Diamyd is Getting Ready for the U.S. Market
Swedish Diamyd presented its annual report today, outlining its plans for a fast-tracked entry into the U.S. market. With insights from San Francisco-based board member Karin Rosén and FDA approval on the horizon, the company is seizing a pivotal launch opportunity for its diabetes treatment.
Diamyd received FDA fast-track designation for its lead therapy in early 2024, significantly accelerating its pathway to the U.S. market. At an online analyst meeting, Karin Rosén highlighted the strategic importance of the U.S. market.
“The fast-track approval process offers a rare and valuable advantage for Diamyd, and early discussions with U.S. insurers indicate potential pricing between $190,000 and $240,000 per patient,” she said.
Diamyd will now start providing information about the medicine to doctors and families.
“We need to engage with key players in the healthcare system, secure support among prescribers, and position Diamyd effectively within the U.S. market,” Karin Rosén said.
Karin Rosén, a seasoned biotech executive with more than 20 years of experience in the U.S. market and leadership roles at Horizon Therapeutics, GlaxoSmithKline, Aimmune Therapeutics, and Genentech, joined Diamyd’s board in March 2023.
Diamyd’s lead therapy, Diamyd, is currently in Phase 3 trials targeting Type 1 diabetes. The treatment, based on antigen-specific immunotherapy, aims to preserve insulin-producing beta cells in newly diagnosed patients—a novel approach that could fill a gap, as no approved therapies currently exist for early-stage Type 1 diabetes.
CEO Ulf Hannelius reported promising interim Phase 3 results and noted that FDA accelerated approval could allow Diamyd to reach the U.S. market one year earlier than anticipated.
“This strong momentum means we are now entering an intensive period of preparation for potential market approval,” Hannelius said.
Diamyd closed the financial year with approximately $12.1 million in cash, which had strengthened to about $14.4 million by mid-November through milestone payments and warrant redemptions. The company anticipates increased activity and costs in the coming year as it finalizes preparations for market entry, which may mean a need for additional financing in the coming year.