On Friday, H.C. Wainwright maintained a positive outlook on Amylyx Pharmaceuticals Inc. (NASDAQ: AMLX), reiterating a Buy rating and a $12.00 price target. The firm's endorsement follows Amylyx's recent disclosure of their Phase 3 trial design for avexitide, named Lucidity, which aligns with the company’s previous commitment to unveil the trial details during the third quarter of this year.
Amylyx's meticulous design for the Phase 3 trial is anticipated to achieve statistical significance, building on the success of the Prevent and Phase 2b trials.
As there are currently no approved drugs for post-bariatric hypoglycemia, and considering the effectiveness of bariatric surgeries as obesity treatments, avexitide has the potential to significantly influence future strategies for treating post-bariatric hypoglycemia (PBH) and potentially other severe hypoglycemic conditions.
For deeper insights into Amylyx's financial health, growth prospects, and comprehensive analysis, investors can access the detailed Pro Research Report available exclusively on InvestingPro. For deeper insights into Amylyx's financial health, growth prospects, and comprehensive analysis, investors can access the detailed Pro Research Report available exclusively on InvestingPro.
The primary endpoint for the Phase 3 trial is a composite of level 2 and 3 hypoglycemia, underpinned by results from both the Prevent and Phase 2b trials that demonstrated avexitide’s ability to substantially decrease all three levels of hypoglycemic events. The multicenter study will employ a continuous glucose monitor (CGM) system, similar to previous trials, to ensure accurate data collection and patient compliance.
Amylyx's meticulous design for the Phase 3 trial is anticipated to achieve statistical significance, building on the success of the Prevent and Phase 2b trials.
As there are currently no approved drugs for post-bariatric hypoglycemia, and considering the effectiveness of bariatric surgeries as obesity treatments, avexitide has the potential to significantly influence future strategies for treating post-bariatric hypoglycemia (PBH) and potentially other severe hypoglycemic conditions.
In other recent news, Amylyx Pharmaceuticals has been in the spotlight for its acquisition of avexitide from Eiger BioPharmaceuticals, a drug set to enter a crucial Phase 3 study for post-bariatric hypoglycemia (PBH) in early 2025. Goldman Sachs (NYSE:GS) maintained a Neutral rating on Amylyx, noting the potential of avexitide to benefit PBH patients, with top-line data expected in 2026. However, this comes amid ongoing discussions about the market opportunity for Amylyx within PBH due to the rarity and unclear prevalence of the condition.
Baird analyst Joel Beatty, on the other hand, upgraded Amylyx's rating from Neutral to Outperform, reflecting optimism about avexitide's market potential. The firm anticipates sales of $815 million by 2033 if the drug is approved, estimating a 60% probability of avexitide's approval.
In their Third Quarter 2024 Earnings Conference Call, Amylyx reported a net loss of $72.7 million, largely due to R&D and SG&A expenses. Despite this, the company maintains a strong financial standing with $234.4 million in cash and investments. These recent developments indicate Amylyx's continued focus on treatments for neurodegenerative diseases and endocrine conditions, with a projected cash runway into 2026 to support its pipeline development.
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