Amylyx signs two manufacturing deals to secure avexitide drug substance supply

Amylyx Pharmaceuticals disclosed in an 8-K that on September 8, 2026, it entered into a Manufacturing and Supply Agreement with Bachem Americas, Inc. and on September 1, 2026, it entered into a term sheet with Polypeptide Group AG, under which Bachem and Polypeptide will manufacture and supply the company's long-term supply requirements of avexitide drug substance for commercial use, if approved.¹ Both Bachem and Polypeptide will act as non-exclusive suppliers, and Amylyx may still procure supplies from other manufacturers.¹

Under the Bachem agreement, Amylyx has agreed to purchase a minimum annual quantity of avexitide drug substance beginning in 2028 at an applicable supply price.¹ The company will provide periodic supply estimates to Bachem, part of which will be binding, and the supply price will be adjusted annually each January 1 to reflect cost changes such as labor, utilities and overhead.¹ The agreement runs for an initial five-year term with automatic three-year renewals unless terminated earlier.¹ Either party can terminate for material breach or insolvency, and Amylyx can also terminate following certain regulatory actions.¹

Separately, the Polypeptide term sheet calls for a definitive agreement to follow, and Amylyx will pay a $30 million upfront fee to Polypeptide for capacity reservation and related commitments.¹ The parties have agreed that beginning in 2028 Amylyx will purchase a minimum annual quantity of avexitide drug substance, provide periodic supply forecasts (part of which will be binding), and use fixed volume-based pricing subject to annual adjustment.¹

Full contract texts are expected to be filed as exhibits to Amylyx's 10-Q for the quarter ending September 30, 2026.¹