of Stargardt Disease Type 1