NEW YORK (TheStreet) -- Threshold Pharmaceuticals (THLD) shares are up 9.3% to $4.11 in trading on Tuesday after the Food and Drug Administration granted its development partner Merck (MRK) fast track status for the two companies' experimental pancreatic cancer treatment, evofosfamide.
This is the second time evofosfamide has received fast track designation. Threshold was granted fast track in November of last year as part of a therapy supplemented with doxorubicin for the treatment of advanced soft tissue sarcoma.
"We are pleased that evofosfamide has been granted Fast Track status for the treatment of patients living with pancreatic cancer," said Threshold CEO Barry Selick, Ph.D. "Evofosfamide is currently being studied in two pivotal Phase 3 clinical trials: one in patients with advanced soft tissue sarcoma and the other in patients with advanced pancreatic cancer. Based on current projections, we expect that the number of protocol-specified events for the pivotal Phase 3 trials of evofosfamide may be reached in the second half of 2015, with the results of the primary efficacy analyses to be available shortly thereafter."
"Many patients with pancreatic cancer present with advanced, inoperable tumors, and there are limited treatment options currently available for them. The Fast Track designation for evofosfamide in pancreatic cancer, which is currently being studied in the MAESTRO Phase 3 study, will help to facilitate the timely development of this high-priority program for Merck," said Merck's Head of Global Research and Development for the biopharmaceutical business, Luciano Rossetti.
TheStreet Ratings team rates THRESHOLD PHARMACEUTICALS as a Sell with a ratings score of E+. TheStreet Ratings Team has this to say about their recommendation: