Faron Pharmaceuticals Limited's (AIM:FARN) share price surged 12% in early trading after securing fast-track approval from the US Food and Drug Administration (FDA) for its lead drug candidate, bexmarilimab.
Intended to treat relapsed or refractory myelodysplastic syndrome (r/r MDS) in combination with a chemotherapy called azacitidine, the treatment delivered an overall response rate of 79% in phase II trials, with 11 of 14 patients benefiting from the regimen.
Broker Peel Hunt noted: "Fast track designation is often granted for therapies indicated for serious diseases that demonstrate the potential to address an unmet medical need.
"The designation offers the opportunity for frequent interactions with the FDA to discuss bexmarilimab’s development plan to support drug approval, as well as eligibility for rolling submission (components/data packets can be submitted as they are developed rather than waiting for a complete submission) of a new drug application."
Faron CEO Juho Jalkanen highlighted the importance of new treatment options for higher-risk MDS, noting that bexmarilimab has shown potential to overcome resistance to current therapies.
Peel Hunt, meanwhile, described bexmarilimab as a "very exciting asset on the oncology landscape".
In early trading, the stock was up 20.57p at 193.58p.