Amylyx Pharmaceuticals announced that AMX0318, a long‑acting glucagon‑like peptide‑1 (GLP‑1) receptor antagonist, has been named a development candidate for post‑bariatric hypoglycemia (PBH) and other rare diseases. The decision follows a research collaboration with Gubra A/S, which identified the peptide through its proprietary peptide‑drug discovery platform and triggered a $4 million milestone payment to Gubra, with the potential for more than $50 million in future development and commercialization milestones and mid‑single‑digit royalties.
The company highlighted AMX0318’s robust pre‑clinical profile, noting strong stability, solubility, potency, and favorable in‑vivo pharmacokinetics and pharmacodynamics. Amylyx plans to advance the program into investigational new drug (IND)‑enabling studies later in 2026, with an IND filing targeted for 2027, contingent on successful completion of the required studies.
Amylyx’s pipeline expansion is significant because it diversifies the company’s focus beyond its lead asset avexitide, which is in a Phase 3 LUCIDITY trial for PBH with topline data expected in Q3 2026 and a potential 2027 launch. By adding a second GLP‑1 receptor antagonist, Amylyx reinforces its rare‑disease strategy and creates a new potential revenue stream while leveraging its existing expertise in the GLP‑1 pathway.
"AMX0318 has thus far shown robust preclinical and chemical properties, including a pharmacokinetic profile that may support long‑acting administration," said Camille L. Bedrosian, MD, Chief Medical Officer. Louise S. Dalbøge, Chief Science Officer at Gubra, added, "We are pleased to see AMX0318 advance as a development candidate, a milestone that reflects both the strong collaboration between the Gubra and Amylyx teams and the capabilities of Gubra’s proprietary peptide drug discovery platform." Co‑CEOs Joshua Cohen and Justin Klee emphasized, "Given the highly significant data avexitide has generated, we are excited to further explore this known pathway and the potential of adding to our pipeline a new long‑acting GLP‑1 receptor antagonist."
Shares of Amylyx Pharmaceuticals rose more than 3 % in pre‑bell trading on January 8, 2026. The market reaction was driven by the announcement of a new development candidate that diversifies the company’s pipeline and signals progress in its rare‑disease strategy, reinforcing investor confidence in Amylyx’s ability to leverage external collaborations and expand its therapeutic portfolio.
The milestone payment and potential future royalties underscore the financial upside of the partnership with Gubra, while the planned IND studies and 2027 filing target demonstrate a clear development roadmap. Together, these elements position Amylyx to strengthen its rare‑disease pipeline, capitalize on its GLP‑1 expertise, and potentially unlock new revenue opportunities in a market with an unmet medical need.
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