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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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April 28, 2015
05:09 EDTMACKMerrimack completes MM-398 NDA submission to FDA
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April 27, 2015
07:04 EDTMACKMerrimack and Baxter complete submission of NDA for MM-398
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April 21, 2015
09:22 EDTMACKOn The Fly: Pre-market Movers
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08:10 EDTMACKMerrimack to present updated clinical data from Phase 1 study of MM-141
Merrimack Pharmaceuticals announced updated clinical data from a multi-arm Phase 1 study of MM-141, a bispecific antibody targeting IGF-1R and ErbB3. The data were presented in an oral session at the 2015 American Association for Cancer Research Annual Meeting in Philadelphia, PA. The trial evaluated the safety and tolerability of MM-141 as a monotherapy and in combination with everolimus or with nab-paclitaxel and gemcitabine in patients with advanced solid tumors.
06:01 EDTMACKMerrimack price target raised to $16 from $13 at Mizuho
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April 20, 2015
16:07 EDTMACKMerrimack announces final clinical results for MM-302 Phase 1 study
Merrimack Pharmaceuticals announced updated and final clinical results for the Phase 1 study of MM-302, a novel HER2-targeted liposomal doxorubicin, in HER2-positive metastatic breast cancer. Data described the safety and promising clinical activity of MM-302 in patients with advanced HER2-positive metastatic breast cancer. Results from the trial showed that the group of patients treated with 30 mg/m2 or more of MM-302 alone, in combination with trastuzumab or with trastuzumab and cyclophosphamide, had a median progression free survival, or mPFS, of 7.6 months and an overall response rate, or ORR, of 11%. Of note, 25 patients who had not been previously treated with anthracyclines had an mPFS of 11 months and an ORR of 24%. The most frequent adverse events occurring in greater than 20% of the population in this Phase 1 study were constipation, cough, decreased appetite, diarrhea, dyspnea, fatigue, nausea, neutropenia, stomatitis and vomiting. The most common Grade 3/4 adverse event was neutropenia observed in 8 patients. Six out of 69 patients 9% had protocol-defined asymptomatic declines in left ventricular ejection fraction, or LVEF. In 1 of the 6 patients, this was reported as a Grade 1 cardiac failure that was possibly related to study treatment. Merrimack is currently enrolling the HERMIONE study that is designed to support a potential application for accelerated approval in the U.S. and conditional marketing authorization in the E.U. The HERMIONE study is for HER2-positive, metastatic breast cancer patients who are anthracycline-naive and have not been previously treated with pertuzumab and T-DM1-containing regimens.
07:20 EDTMACKAmerican Association for Cancer Research to hold annual meeting
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April 14, 2015
09:17 EDTMACKMerrimack management to meet with Brean Capital
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