The Food and Drug Administration (FDA) is scheduled to hold an advisory committee meeting on Friday to review AcelRx’s (ACRX) pain medication Dsuvia. The agency usually publicly posts the briefing documents two business days before the meeting, so investors should expect these materials to be posted on the FDA website tomorrow morning. AcelRx shares closed today at $2.65, down $0.34 or -11.37%.
Oppenheimer analyst Leland Gershell commented, “Today’s oliceridine briefing docs offer little read-across, in our view, with the FDA concluding that TRVN’s (NC) drug: 1) offers lower benefit-risk vs. morphine; 2) lacks an abuse potential advantage; and 3) may possess arrhythmic liability despite a dosing paradigm designed to obviate. Apart from the abuse concerns general to opioids, we do not see these as informative for Dsuvia.”
The analyst continued, “We note that Dsuvia’s first-cycle review did not feature an AdComm prior to the October 2017 CRL. We have no specific concerns in other areas, e.g. efficacy, and while the materials may well set the stage for a positive vote and potential approval on/around Dsuvia’s 11/3/18 PDUFA, we cannot ignore the likelihood that Friday’s discussion will be colored by negative sentiment and dialogue around opioid class-related issues including misuse/abuse liabilities. We expect to provide further commentary pending the briefing docs.”
As such, Gershell reiterates a Perform rating on Acelrx shares, without providing a price target.
According to TipRanks, which measures analysts’ and bloggers’ success rate based on how their calls perform, analyst Leland Gershell has a yearly average return of 2.1% and a 50% success rate. Gershell is ranked #2850 out of 4908 analysts.
Net net, cautious optimism circles this biotech player, as TipRanks analytics exhibit ACRX as a Moderate Buy. Out of 5 analysts polled in the last 3 months, 3 are bullish on AcelRx stock, while 2 remain sidelined. With a return potential of nearly 117%, the stock’s consensus target price stands at $5.75. (See ACRX’s price targets and analyst ratings on TipRanks)