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Belite Bio, Inc, ADR (BLTE) PT Raised to $245 at H.C. Wainwright

Wed, 09 Sep 2026 07:25:39 -0400

(Updated - September 9, 2026 7:25 AM EDT)

H.C. Wainwright analyst Yi Chen raised the price target on Belite Bio, Inc, ADR (NASDAQ: BLTE) to $245.00 (from $214.00) while maintaining a Buy rating.

The analyst commented: "This morning, Belite Bio 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 has been designated a SAKIGAKE pharmaceutical product for accelerated review. The Sakigake designation system is Japan’s expedited regulatory pathway for innovative medical products. If approved, tinlarebant would become the first Sakigake pharmaceutical product

Belite Bio, Inc, ADR (BLTE) PT Raised to $245 at H.C. Wainwright

Wed, 09 Sep 2026 07:25:39 -0400

(Updated - September 9, 2026 7:25 AM EDT)

H.C. Wainwright analyst Yi Chen raised the price target on Belite Bio, Inc, ADR (NASDAQ: BLTE) to $245.00 (from $214.00) while maintaining a Buy rating.

Belite Bio, Inc, ADR (BLTE) PT Raised to $234 at Mizuho

Wed, 09 Sep 2026 06:55:05 -0400

(Updated - September 9, 2026 6:55 AM EDT)

Mizuho analyst Graig Suvannavejh raised the price target on Belite Bio, Inc, ADR (NASDAQ: BLTE) to $234.00 (from $220.00) while maintaining a Outperform rating.

The analyst commented: "We raise our PT on BLTE to $234 (vs. $220 prior) following yesterday's news of a company submission of a New Drug Application/NDA in Japan for tinlarebant in Stargardt disease type 1/STGD1. Given Sakigake Designation (Japan's fast-track regulatory pathway for innovative drugs), we believe a Japan approval and launch could now come in 1H27, ahead of our initial expectations, and on a model update (and with details

Belite Bio, Inc, ADR (BLTE) PT Raised to $234 at Mizuho

Wed, 09 Sep 2026 06:55:05 -0400

(Updated - September 9, 2026 6:55 AM EDT)

Mizuho analyst Graig Suvannavejh raised the price target on Belite Bio, Inc, ADR (NASDAQ: BLTE) to $234.00 (from $220.00) while maintaining a Outperform rating.

Belite Bio files Japan drug application for Stargardt disease treatment

Tue, 08 Sep 2026 06:00:37 -0400

Belite Bio, Inc. (NASDAQ: BLTE) announced it has submitted a New Drug Application (NDA) to Japan's Ministry of Health, Labour, and Welfare (MHLW) for tinlarebant, an investigational oral therapy for Stargardt disease type 1 (STGD1), a rare inherited retinal disease with no currently approved treatments.

The application was filed under Japan's Sakigake Designation System, an expedited regulatory pathway for innovative medical products targeting serious diseases. The Japan NDA was submitted alongside a previously filed U.S. NDA, which the Food and Drug Administration accepted with Priority Review, setting a Prescription Drug User Fee Act target action date of February 12, 2027.

STGD1 is

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 Dis

Tue, 08 Sep 2026 06:00:00 -0400

U.S. Food and Drug Administration accepted the New Drug Application with Priority Review for tinlarebant for the treatment of Stargardt disease type 1; Prescription Drug User Fee Act target action date of February 12, 2027
If approved, tinlarebant would be the first-ever approved treatment for Stargardt Disease Type 1 and could become the first Sakigake pharmaceutical product for ophthalmology disease in Japan

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

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 Dis

Tue, 08 Sep 2026 06:00:00 -0400

U.S. Food and Drug Administration accepted the New Drug Application with Priority Review for tinlarebant for the treatment of Stargardt disease type 1; Prescription Drug User Fee Act target action date of February 12, 2027
If approved, tinlarebant would be the first-ever approved treatment for Stargardt Disease Type 1 and could become the first Sakigake pharmaceutical product for ophthalmology disease in Japan

Canaccord Starts Belite Bio, Inc, ADR (BLTE) at Buy

Fri, 04 Sep 2026 06:31:06 -0400

(Updated - September 4, 2026 6:31 AM EDT)

Canaccord analyst Whitney Ijem initiates coverage on Belite Bio, Inc, ADR (NASDAQ: BLTE) with a Buy rating.

The analyst comments "We are initiating coverage of BLTE shares with a BUY rating and $303 target. Despite strong price performance since the IPO, we see near-, medium-, and longer-term drivers for additional upside. BLTE's lead drug is Tinlarebant, a once-daily oral RBP4 antagonist designed to slow vision loss by reducing delivery of vitamin A to the eye and thereby limiting toxic byproduct accumulation that drives retinal cell damage in Stargardt disease and potentially GA. Our near-term

Canaccord Starts Belite Bio, Inc, ADR (BLTE) at Buy

Fri, 04 Sep 2026 06:31:06 -0400

(Updated - September 4, 2026 6:31 AM EDT)

Canaccord analyst Whitney Ijem initiates coverage on Belite Bio, Inc, ADR (NASDAQ: BLTE) with a Buy rating.

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

Thu, 03 Sep 2026 06:56:36 -0400

H.C. Wainwright analyst Yi Chen reiterated a Buy rating and $214.00 price target on Belite Bio, Inc, ADR (NASDAQ: BLTE).

