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CLINUVEL PHARMACEUTICALS LTD

8.470

-0.710-7.73%

Volume:571.70K

Turnover:4.89M

Market Cap:425.20M

PE:12.68

High:9.100

Open:9.100

Low:8.370

Close:9.180

52wk High:13.480

52wk Low:8.350

Shares:50.20M

Float Shares:41.32M

Volume Ratio:3.70

T/O Rate:1.38%

Dividend:0.05

Dividend Rate:0.59%

EPS(TTM):0.668

EPS(LYR):0.718

ROE:13.21%

ROA:8.94%

PB:1.56

PE(LYR):11.80

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Overview Company News Filings

High Growth Tech Stocks In Australia Featuring Three Prominent Companies

Simply Wall St.

3 ASX Growth Stocks With High Insider Ownership Growing Earnings At 24%

Simply Wall St.

Clinuvel publishes investor deck outlining melanocortin drug pipeline led by Scenesse and Neuracthel

High Growth Tech Stocks in Australia for May 2026

Simply Wall St.

ASX Growth Leaders With Insider Stakes May 2026

Simply Wall St.

Clinuvel expects SEC review for Nasdaq ADR uplist to finish by June 30

Clinuvel Pharmaceuticals Updates On Level II ADR Upgrade, Nasdaq Uplist

Clinuvel Pharmaceuticals Advances Nasdaq ADR Uplisting With US SEC Review Underway

MT Newswires Live

Clinuvel Pharmaceuticals Ltd - Expects SEC Review to Complete Before End of FY2026

THOMSON REUTERS

Clinuvel Pharmaceuticals Ltd-Clinuvel Update on Level Ii Adr Upgrade, Nasdaq Uplist

THOMSON REUTERS

FDA drops Clinuvel SCENESSE postmarketing QT cardiac study requirement

BUZZ-Australia's Clinuvel Pharmaceuticals slips after Jefferies cuts target price on trial setback

BRIEF-Clinuvel Pharmaceuticals Says FDA Relaxes Scenesse Postmarketing Requirement

Clinuvel Pharmaceuticals Says FDA Removes Post-Authorization Requirement for Implant

MT Newswires Live

Clinuvel Unlikely to Seek Scenesse's Vitiligo Approval Before Phase 3 Completion, Says Jefferies

MT Newswires Live

Clinuvel Pharmaceuticals Ltd-FDA Relaxes Scenesse Postmarketing Requirement

THOMSON REUTERS

Clinuvel Pharmaceuticals Ltd - Qt Study Removed From U.S. Post-Authorization Requirements for Scenesse

THOMSON REUTERS

How Investors Are Reacting To Clinuvel Pharmaceuticals (ASX:CUV) EMA Guidance On SCENESSE Vitiligo Trial Design

Simply Wall St.

Clinuvel plans Phase III CUV107 vitiligo trial of Scenesse plus NB-UVB vs NB-UVB

BRIEF-Clinuvel Pharmaceuticals Receives Final EMA Scientific Advice For Pivotal Phase III Vitiligo Study

