Amylyx Pharmaceuticals stock surged more than 45% on Tuesday after its experimental drug avexitide sharply reduced dangerous low blood sugar episodes in a late-stage clinical trial. AMLX rose to $31.72 in morning trading.
Amylyx Pharmaceuticals, Inc., AMLX
The 78-patient trial tested avexitide in patients who had undergone Roux-en-Y gastric bypass surgery. The drug reduced hypoglycemic episodes by 55% compared to placebo over 16 weeks, meeting the trial’s main goal.
There are currently no approved treatments for post-bariatric hypoglycemia, a condition that can cause cognitive impairment, loss of consciousness, or seizures.
Stifel analyst James Condulis called the reduction a “best-case scenario,” saying the result came in better than investors had expected.
“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.
Avexitide works by blocking certain GLP-1 receptors in the pancreas to reduce excess insulin secretion and stabilize blood glucose levels. Side effects were mild to moderate, including diarrhea and bruising.
The trial result is a major comeback story for Amylyx. The company was forced to pull its ALS drug Relyvrio from the market in 2024 after a late-stage trial failure, which led to layoffs and a corporate restructuring.
With $250 million in cash on hand, Amylyx said it is moving quickly toward a U.S. marketing application by year-end, targeting a commercial launch in 2027.
TD Cowen analysts projected peak U.S. sales of $2.2 billion for avexitide. Citi analyst Geoffrey Meacham said attention now shifts to “filing acceptance, label breadth, and launch execution in an underrecognized market.”
Amylyx acquired avexitide from Eiger BioPharmaceuticals for $35.1 million in 2024 during Eiger’s bankruptcy auction. The condition is typically managed through dietary changes, blood sugar monitoring, and carbohydrate-blocking medications.
Later on Tuesday, Amylyx announced a $350 million underwritten public stock offering. The company also gave underwriters a 30-day option to purchase up to an additional $52.5 million worth of stock.
Proceeds will go toward pre-commercial activities for avexitide, including securing additional manufacturing capacity, research and development, and general corporate purposes.
Leerink Partners, Morgan Stanley, Guggenheim Securities, and LifeSci Capital are serving as joint bookrunning managers for the offering.
The offering is subject to market conditions, and the company stated there is no assurance as to whether or when it may be completed.
Amylyx is currently focused on four investigational therapies across endocrine conditions and neurodegenerative diseases.
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