AcelRx Pharmaceuticals Inc. (NASDAQ: ACRX) shares made a solid gain on Wednesday despite a less-than-favorable update from the U.S. Food and Drug Administration (FDA). However, there is a vote for approval on Friday, and that seems to be what investors are optimistic about.
The staff reviewers at the FDA announced that AcelRx’s opioid painkiller, Dsuvia, offered no apparent advantage to currently available therapies. The FDA staff also highlighted that the small size of the oral Dsuvia pills makes it easier for patients to misplace them, potentially resulting in accidental use by others.
According to Seeking Alpha:
The company appears to have sufficiently addressed the review team’s concerns over the safety of the 30 mcg tablets at maximum dosing and the risk of misplaced tablets, two areas cited in the CRL the company received in response to its original filing.
An advisory panel to the FDA will vote on the drug on Friday, before the regulator’s final decision by November 3.
Excluding Wednesday’s move, AcelRx has underperformed the broad markets, with the stock down 49% in the past 52 weeks. In just 2018 alone, the stock is up 31%.
Shares of AcelRx were last seen up about 33% at $3.52, with a consensus analyst price target of $5.60 and a 52-week trading range of $1.55 to $5.75.