In a research report issued Friday, Jefferies analyst Matthew Andrews assumed coverage on shares of AcelRx Pharmaceuticals Inc (NASDAQ:ACRX), with a Buy rating and a $7.00 price target, which implies an upside of 208% from current levels.
In early June 2017, the FDA canceled a tentative joint Anesthetic and Analgesic Drug Products and Drug Safety and Risk Management Advisory Committee meeting in connection with its review of the Company’s New Drug Application (NDA) for DSUVIA for the treatment of moderate-to-severe acute pain. Andrews believes the reason in part has to do with the uncontroversial product profile; thus the analyst believes Dsuvia will be approved on its October 12, 2017, PDUFA date.
“While the FDA under Dr. Gottlieb is focused on addressing the U.S.’s opioid crisis, we believe this will largely focus on the appropriate use and duration of chronic (not acute) opioid therapy. The CHMP’s decision on the Dsuvia MAA in Europe is expected in H1 2018, and the EMA has already approved Zalviso (a 15mcg tablet of sufentanil). We probability weight our U.S. and Europe Dsuvia estimates at 75% and 80%, respectively,” Andrews said.
The analyst concluded, “ACRX is under-valued due to potent oral opioid Dsuvia’s promise in medicallysupervised acute pain markets (~92M patients) and we see high likelihood of U.S./EU approvals in Q4’17/H1’18. Risk/reward is favorable into H1’18 with floor of ~$1.25 (no approvals) vs. $12/share (upside scenario).”