Fennec Pharmaceuticals (FENC)
Fennec Pharmaceuticals is a late clinical stage biotech company that leverages their key product, Pedmark (a proprietarily formulated sodium thiosulfate or STS) as a potential prevention of platinum-induced ototoxicity (hearing loss) in children. FENC has completed a pivotal (SIOPEL 6) trial, which met the primary endpoint demonstrating compelling efficacy and safety outcomes. The company is scheduled to discuss with the FDA with potential NDA filing in 2018, and possible approval and product launch in 2019. There are currently no approved drugs for preventing platinum-induced hearing loss in children with cancer. Hearing loss is an unresolved problem that has been managed only by reducing platinum dosing or by hearing aids or cochlear implants afterwards. Often children suffered delayed speech and language development, leading to problems in academic and social-emotional progress. Pedmark is likely to be the first drug available for preventing platinum-induced hearing loss in children if it is approved.
FENC-2018-12-20-Pedmark rolling NDA submission started
FENC-2018-03-27-Breakthrough therapy designation