Roth Capital Reiterates Buy on AcelRx Pharmaceuticals Inc Following Informal Meeting with FDA

Roth Capital’s healthcare analyst Michael Higgins weighed in with a few insights on AcelRx Pharmaceuticals Inc (NASDAQ:ACRX), after the company announced that it held an informal meeting with the FDA last week to discuss the requirements and timeline for Zalviso’s approval.

Higgins noted, “Given the degree of changes to the device, we are not surprised with the FDA’s March 9th request for a confirmatory, clinical trial. From our view, the FDA’s initial request for a complete repeat of the Phase 3 program is excessive (i.e. MannKind’s 2nd CRL Ph3 trials). With agreement on a ~150pt trial and its initiation in 4Q15, we believe ACRX shares will appreciate as investors’ uncertainty reduces.”

Bottom line: “The results of the meeting are in-line with our expectations. We continue to look for a 4Q’15 start to a Ph3 confirmatory trial, with mid-’16 results and YE’16 resubmission. Next events include EU approval this fall, plus ARX-04’s Ph3 results and Analyst Day in Oct.”

The analyst reiterated a Buy rating on Acelrx shares, with a $7.50 price target, which implies an upside of 90% from current levels.

According to, which measures analysts’ and bloggers’ success rate based on how their calls perform, analyst Michael Higgins has a total average return of 18.2% and a 57.9% success rate. Higgins has a -4.8% average return when recommending ACRX, and is ranked #669 out of 3752 analysts.

Out of the 7 analysts polled by TipRanks, 4 rate Acelrx Pharmaceuticals stock a Hold, while 3 rate the stock a Buy. With a return potential of 65%, the stock’s consensus target price stands at $6.50.

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