FDA Announces Priority Review For Merrimack's Pancreatic Cancer Drug

Shares of Merrimack Pharmaceuticals (MACK) are up 7% after announcing that the FDA has given MM-398 Priority Review. Merrimack has partnered out MM-398 with Baxter (BAX) to co-develop and co-commercialize the drug. This FDA priority review allows the FDA to review the drug by 6 months instead of 10 months after the application has been sent in. This will allow a quick access for patients who desperately need this treatment. 

MM-398 treats patients with metastatic pancreatic cancer, meaning that the cancer has advanced to the last stage. In addition the phase 3 trial that was ran by Merrimack, enrolled patients who had already attempted therapy with gemcitabine - a chemotherapeutic agent - and were unsuccessful in obtaining a response to therapy. 

Merrimack's FDA PDUFA date will take place by October 24, 2015, at which the FDA will decide whether or not MM-398 merits approval for these metastatic pancreatic cancer patients. The company has filed the NDA with data from a phase 3 study, known as NAPOLI-1, in which MM-398 met on both the primary endpoint and secondary endpoint of the study as compared to placebo. 

Disclosure: None.

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