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Belite Bio, Inc.

59.04

-0.8600-1.44%

Volume:31.50K

Turnover:1.89M

Market Cap:1.92B

PE:-43.21

High:60.80

Open:59.94

Low:59.04

Close:59.90

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Overview Company News Filings

Sector Update: Health Care Stocks Flat to Lower Pre-Bell Wednesday

MT Newswires Live

Belite Bio Announces FDA Breakthrough Therapy Designation for Tinlarebant in Stargardt Disease Treatment Following Promising Phase 3 Trial Results

Belite Bio announces Breakthrough Therapy Designation for Tinlarebant from FDA

Belite Bio Says FDA Grants Breakthrough Therapy Tag to Stargardt Disease Drug

MT Newswires Live

BRIEF-Belite Bio Announces FDA Granting Of Breakthrough Therapy Designation For Tinlarebant For The Treatment Of Stargardt Disease

Belite Bio Secures FDA Breakthrough Therapy Designation for Tinlarebant in Stargardt Disease Treatment

Belite Bio Announces FDA Granting of Breakthrough Therapy Designation for Tinlarebant for the Treatment of Stargardt Disease

THOMSON REUTERS

Analysts Offer Insights on Healthcare Companies: Centessa Pharmaceuticals (CNTA), Arcellx Inc (ACLX) and Belite Bio, Inc. ADR (BLTE)

Maxim Group Sticks to Its Buy Rating for Belite Bio, Inc. ADR (BLTE)

Stock Track | Belite Bio Soars 5.11% as HC Wainwright Maintains $100 Price Target

Belite Bio Price Target Maintained With a $100.00/Share by HC Wainwright & Co.

Belite Bio Q1 Net Loss Widens

MT Newswires Live

Belite Bio Inc reports results for the quarter ended March 31 - Earnings Summary

Earnings Flash (BLTE) Belite Bio Q1 Loss $0.45 Vs. FactSet Est. $0.35 Loss

MT Newswires Live

Belite Bio Q1 EPS $(0.45) Misses $(0.35) Estimate

Belite Bio Reports Increased Net Loss of $14.3M in Q1 2025, Up from $7.9M in 2024; R&D Expenses Rise to $9.4M

