REG - CRISM Therapeutics - Awarding of Orphan Drug Designation by the FDA

CRISM TherapeuticsAnnouncement

17/03/2026 07:00

For best results when printing this announcement, please click on link below:
https://newsfile.refinitiv.com/getnewsfile/v1/story?guid=urn:newsml:reuters.com:20260317:nRSQ8471Wa&default-theme=true

RNS Number : 8471W  CRISM Therapeutics Corporation  17 March 2026

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 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.

 

 

 

 

17 March 2026

 

 

CRISM Therapeutics Corporation

("CRISM", "CRISM Therapeutics" or the "Company")

 

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.

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™ 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.''

 

-Ends-

 

 

 

 

Enquiries:

 

 Company                         Nomad and Broker                  Financial PR
 CRISM Therapeutics Corporation  S.P. Angel Corporate Finance LLP  Burson Buchanan
 Andrew Webb, CEO                Richard Morrison                  Henry Harrison Topham / Jamie Hooper

 Chris McConville, CSO           Vadim Alexandre                   CRISM@buchanancomms.co.uk

                                 Adam Cowl
 via Burson Buchanan             +44 (0) 20 3470 0470              +44 (0) 20 7466 5000

 

 

About CRISM Therapeutics Corporation

 

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.

 

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.

 

For more information please visit: https://www.crismtherapeutics.com/
(https://www.crismtherapeutics.com/)

 

The Company's LEI is 213800XFW6MKVCHHPW88.

 

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 (mailto:rns@lseg.com)
 or visit
www.rns.com (http://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 (https://www.lseg.com/privacy-and-cookie-policy)
.   END  MSCFLFLDVDIRLIR



            Copyright 2019 Regulatory News Service, all rights reserved