Apricus Biosciences, Inc. announced that it intends to resubmit its new drug application (NDA) for its drug Vitaros in 2017.
Apricus had a Type B meeting with the FDA as previously announced to confirm its plans for addressing the deficiencies contained in the 2008 Complete Response Letter (CRL) for Vitaros.
Notably, Vitaros is already approved in Canada and certain countries in Europe, Latin America and the Middle East, and is marketed in several European countries.
The FDA suggested including additional analysis of existing clinical and non-clinical data in the re-submitted NDA and did not indicate that new clinical studies would be required for re-submission. The company intends to resubmit the NDA as soon as possible in 2017.
Importantly, according to the present regulations, the FDA determined that Vitaros should be considered a drug-device combination. Apricus was advised to meet with the Office of Product Quality to confirm the necessary compliance requirements for the NDA resubmission.
Apricus currently carries a Zacks Rank #2 (Buy). Some other favorably ranked stocks in the healthcare sector include Arbutus Biopharma Corporation (ABUS - Free Report) , Heska Corporation (HSKA - Free Report) and Anika Therapeutics Inc. (ANIK - Free Report) . Arbutus and Heska sport a Zacks Rank #1 (Strong Buy), while Anika carries a Zacks Rank #2. You can see the complete list of today’s Zacks #1 Rank stocks here.
Arbutus’ loss estimates narrowed from $2.15 to $1.74 for 2016 and from $1.96 to $1.51 for 2017 over the last 60 days. The company posted positive surprises in three of the trailing four quarters, with an average beat of 59.31%.
Heska’s earnings estimates increased from $1.13 to $1.35 for 2016 and from $1.38 to $1.53 for 2017 over the last 60 days. The company posted positive surprises in each of the four trailing quarters, with an average beat of 301.64%.
Anika’s earnings estimates increased from $1.96 to $2.06 for 2016 and from $2.03 to $2.09 for 2017 over the last 60 days. The company posted positive surprises in each of the four trailing quarters, with an average beat of 33.14%.
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