Cowen Raises Red Flag on AcelRx Pharmaceuticals Inc (ACRX) Ahead of Dsuvia’s PDUFA

The next key catalyst for AcelRx Pharmaceuticals Inc (NASDAQ:ACRX) is Dsuvia’s Prescription Drug User Fee Act (PDUFA) on October 12, 2017 for the treatment of patients experiencing moderate-to-severe acute pain in a medically supervised setting.

Cowen analyst Boris Peaker points out that given the current opioid abuse epidemic, there is significant uncertainty as to whether regulatory authorities would be comfortable approving a new highly potent opioid.

Peaker noted, “There is significant regulatory risk due to the on-going opioid abuse epidemic which has drawn political attention. While Dsuvia offers a fast on-set of action and sublingual ease of administration, it is also 5-10x more potent than fentanyl and has no abuse deterrent properties outside of limited distribution. Due to the uncertainty associated with potential approval and commercial adoption, the company is minimizing pre-launch expenditures,”

As such, the analyst reiterates a Market Perform rating on Acelrx shares, while no price target was provided. (To watch Peaker’s track record, click here)

Out of the 5 analysts polled in the past 3 months, 3 rate Acelrx stock a Buy, while 2 rate the stock a Hold. With a return potential of 135%, the stock’s consensus target price stands at $8.00. AcelRx shares closed toady at $3.40, down $0.50 or -13%.


  • Elmore James

    The opioid epidemic is being fed by drugs prescribed by doctors that are then filled at the local drug store. Abusers, enabled by pill mill doctors, are walking out of CVS with bags of pills that are then diverted to junkies. ACRX products are for use in controlled environments, under direct medical supervision, like hospitals and surgery centers, not at home.

    With all due respect, the analyst is conflating the two issues. His reasoning is similar to proclaiming the military shouldn’t have bazookas because of all the gun violence in the streets. Access to bazookas is tightly controlled… That’s why you don’t see them contributing to gun violence. The same goes for ACRX products.