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Sunesis Offers Updates on SNS-062 and Qinprezo Programs
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Sunesis Pharmaceuticals, Inc. provided clinical and regulatory updates on two of its lead programs – SNS-062, a second-generation reversible and non-covalent Bruton's tyrosine kinase (BTK) inhibitor, and Qinprezo (vosaroxin), an anti-cancer quinolone derivative.
A look at Sunesis’ price movement shows that the company has underperformed the Medical-Biomedical/Genetics industry in the past one year. The stock declined 17.4% during this period, compared to the industry’s 3.9% drop.
Coming back to the latest news, Sunesis stated that the FDA has completed reviewing its Investigational New Drug (IND) application for SNS-062. A phase IB/II study on the candidate is expected to be initiated in the first half of 2017. The study will evaluate the safety and efficacy of SNS-062 in patients with advanced B-cell malignancies after prior exposure to AbbVie Inc. (ABBV - Free Report) and Johnson & Johnson’s (JNJ - Free Report) Imbruvica (ibrutinib), including those patients with C481S mutations.
In addition, Sunesis announced that it has received the Day 180 List of Outstanding Issues from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP), as part of the centralized review process of the company’s marketing authorization application (MAA) for Qinprezo (vosaroxin).
The company stated that it expects to respond to the Day 180 List of Outstanding Issues by the end of the first quarter and go before the Scientific Advisory Group’s Oncology Division (SAG-O) in April. An opinion from the EMAs CHMP is expected in mid-2017. Also, a decision on the approval status of Qinprezo should be out in 2017.
Notably, Sunesis is looking to get Qinprezo approved for the treatment of patients with relapsed/refractory acute myeloid leukemia (AML). The candidate enjoys orphan drug status in both the U.S. and the EU.
We remind investors that in Oct 2014, Sunesis had reported disappointing data from the phase III VALOR study on Qinprezo, in combination with cytarabine, in patients with relapsed or refractory AML. The study failed to meet the primary endpoint of demonstrating a statistically significant improvement in overall survival. In Jul 2015, the company met with the FDA to discuss a potential regulatory filing in the U.S.
Based upon the meeting, the FDA recommended the company to provide additional data prior to any regulatory filing in the U.S. Sunesis is currently exploring regulatory and clinical strategies to seek approval in the U.S.
Going forward, we expect investors to remain focus on further updates by the company on its lead candidate, Qinprezo.
Sucmapo’s earnings estimates were stable at $1.22 for 2016 but have increased from $1.30 to $1.74 for 2017 over the last 60 days. The company posted a positive earnings surprise in all of the four trailing quarters with an average beat of 35.5%.
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Sunesis Offers Updates on SNS-062 and Qinprezo Programs
Sunesis Pharmaceuticals, Inc. provided clinical and regulatory updates on two of its lead programs – SNS-062, a second-generation reversible and non-covalent Bruton's tyrosine kinase (BTK) inhibitor, and Qinprezo (vosaroxin), an anti-cancer quinolone derivative.
A look at Sunesis’ price movement shows that the company has underperformed the Medical-Biomedical/Genetics industry in the past one year. The stock declined 17.4% during this period, compared to the industry’s 3.9% drop.
Coming back to the latest news, Sunesis stated that the FDA has completed reviewing its Investigational New Drug (IND) application for SNS-062. A phase IB/II study on the candidate is expected to be initiated in the first half of 2017. The study will evaluate the safety and efficacy of SNS-062 in patients with advanced B-cell malignancies after prior exposure to AbbVie Inc. (ABBV - Free Report) and Johnson & Johnson’s (JNJ - Free Report) Imbruvica (ibrutinib), including those patients with C481S mutations.
In addition, Sunesis announced that it has received the Day 180 List of Outstanding Issues from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP), as part of the centralized review process of the company’s marketing authorization application (MAA) for Qinprezo (vosaroxin).
The company stated that it expects to respond to the Day 180 List of Outstanding Issues by the end of the first quarter and go before the Scientific Advisory Group’s Oncology Division (SAG-O) in April. An opinion from the EMAs CHMP is expected in mid-2017. Also, a decision on the approval status of Qinprezo should be out in 2017.
Notably, Sunesis is looking to get Qinprezo approved for the treatment of patients with relapsed/refractory acute myeloid leukemia (AML). The candidate enjoys orphan drug status in both the U.S. and the EU.
We remind investors that in Oct 2014, Sunesis had reported disappointing data from the phase III VALOR study on Qinprezo, in combination with cytarabine, in patients with relapsed or refractory AML. The study failed to meet the primary endpoint of demonstrating a statistically significant improvement in overall survival. In Jul 2015, the company met with the FDA to discuss a potential regulatory filing in the U.S.
Based upon the meeting, the FDA recommended the company to provide additional data prior to any regulatory filing in the U.S. Sunesis is currently exploring regulatory and clinical strategies to seek approval in the U.S.
Going forward, we expect investors to remain focus on further updates by the company on its lead candidate, Qinprezo.
Sunesis Pharmaceuticals, Inc. Price and Consensus
Sunesis Pharmaceuticals, Inc. Price and Consensus | Sunesis Pharmaceuticals, Inc. Quote
Currently, Sunesis carries a Zacks Rank #1 (Strong Buy).
Other Key Pick
Another favorably ranked stock in the health care sector is Sucampo Pharmaceuticals, Inc. with a Zacks Rank #1. You can see the complete list of today’s Zacks #1 Rank stocks here.
Sucmapo’s earnings estimates were stable at $1.22 for 2016 but have increased from $1.30 to $1.74 for 2017 over the last 60 days. The company posted a positive earnings surprise in all of the four trailing quarters with an average beat of 35.5%.
Zacks' Top 10 Stocks for 2017
In addition to the stocks discussed above, would you like to know about our 10 finest tickers for the entirety of 2017?
Who wouldn't? These 10 are painstakingly hand-picked from 4,400 companies covered by the Zacks Rank. They are our primary picks to buy and hold. Be among the very first to see them >>