Amylyx Pharmaceuticals Announces Nomination of AMX0318 as a Novel, Long-Acting GLP-1 Receptor Antagonist Development Candidate, Identified in Collaboration with Gubra A/S

Key Terms

glucagon-like peptide-1 (GLP-1) receptor antagonist medical

A glucagon-like peptide-1 (GLP-1) receptor antagonist is a medicine that blocks the cell receptor that normally responds to the GLP-1 hormone, reducing signals that tell the body to release insulin and suppress appetite. For investors, these drugs matter because they can alter the competitive landscape and sales potential in diabetes and weight-management markets, while raising regulatory, safety and reimbursement questions that affect a company’s commercial prospects.

post-bariatric hypoglycemia (PBH) medical

Post-bariatric hypoglycemia (PBH) is a condition where people who have had weight-loss surgery experience episodes of dangerously low blood sugar, often a few hours after eating. Think of it like the body's fuel system overreacting after a major engine upgrade, causing sugar to drop too far; symptoms can include dizziness, sweating, confusion, or fainting. Investors should care because PBH drives demand for medical follow-up, diagnostics, new therapies, and can influence regulatory scrutiny, reimbursement decisions, and market opportunities in diabetes and surgical aftercare.

pharmacokinetic medical

Pharmacokinetic describes how a drug moves through and leaves the body — how it is absorbed, spread to tissues, broken down and excreted — like tracking a package from pickup to delivery and disposal. For investors, these properties determine effective dose, safety risks, how often a medicine must be taken, and how reliably it works, which in turn influence clinical trial success, regulatory approval chances, production complexity and a drug’s commercial value.

pharmacodynamics medical

Pharmacodynamics is how a drug actually affects the body — the strength, type and duration of its effects and the relationship between dose and response. Think of it like how turning a thermostat changes room temperature: it shows what the drug does and how much is needed to get the desired effect. Investors care because these properties drive clinical success, dosing convenience, safety profile and competitive advantage, all of which influence commercial potential and regulatory approval.

investigational new drug (IND) regulatory

An investigational new drug (IND) is a drug or biologic that is being tested but has not yet been approved for general use; it is the application and formal status that allows a company to begin human clinical trials under regulator oversight. Investors care because an IND marks the transition from lab work to human testing — like getting a permit to run real-world experiments — which creates important milestones, costs, timelines and regulatory risk that drive a development-stage company's value.

IND-enabling studies regulatory

Ind-enabling studies are early research efforts that test whether a new drug or treatment is safe and effective enough to move forward in development. They are like preliminary tests to ensure a product works as intended before investing more resources into large-scale trials. For investors, these studies are important because successful results can signal potential progress toward bringing a new product to market, impacting its future value.

Phase 3 medical

Phase 3 is the late-stage clinical testing step for a new drug or medical treatment, where the product is given to large groups of patients to confirm effectiveness, monitor side effects, and compare it to standard care. Successful Phase 3 results are often the final scientific hurdle before regulators decide on approval and market launch—like passing a final exam before graduation—and can sharply change a company's valuation and future revenue prospects.

• AMX0318 selected as development candidate after meeting key criteria, demonstrating a robust chemical stability profile, strong in vitro potency, evidence of in vivo efficacy and tolerability, high solubility, and a favorable pharmacokinetic profile consistent with a long-acting peptide
  
  
  
  
• IND-enabling studies expected to initiate in 2026 with an IND targeted for 2027, pending successful completion of IND-enabling studies

CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Amylyx Pharmaceuticals, Inc. (NASDAQ: AMLX) (“Amylyx” or the “Company”) today announced the selection of AMX0318, a long-acting glucagon-like peptide-1 (GLP-1) receptor antagonist, as a development candidate for post-bariatric hypoglycemia (PBH) and other rare diseases. AMX0318 was identified through a research collaboration with Gubra A/S (“Gubra”), a company specializing in peptide-based drug discovery and preclinical contract research services.

“We are very pleased to nominate AMX0318 as a development candidate and were highly impressed by Gubra’s proprietary and innovative process, which identified a peptide that surpassed our research target profile for a long-acting GLP-1 receptor antagonist. 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 at Amylyx. “We are excited about the opportunity to develop additional therapeutic possibilities for people who may benefit from inhibiting GLP-1 receptor activity, including people with PBH and other rare diseases. The GLP-1 receptor is a well-characterized biological target and one of the key regulators of glucose-insulin homeostasis.”

