Faron Pharmaceuticals Limited (AIM:FARN, OTC:FPHAF) is a ‘buy’ up to 524p, according to Peel Hunt in a note reacting to positive feedback from the US regulator following the completion of early-stage trials of the drug discovery group’s promising putative cancer treatment.
“Management commented that these trial data lay the groundwork for multiple routes to market and we believe this is an important milestone for the company, with Faron now able to reflect – with any future interaction with pharma – that their asset and plans align with FDA [Food & Drug Administration] thinking,” the broker told investors.
Earlier, Faron said it received positive feedback and a green light from the FDA for further trials of cancer drug bexmarilimab as a monotherapy for solid tumours.
"FDA's feedback on the MATINS study gives Faron an excellent roadmap to plot out bexmarilimab's future strategy," said Marie-Louise Fjällskog, the company’s chief medical officer.
In a statement, Faron said the FDA had made its indication following a review of the initial data from the MATINS trial and had agreed with the company’s dose escalation plans.
The phase I/II MATINS trial is investigating bexmarilimab, an immunotherapy drug, in multiple cancer indications.
FDA feedback concluded that the completed toxicology studies are adequate to support further clinical development of single-agent bexmarilimab into a registration trial.
That selection of 1 mg/kg IV Q3W as dose for further evaluation appears reasonable, although additional data are required to establish the recommended phase II/III dose for specific cancer(s).
The FDA also gave guidance about the further development of a simple, validated staining assay to identify patients with CLEVER-1 positive tumours for clinical trial inclusion.
"We are pleased to have received these positive and supportive FDA recommendations for the continued clinical development of bexmarilimab as a monotherapy in solid tumours," said CEO Markku Jalkanen.
Faron had previously announced a meeting with the agency would occur this quarter.
The shares, up 31% in the past year, ended a busy session off 5p at 307.5p.