Shares of Threshold Pharmaceuticals jumped about 10% this morning on news that the FDA is granting fast-track status to TH-302, the company's sole therapy now in a pair of late-stage cancer studies.
Th-302--partnered with Merck KGaA in a $525 million deal--has had a long history of ups and downs in the clinic. The drug is designed to be triggered in oxygen-starved solid tumors, a characteristic of many hematologic al malignancies. A couple of years ago the drug fell short on an all-important endpoint for overall survival (it hit the mark on progression-free survival) and just weeks ago the company disappointed investors with the news that its Phase III study for soft tissue sarcoma would have to go past the interim analysis and all the way to final analysis.
Fast-track status can be a boon, offering a faster review for a drug--though that doesn't always play out as hoped for among the biotechs which win this distinction. Right now Threshold says its final analysis on soft tissue sarcoma will be in the first quarter of 2016. The drug is also in Phase III for pancreatic cancer.
While Threshold--which holds co-marketing rights in the U.S. - has just about everything riding on TH-302, Merck KGaA has quite a bit invested in the program as well. After its cancer vaccine foundered in an ill-fated attempt to revive its faded prospects, TH-302 has been spotlighted as one of its top late-stage therapies.
That's not a sign of strength. South San Francisco-based Threshold has a market cap of about $195 million.
"We are pleased that FDA has granted fast track status for TH-302 for the treatment of previously untreated patients with metastatic or locally advanced unresectable soft tissue sarcoma," said Threshold CEO Barry Selick. "Our ongoing Phase III trial of TH-302 in these patients is being conducted under a Special Protocol Assessment with the FDA. If successful, the fast track designation may provide an added benefit of facilitating the NDA review process. Currently, we anticipate the primary analysis of overall survival of the Phase III trial to be conducted in the first quarter of 2016."
- here's the release