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sunesis pharmaceuticals inc (RYIN) Details

Sunesis Pharmaceuticals, Inc., a biopharmaceutical company, focuses on the development and commercialization of oncology therapeutics for the treatment of solid and hematologic cancers. The company’s lead product candidate is vosaroxin, an anti-cancer quinolone derivative for the treatment of acute myeloid leukemia or AML. It has completed a Phase III, randomized, double-blind, placebo-controlled, and pivotal clinical trial of vosaroxin in combination with cytarabine in patients with relapsed or refractory AMl. The company also completed a Phase II single-agent trial of vosaroxin in platinum-resistant ovarian cancer. In addition, it is involved in the initiation of an investigator-sponsored trial of vosaroxin in combination with decitabine in older patients with untreated AML and high-risk myelodysplastic syndrome. Sunesis Pharmaceuticals, Inc. has a collaboration agreement with Biogen Idec to discover, develop, and commercialize small molecule inhibitors of the human protein Raf kinase; and licensing agreements with Millennium to provide worldwide license to develop and commercialize preclinical inhibitors of PDK1. The company was founded in 1998 and is headquartered in South San Francisco, California.

32 Employees
Last Reported Date: 03/6/14
Founded in 1998

sunesis pharmaceuticals inc (RYIN) Top Compensated Officers

Chief Executive Officer, President and Direct...
Total Annual Compensation: $469.9K
Chief Financial Officer, Principal Accounting...
Total Annual Compensation: $378.8K
Chief Medical Officer and Executive Vice Pres...
Total Annual Compensation: $408.8K
Compensation as of Fiscal Year 2013.

sunesis pharmaceuticals inc (RYIN) Key Developments

Sunesis Pharmaceuticals Announces European Medicines Agency Acceptance of Pediatric Investigation Plan for Qinprezo(TM) (Vosaroxin) for AML

Sunesis Pharmaceuticals, Inc. announced that the Pediatric Committee of the European Medicines Agency has issued a positive opinion on the company's Pediatric Investigation Plan (PIP) for Qinprezo(TM) (vosaroxin). Sunesis is currently conducting the VALOR trial, a pivotal Phase 3, randomized, double-blind, placebo-controlled clinical trial in patients with first relapsed or refractory acute myeloid leukemia (AML). A PIP is part of the EMA approval process and must be accepted prior to submission of a Marketing Authorization Application (MAA) for the drug in the European Union. Qinprezo(TM) (vosaroxin) is a first-in-class anti-cancer quinolone derivative (AQD), a class of compounds that has not been used previously for the treatment of cancer. Preclinical data demonstrate that Qinprezo both intercalates DNA and inhibits topoisomerase II, resulting in replication-dependent, site-selective DNA damage, G2 arrest and apoptosis. Both the U.S. Food and Drug Administration (FDA) and European Commission have granted orphan drug designation to Qinprezo for the treatment of AML. Additionally, Qinprezo has been granted fast track designation by the FDA for the potential treatment of relapsed or refractory AML in combination with cytarabine. Qinprezo is an investigational drug that has not been approved for use in any jurisdiction.

Sunesis Pharmaceuticals, Inc. Announces Presentation of Positive Updated Results from Ongoing MD Anderson-Sponsored Trial of Vosaroxin in AML and High-Risk MDS at ASCO 2014 Annual Meeting

Sunesis Pharmaceuticals, Inc. announced the presentation of updated results from an ongoing Phase 1b/2 University of Texas MD Anderson Cancer Center-sponsored trial of Qinprezo(TM) (vosaroxin) in combination with decitabine in older patients with previously untreated acute myeloid leukemia (AML) and high-risk myelodysplastic syndrome (MDS). The results will be presented at the Leukemia, Myelodysplasia, and Transplantation General Poster Session of the American Society of Clinical Oncology Annual Meeting 2014 (ASCO) in Chicago, Illinois. The poster (Poster #383, S Hall A2) is titled "Phase I/II study of vosaroxin and decitabine in older patients with acute myeloid leukemia (AML) and high risk myelodysplastic syndrome (MDS)." The Phase 1b/2 trial is expected to enroll up to a combined total of approximately 70 patients. As previously announced, the Phase 2 cohort was initiated in October 2013, following successful completion of a Phase 1b open-label, single-arm dose optimization phase. Patients in the ongoing trial are being followed for response, leukemia-free survival, overall survival and safety. Enrollment in the trial is ongoing. To date, 34 patients (31 AML, 3 high-risk MDS) with a median age of 70 years (range, 41-78) have been enrolled; 97% were older than 60 years and 50% were older than 70 years. Of these, 30 patients were evaluable for response; 13 patients (43%) achieved complete response (CR), 6 patients (20%) achieved CR with incomplete platelet recovery (CRp), and 3 patients (10%) achieved CR with incomplete peripheral blood count recovery (CRi), for an overall response rate of 73%. Four patients are too early for response assessment. Patients have received a median of 2 (1 - 6) treatment cycles with median number of cycles to response being 1 (1 - 4). The main grade >= 3 toxicity was mucositis in 8 patients (24%). No patients died during the initial 30-day induction period. Patients were also assessed for response by baseline characteristics, including mutation status. Among them, 6 patients had a documented mutation in isocitrate dehydrogenase-2 (IDH2) and 8 patients in tumor protein 53 (TP53, or mutational p53). The overall response rate among evaluable patients with IDH2 and TP53 mutations was 100% (6/6) and 63% (5/8), respectively. For the trial, patients are treated with Qinprezo (70 or 90 mg/m(2)) intravenously on days one and four in combination with decitabine (20 mg/m(2)) on days one to five. Vosaroxin dose is 70 mg/m(2) in consolidation cycles, which are repeated in approximately four to five week intervals for a total of up to seven cycles. Dose adjustments and dose delays of one or both agents are allowed based on toxicity. Patients are eligible if they had AML or high-risk MDS (defined as having >= 10% blasts in the bone marrow), are 60 years of age or older, and have adequate performance status (ECOG <= 2) and organ function. Patients younger than 60 who are unsuited for standard chemotherapy are also eligible. The primary endpoint of the study is to determine the overall combined complete response rate. Secondary endpoints include CR duration, disease-free survival, overall survival, safety and early mortality.

Sunesis Pharmaceuticals, Inc. Presents at Jefferies 2014 Global Healthcare Conference, Jun-03-2014 03:30 PM

Sunesis Pharmaceuticals, Inc. Presents at Jefferies 2014 Global Healthcare Conference, Jun-03-2014 03:30 PM. Venue: Grand Hyatt, New York, New York, United States. Speakers: Eric H. Bjerkholt, Chief Financial Officer, Principal Accounting Officer, Executive Vice President of Corporate Development & Finance and Corporate Secretary.


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