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Solvonis Achieves Key FDA Milestone with AWKN-002 for AUD Treatment

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Solvonis Achieves Key FDA Milestone with AWKN-002 for AUD Treatment

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Graft Polymer (UK) PLC ( (GB:SVNS) ) just unveiled an update.

Solvonis Therapeutics plc announced a significant regulatory milestone for AWKN-002, a drug candidate developed by Awakn Life Sciences Corp., which Solvonis plans to acquire. The FDA has endorsed the progression of AWKN-002 to Phase 2b clinical trials for treating alcohol use disorder (AUD) in the U.S. without the need for additional clinical data. This approval under the 505(b)(2) NDA pathway allows for a streamlined regulatory process, potentially accelerating market access. This development is crucial for Solvonis and Awakn, as AWKN-002 demonstrates potential as a breakthrough treatment for AUD, addressing a condition with a high prevalence and low treatment success rate. It also strengthens Solvonis’ positioning in the mental health and substance use disorder treatment market.

More about Graft Polymer (UK) PLC

Solvonis Therapeutics plc is an innovative biotechnology company focused on developing intellectual property related to the treatment of mental health and substance use disorders. It co-develops therapeutics for mental health disorders, with an initial focus on trauma-related mental health conditions, such as PTSD. Solvonis aims to improve outcomes for individuals suffering from these disorders, addressing significant unmet needs in the market.

YTD Price Performance: -9.76%

Average Trading Volume: 24,351,962

Technical Sentiment Consensus Rating: Buy

Current Market Cap: £4.25M

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