Cloudbreak Pharma Receives FDA Clearance to Begin Phase 2 Trials for CBT-199

Reuters

Feb 16

Cloudbreak Pharma Receives FDA Clearance to Begin Phase 2 Trials for CBT-199

Cloudbreak Pharma Inc. announced that its wholly-owned subsidiary, ADS Therapeutics LLC, has received confirmation from the U.S. Food and Drug Administration (FDA) that its Investigational New Drug $(IND)$ application for CBT-199, a potential ophthalmic treatment for presbyopia, has become effective. The FDA did not issue any clinical hold, allowing the clinical trial to proceed. This regulatory development authorizes Cloudbreak Pharma Inc. to initiate Phase 2 clinical trials of CBT-199 in the United States. The company stated that it will continue to monitor the evaluation process and provide updates as appropriate.

Disclaimer: This news brief was created by Public Technologies (PUBT) 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. Cloudbreak Pharma Inc. published the original content used to generate this news brief via IIS, the Issuer Information Service operated by the Hong Kong Stock Exchange (HKex) (Ref. ID: HKEX-EPS-20260216-12025824), on February 16, 2026, and is solely responsible for the information contained therein.

Disclaimer: Investing carries risk. This is not financial advice. The above content should not be regarded as an offer, recommendation, or solicitation on acquiring or disposing of any financial products, any associated discussions, comments, or posts by author or other users should not be considered as such either. It is solely for general information purpose only, which does not consider your own investment objectives, financial situations or needs. TTM assumes no responsibility or warranty for the accuracy and completeness of the information, investors should do their own research and may seek professional advice before investing.

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ID: HKEX-EPS-20260216-12025824), on February 16, 2026, and is solely responsible for the information contained therein.</span></i>\n</p>\n</div></body></html>\n\n</article>\n</div>\n</body>\n</html>\n","isBrief":false,"type":0,"news_type":1,"symbol":"BK1161","symbol_name":"生物科技","start_time":0,"source_url":"https://api.refinitiv.com/data/news/v1/stories/urn:newsml:reuters.com:20260216:nNDL6X8gVL:1","article_id":"2611080211","we_media_id":"1032215980","thumbnails":[],"rights":null,"url":"https://stock-news.laohu8.com/highlight/detail?id=2611080211","pubTimestamp":1771216490,"columns":[],"sourceInfo":null,"weMediaInfo":{"media_name":"Reuters","introduction":"Reuters.com brings you the latest news from around the world, covering breaking news in markets, business, politics, entertainment and technology","home_visible":1,"id":"1032215980","head_image":"https://community-static.tradeup.com/news/4567337cbdf294b657b1fa87c5488b48"},"summary":"Cloudbreak Pharma Inc. announced that its wholly-owned subsidiary, ADS Therapeutics LLC, has received confirmation from the U.S. Food and Drug Administration  that its Investigational New Drug  application for CBT-199, a potential ophthalmic treatment for presbyopia, has become effective. The FDA did not issue any clinical hold, allowing the clinical trial to proceed. This regulatory development authorizes Cloudbreak Pharma Inc. to initiate Phase 2 clinical trials of CBT-199 in the United States. The company stated that it will continue to monitor the evaluation process and provide updates as appropriate.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. Cloudbreak Pharma Inc. published the original content used to generate this news brie","collect":0,"end_time":0,"defaultTopTitle":"","property":[],"viewcount":null,"language":"en","relate_stocks":{"BK1161":"生物科技","02592":"拨康视云-B"},"translate_title":"Cloudbreak Pharma获得FDA批准开始CBT-199的2期试验","themeId":null,"isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"02592":0.9},"content_text":"Cloudbreak Pharma Receives FDA Clearance to Begin Phase 2 Trials for CBT-199\n    \n\n        Cloudbreak Pharma Inc. announced that its wholly-owned subsidiary, ADS Therapeutics LLC, has received confirmation from the U.S. Food and Drug Administration (FDA) that its Investigational New Drug $(IND)$ application for CBT-199, a potential ophthalmic treatment for presbyopia, has become effective. The FDA did not issue any clinical hold, allowing the clinical trial to proceed. This regulatory development authorizes Cloudbreak Pharma Inc. to initiate Phase 2 clinical trials of CBT-199 in the United States. 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