US LNG exports surge but will buyers in China turn up?
CAMBRIDGE, Mass. - Amylyx Pharmaceuticals Inc. (NASDAQ: AMLX), a $434 million market cap biotech company whose stock has surged 170% over the past year, announced the initiation of a Phase 3 clinical trial for avexitide, a drug aimed at treating post-bariatric hypoglycemia (PBH). The trial, named LUCIDITY, began with the dosing of its first participant earlier this week. According to InvestingPro analysis, the company maintains a GOOD overall Financial Health Score, suggesting strong operational fundamentals.
The LUCIDITY trial will assess the efficacy and safety of avexitide in approximately 75 participants who have undergone Roux-en-Y gastric bypass surgery, a common bariatric procedure. The study will take place at around 20 sites across the United States, focusing on a primary endpoint agreed upon with the FDA: the reduction in the composite of Level 2 and Level 3 hypoglycemic events through Week 16 of treatment. Analyst consensus remains optimistic, with price targets ranging from $4 to $12 per share. Get deeper insights into AMLX’s valuation and growth potential with InvestingPro’s comprehensive research reports.
Avexitide has previously shown promise in five clinical trials, demonstrating consistent, dose-dependent effects with statistically significant reductions in hypoglycemic events. The drug has received FDA Breakthrough Therapy Designation and Orphan Drug Designation due to its potential benefits.
The LUCIDITY trial includes a 16-week double-blind treatment period, followed by an option for participants to enter a 32-week open-label extension period. This trial is informed by the positive outcomes of earlier Phase 2 trials, where avexitide was generally well-tolerated with a favorable safety profile.
PBH is a condition that affects an estimated 8% of U.S. individuals who have undergone bariatric surgery, leading to frequent and unpredictable hypoglycemic events that can severely impact quality of life. Currently, there are no approved treatments for PBH, making the development of avexitide a potentially significant advancement.
Amylyx anticipates completing recruitment for the LUCIDITY trial in 2025, with topline data expected in the first half of 2026. The company’s strong financial position, evidenced by a healthy current ratio of 6.67, supports its projection to maintain cash runway through the end of 2026, which will support the completion of the trial. Investors should note that AMLX’s next earnings report is scheduled for May 8, 2025. For comprehensive financial analysis and exclusive ProTips, visit InvestingPro, where you’ll find detailed insights into the company’s financial health and growth prospects.
The information in this article is based on a press release statement from Amylyx Pharmaceuticals.
In other recent news, Mizuho analysts have upgraded the stock rating of Amylyx Pharmaceuticals Inc. from Neutral to Outperform. This change comes alongside a significant increase in the price target from $3.00 to $7.00, suggesting a notable upside potential. The upgrade is driven by the introduction of projections for Amylyx’s avexitide, which is focused on treating post-bariatric hypoglycemia (PBH). Mizuho’s analysts have also reintegrated contributions from Amylyx’s AMX0035 for progressive supranuclear palsy (PSP) and Wolfram Syndrome (WS) into their valuation model. The firm has shifted to a discounted cash flow-based valuation methodology, reflecting a strategic change in their financial assessment. The analysts emphasized the potential of avexitide and expressed confidence in the company’s research and development pipeline. Amylyx’s focus on PBH, PSP, and WS is seen as a key factor in Mizuho’s revised outlook. These developments indicate a positive shift in expectations for Amylyx’s market potential and financial performance.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.