Amylyx Surges 16% on New Pipeline Drug, CEO Option Exercise
Shares rally as company unveils new candidate for hypoglycemia, building a franchise beyond its past ALS drug setback and signaling a strategic pivot.
Amylyx Pharmaceuticals Inc. (NASDAQ: AMLX) shares surged 15.7% on Tuesday to close at $16.55, as investors rallied behind the announcement of a new drug candidate that signals a strategic pivot for the company following last year’s high-profile setback with its ALS drug.
The rally was ignited by news of AMX0318, a novel, long-acting GLP-1 receptor antagonist being developed for post-bariatric hypoglycemia (PBH), a debilitating condition that can occur after weight-loss surgery. The announcement recasts Amylyx’s growth story, establishing a new focus on a potential franchise in rare metabolic diseases. This comes as a Co-Chief Executive Officer exercised a significant number of stock options, a move viewed as a strong signal of internal confidence in the company's new direction.
The stock’s sharp upward move, which saw it touch a 52-week high, reflects renewed investor optimism. This enthusiasm is not just for the new AMX0318 candidate; it also builds on mounting anticipation for the company’s lead asset, avexitide, which is currently in a pivotal Phase 3 trial, known as LUCIDITY, for the same indication. Amylyx expects to complete recruitment for that trial in the first quarter of 2026, with topline data expected in the third quarter of 2026.
This strategic focus on hypoglycemia marks a critical turnaround effort for Amylyx. The company faced a major challenge in 2024 when it voluntarily withdrew its approved amyotrophic lateral sclerosis (ALS) drug, Relyvrio, from the market after a large-scale clinical trial failed to confirm its effectiveness. The event erased billions in market value and forced a corporate restructuring.
Now, the company is rebuilding its pipeline. The development of AMX0318 alongside the late-stage avexitide program suggests a concerted strategy to become a leader in treating complications from bariatric surgery. Amylyx stated it plans to initiate IND-enabling studies for AMX0318 later in 2026, with a target for filing an Investigational New Drug application in 2027.
Underscoring the positive turn, Co-Chief Executive Officer Joshua B. Cohen exercised options to acquire 200,000 shares at a price of $7.57 per share. While the executive paid approximately $1.5 million to acquire the shares, the stake was valued at over $3.3 million based on Tuesday's closing price. Such insider transactions ahead of key clinical data readouts are often interpreted by the market as a bullish indicator of leadership's belief in the underlying science and commercial prospects.
Wall Street has taken note of the company’s renewed focus. Several analysts hold “Buy” or “Strong Buy” ratings on the stock. Recently, both Citigroup and Goldman Sachs raised their price targets on Amylyx to $20 per share. The consensus one-year price target sits near $20.22, suggesting further potential upside from its current level, according to data from WallStreetZen.
With a market capitalization that has climbed back to $1.57 billion, Amylyx appears to be regaining its footing. The success of the LUCIDITY trial for avexitide later this year will be the next major test for the company, potentially validating its pivot to metabolic diseases and cementing its comeback story.