Dimerix Soars 41% on $892M U.S. Licensing Deal with Amicus Therapeutics

Key Highlights:

• Shares surge 40.6% to $0.675 on record volume after U.S. licensing deal for DMX-200
• Amicus to pay US$30M upfront, with total deal value up to US$665M + royalties
• U.S. commercialization pathway now secured for Phase 3 kidney drug candidate
   

Dimerix Ltd (ASX: DXB) exploded higher on Wednesday, with shares jumping 40.63% to $0.675 after the company announced a transformative licensing agreement with Amicus Therapeutics (NASDAQ: FOLD) for the U.S. rights to its lead kidney disease candidate DMX-200. The deal includes a US$30 million upfront payment (~A$48 million), with total potential milestone payments reaching US$665 million (~A$1.06 billion), alongside tiered royalties on future net U.S. sales.

The agreement catapults Dimerix into the global biopharmaceutical spotlight, with investors responding in kind. More than 28.7 million shares changed hands, dwarfing the 4-week average and pushing the company’s market cap to A$377.6 million. The stock has now gained over 110% in the past year.

DMX-200, a proprietary CCR2 inhibitor, is currently in a pivotal Phase 3 trial (ACTION3) for Focal Segmental Glomerulosclerosis (FSGS), a rare and progressive kidney disorder with no approved therapies in the U.S. The licensing deal follows a successful FDA Type C meeting in March, in which the agency agreed to proteinuria reduction as the primary efficacy endpoint, aligning the trial with regulatory expectations.

Under the terms of the agreement, Dimerix will continue to run the Phase 3 trial and retain rights to commercialize DMX-200 in all other global markets. Amicus will assume all U.S. regulatory and commercial responsibilities, including future development in other indications. A joint steering committee will coordinate the U.S. strategy.

“This is a defining moment for Dimerix,” said CEO Dr. Nina Webster. “Partnering with a rare disease leader like Amicus dramatically accelerates our pathway to patients in the U.S., while validating the potential of DMX-200 as a first-in-class treatment for FSGS.”

The financial structure is equally compelling. In addition to the US$30 million upfront payment, Dimerix is eligible for:

• Up to US$75 million in development and regulatory milestones pre-approval
• US$35 million upon first commercial sale
• Up to US$410 million in commercial milestones
• Up to US$40 million for other future indications
• Royalties ranging from low-teens to low-twenties percentages
   

Amicus CEO Bradley Campbell said the deal aligns with the company’s strategic expansion into nephrology. “We are incredibly impressed by Dimerix’s scientific and regulatory execution to date, and we’re excited to bring this potentially transformative therapy to U.S. patients.”

With FSGS affecting over 40,000 Americans, and no approved treatments on the market, DMX-200 represents a high-stakes, first-mover opportunity. Analysts note that even a modest market share could yield significant returns given the orphan nature of the disease.

The ACTION3 trial is expected to fully enroll by year-end 2025, with a key blinded interim analysis planned. Dimerix’s broader pipeline includes DMX-700, in development for COPD.

As one of the most significant Australian biotech licensing deals in recent years, Dimerix’s agreement with Amicus not only unlocks capital and market access — it positions the company as a serious contender in global rare disease therapeutics.