Successful Launch of RYTELO
RYTELO achieved $28.2 million in net product revenue in its first full quarter of U.S. sales, exceeding expectations and coming from 388 ordering centers.
Strong Intellectual Property Position
Geron's IP position and FDA's orphan drug exclusivity are expected to provide exclusivity in the U.S. through August 2037.
Financial Transactions Secured
Completed a synthetic royalty transaction and a debt financing transaction, generating $250 million in gross proceeds to support future growth.
Positive Initial Real-World Data
Real-world experience with RYTELO is consistent with clinical trials, with physicians managing cytopenia effectively.
Potential for EU Expansion
CHMP review of RYTELO marketing authorization for lower-risk MDS in Europe could be completed in late 2024 or early 2025, with a potential launch in select EU markets by 2026.