Shares of Fennec Pharmaceuticals Inc. FENC, -0.37% were indicated up over 12% in premarket trade Tuesday, after the specialty pharmaceutical company said its PEDMARK to prevent cisplatin ototoxicity in pediatric patients with liver cancer was granted a "breakthrough therapy" designation by the Food and Drug Administration. Breakthrough therapy designation is given when there is preliminary clinical evidence that a treatment represents substantial improvement over available therapies, and includes fast-track program features. "his designation is another significant milestone for the advancement of PEDMARK, as we work closely with the Agency to expedite the NDA filing," said Fennec Chief Executive Rosty Raykov. The stock had rocketed more than four-fold (311%) over the past 12 months through Monday, while the S&P 500 SPX, +2.72% has gained 13.5%.