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In such volatile times, growth companies with high insider ownership can offer a compelling investment narrative as they often signal strong confidence from those who know the business best.","market":"nz","thumbnail":"https://images.simplywall.st/asset/industry/8041000-choice2-main-header/1585186556238","type":0,"news_type":0,"thumbnails":["https://images.simplywall.st/asset/industry/8041000-choice2-main-header/1585186556238"],"rights":{"source":"simplywall_highlight","url":"https://simplywall.st/stocks/au/software/asx-eol/energy-one-shares/news/3-asx-growth-stocks-with-high-insider-ownership-growing-earn-1","rn_cache_url":null,"directOrigin":true},"property":[],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://simplywall.st/stocks/au/software/asx-eol/energy-one-shares/news/3-asx-growth-stocks-with-high-insider-ownership-growing-earn-1","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":"simplywall_highlight","symbols":["BK7095","SPL.AU","IISV.AU","BK7508","BEAR.AU","EIGA.AU","STW.AU","BK7104","OZF.AU","SLF.AU","QRE.AU","IOZ.AU","SKS.AU","IIGF.AU","MAU.AU","GIVE.AU","VAP.AU","AR1.AU","BK7067","OZR.AU","QFN.AU","BBOZ.AU","IMLC.AU","GEAR.AU","LIN.AU","BK7016","VAS.AU","CUV.AU","ZYAU.AU","AV1.AU","DACE.AU","E200.AU","PNI.AU","EIQ.AU","BK7062","XKO.AU","BK7096","BK7017","TOR.AU","XAO.AU","BK7023","FRS.AU","XJO.AU","EOL.AU","BK7501","AEM.AU","BK7110"],"isVideo":false,"video":null,"gpt_icon":0},{"id":"2640927899","title":"Clinuvel publishes investor deck outlining melanocortin drug pipeline led by Scenesse and Neuracthel","url":"https://stock-news.laohu8.com/highlight/detail?id=2640927899","media":"Reuters","labels":["productRelease"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2640927899?lang=en_us&edition=fundamental","pubTime":"2026-06-03 09:25","pubTimestamp":1780449935,"startTime":"0","endTime":"0","summary":"Clinuvel outlined a profitable track record through Dec. 31, 2025, with zero debt, cash reserves of US$155 million, and a 3+ year cash runway.Pipeline focus remains SCENESSE , marketed for adult EPP across Europe, Switzerland, the US, Iceland, and Canada under review.Regulatory filing for SCENESSE in adolescent EPP targeted for H2 2026; topline results for the CUV105 vitiligo study also slated for H2 2026.NEURACTHEL instant is positioned for infantile spasms and multiple sclerosis, with a first European filing expected in mid 2026.VLRX-L controlled-release peptide platform flagged for preclinical results in H2 2026.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. 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In such an environment, identifying tech stocks with robust innovation and adaptability can be crucial for navigating potential volatility and capitalizing on opportunities within Australia's dynamic tech landscape.","market":"sg","thumbnail":"https://images.simplywall.st/asset/industry/6111000-choice2-main-header/1585186599552","type":0,"news_type":0,"thumbnails":["https://images.simplywall.st/asset/industry/6111000-choice2-main-header/1585186599552"],"rights":{"source":"simplywall_highlight","url":"https://simplywall.st/stocks/au/pharmaceuticals-biotech/asx-cuv/clinuvel-pharmaceuticals-shares/news/high-growth-tech-stocks-in-australia-for-may-2026","rn_cache_url":null,"directOrigin":true},"property":[],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://simplywall.st/stocks/au/pharmaceuticals-biotech/asx-cuv/clinuvel-pharmaceuticals-shares/news/high-growth-tech-stocks-in-australia-for-may-2026","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":"simplywall_highlight","symbols":["AIYY","IISV.AU","GEAR.AU","XKO.AU","ARTY","IMLC.AU","BK7067","XRO.AU","QRE.AU","BK7016","AIPO","BK4551","DACE.AU","VAS.AU","BK7503","AI","BK4543","CUV.AU","BEAR.AU","BK7508","VAP.AU","IIGF.AU","REA.AU","E200.AU","OZF.AU","AGIX","ZYAU.AU","SLF.AU","CHAT","QFN.AU","BK4528","GIVE.AU","OZR.AU","BBOZ.AU","IOZ.AU","ROE","XAO.AU","XJO.AU","EIGA.AU","BK7002","STW.AU","BK4585","BK4588","BK4023","BK4587"],"isVideo":false,"video":null,"gpt_icon":0},{"id":"2635566437","title":"ASX Growth Leaders With Insider Stakes May 2026","url":"https://stock-news.laohu8.com/highlight/detail?id=2635566437","media":"Simply Wall St.","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2635566437?lang=en_us&edition=fundamental","pubTime":"2026-05-14 03:10","pubTimestamp":1778699413,"startTime":"0","endTime":"0","summary":"As the Australian share market navigates a post-Budget