SMALL CAP MOVERS: Faron Pharma boosted by US FDA green light By Ian Lyall At Proactive Investors For Thisismoney.co.uk Updated: 06:29 EDT, 12 July 2024 e-mail View comments Faron Pharmaceuticals was one of the week’s significant gainers, with its stock rising by 35 per cent.
This surge was driven by positive news from an unexpected source—the US Food & Drug Administration (FDA). The FDA has effectively simplified and potentially fast-tracked a phase III clinical trial of Faron’s lead drug, Bexmarilimab, which is designed to treat myelodysplastic syndrome, a type of cancer affecting bone marrow. The FDA has effectively simplified and potentially fast-tracked a phase III clinical trial of Faron’s lead drug, Bexmarilimab, The FDA acknowledged the challenges of running a comparative trial in patients whose disease has returned or is resistant to treatment.
Instead, it proposed a phase III evaluation for newly diagnosed high-risk patients, eliminating the need for a separate study for patients with relapsed or refractory disease. This guidance is part of the FDA's Project Frontrunner, an initiative aimed at accelerating the delivery of promising cancer treatments to patients. For Faron, this means the proposed study could target a larger patient group, reduce development costs, and ultimately increase sales.
This development is likely to attract interest from major pharmaceutical companies, which often partner with and finance smaller companies like Faron to develop promis.