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News Breaks
March 26, 2013
11:40 EDTZIOP, THLDThreshold higher after Ziopharm terminates STS drug development
Threshold Pharmaceuticals (THLD) shares are trading higher today after rival cancer drug discovery company Ziopharm (ZIOP) terminated its development of palifosfamide. WHAT'S NEW: Earlier today, Ziopharm announced that its Phase 3 trial of palifosfamide for the treatment of metastatic soft tissue sarcoma, or STS, in the first-line setting did not meet its primary endpoint of progression-free survival. Like Ziopharm, Threshold focuses on the discovery and development of cancer therapeutics and is also in the process of evaluating a drug to treat patients with soft tissue sarcoma with its development of TH-302. WHAT'S NOTABLE: Threshold's TH-302 is currently under evaluation in two Phase 3 trials: one in combination with doxorubicin versus doxorubicin alone in patients with soft tissue sarcoma and the other in combination with gemcitabine versus gemcitabine and placebo in patients with advanced pancreatic cancer. Both Phase 3 trials are being conducted under a Special Protocol Assessment agreement with the U.S. Food and Drug Administration. TODAY'S PRICE ACTION: Shares of Threshold Pharmaceuticals are up 11c, or 2.3% to $4.90 in late morning trading. Meanwhile, shares of Ziopharm, which were downgraded by at least four analyst firms after its announcement, plunged 62% to $1.94.
News For THLD;ZIOP From The Last 14 Days
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November 17, 2014
07:05 EDTTHLDThreshold Pharmaceuticals announces TH-302, bevacizumab Phase 1/2 interim data
Threshold Pharmaceuticals announced interim data from a U.S. investigator-sponsored Phase 1/2 clinical trial of the investigational anticancer drug TH-302 in combination with bevacizumab for the treatment of glioblastoma, or GBM, the most lethal form of brain cancer. All patients in the study had previously progressed on single-agent bevacizumab, the only FDA-approved therapy for GBM patients with progressive disease following prior therapy. As reported by the investigator, in a total of 22 evaluable patients, best responses included one complete response and three partial responses for a response rate of 18%, and ten stable disease assessments for a clinical benefit rate of 64%; eight patients had progressive disease. Median progression-free survival was 2.8 months, and median overall survival was 4.6 months. In addition, the FDA, through its Office of Orphan Product Development, recently awarded Dr. Brenner a grant for a Phase 2 clinical trial of TH-302 for the treatment of GBM. His is one of 15 grants the FDA awarded in 2014 in order to boost the development of medical device, drug, and biological products for patients with rare diseases. According to the FDA, the grants are for clinical studies on safety and/or effectiveness of products that could either result in, or substantially contribute to, approval of the products.
November 13, 2014
07:10 EDTTHLDSociety for NeuroOncology to hold a meeting
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November 12, 2014
08:13 EDTZIOPBoston Biotech to hold a conference
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November 11, 2014
07:07 EDTTHLDThreshold Pharmaceuticals receives FDA fast track designation for TH-302
Threshold Pharmaceuticals announced that the FDA granted Fast Track designation for TH-302, an investigational anticancer drug, for the treatment of previously untreated patients with metastatic or locally advanced unresectable soft tissue sarcoma, or STS. The FDA established the Fast Track designation process to facilitate the development and expedite the review of drugs intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs. An important feature of Fast Track is that the FDA may consider a "rolling review" of completed sections of the New Drug Application before the complete application is submitted.

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