3 Catalysts To Watch Over The Next 2 Months For This Pharma Co.

• AcelRx Pharmaceuticals Inc ACRX shares are down 33 percent year-to-date after having peaked at $9.32 on March 2.
• HC Wainwright analyst Ed Arce initiated coverage of the company with a Buy rating and a price target of $8.50.
• Three critical milestones within the next two months are expected to drive the company’s share price performance, Arce said.

Analyst Ed Arce pointed out that AcelRx is a specialty pharmaceutical company focused on acute pain and its lead candidate Zalviso is a “drug device combination that offers patient-controlled analgesia (PCA) via oral transmucosal delivery of Sufentanil.”

The company’s second candidate ARX-04 has double the dose of Zalviso and is intended to be administered by a healthcare professional.

Arce outlined three important catalysts to watch out for over the next two months: the company’s general advice meeting with the FDA for seeking a regulatory path for Zalviso, formal approval for the marketing of Zalviso in Europe and top line results of ARX-04 pivotal phase 3 trial.

In the report HC Wainwright noted, “[W]e model (85% probability) Zalviso approval in the U.S. in 4Q17, following positive results from another full (~700 patients) Phase 3 trial, and peak U.S. sales of $422M in 2027; commercial launch of Zalviso in the EU beginning in 2Q16 with peak sales of $134M; and U.S. approval (60% probability) of ARX-04 in 3Q17 with peak sales of $131M.”