Amylyx shares hit three-year high as Avexitide clears phase 3 hurdles

Amylyx Pharmaceuticals shares surged 63.84 per cent on Tuesday to reach a three-year high, closing at $35.11 after intraday trading peaked at $35.39. The sharp rally followed the release of positive phase 3 clinical trial results for Avexitide, a drug candidate designed to treat post-bariatric hypoglycemia (PBH). The data provided a significant validation for the company’s lead asset, which had previously received Breakthrough Therapy Designation from the US Food and Drug Administration (FDA).

In the pivotal study, Avexitide demonstrated a 55 per cent reduction in moderate-to-severe low-blood-sugar episodes among 78 enrolled participants compared with a placebo. The drug candidate also met all secondary endpoints, showing consistent and clinically meaningful reductions in level 2 and level 3 hypoglycemic events. Amylyx’s Chief Medical Officer, Camille Bedrosian, described the results as a major milestone that addresses a critical treatment gap for the PBH community.

The therapeutic landscape for PBH remains largely empty, as the chronic metabolic condition is estimated to affect approximately 8 per cent of people in the US with no currently FDA-approved therapies. This unmet medical need positions Avexitide to build a commercial franchise around a relatively underserved patient population, assuming regulatory approval. The company noted that minor side effects recorded during the trial included diarrhea, erythema, and bruising at the injection site.

Amylyx is moving with urgency to submit a new drug application to the FDA by the end of the year, targeting commercialisation in 2027. The company also plans to present the clinical trial data at an upcoming medical meeting. This timeline follows a period of uncertainty for the firm, which previously experienced a weak phase 3 study for its former ALS asset, Relyvrio.

Investment firms responded quickly to the data, with several raising their price targets. HC Wainwright was the most bullish, lifting its target to $55 from $34 while maintaining a buy recommendation. Stifel increased its target to $45 from $21, reaffirming its buy stance, while Mizuho raised its target to $42 from $30 and designated Amylyx a top pick for 2026.

Hedge fund sentiment has also shifted, with 34 funds holding positions in the stock in the first quarter. Although the number of holders decreased from 40 in the previous quarter, combined holdings increased by 16.45 per cent to $567 million. Analysts now face the question of whether the stock offers further upside after the market has largely priced in the successful clinical trial.