Belite Bio Q1 Pretax Profit USD -14.277 Million

THOMSON REUTERS

Belite Bio Inc expected to post a loss of 37 cents a share - Earnings Preview

Calendar of U.S. Earnings Expected in the Week Ahead

Belite Bio, Inc. Appoints New Auditor

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Shares of Moderna were more than 1% higher premarket.Belite Bio  shares were up 0.4% after the company said the US Food and Drug Administration granted breakthrough therapy designation to its Tinlarebant drug for treating Stargardt disease.","market":"hk","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":null,"property":[],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://www.mtnewswires.com/","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"0","news_top_title":null,"news_tag":"","news_rank":0,"length":0,"strategy_id":0,"source":"mtnewswires_news","symbols":["BK4501","BK4551","MDT","IE00BQXX3C00.GBP","LU2023251221.USD","LU2468319806.SGD","LU1291159041.SGD","BK4533","LU0976567544.SGD","BLTE","BK4568","LU0162691827.USD","LU2089283258.USD","LU1116320901.HKD","LU0070302665.USD","BK4581","LU0208291251.USD","LU0496365809.HKD","LU1989771016.USD","BK4007","LU1571399168.USD","LU2271345857.HKD","IE00BFXG1179.USD","BK4548","LU1989764664.SGD","LU2089984988.USD","BK4585","LU0072461881.USD","MRNA","BK4566","LU1116320737.USD","LU2089284900.SGD","LU0211326755.USD","BK4588","IBB","IE00B3T34201.USD","IE00BQXX3F31.USD","LU0265550359.USD","LU1983299246.USD","LU0320765489.SGD","IE000M9KFDE8.USD","BK4139","LU0158827948.USD","LU0211326839.USD","LU1989764748.USD","LU0265550946.USD","BK4082","BK4534","LU2111349929.HKD","XLV"],"gpt_icon":1},{"id":"2537989474","title":"Belite Bio Announces FDA Breakthrough Therapy Designation for Tinlarebant in Stargardt Disease Treatment Following Promising Phase 3 Trial Results","url":"https://stock-news.laohu8.com/highlight/detail?id=2537989474","media":"Reuters","labels":["policyRegulatory"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2537989474?lang=en_us&edition=fundamental","pubTime":"2025-05-21 18:02","pubTimestamp":1747821756,"startTime":"0","endTime":"0","summary":"Belite Bio Announces FDA Breakthrough Therapy Designation for Tinlarebant in Stargardt Disease Treatment Following Promising Phase 3 Trial Results. Disclaimer: This news brief was created by Public Technologies  using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Belite Bio Inc. published the original content used to generate this news brief via EDGAR, the Electronic Data Gathering, Analysis, and Retrieval system operated by the U.S. Securities and Exchange Commission , on May 21, 2025, and is solely responsible for the information contained therein.","market":"nz","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":null,"property":[],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://api.refinitiv.com/data/news/v1/stories/urn:newsml:reuters.com:20250521:nNDLb5BHwh:1","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"1","news_top_title":null,"news_tag":"policyRegulatory","news_rank":0,"length":0,"strategy_id":0,"source":null,"symbols":["BLTE","BK4007"],"gpt_icon":0},{"id":"2537986983","title":"Belite Bio announces Breakthrough Therapy Designation for Tinlarebant from 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Drug","url":"https://stock-news.laohu8.com/highlight/detail?id=2537460485","media":"MT Newswires Live","labels":["productRelease"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2537460485?lang=en_us&edition=fundamental","pubTime":"2025-05-21 16:13","pubTimestamp":1747815189,"startTime":"0","endTime":"0","summary":"Belite Bio  said Wednesday the US Food and Drug Administration granted breakthrough therapy designation to its Tinlarebant drug for treating Stargardt disease.The company said the decision is based on early results from an ongoing phase 3 trial, which showed that the drug may significantly improve over current treatment options.The designation expedites the development and regulatory review of drugs that are intended for serious or life-threatening conditions, Belite Bio said.","market":"hk","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":null,"property":[],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://www.mtnewswires.com/","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"1","news_top_title":null,"news_tag":"productRelease","news_rank":0,"length":0,"strategy_id":0,"source":"mtnewswires_news","symbols":["BLTE","BK4007"],"gpt_icon":0},{"id":"2537090026","title":"BRIEF-Belite Bio Announces FDA Granting Of Breakthrough Therapy Designation For Tinlarebant For The Treatment Of Stargardt Disease","url":"https://stock-news.laohu8.com/highlight/detail?id=2537090026","media":"Reuters","labels":["productRelease"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2537090026?lang=en_us&edition=fundamental","pubTime":"2025-05-21 15:51","pubTimestamp":1747813871,"startTime":"0","endTime":"0","summary":"BRIEF-Belite Bio Announces FDA Granting Of Breakthrough Therapy Designation For Tinlarebant For The Treatment Of Stargardt DiseaseBelite Bio Inc BLTE.O:BELITE BIO ANNOUNCES FDA GRANTING OF