Fennec drops 9% after delaying new drug application for Pedmark
Shares of Fennec Pharmaceutical are trading lower after the company delayed the submission of its new drug application for Pedmark to late 2019 or early 2020. Pedmark is a water-soluble thiol compound that has the potential to prevent chemotherapy-induced hearing loss. Fennec said earlier today in its earnings release, "In December 2018, following a pre-submission meeting with the FDA, Fennec initiated a rolling New Drug Application for PEDMARK in patients 1 month to less than 18 years of age with localized, non-metastatic, solid tumors. The NDA submission process is currently well underway. The Company has notified the FDA that the drug substance manufacturer for PEDMARK was recently acquired requiring a site transition for the commercial manufacturing site. The new facility of the acquiring company has large scale commercial capabilities and a proven and extensive track record of successful FDA inspections and product launches. As such, full submission is targeted for late 2019 to early 2020. If approved, Fennec expects a first commercial launch for PEDMARK in the second half of 2020." In its previous earnings release on November 13, the company said, "We will continue to advance our regulatory submissions with a targeted US approval in the second half of 2019." Shares of Fennec are down 9%, or 64c, to $6.21 in midday trading.