SOUTH SAN FRANCISCO, Calif. (AP) -- Threshold Pharmaceuticals Inc. said Friday the Food and Drug Administration is granting orphan drug incentives to its drug TH-302 as a treatment for soft tissue sarcoma.
The FDA grants orphan drug status to drugs that treat illnesses that affect fewer than 200,000 people in the U.S. The FDA's decision means Threshold will get tax benefits and other benefits for developing TH-302 as a treatment for that disease.
If the drug is approved, it will have up to seven years of marketing exclusivity. European Union regulators granted orphan drug status to TH-302 earlier this month, giving the drug up to 10 years of exclusivity in that market.
TH-302 is the company's main drug candidate. It is in late-stage clinical testing as a treatment for soft tissue sarcoma, which is a rare cancer that affects connective tissue. Threshold is also studying the drug as a treatment for pancreatic cancer and other cancers.
Shares of Threshold rose 8 cents to $8.50 in midday trading after rising to a 52-week high of $9.07 earlier. It shares traded as low as $1.18 in mid-December.