BREAKTHROUG","market":"nz","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":null,"property":[],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://api.refinitiv.com/data/news/v1/stories/urn:newsml:reuters.com:20250521:nFWN3RS25M:1","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"1","news_top_title":null,"news_tag":"productRelease","news_rank":0,"length":0,"strategy_id":0,"source":null,"symbols":["BK4007","BLTE"],"gpt_icon":0},{"id":"2537605170","title":"Belite Bio Secures FDA Breakthrough Therapy Designation for Tinlarebant in Stargardt Disease Treatment","url":"https://stock-news.laohu8.com/highlight/detail?id=2537605170","media":"Reuters","labels":["policyRegulatory"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2537605170?lang=en_us&edition=fundamental","pubTime":"2025-05-21 15:00","pubTimestamp":1747810844,"startTime":"0","endTime":"0","summary":"SAN DIEGO, May 21, 2025  -- Belite Bio, Inc. , a clinical-stage biopharmaceutical company, announced that the U.S. Food and Drug Administration  has granted Breakthrough Therapy Designation for its drug Tinlarebant, aimed at treating Stargardt disease . This designation is based on interim results from the Phase 3 DRAGON trial, showcasing Tinlarebant's efficacy and safety. Notably, there are currently no approved treatments for STGD1. This grant marks a significant step forward in addressing the serious unmet needs of the Stargardt community. Trial completion is expected by Q4 2025. Belite Bio has previously received multiple designations for Tinlarebant, including Fast Track and Rare Pediatric Disease Designations in the U.S., and Orphan Drug Designation in the U.S., Europe, and Japan.Disclaimer: This news brief was created by Public Technologies  using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for i","market":"nz","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":null,"property":[],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://api.refinitiv.com/data/news/v1/stories/urn:newsml:reuters.com:20250521:nNDL2qYGB9:1","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"1","news_top_title":null,"news_tag":"policyRegulatory","news_rank":0,"length":0,"strategy_id":0,"source":null,"symbols":["LU2095319765.USD","LU2210149790.SGD","BK4112","BLTE","IE00BGHQF748.EUR","NDAQ","BK4588","BK4007","IE00B64PRP62.GBP","LU2210150020.SGD","IE00B3QW5Z07.USD","BK4585","IE00BKPKM429.USD"],"gpt_icon":0},{"id":"2537121605","title":"Belite Bio Announces FDA Granting of Breakthrough Therapy Designation for Tinlarebant for the Treatment of Stargardt Disease","url":"https://stock-news.laohu8.com/highlight/detail?id=2537121605","media":"THOMSON REUTERS","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2537121605?lang=en_us&edition=fundamental","pubTime":"2025-05-21 15:00","pubTimestamp":1747810811,"startTime":"0","endTime":"0","summary":null,"market":"us","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":null,"property":[],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://api.refinitiv.com/data/news/v1/stories/urn:newsml:reuters.com:20250521:nFWN3RS25M:1","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"0","news_top_title":null,"news_tag":"","news_rank":0,"length":0,"strategy_id":0,"source":"reuters_en_live","symbols":["BK4007","BLTE"],"gpt_icon":0},{"id":"2536503688","title":"Analysts Offer Insights on Healthcare Companies: Centessa Pharmaceuticals (CNTA), Arcellx Inc (ACLX) and Belite Bio, Inc. ADR (BLTE)","url":"https://stock-news.laohu8.com/highlight/detail?id=2536503688","media":"TIPRANKS","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2536503688?lang=en_us&edition=fundamental","pubTime":"2025-05-19 16:20","pubTimestamp":1747642830,"startTime":"0","endTime":"0","summary":"There’s a lot to be optimistic about in the Healthcare sector as 3 analysts just weighed in on Centessa Pharmaceuticals (CNTA – Research Report), A...","market":"fut","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":{"source":"tipranks_highlight","url":"https://www.tipranks.com/news/blurbs/analysts-offer-insights-on-healthcare-companies-centessa-pharmaceuticals-cnta-arcellx-inc-aclx-and-belite-bio-inc-adr-blte?utm_source=itigerup.com&utm_medium=referral","rn_cache_url":null,"directOrigin":true},"property":[],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://www.tipranks.com/news/blurbs/analysts-offer-insights-on-healthcare-companies-centessa-pharmaceuticals-cnta-arcellx-inc-aclx-and-belite-bio-inc-adr-blte?utm_source=itigerup.com&utm_medium=referral","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"0","news_top_title":null,"news_tag":"","news_rank":0,"length":0,"strategy_id":0,"source":"tipranks_highlight","symbols":["HCSG","BK4137","BLTE","BK4007","BK4535","BK4539","BK4139","CNTA","ACLX"],"gpt_icon":0},{"id":"2535118953","title":"Maxim Group Sticks to Its Buy Rating for Belite Bio, Inc. ADR (BLTE)","url":"https://stock-news.laohu8.com/highlight/detail?id=2535118953","media":"TIPRANKS","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2535118953?lang=en_us&edition=fundamental","pubTime":"2025-05-16 22:35","pubTimestamp":1747406113,"startTime":"0","endTime":"0","summary":"In a report released yesterday, Michael Okunewitch from Maxim Group maintained a Buy rating on Belite Bio, Inc. ADR (BLTE – Research Report), with ...","market":"us","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":{"source":"tipranks_highlight","url":"https://www.tipranks.com/news/blurbs/maxim-group-sticks-to-its-buy-rating-for-belite-bio-inc-adr-blte?utm_source=itigerup.com&utm_medium=referral","rn_cache_url":null,"directOrigin":true},"property":["rate"],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://www.tipranks.com/news/blurbs/maxim-group-sticks-to-its-buy-rating-for-belite-bio-inc-adr-blte?utm_source=itigerup.com&utm_medium=referral","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"1","news_top_title":null,"news_tag":"","news_rank":0,"length":0,"strategy_id":0,"source":"tipranks_highlight","symbols":["BLTE"],"gpt_icon":0},{"id":"1117112579","title":"Stock Track | Belite Bio Soars 5.11% as HC Wainwright Maintains $100 Price Target","url":"https://stock-news.laohu8.com/highlight/detail?id=1117112579","media":"Stock Track","labels":["movement"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/1117112579?lang=en_us&edition=fundamental","pubTime":"2025-05-16 14:52","pubTimestamp":1747378347,"startTime":"0","endTime":"0","summary":"Shares of Belite Bio, Inc.  are soaring in intraday trading, climbing 5.11% as investors react to a bullish analyst report. The surge comes after HC Wainwright & Co. reaffirmed its price target for the company at $100.00 per share, signaling strong confidence in the stock's potential.The maintained price target from HC Wainwright, a well-respected investment bank, suggests that analysts see significant upside potential for Belite Bio. This vote of confidence appears to be driving positive sentim","market":"hk","thumbnail":"","type":0,"news_type":0,"thumbnails":[],"rights":null,"property":[],"language":"en","translate_title":"","themeId":"","theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"1","news_top_title":"Stock Track | Belite Bio Soars 5.11% as HC Wainwright Maintains $100 Price Target","news_tag":"movement","news_rank":0,"length":0,"strategy_id":0,"source":"ai_movement_en","symbols":["BLTE"],"gpt_icon":0},{"id":"2535841611","title":"Belite Bio Price Target Maintained With a $100.00/Share by HC Wainwright & Co.","url":"https://stock-news.laohu8.com/highlight/detail?id=2535841611","media":"Dow Jones","labels":["dataReport"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2535841611?lang=en_us&edition=fundamental","pubTime":"2025-05-15 19:38","pubTimestamp":1747309080,"startTime":"0","endTime":"0","summary":"Ratings actions from Benzinga: https://www.benzinga.com/quote/BLTE/analyst-ratings \n\n\n \n\n\n  (END) Dow Jones Newswires\n\n\n  May 15, 2025 07:38 ET (11:38 GMT)","market":"us","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":null,"property":["rate"],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://dowjonesnews.com/newdjn/logon.aspx?AL=N","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"1","news_top_title":null,"news_tag":"dataReport","news_rank":0,"length":0,"strategy_id":0,"source":null,"symbols":["BLTE"],"gpt_icon":0},{"id":"2535883832","title":"Belite Bio Q1 Net Loss Widens","url":"https://stock-news.laohu8.com/highlight/detail?id=2535883832","media":"MT Newswires Live","labels":["dataReport"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2535883832?lang=en_us&edition=fundamental","pubTime":"2025-05-15 05:02","pubTimestamp":1747256541,"startTime":"0","endTime":"0","summary":"Belite Bio (BLTE) reported a Q1 net loss late Wednesday of $0.45 per diluted share, widening from the loss of $0.27 a year earlier.Analysts polled by FactSet expected a loss of $0.35.As of March 31, the company had $157.4 million in cash, liquidity funds, time deposits and US treasury bills.","market":"sg","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":null,"property":[],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://www.mtnewswires.com/","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"-2","news_top_title":null,"news_tag":"dataReport","news_rank":0,"length":0,"strategy_id":0,"source":"mtnewswires_news","symbols":["BK4007","BLTE"],"gpt_icon":0},{"id":"2535888048","title":"Belite Bio Inc reports results for the quarter ended March 31 - Earnings Summary","url":"https://stock-news.laohu8.com/highlight/detail?id=2535888048","media":"Reuters","labels":["dataReport"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2535888048?lang=en_us&edition=fundamental","pubTime":"2025-05-15 05:01","pubTimestamp":1747256461,"startTime":"0","endTime":"0","summary":"Belite Bio Inc reports results for the quarter ended March 31 - Earnings SummaryBelite Bio Inc BLTE.OQ reported a quarterly adjusted loss of 45 cents per share for the quarter ended March 31, lower th","market":"nz","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":null,"property":["earning"],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://api.refinitiv.com/data/news/v1/stories/urn:newsml:reuters.com:20250514:nL8N3RM2OW:1","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"0","news_top_title":null,"news_tag":"dataReport","news_rank":0,"length":0,"strategy_id":0,"source":null,"symbols":["BLTE"],"gpt_icon":0},{"id":"2535888635","title":"Earnings Flash (BLTE) Belite Bio Q1 Loss $0.45 Vs. FactSet Est. $0.35 Loss","url":"https://stock-news.laohu8.com/highlight/detail?id=2535888635","media":"MT Newswires Live","labels":["dataReport"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2535888635?lang=en_us&edition=fundamental","pubTime":"2025-05-15 04:48","pubTimestamp":1747255722,"startTime":"0","endTime":"0","summary":"Earnings Flash (BLTE) Belite Bio Q1 Loss $0.45 Vs. 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