Faron Pharmaceuticals Limited (AIM:FARN) hailed as a 'significant milestone' backing from a regulator for its cancer treatment, bexmarilimab.
The European Medicines Agency (EMA) issued a positive opinion recommending "orphan drug" status for the drug, used to treat myelodysplastic syndrome (MDS), a rare blood cancer.
Orphan drug status is important because it offers benefits that help speed up drug development and commercialisation.
These include exclusive market access in Europe once approved, along with financial incentives like fee reductions and extra support during trials.
Bexmarilimab already had a boost from US regulators, who fast-tracked its review last August.
The EMA's backing adds another layer of support, showing confidence in the drug's effectiveness against MDS.
Faron expects to report crucial trial results in April. These results could set the stage for getting bexmarilimab approved and onto the market. It's a significant step forward for the company and patients needing new treatment options.
Faron's chief medical officer, Dr Petri Bono, said: "Receiving positive opinion on orphan drug designation for bexmarilimab for the treatment of myelodysplastic syndrome (MDS) in combination with azacitidine marks a significant milestone for Faron Pharmaceuticals as we continue to develop bexmarilimab for MDS and other cancers."
The EMA reviewed interim results from the bexmarilimab Phase I/II BEXMAB MDS trial, showing a median overall survival of 13.4 months - much longer than the 5-6 months reported in earlier studies.