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:

Matthew Andrews, Wells Fargo Securities (7/24/15)
"We aren't surprised that the European commission's rapporteur/co-rapporteurs encouraged Sunesis Pharmaceuticals Inc. to proceed with a marketing authorization application (MAA) submission in relapsed/refractory acute myelogenous leukemia (AML) greater than 60 years, considering its flexibility with the Dacogen first-line elderly AML MAA, where at the initial Phase 3 overall survival analysis it was not statistically significant, and 2012 approval. Our base case has been that an MAA filing would proceed based on this regulatory precedent."

Hartaj Singh, BTIG Research (7/23/15)
"The European Medicines Agency meetings, independently with two different representatives, were positive in both instances, and Sunesis Pharmaceuticals Inc. will now focus on driving the European Union (EU) application forward. We assume a filing in Q4 EY/15, with a potential approval in late 2016; we still assume a 60% chance of EU approval."

David Nierengarten, Wedbush (7/23/15)
"Sunesis Pharmaceuticals Inc. says filing the marketing authorization application (MAA) is now its top priority, and said it will file soon after it receives final guidance from the rapporteur and co-rapporteur in a pre-submission meeting to be held in the fall. We currently model for a European Union launch in Q3/16."

Hartaj Singh, BTIG Research (6/17/15)
"Sunesis Pharmaceuticals Inc. recently presented abstracts at both ASCO 2015 and at EHA 2015 in Vienna. The data presented by Sunesis underlies our thesis that vosaroxin is an active compound in acute myeloid leukemia where there is a large unmet need. . .going into the FDA meeting, we believe that current risk/reward is well-balanced. We assume a 60% chance of FDA giving a favorable review (versus oncology phase 3 trials that progress to NDA/BLA ~45% of the time) with a potential 30% upside move on NDA filing and a 45% downside move if not."

"Sunesis Pharmaceuticals Inc. has been developing Qinprezo (vosaroxin) in acute myeloid leukemia (AML) for a very long time now. The company showed some intriguing Phase 2 data for the therapy, and ran a somewhat large Phase 3 study, with more than 700 patients, called VALOR. . .the data did not reach statistical significance with regard to overall survival, which was the primary endpoint. But I think Qinprezo definitely falls into the category of questioning what's left following bad data. . .the data did show a significant survival benefit when censored for stem cell transplant in AML patients. . .additionally, the intriguing component of the study, in my belief, is that a nice survival benefit was seen in patients 60 years and older, and these data were highlighted at the recent American Society of Clinical Oncology (ASCO) conference. . ." read more >

Joseph Pantginis, ROTH Capital Partners (6/15/15)
"Sunesis Pharmaceuticals Inc.'s two European Hematology Association presentations provide subgroup analyses by (a) cytogenetic risk, in which only the intermediate group achieved a statistically significant improvement in complete response rate and (b) by disease status, in which refractory and early relapse patients achieved significant improvements in overall survival, complete response, event-free survival and leukemia-free survival. We believe these could be meaningful to regulators and await announcement on the outcomes of discussions with the U.S. Food and Drug Administration and the European Medicines Agency."

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.
read more >

More Expert Comments

Experts Commenting on This Company

Matthew Andrews, Equity Senior Analyst – Wells Fargo Securities
Reni Benjamin, Senior Biotechnology Analyst – H.C. Wainwright & Co.
Mara Goldstein, Senior Analyst – Cantor Fitzgerald
David Nierengarten, Research Analyst – Wedbush
Joseph Pantginis, Senior Analyst – ROTH Capital Partners
Hartaj Singh, Biotechnology Analyst – BTIG Research
George Zavoico, Senior Equity Analyst – JonesTrading International Services LLC

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