Amylyx Pharmaceuticals stock jumped roughly 21% in pre-market trading on Tuesday after the company announced that avexitide, its investigational GLP-1 receptor antagonist, succeeded in a late-stage clinical trial. The stock hit a pre-market price of $26.76, clearing its prior 52-week high of $24.60.
Amylyx Pharmaceuticals, Inc., AMLX
The Phase 3 LUCIDITY trial was a 16-week, multicenter, randomized, double-blind, placebo-controlled study enrolling 78 participants. It was designed to test avexitide in patients with post-bariatric hypoglycemia, a condition that causes dangerous drops in blood sugar after eating, often appearing years after weight-loss surgery.
$AMLX PHASE 3 TRIAL HITS PRIMARY ENDPOINT
Amylyx said avexitide reduced Level 2 and Level 3 hypoglycemic events by 55% versus placebo in its Phase 3 LUCIDITY trial for post-bariatric hypoglycemia, with p=0.000003.
The trial also met all secondary endpoints and showed no…
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The trial hit its primary endpoint, which had been agreed upon with regulators in advance. Patients taking avexitide had 55% fewer severe hypoglycemic events than those on placebo.
The drug also cleared every secondary benchmark. That includes results from both self-monitored fingerstick testing and continuous glucose monitoring.
Avexitide works differently from GLP-1 drugs like Wegovy and Zepbound. Rather than mimicking the GLP-1 hormone to lower blood sugar, it blocks GLP-1 receptors on the pancreas, stopping the hormone from over-signaling after meals.
Mizuho raised its price target on AMLX to $30 from $24 ahead of the readout, keeping its Outperform rating. The firm also named the stock a top 2026 pick and estimated a potential move of $10 to $15 higher from prior levels if the Phase 3 came back positive.
Avexitide carries both FDA Breakthrough Therapy Designation and Orphan Drug Designation, which could support a faster path to regulatory approval.
Amylyx said early NDA-readiness preparations are already underway. A potential commercial launch is targeted for 2027.
The move came on a rough day for the broader market. The Nasdaq fell 1.2% and the S&P 500 slipped 0.5% in pre-market trading. The biotech sector also faced headwinds on the day.
Amylyx hosted a senior management conference call at 8:00 a.m. ET on Tuesday to discuss the trial findings.
The company had previously guided for a broader Q3 2026 timeline for the data release. Tuesday’s announcement pulled that forward.
AMLX’s pre-market price of $26.76 pushed the stock well above its previous 52-week high of $24.60.
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