In a research report issued today, Canaccord Genuity analyst John Newman maintained a Hold rating on Acelrx Pharmaceuticals (NASDAQ:ACRX) with an $8 price target, as the company continues to await feedback from the FDA regarding the human factors (HF) studies for Zalviso™ (sufentanil sublingual tablet system).
Newman noted, “There remains a risk that the agency may not approve of the way current HF trials are conducted, which may require the company to collect additional data or run new studies, further delaying the resubmission of Zalviso. We expect to receive feedback on the HF study from the agency during 1Q15, potentially during February.”
The analyst added, “We maintain our HOLD rating, mainly due to the uncertainty regarding the FDA feedback on the human factors studies and risk regarding FDA approval, which we believe remains an overhang on the stock.”
AcelRx Pharmaceuticals, Inc., a development stage specialty pharmaceutical company, focuses on the development and commercialization of therapies for the treatment of acute and breakthrough pain (BTP).