Crism Therapeutics Corporation Ord Npv (CRTX): Awarding of Orphan Drug Designation by the FDA

Crism Therapeutics Corporation Ord Npv

Awarding of Orphan Drug Designation by the FDA | Company Announcement | Investegate Fundraise Welcome About Contact Us Help Home Companies Advanced search Archive UK Short Positions Meetings UK Newswire New Login Register Awarding of Orphan Drug Designation by the FDA Summary by AI BETA Close X 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* CRISM Therapeutics Corporation 17 March 2026 &#160; The 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&#160;law by the&#160;European Union (Withdrawal) Act 2018. Upon the publication of this announcement, this inside information is now considered to be in the public domain. &#160; &#160; &#160; &#160; 17 March 2026 &#160; &#160; CRISM Therapeutics Corporation ("CRISM", "CRISM Therapeutics" or the "Company") &#160; Awarding of Orphan Drug Designation by the FDA CRISM 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. &#160; The award of ODD represents an important regulatory and commercial milestone for CRISM and strengthens the development and value proposition of the irinotecan-ChemoSeed programme. ODD 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. This U.S. regulatory milestone follows the previously granted Innovation Passport for the ChemoSeed&#8482; platform by the UK's Medicines and Healthcare products Regulatory Agency (MHRA) under the Innovative Licensing and Access Pathway (ILAP). The Company believes that this designation significantly enhances the strategic and commercial profile of the irinotecan-ChemoSeed programme. CRISM 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. Innovative oncology therapies may also be considered for international collaborative review programmes such as Project Orbis, led by the FDA, which enables participating regulators to review promising cancer treatments concurrently. While participation in such programmes is determined by regulators, CRISM believes that the regulatory designations and engagement achieved to date create a supportive framework for potential streamlined global regulatory development for irinotecan-ChemoSeed. Together, these coordinated efforts are designed to position ChemoSeed for accelerated development, regulatory review, and commercial readiness across key global markets. Professor Chris McConville , Chief Scientific Officer of CRISM Therapeutics, commented: "Receiving Orphan Drug Designation from the FDA is a strong validation of the potential of irinotecan-ChemoSeed. From a strategic perspective, this designation enhances the regulatory profile and potential commercial attractiveness of the programme and supports our strategy of advancing differentiated oncology assets that address significant unmet medical needs. When combined with our Innovation Passport and participation in the UK's ILAP programme, we believe irinotecan-ChemoSeed is well positioned for constructive regulatory engagement as we progress with our registration-grade Phase 2 clinical trial of Irinotecan ChemoSeed in surgically resectable glioblastoma.'' &#160; -Ends- &#160; &#160; &#160; &#160; Enquiries: &#160; Company Nomad and Broker Financial PR CRISM Therapeutics Corporation S.P. Angel Corporate Finance LLP Burson Buchanan Andrew Webb, CEO Chris McConville, CSO Richard Morrison Vadim Alexandre Adam Cowl Henry Harrison Topham / Jamie Hooper CRISM@buchanancomms.co.uk via Burson Buchanan +44 (0) 20 3470 0470 +44 (0) 20 7466 5000 &#160; &#160; About CRISM Therapeutics Corporation &#160; CRISM Therapeutics Corporation has developed an innovative drug delivery technology to improve the clinical performance of cancer treatments for solid tumours through the local delivery of chemotherapy drugs. &#160; ChemoSeed, CRISM's lead product, can be implanted directly into the tumour or the resection margin following the removal of a tumour. This directs that therapeutic concentrations of chemotherapy drugs reach the deep-seated tumour tissue or cover the entire resection margin. In the case of treating glioblastoma, ChemoSeeds can be implanted during surgery thereby bypassing the blood brain barrier, which prevents other treatments from being able to reach the tumour and be effective. &#160; For more information please visit: https://www.crismtherapeutics.com/ &#160; The Company's LEI is 213800XFW6MKVCHHPW88. &#160; This information is provided by RNS, the news service of the London Stock Exchange. RNS is approved by the Financial Conduct Authority to act as a Primary Information Provider in the United Kingdom. Terms and conditions relating to the use and distribution of this information may apply. For further information, please contact rns@lseg.com or visit www.rns.com . RNS may use your IP address to confirm compliance with the terms and conditions, to analyse how you engage with the information contained in this communication, and to share such analysis on an anonymised basis with others as part of our commercial services. For further information about how RNS and the London Stock Exchange use the personal data you provide us, please see our Privacy Policy . &#160; END &#160; &#160; AI Summary Disclaimer BETA &times; The content you are viewing has been generated or assisted by artificial intelligence (AI). While efforts are made to ensure accuracy and clarity, AI-generated text may contain inaccuracies, outdated information, or subjective interpretations. This content is intended for general informational purposes only and should not be considered professional advice or factual confirmation. We encourage you to independently verify any information provided, especially if it will be relied upon for making decisions or taking action. Any reliance you place on this material is strictly at your own risk. 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