Tue, May 12, 7:53 AM
- Threshold Pharmaceuticals (NASDAQ:THLD) announces that the FDA has designated evofosfamide, in combination with gemcitabine, for Fast Track review for treatment-naive patients with metastatic or locally advanced unresectable pancreatic cancer. This is the second Fast Track tag for the drug candidate. In November 2014 the FDA granted it for the treatment, in combination with doxorubicin, of advanced soft tissue sarcoma.
- Evofosfamide (TH-302) is an investigational hypoxia-activated prodrug which is activated under tumor hypoxic (low oxygen) conditions which typify many cancers. Low oxygen levels in solid tumors are due to insufficient blood supply as a result of abnormal vasculature.
- Threshold has a global license and co-development agreement for evofosfamide with Merck KGaA (OTCPK:MKGAF) (OTCPK:MKGAY), which includes an option for Threshold to co-commercialize it in the U.S.
- Fast Track status provides for more frequent interactions with the FDA review team and a rolling review of the New Drug Application (NDA).
- THLD is up 17% premarket on robust volume.
Sep. 25, 2013, 7:35 AM
- Oncothyreon (ONTY) surges 29% after saying that Merck KGa (MKGAF.PK) intends to carry out a Phase III trial of Oncothyreon's tecemotide immunotherapy in patients with advanced non-small cell lung cancer.
- While tecemotide failed to meet the primary goal of a previous trial of improving survival in the overall patient population, the drug did achieve survival times 30.8 months vs 20.6 months for a placebo in a sub-group. (PR)
Aug. 7, 2013, 9:09 AM
- The rumor mill is abuzz: Comments from Merck KGaA (MKGAF.PK) regarding a 2-3% market share loss (transcript) for the MS treatment Rebif at the hands of Biogen's Tecfidera are fueling speculation that the German drug and materials company may heighten its focus on Tcelna, a treatment for Secondary Progressive MS being developed in conjunction with Opexa Therapeutics (OPXA).
- Shares of OPXA are now up 57% before the bell.
Dec. 19, 2012, 8:39 AMStimuvax, a lung cancer vaccine that Germany's Merck (MKGAF.PK) has licensed from Oncothyreon (ONTY), failed to improve overall survival in a Phase III study. However, "notable treatment effects were observed in certain subgroups of patients." That's not enough to convince analysts: "Despite potential positive effects in subgroups, we consider the drug dead," says Deutsche Bank. Oncothyreon collapses 61%, while Merck is -2.9% in Frankfurt. (PR) | Comment!
Oct. 16, 2012, 9:01 AM
Mar. 6, 2012, 6:52 AM
Feb. 3, 2012, 7:39 AM
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Merck KGaA is a global pharmaceutical, chemical and life science company with a history that began in 1668 and a future shaped by approximately 40,000 employees in 67 countries. Merck KGaA's subsidiaries in North America operate using the umbrella brand "EMD".
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