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On Monday, H.C. Wainwright analyst increased the price target for Amylyx Pharmaceuticals Inc. (NASDAQ:AMLX) shares from $12.00 to $16.00, while maintaining a Buy rating. Currently trading at $4.61, the stock shows significant upside potential to analyst targets ranging from $7.00 to $16.00. According to InvestingPro data, AMLX has delivered an impressive 162.7% return over the past year, despite recent market volatility. The adjustment followed the announcement on May 8 that Amylyx’s Phase 3 LUCIDITY trial for avexitide is in progress, with expected topline data in the first half of 2026. With a market capitalization of $408.5 million and an overall Financial Health score rated as "FAIR" by InvestingPro, the company appears well-positioned to advance its clinical programs.
Avexitide is being evaluated for its potential to address the severity of Post Bariatric Hypoglycemia (PBH), a condition that can have serious implications for patients who have undergone gastric bypass surgery. The firm’s research into patient experiences with PBH revealed significant challenges, including severe symptoms such as seizures and passing out, which in some cases have led patients to consider reversing the surgery.
The investigation, which involved social media patient communities, uncovered reports of symptoms like uncontrollable shaking and an inability to speak during hypoglycemic events. Some patients experienced these issues irrespective of dietary or nutritional control. The research indicated that these hypoglycemic events could happen as soon as three days post-operation or even up to a decade later, with some patients having to manage their condition with regular infusions to maintain iron levels.
The analyst noted that the PBH represents a serious unmet need among post-bariatric surgery patients, with a well-informed patient and caregiver community keenly aware of the challenges. The potential approval of avexitide could fill this significant gap in treatment options.
The reevaluation of the market for avexitide and its potential penetration led to the increased price target. Amylyx’s ongoing trial and the unmet medical need it aims to address are key factors underpinning the analyst’s optimistic outlook on the stock’s value. Based on InvestingPro’s comprehensive analysis, the stock is currently fairly valued, with a strong cash flow score of 2.77 out of 3. Investors seeking deeper insights can access the detailed Pro Research Report, which provides extensive analysis of AMLX’s market position and growth potential among 1,400+ top US stocks.
In other recent news, Amylyx Pharmaceuticals has announced positive 48-week results from its Phase 2 HELIOS trial for AMX0035, aimed at treating Wolfram syndrome. The trial data suggests stabilization or improvement in disease markers such as pancreatic function and glycemic control. This development comes as Amylyx focuses on working with the FDA for a Phase 3 trial design. Additionally, Amylyx has initiated a Phase 3 trial for avexitide, targeting post-bariatric hypoglycemia (PBH), with the LUCIDITY trial now underway. The trial will evaluate the drug’s efficacy in reducing hypoglycemic events in participants who have undergone gastric bypass surgery. In a related development, Mizuho (NYSE:MFG) analysts upgraded Amylyx’s stock rating from Neutral to Outperform, doubling the price target to $7.00. This upgrade reflects Mizuho’s positive outlook on Amylyx’s research and development pipeline, particularly for avexitide in treating PBH. These recent developments highlight Amylyx’s strategic focus on advancing its drug candidates and securing regulatory approvals.
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