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.

Published Reports

FENC-2018-12-20-Pedmark rolling NDA submission started
FENC-2018-11-14-3Q18
FENC-2018-11-13-Mgmt update
FENC-2018-09-17-Mgmt update
FENC-2018-08-13-2Q18
FENC-2018-08-08-PIP Accepted
FENC-2018-05-15-1Q18
FENC-2018-03-27-Breakthrough therapy designation
FENC-2018-03-27-4Q17
FENC-2017-11-29-Initiation-Final