environment marked by cautious spending and external pressures from U.S. inflation concerns, investors are keenly observing how these factors influence local indices. In such a climate, growth companies with high insider ownership may offer unique insights into potential resilience and alignment of interests between management and shareholders, making them noteworthy for those seeking stability amid broader market fluctuations.","market":"nz","thumbnail":"https://images.simplywall.st/asset/industry/8041000-choice2-main-header/1585186556238","type":0,"news_type":0,"thumbnails":["https://images.simplywall.st/asset/industry/8041000-choice2-main-header/1585186556238"],"rights":{"source":"simplywall_highlight","url":"https://simplywall.st/stocks/au/software/asx-eol/energy-one-shares/news/asx-growth-leaders-with-insider-stakes-may-2026","rn_cache_url":null,"directOrigin":true},"property":[],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://simplywall.st/stocks/au/software/asx-eol/energy-one-shares/news/asx-growth-leaders-with-insider-stakes-may-2026","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":"simplywall_highlight","symbols":["BK7096","PNI.AU","BK7067","AR1.AU","EIQ.AU","BK7017","AV1.AU","CUV.AU","BK7091","BK7104","BK7110","BK7095","MAU.AU","CU6.AU","BK7016","SKS.AU","SPL.AU","EOL.AU","BK7508","BK7501","AEM.AU","BK7062","TOR.AU","BK7023","PNC.AU"],"isVideo":false,"video":null,"gpt_icon":0},{"id":"2630347340","title":"Clinuvel expects SEC review for Nasdaq ADR uplist to finish by June 30","url":"https://stock-news.laohu8.com/highlight/detail?id=2630347340","media":"Reuters","labels":["corporation"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2630347340?lang=en_us&edition=fundamental","pubTime":"2026-04-28 10:17","pubTimestamp":1777342668,"startTime":"0","endTime":"0","summary":"Clinuvel continued talks on draft registration statement supporting plan to upgrade Level I ADR program to Level II on Nasdaq.Four rounds of questions received so far in review process.Nasdaq trading expected under updated ticker CUVL once review finishes.Uplist remains subject to review completion, meeting Nasdaq listing requirements.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. Clinuvel Pharmaceuticals Limited published the original content used to generate this news brief on April 28, 2026, 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:20260428:nNDL14JZpz:1","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"1","news_top_title":null,"news_tag":"corporation","news_rank":0,"length":0,"strategy_id":0,"source":null,"symbols":["BK7508","BK7067","CUV.AU"],"isVideo":false,"video":null,"gpt_icon":0},{"id":"2630342042","title":"Clinuvel Pharmaceuticals Updates On Level II ADR Upgrade, Nasdaq Uplist","url":"https://stock-news.laohu8.com/highlight/detail?id=2630342042","media":"Reuters","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2630342042?lang=en_us&edition=fundamental","pubTime":"2026-04-28 09:38","pubTimestamp":1777340318,"startTime":"0","endTime":"0","summary":"April 28 (Reuters) - Clinuvel Pharmaceuticals Ltd ::*CLINUVEL UPDATE ON LEVEL II ADR UPGRADE, NASDAQ UPLIST*CONTINUES SEC ENGAGEMENT FOR NASDAQ ADR UPLISTING*PLANS LEVEL II ADR UPGRADE AND NASDAQ LIST","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:20260428:nRSD97WR0T:1","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":null,"symbols":["BK7067","BK7508","CUV.AU"],"isVideo":false,"video":null,"gpt_icon":0},{"id":"2630449593","title":"Clinuvel Pharmaceuticals Advances Nasdaq ADR Uplisting With US SEC Review Underway","url":"https://stock-news.laohu8.com/highlight/detail?id=2630449593","media":"MT Newswires Live","labels":["corporation"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2630449593?lang=en_us&edition=fundamental","pubTime":"2026-04-28 08:57","pubTimestamp":1777337867,"startTime":"0","endTime":"0","summary":"Clinuvel Pharmaceuticals  said it is working with the US Securities and Exchange Commission  on its draft registration statement as it advances plans to uplist its American depositary receipt  program on the Nasdaq stock market, according to a Tuesday filing with the Australian bourse.The company received four rounds of US SEC comments and expects the review process to be completed before the end of the fiscal year, after which it plans to upgrade its ADR program to level two from level one and list on Nasdaq under the revised ticker \"CUVL,\" per the filing.The company stated that the uplisting is still subject to