SAN DIEGO, Aug.  24, 2026  (GLOBE NEWSWIRE) -- Belite Bio, Inc (NASDAQ:BLTE) (&#34;Belite Bio®&#34; or the &#34;Company&#34;), a clinical-stage drug development company focused on advancing novel therapeutics targeting

BLTE

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

FDA Priority Review for Tinlarebant in STGD1 Signals BLTE Upside

<section class="insight" data-version="1">
  <section data-block="information">
    <h3>Information</h3>
    <p>SAN DIEGO, Aug.  24, 2026  (GLOBE NEWSWIRE) -- Belite Bio, Inc (NASDAQ:BLTE) (&amp;#34;Belite Bio®&amp;#34; or the &amp;#34;Company&amp;#34;), a clinical-stage drug development company focused on advancing novel therapeutics targeting</p>
  </section>

  <section data-block="ai-summary-paragraph">
    <h3>AI Summary</h3>
    <p>Belite Bio reported that the FDA granted Priority Review to tinlarebant for STGD1 with a February 12, 2027 PDUFA date. The company will host a Sep 2, 2026 virtual Commercial Day to discuss unmet STGD1 needs and prelaunch plans. Positive DRAGON Phase 3 results support approval prospects, while DRAGON II and PHOENIX trials continue, underpinning potential US commercialization.</p>
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  <section data-block="ai-summary-bullets">
    <h3>Key Points</h3>
    <ul><li>FDA granted Priority Review for tinlarebant in STGD1; PDUFA due 2/12/2027.</li><li>BLTE to host Sep 2, 2026 Virtual Commercial Day.</li><li>DRAGON Phase 3 in STGD1 met primary endpoint; DRAGON II ongoing.</li><li>PHOENIX Phase 3 in geographic atrophy ongoing; potential expansion.</li><li>Tinlarebant is an oral therapy aimed at reducing bisretinoid toxins.</li></ul>
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  <section data-block="companies-mentioned">
    <h3>Companies Mentioned</h3>
    <ul><li><strong>Belite Bio, Inc. (BLTE)</strong>: Positive regulatory milestone and upcoming events that could support a re-rating.</li><li><strong>U.S. Food and Drug Administration (FDA)</strong>: Regulator granting Priority Review and setting PDUFA date; key regulatory catalyst.</li><li><strong>Stargardt Disease Type 1 (STGD1) (STGD1)</strong>: Target patient population; regulatory success could unlock large clinical opportunity.</li><li><strong>Q4 Inc (QFOR)</strong>: Webcast host for Belite’s event; minor market-moving potential around investor communications.</li></ul>
  </section>

  <section data-block="category">
    <h3>Corporate Developments</h3>
    <p>Category: Corporate Developments. Regulatory milestones and clinical-readouts drive BLTE&#039;s potential commercialization path and valuation, making near-term catalysts highly relevant.</p>
  </section>

  <section data-block="market-moving">
    <h3>Market-Moving</h3>
    <ul><li>Priority Review designation and 2/12/2027 PDUFA date.</li><li>DRAGON Phase 3 met primary endpoint for STGD1.</li><li>DRAGON II and PHOENIX ongoing, potentially expanding TAM.</li><li>Sep 2, 2026 Virtual Commercial Day enhances investor visibility.</li></ul>
  </section>

  <section data-block="key-facts">
    <h3>Key Facts</h3>
    <ul><li>FDA accepted and granted Priority Review for tinlarebant in STGD1 in Aug 2026.</li><li>PDUFA date set for February 12, 2027.</li><li>DRAGON Phase 3 in STGD1 met primary endpoint.</li><li>DRAGON II (STGD1) and PHOENIX (GA) ongoing.</li><li>Tinlarebant is an oral therapy designed to reduce bisretinoid toxins in the eye.</li></ul>
  </section>

  <section data-block="trading-thesis">
    <h3>Trading Thesis</h3>
    <p>Bullish: regulatory momentum and the 2/12/2027 PDUFA could lift BLTE within the next 12-18 months.</p>
  </section>
</section>


