Blog Coverage Sunesis Pharma Withdraws European Marketing Authorization Application for Vosaroxin

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LONDON, UK / ACCESSWIRE / May 3, 2017 / Active Wall St. blog coverage looks at the headline from Sunesis Pharmaceuticals, Inc. (NASDAQ: SNSS) as the Company announced on May 01, 2017, post-closing of the market announced that the Company will withdraw its European Marketing Authorization Application (MAA) for Vosaroxin as a treatment for relapsed/refractory acute myeloid leukemia (AML) in patients aged 60 years and older. Register with us now for your free membership and blog access at:

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One of Sunesis Pharma’s competitors within the Biotechnology space, Exelixis, Inc. (NASDAQ: EXEL), reported on May 01, 2017, its financial results for Q1 2017 and provided an update on progress toward fulfilling its key corporate objectives, as well as commercial and clinical development milestones. AWS will be initiating a research report on Exelixis in the coming days.

Today, AWS is promoting its blog coverage on SNSS; touching on EXEL. Get all of our free blog coverage and more by clicking on the link below:

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Reason for Pullback

Sunesis took the decision following recent interactions with the European Medicine Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP). Based on feedback from its rapporteurs and input from retained regulatory experts, the Company concluded it was unlikely that the Sunesis would be able to achieve a majority vote of CHMP’s members at this time or upon an immediate re-examination for the proposed indication based on VALOR data from a sub-group of a single pivotal trial that had missed reaching full statistical significance in its primary analysis.

“We are disappointed to not achieve approval for vosaroxin’s MAA given its reported efficacy in a patient population with such poor outcomes. Although, we did not receive a definitive CHMP opinion, we believed that a positive opinion was unlikely,” said Daniel Swisher, President and CEO of Sunesis.

Way Forward

Sunesis stated that in light of the recent development, the Company will reduce its investment in the leukemia program and shift its resources to its kinase inhibitor pipeline, including lead asset SNS-062, the Company’s non-covalent reversible BTK-inhibitor, which will begin dosing this quarter in a Phase-1b/2 trial in cancer patients with B-cell malignancies.

Sunesis stated that it will continue to advance the development of vosaroxin through a modest investment in investigator-sponsored group trials, and will carefully assess business development alternatives to support the conduct of another pivotal trial to achieve future regulatory approval of vosaroxin. The Company stated that it has sufficient cash resources to fund the Company beyond Q1 2018.

What is Vosaroxin?

Vosaroxin is an anti-cancer quinolone derivative (AQD). The Company’s preclinical data demonstrated that vosaroxin both intercalates DNA and inhibits topoisomerase II, resulting in replication-dependent, site-selective DNA damage, G2 arrest and apoptosis. Vosaroxin has been granted orphan drug status by both the US Food and Drug Administration (FDA) and European Commission for the treatment of AML. Additionally, vosaroxin has been granted fast track designation by the FDA for the potential treatment of relapsed/refractory AML in combination with cytarabine.

Stock Performance

At the close of trading session on Tuesday, May 02, 2017, following the announcement, Sunesis Pharma’s stock price tumbled 18.99% to end the day at $2.96. A total volume of 1.30 million shares were exchanged during the session, which was above the 3-month average volume of 81.47 thousand shares. The stock currently has a market cap of $60.99 million.

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