Talphera Inc. (TLPH)

[$$$eeker]

Cowen Maintains An Outperform On AcelRx As FDA Issues CRL For Zalviso’s NDA

July 28, 2014 9:53 AM EDT by SA Staff in Exclusive Area, Healthcare // 0 Comments
In a research report released this morning, Cowen and Company analyst Joon Lee maintained an Outperform rating on AcelRx Pharmaceuticals (ACRX) with a $15 price target, following the news that the FDA issued a CRL for the NDA of Zalviso. Zalviso is a drug-device combination product being developed for moderate to severe in-hospital pain.

Lee wrote, “Zalviso NDA was filed based on two positive pivotal Phase 3 studies in the post-operative setting, one in soft-tissue and one in orthopedic surgeries. Additionally, a head to head Phase 3 study against IVPCA morphine demonstrated superiority of Zalviso over IVPCA. The CRL may delay the launch of Zalviso by approximately 6 to 11 months or potentially longer pending further discussions with the FDA. However, based on the positive results of these three Phase 3 studies and potential pharmacoeconomic benefits associated with Zalviso over IVPCA, we have reasons to believe that Zalviso will eventually be approved and commercialized”.

http://bit.ly/UFJsyd