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Awarding of Orphan Drug Designation by the FDA
CRISM Therapeutics Corporation has received Orphan Drug Designation from the U.S. Food and Drug Administration for irinotecan in the treatment of malignant glioma, a designation that offers seven years of U.S. market exclusivity upon approval, tax credits for clinical trials, and fee exemptions. This regulatory milestone, following the UK's Innovation Passport for the ChemoSeed platform, significantly enhances the strategic and commercial profile of the irinotecan-ChemoSeed program, positioning it for coordinated regulatory interaction across major jurisdictions as the Phase 2 clinical trial progresses. Disclaimer*
About this update from Crism Therapeutics Corporation
[{"type":"text","content":"\n\nThe information contained within this announcement is deemed to constitute inside information as stipulated under the Market Abuse Regulation (EU) No. 596/2014, as incorporated into UK law by the European Union (Withdrawal) Act 2018. Upon the publication of this announcement, this inside information is now considered to be in the public domain.\n \n \n \n \n17 March 2026\n \n\n \nCRISM Therapeutics Corporation\n(\"CRISM\", \"CRISM Therapeutics\" or the \"Company\")\n \nAwarding of Orphan Drug Designation by the FDA\nCRISM Therapeutics Corporation (AIM: CRTX), a UK clinical-stage drug delivery company focused on the localised and sustained delivery of chemotherapy drugs, today is pleased to announce that the U.S. Food and Drug Administration (\"FDA\") has granted Orphan Drug Designation (\"ODD\") to irinotecan for the treatment of malignant glioma, which is broader than the original designation request for glioblastoma (a Grade IV glioma) and includes all high grade (Grade III and IV) gliomas. \nThe award of ODD represents an important regulatory and commercial milestone for CRISM and strengthens the development and value proposition of the irinotecan-ChemoSeed programme.\nODD is granted by the FDA to encourage the development of treatments for rare diseases affecting fewer than 200,000 people in the U.S. The designation provides certain incentives, including a potential seven years of U.S. market exclusivity upon product approval, tax credits for qualified clinical trials, and an exemption from FDA application fees.\nThis U.S. regulatory milestone follows the previously granted Innovation Passport for the ChemoSeed™ platform by the UK's Medicines and Healthcare products Regulatory Agency (MHRA) under the Innovative Licensing and Access Pathway (ILAP).\nThe Company believes that this designation significantly enhances the strategic and commercial profile of the irinotecan-ChemoSeed programme.\nCRISM believes that the combination of ILAP participation in the UK and ODD in the United States places irinotecan-ChemoSeed in a strong position for coordinated regulatory interaction across major jurisdictions as the registration-grade Phase 2 clinical trial of Irinotecan ChemoSeed in surgically resectable glioblastoma progresses.\nInnovative oncology therapies may also be considered ...