Amylyx Pharmaceuticals Inc. announced on January 8 the nomination of AMX0318 as its newest development candidate. The novel, long-acting glucagon-like peptide-1 receptor antagonist was identified through a strategic collaboration with Gubra A/S and is designed to treat post-bariatric hypoglycemia and other rare diseases.
The development of AMX0318 utilized Gubra's proprietary streaMLine platform, an AI-driven technology used to optimize peptide candidates. Amylyx plans to initiate IND-enabling studies for AMX0318 later in 2026, with a target of filing an IND application in 2027.
This new program complements Amylyx's existing lead candidate, avexitide, which is currently being evaluated in the pivotal Phase 3 LUCIDITY trial for PBH. The company expects to finish recruitment for the LUCIDITY trial in Q1 2026 and anticipates a topline data readout in Q3 2026.
Earlier on December 19, Bank of America lowered the firm's price target on Amylyx to $15 from $16, while keeping a Buy rating on the shares. Following Amylyx's Q3 2025 earnings report, the firm highlighted that recent financing secured the company's cash runway through 2028.
BofA noted that the stock's primary catalyst remains the Phase 3 LUCIDITY trial for avexitide. Data from this pivotal study, which targets post-bariatric hypoglycemia, is expected in Q3 2026.