Sunesis Pharmaceuticals, Inc. (SNSS - Free Report) announced that it has submitted its response to the Day 120 List of Questions issued by 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). Sunesis is looking to get Qinprezo approved for the treatment of relapsed/refractory acute myeloid leukemia (AML) in patients aged 60 years and older.
Sunesis expects to receive the Day 180 List of Outstanding Issues from the EMA before the end of 2016. A decision on the approval status of Qinprezo should be out in 2017.
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 had 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.
Currently, Sunesis is exploring regulatory and clinical strategies to seek approval in the U.S.
We note that Qinprezo enjoys orphan drug status in both the U.S. and the EU.
Meanwhile, Sunesis is working on the progress of its novel kinase inhibitor pipeline, which includes proprietary non-covalent BTK-inhibitor, SNS-062.
Zacks Rank & Key Picks
Sunesis currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the health care sector include Amarin Corporation plc (AMRN - Free Report) , BioMarin Pharmaceutical Inc. (BMRN - Free Report) and Exelixis, Inc. (EXEL - Free Report) . While Amarin sports a Zacks Rank #1 (Strong Buy), both BioMarin and Exelixis carry a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Amarin’s loss estimates have narrowed from 53 cents to 40 cents for 2016 and from 36 cents to 27 cents for 2017 over the last 60 days. The company’s share price has soared 65.1% year to date.
BioMarin’s loss estimates narrowed from 28 cents to 27 cents for 2016 and from $1.16 to $1.12 for 2017 over the last 60 days.
Exelixis’ loss estimates narrowed from 76 cents to 63 cents for 2016 and from 22 cents to 3 cents for 2017 over the last 60 days. The company has posted a positive earnings surprise twice in the four trailing quarters with an average beat of 9.1%. Its share price has skyrocketed 116.9% year to date.
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