Sunesis Pharmaceuticals Inc.

Sunesis Pharmaceuticals Inc. is a biopharmaceutical company focused on the development and commercialization of new oncology therapeutics for the treatment of solid and hematologic cancers. The company has built a highly experienced cancer drug development organization committed to advancing its lead product candidate, vosaroxin, in multiple indications to improve the lives of people with cancer.

Expert Comments:

Management Q&A: View From the Top
Daniel Swisher, Jr.
Daniel N. Swisher Jr., president and CEO of Sunesis Pharmaceuticals Inc., describes how his company is making clinical progress toward developing a new treatment for acute myelogenous leukemia, and how the broad Sunesis kinase inhibitor portfolio provides additional firepower against other cancers.
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David Nierengarten, Wedbush (3/16/15)
"Sunesis Pharmaceuticals Inc. will present further analyses of the vosaroxin data at the upcoming European Haematology Association and the American Society of Clinical Oncology meetings in June. . .management reiterated plans to submit a marketing authorization application for vosaroxin plus Cytarabine for the treatment of relapsed or refractory acute myelogenous leukemia with the European Medicines Agency in H2/15."

Mara Goldstein, Cantor Fitzgerald (3/13/15)
"Sunesis Pharmaceuticals Inc. reported Q4/14 earnings per share of ($0.02), which was better than our forecast of ($0.17). . .the company reiterated plans to file an NDA for Qinprezo in Europe by year-end and is in discussion with the FDA regarding an NDA submission. Sunresis’s plan is to begin a rolling submission in Q2/15 based on guidance from the FDA has a bullish tone to it. . .we think the next inflection point for the shares will be the confirmation of NDA filing in the U.S., which we believe will occur."

Joseph Pantginis, ROTH Capital Partners (3/13/15)
"Sunesis Pharmaceuticals Inc. reports Q4/14 earnings per share was ($0.02) compared to our estimate of ($0.23) and consensus estimate of ($0.19). . .investor focus remains on regulatory next steps and discussions following the VALOR outcome. Management reiterated its expectations to file the marketing authorization application with the European Medicines Agency in H2.15. Discussions with the FDA are ongoing regarding the possible paths forward and data analyses, and the company expects to have more clarity by mid-2015 with rolling submissions slated to begin in H2/15. . .we reiterate our Buy rating and $4.30 price target. . .we see upside for the shares in 2015."

Matthew Andrews, Wells Fargo Securities (3/12/15)
"On the regulatory front, progress has been made in Q1/15 with Sunesis Pharmaceuticals Inc. engaging in a 'data-driven' dialog with the U.S. Food and Drug Administration, and the company continues to expect clarity on whether a regulatory path forward exists for Qinprezo in the entire relapsed/refractory acute myelogenous leukemia population or a subset (e.g., greater than 60 years of age) later in Q2/15. . .cash at Dec. 31, 2014 was $43M and based on the recent amendment to its Oxford Finance loan, Sunesis believes cash on hand extends operations into Q1/16."

"Sunesis Pharmaceuticals Inc. had a major inflection point with the readout of the Phase 3 VALOR trial examining Qinprezo (vosaroxin) in acute myeloid leukemia. . .using a prestratified grouping, the trial achieved significance. . .we think there is opportunity for the FDA to accept a new drug application filing from the company given the data generated in the trial and the abysmal clinical trial history of drugs for this disease. . .this, we believe, will be an opportunity to reset the valuation. Whether the FDA would be willing to approve the drug is a very large question mark. . .however, based on other clinical scenarios that we have identified, we think there is such an opportunity, and that drives our interest in the shares in spite of the very binary nature of the next inflection point." read more >

Mara Goldstein, Cantor Fitzgerald (1/6/15)
"We believe the most important near term inflection point for Sunesis Pharmaceuticals Inc. shares will be the outcome of a meeting with the FDA to discuss Valor trial results and the potential for NDA filing. The shares, we believe, largely reflect a bearish scenario, while we believe that FDA will agree to review an NDA filing. Such an outcome could prompt share price revaluation."

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Experts Commenting on This Company

The information provided above is from analysts, newsletters and other contributors. Please contact the company and visit its website before making an investment decision.
Investing Highlights
Totality of VALOR data shows compelling risk-benefit trade-off in disease with significant unmet need
Relapsed/refractory AML is a significant commercial opportunity with no approved agents
Our kinase inhibitor pipeline is poised to progress to the clinic in 2015 and 2016
catalyst Calendar
Sunesis Pharmaceuticals Inc. Content