Analyst: AcelRx Will Address FDA Concerns, Secure Approval This Year

AcelRx Pharmaceuticals Inc ACRX has been slowly recovering from a mid-October plunge following the FDA's issuance of a Complete Response Letter.

Cantor Fitzgerald forecast an additional 160 percent in upside for the stock. 

The Rating

Analyst Brandon Folkes initiated coverage of AcelRx with an Overweight rating and $6 price target.

The Thesis

The firm’s Dsuvia is expected to receive regulatory approval in November with a Risk Evaluation and Mitigation Strategy, Folkes said in the initiation note. 

“Since ACRX obtained a CRL in 2017, the company has addressed the FDA's concerns, and reduced the maximum daily dosage of Dsuvia to 12 doses from 24,” the analyst said. “This aligns with the FDA's goal of reducing opioid usage, and we believe the agency will have an Adcom for Dsuvia where it can discuss any remaining concerns.”

Cantor Fitzgerald anticipates that AcelRx will address enduring safety concerns and REMS questions in the third quarter.

AcelRX's Zalviso could be approved in 2019 after a late 2018 resubmission of the New Drug Application, Folkes said; the analyst expects a 2020 launch. 

“Both Dsuvia and Zalviso offer advantages to the patient, physician/nurse and the treatment facility, that if priced accordingly, we believe will drive uptake of both products beyond the Street's current estimates which should drive the stock higher."

Price Action

At the time of publication, AcelRX shares were trading up 3.42 percent at a rate of $3.78.

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