regulatory approval and Nasdaq requirements, and that its success and timing are not guaranteed, the filing added.","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://www.mtnewswires.com/","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"1","news_top_title":null,"news_tag":"corporation","news_rank":0,"length":0,"strategy_id":0,"source":"mtnewswires_news","symbols":["BK7067","BK7094","CUV.AU","ADR.AU","SEC.AU","NQmain","BK7508"],"isVideo":false,"video":null,"gpt_icon":0},{"id":"2630450183","title":"Clinuvel Pharmaceuticals Ltd - Expects SEC Review to Complete Before End of FY2026","url":"https://stock-news.laohu8.com/highlight/detail?id=2630450183","media":"THOMSON REUTERS","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2630450183?lang=en_us&edition=fundamental","pubTime":"2026-04-28 06:50","pubTimestamp":1777330252,"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:20260427:nTUE3C5RW0:4","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":["BK7508","CUV.AU","BK7067"],"isVideo":false,"video":null,"gpt_icon":0},{"id":"2630345091","title":"Clinuvel Pharmaceuticals Ltd-Clinuvel Update on Level Ii Adr Upgrade, Nasdaq Uplist","url":"https://stock-news.laohu8.com/highlight/detail?id=2630345091","media":"THOMSON REUTERS","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2630345091?lang=en_us&edition=fundamental","pubTime":"2026-04-28 06:50","pubTimestamp":1777330252,"startTime":"0","endTime":"0","summary":null,"market":"fut","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:20260427:nTUE3C5RW0:1","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":["BK7067","CUV.AU","BK7508"],"isVideo":false,"video":null,"gpt_icon":0},{"id":"2630030356","title":"FDA drops Clinuvel SCENESSE postmarketing QT cardiac study requirement","url":"https://stock-news.laohu8.com/highlight/detail?id=2630030356","media":"Reuters","labels":["policyRegulatory"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2630030356?lang=en_us&edition=fundamental","pubTime":"2026-04-27 11:42","pubTimestamp":1777261326,"startTime":"0","endTime":"0","summary":"FDA removed postmarketing requirement for Phase I cardiac repolarization QT study for Clinuvel’s SCENESSE .Decision followed FDA reviews of long-term safety data from clinical use since SCENESSE gained US marketing authorization in October 2019.Clinuvel said FDA concluded QT study would not provide useful additional safety information.SCENESSE remains only FDA-cleared drug for erythropoietic protoporphyria in adults.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. Clinuvel Pharmaceuticals Limited published the original content used to generate this news brief on April 27, 2026, and is solely responsible for the information contained therein.","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:20260427:nNDL2pJQBP: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":["BK7067","BK7508","CUV.AU"],"isVideo":false,"video":null,"gpt_icon":0},{"id":"2630554793","title":"BUZZ-Australia's Clinuvel Pharmaceuticals slips after Jefferies cuts target price on trial setback","url":"https://stock-news.laohu8.com/highlight/detail?id=2630554793","media":"Reuters","labels":["dataReport"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2630554793?lang=en_us&edition=fundamental","pubTime":"2026-04-27 10:58","pubTimestamp":1777258701,"startTime":"0","endTime":"0","summary":"BUZZ-Australia's Clinuvel Pharmaceuticals slips after Jefferies cuts target price on trial setback** Shares of Clinuvel Pharmaceuticals CUV.AX fall as much as 1.2% to A$8.93** Jefferies cuts biopharma co's PT to A$39.2 from A$40.5, maintains \"buy\" rating ** Brokerage flags regulatory snags and delays in clinical trials for vitilgo, an autoimmune disease that affects the skin; phase 3 study of treatment to begin in 2HCY26** Expects revenue from treatment in 2HFY29 from FY28 predicted earlier, cuts FY28 EPS estimate by about 45%** All seven analysts rate stock \"buy\" or higher; median PT is A$23.29 - LSEG-compiled data** YTD, stock down 27.8%","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:20260427:nL6N41A063:1","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":["BK7067","BK7508","CUV.AU"],"isVideo":false,"video":null,"gpt_icon":0},{"id":"2630215330","title":"BRIEF-Clinuvel Pharmaceuticals Says FDA Relaxes Scenesse Postmarketing Requirement","url":"https://stock-news.laohu8.com/highlight/detail?id=2630215330","media":"Reuters","labels":["policyRegulatory"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2630215330?lang=en_us&edition=fundamental","pubTime":"2026-04-27 