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Biotech Pharma Crism Therapeutics

Crism Therapeutics shares rose after FDA Orphan Drug Designation

The AIM-listed biotech reported a full-year loss of £1.9 million for 2025, with post-period milestones including FDA Orphan Drug Designation and nearly £1 million in non-dilutive grant awards setting the stage for first patient dosing.

by tickstock newsroom
The image shows a series of clear test tubes arranged closely together, with a pipette dispensing a purple liquid into one of the tubes. The setting suggests a laboratory environment focused on scientific experimentation. — Credit: Photo by Louis Reed on Unsplash c Photo by Louis Reed on Unsplash

Crism Therapeutics Corporation (AIM:CRTX) Crism Therapeutics shares rose 5.0% to 10.5p after the company disclosed FDA Orphan Drug Designation for its irinotecan-ChemoSeed programme and an £896,088 Innovate UK Biomedical Catalyst grant.

Cash stood at £1.13 million at year end against total assets of £1.79 million, with the company having raised approximately £4.7 million through equity placings and retail offers between June 2025 and June 2026 to fund trial setup and initial patient dosing.

The headline regulatory achievement of the period was MHRA Clinical Trial Authorisation, received in August 2025, clearing Crism to begin an open-label, registration-grade Phase 2 study of irinotecan-ChemoSeed in surgically resectable glioblastoma.

Since the period end, the company secured FDA Orphan Drug Designation for the same programme in March 2026, unlocking potential seven-year US market exclusivity, tax credits and fee waivers, and received a £896,088 Innovate UK Biomedical Catalyst grant covering 70% of Part 1 trial costs, alongside a £99,902 Invest Northern Ireland grant for its docetaxel-ChemoSeed prostate cancer programme.

A Site Initiation Visit for the Phase 2 trial is planned for late July 2026, with first patient dosing targeted as soon as practicable thereafter.

"Securing MHRA authorisation to initiate our Phase 2 clinical trial was a key milestone, providing validation that ChemoSeed is ready to be evaluated as a potential new standard of care for glioblastoma patients," said Executive Chairman Andrew Webb.

by tickstock newsroom

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