<link type="text/css" rel="stylesheet" href="https://www.globenewswire.com/styles/gnw_nitf.css"></link><p>SAN DIEGO, Aug.  24, 2026  (GLOBE NEWSWIRE) -- <a href="https://www.globenewswire.com/Tracker?data=vmxOMmwEElk1898Mtbk4nZFY2vLwB9DnyDrbmPnieW1aPScUsItNFM-tJdVMYDUXwwU6APOt0JwezkZoIfWMs_lDQGh8KBul_ouJTPN0MXTjcIRqbEGG93SoH9wrBy_-7sOu_quZ3bZFCnxPAvwF7tEBTs-Z8lfLvq3I72xvmIX3klNtWvIZbvgmUVD448kUQ-F8mEhic3h9qIjGq8ELzFnGrV70G9p_qEBJZ3WcMtoU_eWXvrZwwNDO0CiGPzkC3jIl1-Hbb8tVsS3MFhlcRTOi0eit-8-135cSMnplIs9n5H3e0j9_mUQX8oCc4t-6Kj5IEiJZTAkBUaZnx7Gv2vDVRgIIwV4LoaNzJYIRZEZgm4ux7gyRzgC4B3E22IDmuBPgClRuPAbT0-nW88sMmev3mWUb_S2vQlMVvi3E1Bw=" rel="nofollow" target="_blank">Belite Bio</a>, Inc (NASDAQ:<a class="ticker" href="https://www.benzinga.com/quote/BLTE">BLTE</a>) ("Belite Bio&#xAE;" 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.</p>  <p>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 the disease, and the current treatment landscape. Management will also provide an update on the Company’s prelaunch preparedness strategies and the potential commercial opportunity for tinlarebant in STGD1, if approved by the U.S. Food and Drug Administration (FDA).</p>  <p>In August 2026, the FDA accepted and granted Priority Review designation of the New Drug Application for tinlarebant for the treatment of STGD1. The FDA has set a Prescription Drug User Fee Act date of February 12, 2027.</p>  <p><strong>Webcast Information</strong><br></br><strong>Date: </strong>Wednesday, September 2, 2026<br></br><strong>Time: </strong>8:00 a.m. Eastern Time (5:00 a.m. Pacific Time)<br></br><strong>Webcast Link: </strong><a href="https://www.globenewswire.com/Tracker?data=lYr_0-ngEAhVLv1plMjtI5GOegy5LSjplsAK9cIBz5KgNuqEI09KR4eVzVY05ZZYkTHrNPXyeSTI4viUaba9fwVDexPp4NVB89tMw-edkOceuWNtC_of0e6vbDhoWni4QHH4LxfyZXTJmvmjb7pzgaAkeE5yuKBb9CNGRfmFHO0=" rel="nofollow" target="_blank">https://events.q4inc.com/attendee/785241581</a></p>  <p><strong>Webcast Link Instructions</strong><br></br>A webcast of the event can be accessed and a replay will be archived under &#34;Events&#34; in the investor relations section of the Belite Bio website at: <a href="https://www.globenewswire.com/Tracker?data=lYr_0-ngEAhVLv1plMjtI4zVILVVYKTKBjCZtNWbp98X-pk08vz084ZnJUpnpNCFLyiOUDa6UzxRuuYeS5eZGYK7CS8EVD2S-bdtT2gqjKGROmnxKwr0_ywcG-NJQ7elLheozaRC7EisGtEbnIk33rfGG8baNHrDUBxCcJd67yoLhJwSMjxFjxwj8DxRWUQof56GKEUi97hQ837bZra6CqhQJiVQrcBkVL_yJo3cze22DJNAmWydD_yid83Hr6Z01J88xSkjYAcEh5T1tWISL5hqL5xQh1NcrscrV1br8smV7V0x_0TiE9yQ885DUzBlSOOrCoP0I0opp88XC3Cfl7OwJSlWpZd-OqfTKuGseZFpFPfi_Qb4YKwO0MK90JB-Ce-22RwCmicWBpOoqcODZL_NK6PnLX9o2ckrprB7cPoGiGbx20XlttjEwzioPzpF1S7ajI8geh3TPWvD6OE7AQ==" rel="nofollow" target="_blank">https://investors.belitebio.com/presentations-events/events</a>.