Key Highlights
- Phase 3 study showed avexitide reduced hypoglycemic episodes by 55% compared to placebo in 78 patients
- Shares climbed to $31.72, adding approximately $1.15 billion in market capitalization
- Analyst from Stifel described the data as a “best-case scenario” for investors
- Peak U.S. revenue potential estimated at $2.2 billion by TD Cowen
- Company initiated $350 million public offering to support commercialization efforts
Shares of Amylyx Pharmaceuticals experienced a dramatic rally on Tuesday, climbing over 45% following the announcement of highly successful late-stage clinical trial data for avexitide, an investigational treatment for post-bariatric hypoglycemia. The stock reached $31.72 during morning hours.
Amylyx Pharmaceuticals, Inc., AMLX
The Phase 3 study enrolled 78 participants who had previously received Roux-en-Y gastric bypass surgery. Results demonstrated that avexitide achieved a 55% reduction in hypoglycemic events versus placebo during the 16-week treatment period, successfully hitting the study’s primary endpoint.
Post-bariatric hypoglycemia represents a significant unmet medical need, with no FDA-approved therapies currently available. The condition can result in serious complications including cognitive dysfunction, fainting, and seizure activity.
James Condulis, an analyst at Stifel, characterized the efficacy data as representing a “best-case scenario,” noting that the magnitude of benefit surpassed market expectations.
“Patients want more than anything to reduce the number of hypoglycemia events so that they can live independently without the fear,” said Dr. Marilyn Tan, the study’s lead investigator.
The mechanism of action for avexitide involves antagonizing specific GLP-1 receptors located in pancreatic tissue, thereby preventing excessive insulin release and maintaining glucose homeostasis. The safety profile was favorable, with most adverse events being mild to moderate in severity, such as diarrhea and bruising.
Recovery Following Previous Setback
These positive results mark a significant turnaround for Amylyx. The biotech company faced a major blow when it withdrew Relyvrio, its ALS therapy, from commercial distribution in 2024 following disappointing confirmatory trial outcomes, resulting in workforce reductions and organizational changes.
Armed with $250 million in available capital, Amylyx indicated plans to submit a New Drug Application to U.S. regulators before year-end, with commercial availability anticipated in 2027.
Analysts at TD Cowen forecast peak domestic sales reaching $2.2 billion for the therapy. Geoffrey Meacham from Citi noted that investor focus will now turn to “filing acceptance, label breadth, and launch execution in an underrecognized market.”
The company obtained rights to avexitide through a $35.1 million acquisition from Eiger BioPharmaceuticals during a 2024 bankruptcy proceeding. Current treatment approaches for post-bariatric hypoglycemia rely primarily on diet modification, glucose monitoring, and medications that inhibit carbohydrate absorption.
Capital Raise of $350 Million Unveiled
On the same day as the trial announcement, Amylyx revealed plans for an underwritten public stock offering valued at $350 million. Underwriters were also granted a 30-day option to acquire an additional $52.5 million in shares.
The capital raised will fund pre-launch activities for avexitide, including expanding manufacturing infrastructure, advancing research initiatives, and supporting general operational needs.
The offering is being led by Leerink Partners, Morgan Stanley, Guggenheim Securities, and LifeSci Capital as joint bookrunning managers.
Completion of the offering remains contingent on market dynamics, with the company noting that there are no guarantees regarding timing or final execution.
The company’s pipeline currently includes four experimental treatments targeting endocrine disorders and neurodegenerative conditions.
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