Shares of Merrimack Pharmaceuticals (NASDAQ: MACK) popped in morning trading on Wednesday where the stock shot past its yearly high of $7.41 after its French partner Ipsen provided an update of primary analysis of the results of its Phase III NAPOLI 3 trial of Onivyde (irinotecan liposome injection). Onivyde is used in the treatment of pancreatic cancer.
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Ipsen stated in its press release that the randomized, open-label Phase 3 trial met “its primary endpoint demonstrating clinically meaningful and statistically significant improvement in overall survival compared to nab-paclitaxel plus gemcitabine in 770 previously untreated patients with metastatic pancreatic ductal adenocarcinoma (mPDAC) [pancreatic cancer] and key secondary efficacy outcome of progression-free survival (PFS) also showed significant improvement over the comparator arm.”
Ipsen indicated that it intends to file a supplemental New Drug Application (NDA) with the U.S. FDA for Onivyde in combination with oxaliplatin plus 5- fluorouracil/leucovorin for the treatment of patients with previously untreated pancreatic cancer.