Dr. Bedrosian continued, “We have strong conviction that inhibiting GLP-1 receptor activity represents an important therapeutic approach given the statistically significant data that avexitide, our investigational, first-in-class GLP-1 receptor antagonist, has generated to date. We continue to expect completion of recruitment in our pivotal Phase 3 LUCIDITY trial of avexitide in Q1 2026, with topline data expected in Q3 2026.”

AMX0318 has completed extensive preclinical evaluation, including stability, solubility, potency, in vivo pharmacokinetics and pharmacodynamics, and in vivo tolerability studies. Amylyx expects the program to advance into investigational new drug (IND)-enabling studies later this year, with an IND targeted for 2027, pending successful completion of IND-enabling studies.

“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,” said Louise S. Dalbøge, Chief Science Officer at Gubra. “Our AI-driven streaMLine platform enables multi-parameter optimization of peptide candidates, and we are excited to see this applied successfully to AMX0318 in close collaboration with Amylyx.”

Under the terms of the research collaboration, Gubra is eligible to receive more than $50 million in success-based development and commercialization milestones plus mid-single digit royalties on worldwide net sales. The selection and handover of the development candidate will provide milestone payments of $4 million to Gubra.

About Gubra

Gubra, founded in 2008 in Denmark and listed on NASDAQ Copenhagen, is a disease-agnostic techbio company specialized in peptide-based drug discovery and preclinical contract research services. Gubra’s activities are focused on the early stages of drug development and are organized in two main business units – Biotech (D&P) and CRO services. The two business areas are highly synergistic and create a unique entity capable of generating a steady cash flow from the CRO business while investing in high-impact biotech R&D projects with significant value inflection potential through partnerships. Gubra has around 300 employees and had revenue of DKK 2.6 billion (around EUR 350 million) in the first 9 months of 2025. See www.gubra.dk for more information.

About Amylyx Pharmaceuticals

At Amylyx, our mission is to usher in a new era of treating diseases with high unmet needs. Where others see challenges, we see opportunities that we pursue with urgency, rigorous science, and unwavering commitment to the communities we serve. We are currently focused on four investigational therapies across several neurodegenerative and endocrine diseases in which we believe they can make the greatest impact. For more information, visit amylyx.com and follow us on LinkedIn and X. For investors, please visit investors.amylyx.com.

Amylyx Forward-Looking Statements

Statements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Such statements include, but are not limited to, Amylyx’ expectations regarding: the therapeutic potential for AMX0318, the expected timeline for the IND-enabling studies and IND submission for AMX0318, the payments and royalties to be received by Gubra, and the expected timeline for certain development, regulatory, and commercial milestones. Any forward-looking statements in this press release are based on management’s current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. Risks that contribute to the uncertain nature of the forward-looking statements include: the success, cost, and timing of Amylyx’ program development activities; Amylyx’ ability to execute on its regulatory development plans and expectations regarding the timing of results from its planned data announcements and initiation of clinical studies; the risk that early-stage results may not reflect later-stage results; Amylyx’ ability to fund operations, and the impact that global macroeconomic uncertainty, geopolitical instability, and public health events will have on Amylyx’ operations, as well as the risks and uncertainties set forth in Amylyx’ United States Securities and Exchange Commission (SEC) filings, including Amylyx’ Annual Report on Form 10-K for the year ended December 31, 2024 and subsequent filings with the SEC. All forward-looking statements contained in this press release speak only as of the date on which they were made. Amylyx undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law.

View source version on businesswire.com: https://www.businesswire.com/news/home/20260108102624/en/

Gubra Media

Sofia Pitt Boserup

+45 4188 9586

sbo@gubra.dk



Gubra Investors

Kristian Borbos

+45 3080 8035

kbo@gubra.dk



Emma Jappe Lange

+45 5361 6755

ejl@gubra.dk



Amylyx Media

Amylyx Media Team

(857) 320-6191

amylyxmediateam@amylyx.com



Amylyx Investors

Lindsey Allen

(857) 320-6244

Investors@amylyx.com

 

Source: Amylyx Pharmaceuticals, Inc.