Sunesis Pharmaceuticals, Inc. (NASDAQ:SNSS) announced that it has submitted its responses to European Medicines Agency (EMA) Day 120 List of Questions issued by the Committee for Medicinal Products for Human Use (CHMP) as part of the centralized review process of the Marketing Authorization Application (MAA) for vosaroxin as a treatment for relapsed/refractory acute myeloid leukemia (AML) in patients aged 60 years and older. Sunesis expects to receive the EMA Day 180 List of Outstanding Issues before year-end.
“We are pleased with the comprehensive set of answers and additional analyses that our team has provided in response to the EMA’s Day 120 list of questions,” said Daniel Swisher, President and Chief Executive Officer of Sunesis. “As our regulatory efforts progress to bring vosaroxin to market in Europe as a treatment for relapsed/refractory AML, we are advancing active dialogues with potential pharma collaborators toward the goal of supporting a market launch in 2017. With the clock now restarting, we anticipate being one step closer to that goal.”. (Original Source)
Shares of Sunesis Pharmaceuticals opened today at $4.26, up $0.14 or -3.18%. SNSS has a 1-year high of $6.30 and a 1-year low of $2.63. The stock’s 50-day moving average is $4.63 and its 200-day moving average is $3.59.
On the ratings front, SNSS stock has been the subject of a number of recent research reports. In a report issued on September 12, Cantor analyst Mara Goldstein reiterated a Buy rating on SNSS. Separately, on the same day, Cowen’s Eric Schmidt reiterated a Hold rating on the stock.
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Mara Goldstein and Eric Schmidt have a total average return of 2.1% and 22.7% respectively. Goldstein has a success rate of 42% and is ranked #1311 out of 4182 analysts, while Schmidt has a success rate of 53.5% and is ranked #70.
Sunesis Pharmaceuticals, Inc. operates as a biopharmaceutical company. It engages in development and commercialization of new oncology therapeutics for the treatment of solid and hematologic cancers. Its efforts are currently focused primarily on the development of vosaroxin for the treatment of acute myeloid leukemia. The company’s primary activities include conducting research and development internally and through corporate collaborators, in-licensing and out-licensing pharmaceutical compounds and technology, conducting clinical trials and raising capital.