Investors are jumping in and out ahead of a Food and Drug Administration (FDA) decision on AcelRx’s (ACRX) opioid pain drug Dsuvia, with a PDUFA date expected by November 3, 2018. That date is only a goal, so the decision could come earlier — or even later.
That said, after a positive FDA advisory committee meeting, an approval seems likely. Specifically, the AdComm voted 10-3 last Friday in favor of recommending approval of Dsuvia for the treatment of moderate-to-severe acute pain. In reaction, AcelRx shares soared over 25% in early Monday trading, before retracing to notch about a 9% gain as of 3:25 p.m. EST.
Ladenburg analyst Michael Higgins commented, “Since the FDA’s review decision typically follows the opinion of the AdCom, and in our view the FDA’s Briefing documents were supportive of Dsuvia, we are very confident the FDA will approve Dsuvia. Additionally, we felt the Division Director, Sharon Hertz, M.D., was supportive of Dsuvia during the open discussion portion of the meeting, given her views on pain drug trial designs and the completeness of Dsuvia’s NDA. Furthermore, in our view, there were no surprises in the FDA’s prepared remarks and slides. In addition to the specific, identifiable, near-term events, we believe the approval increases the likelihood for AcelRx to monetize Dzuveo’s European rights (approved in June) as the US approval improves manufacturing margins.”
The analyst continued, “Per our view of FDA’s Briefing documents and the AdCom, we are not looking for any material limitations in the label, including the number of allowable doses/day (12) or detrimental impacts from the REMS. There was some concern by panel members that its use in “medically supervised settings” was too broad. However, we find any specifics on the setting would be problematic for the medical institutions as to the definition of any healthcare facility outside of the well-recognized term “medically supervised setting.”
Higgins reiterates a Buy rating on Acelrx shares, while lifting his price target to $10.00 (from $7.00), which represents a potential upside of 138% from current levels. (To watch Higgins’ track record, click here)
Net net, TipRanks reveals this biotech player as one drawing bullish attention on Wall Street. Out of 5 analysts polled in the last 3 months, 4 rate a Buy on ACRX stock, while only 1 issues a Hold. The 12-month average price target stands at $7.75, marking a nearly 82% upside potential from where the stock is currently trading. (See ACRX’s price targets and analyst ratings on TipRanks)