**Summary**
CRISM Therapeutics Corporation announced on March 17, 2026, that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to irinotecan for the treatment of malignant glioma, including all high-grade (Grade III and IV) gliomas. This designation is a significant regulatory and commercial milestone, providing incentives such as seven years of U.S. market exclusivity, tax credits for clinical trials, and exemption from FDA application fees. The ODD complements CRISM’s previously granted Innovation Passport for its ChemoSeed™ platform by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) under the Innovative Licensing and Access Pathway (ILAP). These designations strengthen the development and commercial potential of the irinotecan-ChemoSeed program, positioning it for streamlined global regulatory development, including potential participation in international collaborative review programs like Project Orbis. CRISM’s Chief Scientific Officer, Professor Chris McConville, highlighted the strategic importance of these achievements in advancing the company’s oncology assets to address unmet medical needs. The company remains focused on its registration-grade Phase 2 clinical trial of Irinotecan ChemoSeed for surgically resectable glioblastoma.