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June 2, 2014
08:15 EDTMACKMerrimack identifies heregulin as patient response biomarker for MM-121
Merrimack Pharmaceuticals reported that expression of heregulin, the principal ligand that binds to and activates the ErbB3 receptor, is associated with poor response to standard of care therapy for patients with platinum-resistant ovarian cancer, ER/PR+ HER2- breast cancer and EGFR wild-type non-small cell lung cancer. Heregulin-driven drug resistance pathways were found to be active in approximately 30-50% of patients tested. Results from three Phase 2 studies further showed that patients with heregulin-positive tumors experienced a statistically significant reduction in their risk of progression when they received a combination of MM-121 with their standard of care therapy as compared to patients who received the standard of care therapy alone. MM-121 is specifically designed to block heregulin binding to ErbB3. Top line data from these trials had previously been released. Detailed biomarker data for all three studies were presented at the American Society of Clinical Oncology Annual Meeting, May 30-June 3. Akos Czibere, MD, PhD, Senior Medical Director at Merrimack, said, "We look forward to advancing MM-121 into definitive studies that will allow us to prospectively screen patients for heregulin."
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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.
June 19, 2015
05:40 EDTMACKTESARO a favorite stock for second half of year at Mizuho
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