Shares in CRISM Therapeutics (AIM: CRTX) rose 12% to 13.4p on Tuesday after the clinical-stage drug delivery company announced the U.S. Food and Drug Administration has granted Orphan Drug Designation to its irinotecan-ChemoSeed programme for the treatment of malignant glioma.
The designation covers all high-grade gliomas, including Grade III and IV tumours, broader than the company's original request, which was limited to glioblastoma. Glioblastoma is among the most aggressive brain cancers, with median survival typically measured in months.
Orphan Drug Designation, awarded for treatments targeting diseases affecting fewer than 200,000 people in the U.S., carries significant commercial incentives: seven years of market exclusivity on approval, tax credits for qualified clinical trials, and an exemption from FDA application fees.
The FDA milestone follows an Innovation Passport granted by the UK's MHRA under its Innovative Licensing and Access Pathway, giving CRISM regulatory footholds in two major jurisdictions as it advances a registration-grade Phase 2 trial in surgically resectable glioblastoma.
Chief Scientific Officer Professor Chris McConville said the designation enhances the programme's regulatory profile and commercial attractiveness, adding that irinotecan-ChemoSeed is now well positioned for constructive engagement with regulators as the trial progresses.