09:22","pubTimestamp":1777252921,"startTime":"0","endTime":"0","summary":"BRIEF-Clinuvel Pharmaceuticals Says FDA Relaxes Scenesse Postmarketing RequirementApril 27  - Clinuvel Pharmaceuticals Ltd CUV.AX:FDA RELAXES SCENESSE POSTMARKETING REQUIREMENTQT STUDY REMOVED FROM U.S. POST-AUTHORIZATION REQUIREMENTS FOR SCENESSEFurther company coverage: CUV.AX ","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:20260427:nTUE5ZMBJ3:1","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":["BK7067","CUV.AU","BK7508"],"isVideo":false,"video":null,"gpt_icon":0},{"id":"2630337676","title":"Clinuvel Pharmaceuticals Says FDA Removes Post-Authorization Requirement for Implant","url":"https://stock-news.laohu8.com/highlight/detail?id=2630337676","media":"MT Newswires Live","labels":["policyRegulatory"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2630337676?lang=en_us&edition=fundamental","pubTime":"2026-04-27 08:36","pubTimestamp":1777250204,"startTime":"0","endTime":"0","summary":"Clinuvel Pharmaceuticals  said the US Food and Drug Administration  removed a requirement for a post-authorization phase one study on cardiac repolarization in relation to its Scenesse implant upon reviewing its long-term safety profile, according to a Monday filing with the Australian bourse.Scenesse is used to treat patients with erythropoietic protoporphyria, a disease that causes intolerance to light.The FDA concluded that the study was no longer needed since it would not yield valuable safety information, the filing said.","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":"1","news_top_title":null,"news_tag":"policyRegulatory","news_rank":0,"length":0,"strategy_id":0,"source":"mtnewswires_news","symbols":["BK7067","BK4588","CUV.AU","POST","BK7508","LABU","BK4212","BK4585"],"isVideo":false,"video":null,"gpt_icon":0},{"id":"2630333203","title":"Clinuvel Unlikely to Seek Scenesse's Vitiligo Approval Before Phase 3 Completion, Says Jefferies","url":"https://stock-news.laohu8.com/highlight/detail?id=2630333203","media":"MT Newswires Live","labels":["productRelease"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2630333203?lang=en_us&edition=fundamental","pubTime":"2026-04-27 08:14","pubTimestamp":1777248895,"startTime":"0","endTime":"0","summary":"Clinuvel Pharmaceuticals  is unlikely to seek regulatory approval for Scenesse in vitiligo until the Phase 3 CUV105 and CUV107 clinical trials are completed, according to a Friday Jefferies note.The company said on Friday that the European Medicines Agency  has proposed evaluating the company's Scenesse drug for the treatment of systemic vitiligo based on a \"totality of evidence\" regulatory approach.Jefferies said that the EMA's decision is a positive for the company because of the high unmet medical need for Vitiligo treatment.The investment firm has pushed back its revenue expectations from Scenesse in vitiligo, which is now expected to begin in the second half of fiscal 2029 rather than fiscal 2028.Jefferies kept a buy rating on Clinuvel and cut its price target to AU$39.20 from AU$40.50.","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":"-1","news_top_title":null,"news_tag":"productRelease","news_rank":0,"length":0,"strategy_id":0,"source":"mtnewswires_news","symbols":["CUV.AU","BK7067","BK4081","BK7129","EMA","EMA.AU","BK7508"],"isVideo":false,"video":null,"gpt_icon":0},{"id":"2630533105","title":"Clinuvel Pharmaceuticals Ltd-FDA Relaxes Scenesse Postmarketing Requirement","url":"https://stock-news.laohu8.com/highlight/detail?id=2630533105","media":"THOMSON REUTERS","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2630533105?lang=en_us&edition=fundamental","pubTime":"2026-04-27 06:42","pubTimestamp":1777243353,"startTime":"0","endTime":"0","summary":null,"market":"fut","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:20260426:nTUE5ZMBJ3:1","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":["CUV.AU","BK7067","BK7508"],"isVideo":false,"video":null,"gpt_icon":0},{"id":"2630331016","title":"Clinuvel Pharmaceuticals Ltd - Qt Study Removed From U.S. Post-Authorization Requirements for Scenesse","url":"https://stock-news.laohu8.com/highlight/detail?id=2630331016","media":"THOMSON REUTERS","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2630331016?lang=en_us&edition=fundamental","pubTime":"2026-04-27 