Amylyx Pharmaceuticals Inc. shares climbed to a fresh three-year high on Tuesday, reaching an intraday peak of $35.39 before closing at $35.11, representing a gain of 63.84 percent for the session. The rally followed positive phase 3 clinical trial results for Avexitide, the company’s investigational treatment for post-bariatric hypoglycemia, a chronic metabolic condition affecting approximately 8 percent of the U.S. population.
In the clinical study involving 78 participants, Avexitide successfully reduced moderate-to-severe low-blood-sugar episodes by 55 percent compared with placebo. The drug candidate met all secondary endpoints, demonstrating significant reductions in level 2 and level 3 hypoglycemic events as measured through both self-monitoring and continuous glucose monitoring. The most commonly reported adverse effects included diarrhea and minor injection site reactions involving erythema and bruising.
Amylyx indicated plans to submit a new drug application to the Food and Drug Administration by year-end, targeting commercialization of Avexitide in 2027. The company previously received Breakthrough Therapy Designation from the FDA for the treatment. Clinical trial data is scheduled for presentation at an upcoming medical conference.
Three investment firms elevated their price targets and maintained buy or outperform ratings following the results. HC Wainwright raised its price target to $55 from $34, Stifel increased its target to $45 from $21, and Mizuho lifted its target to $42 from $30. Mizuho characterized the trial outcome as a significant company milestone, particularly following earlier disappointment with the phase 3 study of Relyvrio, the company’s former ALS asset.
Hedge fund positioning in Amylyx showed mixed signals in recent quarters. Data indicated 34 hedge funds held positions in the stock during the most recent quarter, down from 40 previously, though their combined holdings increased 16.45 percent quarter-over-quarter to $567 million from $486.9 million. Currently, no FDA-approved therapies exist for post-bariatric hypoglycemia, potentially providing Avexitide with substantial commercial opportunity in an underserved patient population.
Article Attribution | Read More at Article Source
Article summary produced by Claude AI