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

Thu, 15 Oct 2026 07:09:23 -0400

H.C. Wainwright analyst Yi Chen reiterated a Buy rating and $245.00 price target on Belite Bio, Inc, ADR (NASDAQ: BLTE).

The analyst commented: "Yesterday, Belite Bio announced Marketing Authorization Application (MAA) submissions to the regulatory authorities in Singapore, the United Kingdom, and Switzerland for tinlarebant as a treatment of Stargardt disease type 1 (STGD1). The three MAAs have been submitted via the Access Consortium framework in an agreement by the Health Sciences Authority (HSA), Medicines and Healthcare products Regulatory Agency (MHRA), and Swissmedic. Notably, the Access Consortium is a collaborative initiative comprised of multiple regulatory authorities designed to maximize regulatory collaboration

Belite Bio files for tinlarebant approval in three new markets

Wed, 14 Oct 2026 16:03:07 -0400

Belite Bio, Inc. (NASDAQ: BLTE) announced it has submitted Marketing Authorization Applications (MAAs) for tinlarebant in Singapore, the United Kingdom, and Switzerland 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 vision loss.

The three submissions were made through the Access Consortium framework, a collaborative regulatory initiative involving Singapore's Health Sciences Authority, the UK's Medicines and Healthcare products Regulatory Agency, and Swissmedic. The consortium is designed to coordinate regulatory reviews across member countries.

Tinlarebant is an investigational once-daily oral therapy. The company states there are currently

Belite Bio files for tinlarebant approval in three new markets

Wed, 14 Oct 2026 16:03:07 -0400

Tinlarebant is an investigational once-daily oral therapy. The company states there are currently

Belite Bio Announces Multi-Market Submission of Marketing Authorization Applications Via the Access Consortium Pathway for Tinlarebant for the Treatment of Stargardt Disease Type 1

Wed, 14 Oct 2026 16:00:00 -0400

If approved, tinlarebant would be the first-ever approved treatment for Stargardt Disease Type 1 in Singapore, United Kingdom, and Switzerland
Access pathway submission combined with accepted new drug applications in the U.S. (Prescription Drug User Fee Act target action date of February 12, 2027) and in Japan, further advance the Company’s goal to bring tinlarebant to Stargardt disease type 1 patients around the world

SAN DIEGO, Oct. 14, 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

Belite Bio Announces Multi-Market Submission of Marketing Authorization Applications Via the Access Consortium Pathway for Tinlarebant for the Treatment of Stargardt Disease Type 1

Wed, 14 Oct 2026 16:00:00 -0400

If approved, tinlarebant would be the first-ever approved treatment for Stargardt Disease Type 1 in Singapore, United Kingdom, and Switzerland
Access pathway submission combined with accepted new drug applications in the U.S. (Prescription Drug User Fee Act target action date of February 12, 2027) and in Japan, further advance the Company’s goal to bring tinlarebant to Stargardt disease type 1 patients around the world

Form 4 BELITE BIO, INC For: Oct 01 Filed by: Scholl Hendrik Peter

Mon, 05 Oct 2026 19:28:00 -0400

si-local-file:///var/storage/secattach/20261005/27150417.html

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

Thu, 01 Oct 2026 18:04:00 -0400

si-local-file:///var/storage/secattach/20261001/27137492.html

Belite Bio Announces Oral Presentations at Two Upcoming Medical Conferences

Thu, 01 Oct 2026 08:00:00 -0400

SAN DIEGO, Oct. 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 its data will be presented at the Innovate Retina conference being held on October 8, 2026, in New Orleans, Louisiana, and at the American Academy of Ophthalmology (AAO) 2026 being held on October 9-12, 2026, in New Orleans, Louisiana.

Innovate Retina Presentation Details

Session 1: Inherited Retinal Diseases (IRD)
Title: What Is

Belite Bio Announces Oral Presentations at Two Upcoming Medical Conferences

Thu, 01 Oct 2026 08:00:00 -0400

Innovate Retina Presentation Details

Session 1: Inherited Retinal Diseases (IRD)
Title: What Is

Belite Bio Announces Oral Presentations at Two Upcoming Medical Conferences

Mon, 28 Sep 2026 20:00:00 -0400

SAN DIEGO, Sept. 28, 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 Euretina Innovation Spotlight (EIS) being held on September 30, 2026, and Euretina being held on October 1-4, 2026, in Vienna, Austria.

EIS Presentation Details
Session: EURETINA Innovation Spotlight – Inherited and Rare Retinal Diseases
Title: Belite Bio Company Overview
Presenter: Hendrik Scholl, M.D., Chief Medical Officer,

Belite Bio Announces Oral Presentations at Two Upcoming Medical Conferences

Mon, 28 Sep 2026 20:00:00 -0400

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