H.C. Wainwright Reiterates Buy on AcelRx Pharmaceuticals Inc (ACRX) as ARX-04 Met All Endpoints in Phase 3 Study
In a research report released Monday, H.C. Wainwright analyst Ed Arce reiterated a Buy rating on shares of AcelRx Pharmaceuticals Inc (NASDAQ:ACRX) with a $8.50 price target, after the company announced positive top-line results of ARX-04 across the primary and all secondary endpoints of a pivotal Phase 3 study (SAP301) of the short-term treatment of patients with moderate-to-severe acute pain following ambulatory abdominal surgery. The analyst has raised his projected likelihood of approval for ARX-04 to 70% from 60%
Arce noted, “ARX-04 achieved the primary endpoint, the timeweighted summed pain intensity difference over the first 12 hours of treatment (SPID-12), with a score of +25.8 versus +13.1 for placebo (p<0.001). Further, the SPID-12 score of ARX-04 was superior to placebo at just 15 minutes, the earliest time point measured (p=0.002). There were two serious adverse events (SAEs) during the study, both in the placebo group. No patients on ARX-04 dropped out of the study prior to 24 hours due to an adverse event, and fewer patients on ARX-04 versus placebo dropped out of the study prior to 24 hours due to lack of efficacy.”
Furthermore, “Later this month, AcelRx expects to initiate an open-label Phase 3 safety study (SAP302) of ARX-04 in emergency room (ER) patients (NCT02447848).While we expect this study may further elucidate ARX-04’s rapid-acting profile, we note that this study principally serves to reach the minimum cumulative number of ARX-04 study patients for the patient safety database, as required by the FDA. AcelRx has requested a pre-NDA meeting with the FDA by year end, and we continue to expect the NDA filing of ARX-04 by mid-2016.”
According to TipRanks.com, which measures analysts’ and bloggers’ success rate based on how their calls perform, analyst Ed Arce has a total average return of 30.4% and a 44.1% success rate. Arce has a -34.0% average return when recommending ACRX, and is ranked #111 out of 3755 analysts.