Shares in Faron Pharmaceuticals Limited (AIM:FARN) jumped almost 17% in early trading after receiving "very positive" feedback from the US Food & Drug Administration on the design of its phase III clinical trial for bexmarilimab, a treatment for myelodysplastic syndrome, a type of bone marrow cancer.
The FDA's feedback could streamline the development process, targeting newly diagnosed high-risk patients and eliminating the need for a separate study for resistant cases.
This guidance is part of the FDA's Project Frontrunner, which aims to expedite the delivery of promising cancer treatments.
For Faron, this means the study could address a larger patient group, lower development costs, and boost sales.
CEO Juho Jalkanen stated that researchers are now adjusting the development plan accordingly.
"This is very positive feedback and exceeds our expectations," he said.
"The FDA's proposal significantly reduces development costs and timelines to bring bexmarilimab therapy to all high-risk myelodysplastic syndrome patients.
"This feedback highlights the FDA's recognition of the urgent need for new treatments in this area. We are extremely grateful and will work hard to deliver on this recommendation."
The stock was changing hands for 115.55p, up 16.55p.