Fennec Pharmaceuticals Granted Fast Track Designation From FDA

3/25/18

Fennec Pharmaceuticals Inc., a specialty drug company, announced it has been granted fast track designation for its signature drug by the U.S. Food and Drug Administration.

Fast track designation will allow for the company, which is currently pursuing FDA approval for a drug, to expedite the review process and receive closer collaboration with the administration. The designation is a big step for any drug undergoing the approval process, which often can take years at a time.

Fennec’s signature drug is Pedmark, a formulation of sodium thiosulfate. The company’s intended use for the drug is to prevent the risk of hearing loss that can result during the treatment of hepatoblastoma, a cancerous tumor that begins in the liver and primarily affects children from infancy to age three.

No drug in the U.S. has received FDA approval for this treatment. Rosty Raykov, president and CEO of Fennec, saw this as a factor in Pedmark’s fast track designation.

“We believe the receipt of fast track designation from the FDA highlights the serious nature of hearing loss that patients have following cisplatin chemotherapy and the current lack of safe and effective treatments,” Raykov said in a pstatement

Fennec’s shares closed at $14.10 Friday, up 1.9 percent from the previous day. That number is the highest the company’s shares have reached since October 2017, despite the NASDAQ as a whole dropping over 2.4 percent for the day.

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