Faron Pharmaceuticals Limited (AIM:FARN) has received what it described as "very positive" feedback from the US Food and Drug Administration on the design of the Phase III clinical trial for its lead asset.
This feedback could significantly streamline the development process.
Bexmarilimab has been designed to treat myelodysplastic syndrome, a type of cancer affecting bone marrow.
The FDA acknowledged the challenges of running a comparative study in patients whose disease has returned or is resistant to treatment.
Instead, it proposed a phase III evaluation for newly diagnosed high-risk patients. This means Faron will not need a separate study for patients whose disease has returned or is resistant.
This guidance is part of the FDA's Project Frontrunner, an initiative that aims to bring promising cancer treatments to patients faster.
For Faron, it means the proposed study could target a larger group of patients, reduce development costs and, ultimately, increase sales.
Chief executive, Dr Juho Jalkanen, said the company's researchers were now adjusting the development plan "accordingly".
"This is very positive feedback and exceeds our expectations," he added.
"The FDA's proposal significantly reduces development costs and timelines to bring bexmarilimab therapy to all HR MDS patients.
"This feedback underlines that the FDA sees the high unmet need in HR MDS, a condition for which new treatment options are urgently needed.
"The FDA's proposal has provided Faron with clear guidance on the path to approval that will confirm the highly encouraging results bexmarilimab has already obtained in overcoming resistance to azacitidine. We are extremely grateful for this feedback and will work hard to deliver on this recommendation."