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8-K//Current report

Amylyx Pharmaceuticals, Inc. 8-K

Accession 0001193125-26-006991

$AMLXCIK 0001658551operating

Filed

Jan 7, 7:00 PM ET

Accepted

Jan 8, 7:03 AM ET

Size

20.5 MB

Accession

0001193125-26-006991

Research Summary

AI-generated summary of this filing

Updated

Amylyx Pharmaceuticals Announces AMX0318 Development Candidate Selection

What Happened

  • On January 8, 2026 Amylyx Pharmaceuticals (AMLX) filed a Form 8-K disclosing two items: an updated corporate presentation (Regulation FD disclosure, Exhibit 99.1) and the selection of AMX0318, a long‑acting GLP‑1 receptor antagonist, as a development candidate for post‑bariatric hypoglycemia and other rare diseases.
  • AMX0318 was discovered through a research collaboration with Gubra A/S. The candidate handover triggers a $4.0 million milestone payment to Gubra, and under the collaboration Gubra is eligible for more than $50 million in success‑based development and commercialization milestones plus mid‑single‑digit royalties on worldwide net sales.

Key Details

  • Filing date: January 8, 2026 (Form 8‑K).
  • Development candidate: AMX0318 — long‑acting GLP‑1 receptor antagonist for post‑bariatric hypoglycemia and other rare diseases.
  • Collaboration terms noted: $4.0M immediate milestone payment to Gubra upon handover; Gubra eligible for >$50M in future milestones and mid‑single‑digit royalties.
  • Exhibit filed: 99.1 — updated corporate presentation furnished with the 8‑K.

Why It Matters

  • This advances Amylyx’s early‑stage pipeline by adding a new development candidate for a rare metabolic complication (post‑bariatric hypoglycemia), which could expand the company’s therapeutic focus beyond its existing programs.
  • The agreement creates near‑term contractual cash obligations (the $4M payment) and potential future milestone and royalty liabilities tied to AMX0318’s development and commercialization — important for investors monitoring R&D spend and future revenue sharing.
  • The furnished corporate presentation (Reg FD) may contain additional strategic or program updates for investors; review Exhibit 99.1 for more context.

Documents

53 files

Issuer

Amylyx Pharmaceuticals, Inc.

CIK 0001658551

Entity typeoperating
IncorporatedDE

Related Parties

1
  • filerCIK 0001658551

Filing Metadata

Form type
8-K
Filed
Jan 7, 7:00 PM ET
Accepted
Jan 8, 7:03 AM ET
Size
20.5 MB