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Stock Market & Financial Investment News

News Breaks
November 7, 2013
07:11 EDTMACKMerrimack pushes back top line data for NAPOLI-1 to Q2 of 2014
Merrimack now expects to report top line data for NAPOLI-1, its Phase 3 clinical trial of MM-398 in advanced pancreatic cancer, in Q2 of 2014. Merrimack previously disclosed that top line data was expected in Q4 of 2013 or Q1 of 2014. This change is based on a blinded assessment of overall survival events across the entire trial, which are occurring later than forecasted. As previously disclosed, Merrimack met its enrollment target for the trial in August 2013.
News For MACK From The Last 14 Days
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June 25, 2015
07:06 EDTMACKMerrimack's MM-398 NDA granted priority review by FDA
Merrimack (MACK) and Baxalta Incorporated, a wholly-owned subsidiary of Baxter (BAX) announced that the New Drug Application for MM-398 has been accepted for review by the FDA. Merrimack is seeking U.S. marketing approval of MM-398 for the treatment of patients with metastatic adenocarcinoma of the pancreas who have been previously treated with gemcitabine-based therapy. In addition, the FDA has classified the NDA as having Priority Review status. The FDA has set a goal of October 24 to take action under the Prescription Drug User Fee Act. The European Medicines Agency has also accepted for review a Marketing Authorization Application for MM-398 for the treatment of patients with metastatic adenocarcinoma of the pancreas who have been previously treated with gemcitabine-based therapy. The acceptance of the MAA marks the beginning of the review process in the European Union for MM-398 in this indication.

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