EpiCept Corporation (NASDAQ: EPCT) on Monday announced that it received a refusal to file letter from the U.S. Food and Drug Administration (FDA) on the New Drug Application (NDA) for Ceplene(R) (histamine dihydrochloride). Ceplene(R) is EpiCept's novel therapeutic candidate for the remission maintenance and prevention of relapse of patients with acute myeloid leukemia (AML) in first remission, which was approved in the European Union in 2008 and is co-administered with low-dose interleukin-2 (IL-2). Shares of the company slumped more than 41% in pre-market action.
Cumberland Pharmaceuticals Inc. (NASDAQ: CPIX) late Friday announced the U.S. Food and Drug Administration (FDA) has extended its review of the supplemental new drug application for the use of Acetadote Injection in patients with non-acetaminophen acute liver failure. The review has been extended by three months resulting in a new Prescription Drug User Fee Act (PDUFA) goal date in December 2010. Shares of the company plunged more than 7% in pre-market action.
AVI BioPharma, Inc. (NASDAQ: AVII) on Monday announced the publication online in Nature Medicine of new preclinical data demonstrating that AVI-6002 and AVI-6003, the respective lead therapeutic candidates against Ebola and Marburg viruses, both employing AVI's advanced PMOplus chemistry, provide post exposure efficacy in non-human primates. Treatment of Ebola virus-infected primates with AVI-6002 led to 60% survival, and treatment of Marburg-infected primates with AVI-6003 conferred 100% survival, compared to control groups where both viruses were universally lethal. In addition to survival, AVI-6002 and AVI-6003 demonstrated improvements in levels of viremia, harmful inflammatory indicators and measurements of virus induced liver damage. Shares of the company rallied more than 7% in pre-market action.
Full Disclosure: None.
Cumberland Pharmaceuticals Inc. (NASDAQ: CPIX) late Friday announced the U.S. Food and Drug Administration (FDA) has extended its review of the supplemental new drug application for the use of Acetadote Injection in patients with non-acetaminophen acute liver failure. The review has been extended by three months resulting in a new Prescription Drug User Fee Act (PDUFA) goal date in December 2010. Shares of the company plunged more than 7% in pre-market action.
AVI BioPharma, Inc. (NASDAQ: AVII) on Monday announced the publication online in Nature Medicine of new preclinical data demonstrating that AVI-6002 and AVI-6003, the respective lead therapeutic candidates against Ebola and Marburg viruses, both employing AVI's advanced PMOplus chemistry, provide post exposure efficacy in non-human primates. Treatment of Ebola virus-infected primates with AVI-6002 led to 60% survival, and treatment of Marburg-infected primates with AVI-6003 conferred 100% survival, compared to control groups where both viruses were universally lethal. In addition to survival, AVI-6002 and AVI-6003 demonstrated improvements in levels of viremia, harmful inflammatory indicators and measurements of virus induced liver damage. Shares of the company rallied more than 7% in pre-market action.
Full Disclosure: None.
