Ladenburg Thalmann launched coverage of AcelRx Pharmaceuticals (NASDAQ:ACRX) with a “buy” rating and price target of $7. The stock closed at $2.95 on August 15.
AcelRx is focused on the development of acute pain management therapies that are administered in medically supervised settings. Its lead asset is Dsuvia, a 30- mcg sufentanil NanoTab that is placed sublingually by a healthcare professional via a single-dose applicator.
Analyst Michael Higgins writes that Dsuvia is the first drug being developed to treat the some10 million Americans with acute, moderate-to-severe pain in the Emergency Department where the current gold standard is an IV opioid.
A FDA advisory committee meeting is expected in late September, or early October, ahead of a November 3 PDUFA on Dsuvia, with a PDUFA on AcelRx’s Zalviso, a15-mcg sufentanil NanoTab, which is a patient-administered post-operative pain drug/device, expected six months later, he added.
While both of AcelRx’s products have been approved in Europe both have received complete response letters (CRLs) in the U.S. “In our view, there is no overlap in the reasons for the CRLs and both CRLs have been adequately addressed,” Mr. Higgins said.