The analyst commented: "Yesterday, Belite Bio hosted a virtual commercial day to discuss its commercial preparations and market prospects. Importantly, the company aims to commercially launch tinlarebant for the treatment of Stargardt disease (STGD) in March 2027 if the drug is approved by the FDA on the PDUFA date of February 12, 2027, suggesting that commercial inventory, specialty-pharmacy infrastructure, payor engagement and field deployment would be substantially ready before FDA approval. Management estimates approximately 53,000 prevalent U.S. patients and approximately 20,000

Belite Bio to Participate in Four Upcoming Investor Conferences

Tue, 01 Sep 2026 08:00:00 -0400

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:

Wells Fargo 21st Annual Healthcare Conference (Boston, MA)
- September 8, 2026, at 8:45 am ET, fireside chat
2026 Cantor Global Healthcare Conference (New York, NY)
- September 11,

Belite Bio to Participate in Four Upcoming Investor Conferences

Tue, 01 Sep 2026 08:00:00 -0400

Wells Fargo 21st Annual Healthcare Conference (Boston, MA)
- September 8, 2026, at 8:45 am ET, fireside chat
2026 Cantor Global Healthcare Conference (New York, NY)
- September 11,

Belite Bio to Host Virtual Commercial Day on September 2, 2026

Mon, 24 Aug 2026 16:00:00 -0400

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’s management team will be joined by leading experts in ophthalmology and people living with Stargardt disease type 1 (STGD1), and will provide an overview of STGD1, the unmet need of people living with

Belite Bio to Host Virtual Commercial Day on September 2, 2026

Mon, 24 Aug 2026 16:00:00 -0400

Belite Bio Announces Oral Presentations at Two Upcoming Medical Conferences

Fri, 21 Aug 2026 08:00:00 -0400

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.

SOG Presentation Details
Session: Free Communications I – Retina Vitreous
Title: Results from the

Belite Bio Announces Oral Presentations at Two Upcoming Medical Conferences

Fri, 21 Aug 2026 08:00:00 -0400

SOG Presentation Details
Session: Free Communications I – Retina Vitreous
Title: Results from the

Belite Bio, Inc, ADR (BLTE) PT Raised to $206 at Morgan Stanley

Mon, 17 Aug 2026 08:58:07 -0400

Morgan Stanley analyst Judah Frommer raised the price target on Belite Bio, Inc, ADR (NASDAQ: BLTE) to $206.00 (from $201.00) while maintaining a Overweight rating.

Belite Bio, Inc, ADR (BLTE) PT Raised to $206 at Morgan Stanley

Fri, 14 Aug 2026 08:35:16 -0400

Morgan Stanley analyst Judah Frommer raised the price target on Belite Bio, Inc, ADR (NASDAQ: BLTE) to $206.00 (from $201.00) while maintaining a Overweight rating.

Belite Bio (BLTE) Reiterated at Buy by Benchmark on Tinlarebant NDA Acceptance by FDA

Fri, 14 Aug 2026 07:54:58 -0400

Benchmark analyst Bruce D. Jackson reiterated a Buy rating and $217.00 price target on Belite Bio, Inc, ADR (NASDAQ: BLTE).

The analyst commented, "Belite Bio hosted a 2Q business update. Earlier this week, the FDA accepted the New Drug Application (NDA) for Tinlarebant and granted Priority Review with a PDUFA target date of February 12, 2027. The company continues to prepare for commercial launch, which is planned for Q1 2027 immediately following the anticipated FDA approval. The company did not provide any specific financial guidance for 2026, but over the next three years they plan to spend $150 million on

Belite Bio, Inc, ADR (BLTE) PT Raised to $220 at Mizuho

Fri, 14 Aug 2026 06:38:16 -0400

(Updated - August 14, 2026 6:38 AM EDT)

Mizuho analyst Graig Suvannavejh raised the price target on Belite Bio, Inc, ADR (NASDAQ: BLTE) to $220.00 (from $215.00) while maintaining a Outperform rating.

The analyst commented: "BLTE hosted its 2Q26 update call yesterday, with incremental, but no major updates. As previously disclosed, the main highlight was FDA acceptance of the company's NDA for tinlarebant in Stargardt disease type 1/STGD1, for which a priority review has been granted and a February 12, 2027 PDUFA established. While it remains unclear whether FDA will ask for an AdCom before the PDUFA, as a next potential catalyst,

Belite Bio, Inc, ADR (BLTE) PT Raised to $220 at Mizuho

Fri, 14 Aug 2026 06:38:16 -0400

(Updated - August 14, 2026 6:38 AM EDT)

Mizuho analyst Graig Suvannavejh raised the price target on Belite Bio, Inc, ADR (NASDAQ: BLTE) to $220.00 (from $215.00) while maintaining a Outperform rating.

Form 4 BELITE BIO, INC For: Aug 12 Filed by: Chuang Hao-Yuan

Fri, 14 Aug 2026 06:10:00 -0400

si-local-file:///var/storage/secattach/20260814/26924146.html

Form 4 BELITE BIO, INC For: Aug 12 Filed by: Chuang Hao-Yuan

Fri, 14 Aug 2026 06:10:00 -0400

si-local-file:///var/storage/secattach/20260814/26924146.html

Form 4 BELITE BIO, INC For: Aug 12 Filed by: Lin Yu-Hsin

Fri, 14 Aug 2026 06:10:00 -0400

si-local-file:///var/storage/secattach/20260814/26924147.html

Form 4 BELITE BIO, INC For: Aug 12 Filed by: Lin Yu-Hsin

Fri, 14 Aug 2026 06:10:00 -0400

si-local-file:///var/storage/secattach/20260814/26924147.html