06:42","pubTimestamp":1777243353,"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:20260426:nTUE5ZMBJ3:2","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":["BK7067","BK7508","CUV.AU"],"isVideo":false,"video":null,"gpt_icon":0},{"id":"2630980518","title":"How Investors Are Reacting To Clinuvel Pharmaceuticals (ASX:CUV) EMA Guidance On SCENESSE Vitiligo Trial Design","url":"https://stock-news.laohu8.com/highlight/detail?id=2630980518","media":"Simply Wall St.","labels":["productRelease"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2630980518?lang=en_us&edition=fundamental","pubTime":"2026-04-25 20:10","pubTimestamp":1777119025,"startTime":"0","endTime":"0","summary":"Clinuvel Pharmaceuticals recently reported that the European Medicines Agency issued final scientific advice on its planned pivotal Phase III CUV107 trial, outlining how SCENESSE (afamelanotide) will be evaluated as a systemic treatment for non-segmental vitiligo in adults and adolescents.\nThe regulator’s “totality of evidence” approach, with T-VASI50 as the primary endpoint and strong emphasis on patient-reported and photographic outcomes, underscores both the complexity and patient-centric...","market":"sg","thumbnail":"https://images.simplywall.st/asset/industry/6111000-choice2-main-header/1585186599552","type":0,"news_type":0,"thumbnails":["https://images.simplywall.st/asset/industry/6111000-choice2-main-header/1585186599552"],"rights":{"source":"simplywall_highlight","url":"https://simplywall.st/stocks/au/pharmaceuticals-biotech/asx-cuv/clinuvel-pharmaceuticals-shares/news/how-investors-are-reacting-to-clinuvel-pharmaceuticals-asxcu-1","rn_cache_url":null,"directOrigin":true},"property":[],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://simplywall.st/stocks/au/pharmaceuticals-biotech/asx-cuv/clinuvel-pharmaceuticals-shares/news/how-investors-are-reacting-to-clinuvel-pharmaceuticals-asxcu-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":"simplywall_highlight","symbols":["BK4543","AIYY","BK4587","BK4528","BK4081","AI","ARTY","BK4551","BK4211","ISBC","BK7067","CUV.AU","AGIX","BK4023","BK7508","AIPO","CHAT","EMA","BK4585","BK4588"],"isVideo":false,"video":null,"gpt_icon":0},{"id":"2629689980","title":"Clinuvel plans Phase III CUV107 vitiligo trial of Scenesse plus NB-UVB vs NB-UVB","url":"https://stock-news.laohu8.com/highlight/detail?id=2629689980","media":"Reuters","labels":["productRelease"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2629689980?lang=en_us&edition=fundamental","pubTime":"2026-04-24 11:46","pubTimestamp":1777002368,"startTime":"0","endTime":"0","summary":"Clinuvel received final European Medicines Agency scientific advice on design of pivotal Phase III CUV107 study testing SCENESSE as systemic treatment for non-segmental vitiligo.Trial results have not been presented; study is slated to start in 2H 2026.CUV107 will compare SCENESSE used with narrowband UVB therapy versus narrowband UVB alone in 300 patients.EMA signaled it will weigh overall clinical package, including patient-reported assessments, when judging whether repigmentation benefits support marketing authorization.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. Clinuvel Pharmaceuticals Limited published the original content used to generate this news brief on April 24, 2026, and is solely responsible for the information contai","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:20260424:nNDL59dwNM: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":["CUV.AU","BK7067","BK7508"],"isVideo":false,"video":null,"gpt_icon":0},{"id":"2629898305","title":"BRIEF-Clinuvel Pharmaceuticals Receives Final EMA Scientific Advice For Pivotal Phase III Vitiligo Study","url":"https://stock-news.laohu8.com/highlight/detail?id=2629898305","media":"Reuters","labels":["dataReport"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2629898305?lang=en_us&edition=fundamental","pubTime":"2026-04-24 09:29","pubTimestamp":1776994152,"startTime":"0","endTime":"0","summary":"BRIEF-Clinuvel Pharmaceuticals Receives Final EMA Scientific Advice For Pivotal Phase III Vitiligo StudyApril 24  - Clinuvel Pharmaceuticals Ltd CUV.AX:RECEIVES FINAL EMA SCIENTIFIC ADVICE FOR PIVOTAL PHASE III VITILIGO STUDYCUV107 STUDY TO COMMENCE IN 2H 2026Further company coverage: CUV.AX ","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:20260424:nFWN4161BB:1","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":["BK7508","CUV.AU","BK7067"],"isVideo":false,"video":null,"gpt_icon":0}],"pageSize":20,"totalPage":5,"pageCount":3,"totalSize":90,"code":"91000000","status":"200"}]}}