</p>  <p><strong>About Belite Bio</strong><br></br>Belite Bio is a clinical-stage drug development company focused on advancing novel therapeutics targeting degenerative retinal diseases that have significant unmet medical needs, such as Stargardt disease type 1 (STGD1) and geographic atrophy (GA) in advanced dry age-related macular degeneration (AMD), in addition to specific metabolic diseases. Belite Bio’s lead candidate, tinlarebant, is an oral therapy intended to reduce the accumulation of bisretinoid toxins in the eye. The Company has completed a Phase 3 trial (DRAGON) in adolescent and adult subjects with STGD1, which met its primary endpoint, and the drug is currently being evaluated in a Phase 2/3 trial (DRAGON II) in adolescent and adult subjects with STGD1 and a Phase 3 trial (PHOENIX) in subjects with GA. For more information, follow us on X, Instagram, LinkedIn, and Facebook, or visit us at <a href="https://www.globenewswire.com/Tracker?data=MG6mgGREjszYJHAezEzZHEy5297G1UqZ2GFtLAjM1ucaVsYbaN50Vz40LKy6E-kLQC9UDhmSM6VNtj_4dM4dWAKQpDhLY5SkGaNM4_Qv1cCIOe5UkhuyBFIvmWZTLiMiHjoU2iacwWiM46Wi3kLUSccoaUD-M3r6-Npa1_-B_Cfoed7yyjaDhOCxoOjYAQzFgx49kaE78PjeByTRJune-PKjAZjOH3aFniO-Q_2ZJ68_5AyOsLEzjiM4KbP4VqXpsF7x7hjs-yeXZl-JU3Nxlg==" rel="nofollow" target="_blank">www.belitebio.com</a>.</p>  <p><strong>Media and Investor Relations Contact:</strong><br></br><a href="https://www.globenewswire.com/Tracker?data=l2dpK2Qyj7rSL17v3VPFPjkN9c4jswc5CUyc9ac6olGRwix7X7xdb2JWdHUiMJqThtdmpoMfhCmVT4esQr9Q2VW8C0aEBizVg_PY8D6bQyM=" rel="nofollow" target="_blank">ir@belitebio.com</a></p> <img alt="" class="__GNW8366DE3E__IMG" src="https://www.globenewswire.com/newsroom/ti?nf=OTgxNTE1MiM3ODAwODE1IzIyMzM3MzI="></img> <br></br><img alt="" src="https://ml.globenewswire.com/media/OTZiMDI3MmUtMmM3YS00MzJlLTg4M2YtNDhlNDgwYWRjYmUyLTEyNDUyODUtMjAyNi0wOC0yNC1lbg==/tiny/Belite-Bio-Inc.png" referrerpolicy="no-referrer-when-downgrade"></img><p><a href="https://www.globenewswire.com/NewsRoom/AttachmentNg/7f86ac70-6347-41c6-a622-e7000c42ad35"><img src="https://ml.globenewswire.com/media/7f86ac70-6347-41c6-a622-e7000c42ad35/small/belite-bio-logo-digital-full-color-png.png" border="0" width="150" height="150" alt="Primary Logo"></img></a></p>

Belite Bio reported that the FDA granted Priority Review to tinlarebant for STGD1 with a February 12, 2027 PDUFA date. The company will host a Sep 2, 2026 virtual Commercial Day to discuss unmet STGD1 needs and prelaunch plans. Positive DRAGON Phase 3 results support approval prospects, while DRAGON II and PHOENIX trials continue, underpinning potential US commercialization.

News insight

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

AI summary

Sentiment rationale

Key facts

Corporate Developments