Biotechnology company Amylyx Pharmaceuticals (AMLX) achieved positive results in the Phase 3 clinical trial of its core investigational drug avexitide, effectively addressing a long-standing treatment gap in the field of PBH. On Tuesday local time, Amylyx Pharmaceuticals shares rose sharply by 63.84%. This followed the company’s announcement of positive clinical trial results for its investigational glucagon-like peptide-1 (GLP-1) receptor antagonist avexitide.
In the United States, approximately 160,000 people have undergone the two most common weight-loss surgeries—sleeve gastrectomy and Roux-en-Y gastric bypass (RYGB)—and about 8% of these patients develop chronic hypoglycemia, known as postprandial hypoglycemia (PBH). PBH can cause serious medical issues, including cognitive dysfunction, impaired physical function, loss of consciousness, and seizures. However, the U.S. Food and Drug Administration (FDA) has not yet approved any therapy for PBH. The medical community believes that an overactive GLP-1 response in the body after eating, leading to a rapid drop in blood sugar, is the primary driver of PBH.
Avexitide achieved its primary endpoint in a Phase 3 clinical study involving PBH participants who had undergone RYGB surgery. Data showed that avexitide reduced the incidence of severe hypoglycemic events by 55% compared to placebo. Importantly, avexitide was generally well-tolerated, with no treatment-related serious adverse events reported.
Amylyx Chief Medical Officer Camille Bedrosian stated: “Today’s results are an important milestone, demonstrating that avexitide has the potential to fill a critical treatment gap for the PBH patient population, and represent a meaningful step forward for people living with this condition.”
Amylyx plans to submit a New Drug Application (NDA) to the FDA by the end of this year.
According to Form 4 filings submitted to the U.S. Securities and Exchange Commission (SEC), on January 15 and 16, 2026, Amylyx Pharmaceuticals co-Chief Executive Officer Joshua B Cohen exercised options for 200,000 shares of stock and sold 138,167 shares on the open market, with a total transaction value of approximately $1.9 million. It should be noted that these sales were conducted to cover option costs and tax obligations associated with the new shares, and therefore do not represent discretionary selling decisions made by Cohen on those two days.
Previously, Amylyx had erased all its gains following its initial public offering (IPO) in 2022, but delivered a strong performance in 2025, with a full-year increase of approximately 223%. The company’s drug candidates developed to date have continued to make progress, particularly its flagship therapy AMX0035 (also known as RELYVRIO). This product is designed to help patients with amyotrophic lateral sclerosis (ALS) and has been shown to effectively slow disease progression and extend patient survival.
