Sunesis shares up on vosaroxin MAA filing plan news

USA-based Sunesis Pharmaceuticals (Nasdaq: SNSS) saw its shares rise 4.8% to $0.9234, after it said it intends to submit a Marketing Authorization Application for vosaroxin (proposed trade name Qinprezo) as a treatment for acute myeloid leukemia (AML) with the European Medicines Agency by the end of 2015.

Sunesis recently announced that it met separately with the Rapporteur (UK) and Co-Rapporteur (Netherlands) assigned to provide advice and guidance to the company through the MAA process. Based on these discussions, the company is proceeding with an MAA filing for the indication of relapsed/refractory AML in patients age 60 years and older, a population with the greatest medical need and for whom the greatest benefit was observed in the vosaroxin/cytarabine treatment arm of VALOR, the company's pivotal Phase III study of vosaroxin and cytarabine in adult patients with relapsed or refractory AML.

"The filing of an MAA for vosaroxin in Europe by year end is our top corporate priority. As for the US, we are refining a plan to find a timely path towards market," said Daniel Swisher, chief executive of Sunesis, adding: "With these efforts underway, we also expect to achieve meaningful progress in our kinase inhibitor pipeline, including data presentations at the upcoming November AACR-NCI-EORTC Conference in Boston. Among those being highlighted at the conference is our second generation, differentiated BTK program, SNS-062."