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Amylyx shares surge to three-year high on Avexitide phase 3 data
The company’s phase 3 results showed Avexitide cut moderate-to-severe low-blood-sugar episodes by 55% in 78 participants, and Amylyx plans to file with the FDA by year end.
Amylyx Pharmaceuticals (NASDAQ:AMLX) jumped to a fresh three-year high Tuesday after phase 3 results for its treatment candidate Avexitide for post-bariatric hypoglycemia showed strong efficacy, moving the company closer to commercialization.
According to Yahoo Finance, Avexitide reduced moderate-to-severe low-blood-sugar episodes by 55% versus placebo in a study of 78 enrolled participants, and it met all secondary endpoints, including statistically significant reductions in level 2 and level 3 hypoglycemic events measured through self-monitoring of blood glucose and continuous glucose monitoring.
The report also said the trial’s only minor side effects included diarrhea, along with erythema and bruising at the injection site. Amylyx Chief Medical Officer Camille Bedrosian called the results a major milestone and said they support the candidate’s potential to address a treatment gap.
In line with the data, Amylyx said it is moving with urgency to submit a new drug application for Avexitide to the FDA by the end of the year, targeting commercialization in 2027. The article added that the FDA previously granted Avexitide Breakthrough Therapy Designation, and that three investment firms raised price targets following the results.
Latest closeSugar $16.60 ▼1.3%|Nasdaq Comp. 26,729.16 ▼0.3%