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News Breaks
December 10, 2012
09:06 EDTMACKMerrimack announces positive clinical data for agent to treat breast cancer
Merrimack announced Phase I clinical trial results for MM-302, the company's agent for the treatment of advanced HER2 positive breast cancer. The findings demonstrated preliminary safety and tolerability.
News For MACK From The Last 14 Days
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May 5, 2015
08:14 EDTMACKMerrimack begins Phase 2 clinical trial of MM-141
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May 4, 2015
10:03 EDTMACKMerrimack, Baxter announce filing of MAA for MM-398 with EMA
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09:04 EDTMACKBaxter, Merrimack announce filing for European approval of MM-398
Baxter International (BAX) and Merrimack Pharmaceuticals (MACK) jointly announced that Baxter has submitted a marketing authorization application to the European Medicines Agency (EMA) for approval of MM-398, also known as ''nal-IRI,'' an investigational treatment for patients with metastatic adenocarcinoma of the pancreas who have been previously treated with gemcitabine-based therapy. The submission follows Merrimack’s recent filing of a new drug application for this indication with the FDA. Both the U.S. and European submissions were based on the positive results of the international Phase 3 NAPOLI-1 study, which was conducted among patients with metastatic pancreatic cancer who previously received gemcitabine-based therapy. MM-398 in combination with 5-fluorouracil and leucovorin achieved its primary and secondary endpoints by demonstrating a clinically and statistically significant improvement in overall survival, progression free survival and overall response rate compared to the control group of patients who received a combination of 5-FU and LV. The most common Grade 3 or higher adverse events in patients receiving MM-398 and 5-FU/LV were neutropenia, fatigue and gastrointestinal effects. This was the first global Phase 3 study in a post-gemcitabine setting to show a survival benefit in this aggressive disease. The data were presented in June 2014.
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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