Celator Pharma to file VYXEOS NDA by end of Q3; shares up 17%

• After the close yesterday, Celator Pharmaceuticals (NASDAQ:CPXX +16.9%) announced that it intends to file a New Drug Application (NDA) with the FDA by the end of Q3 seeking approval of VYXEOS (cytarabine:daunorubicin) for the treatment of high-risk acute myeloid leukemia (AML). If all goes according to plan, regulatory approval could happen by mid-2017 followed by market launch in Q3 2017.
• Shares galloped upward in March after the company reported Phase 3 data that showed treatment with VYXEOS extended overall survival in AML patients over 60% compared to the standard-of-care chemo regimen with a 31% lower risk of death.
• VYXEOS, based on the company's CombiPlex platform, is an optimized 5:1 formulation of the commonly used chemo agents cytarabine and daunorubicin.
• Previously: Celator Pharma up big on positive late-stage results for lead product candidate in high-risk leukemia; shares up 340% after hours (March 14)