AcelRx Pharmaceuticals Inc (NASDAQ:ACRX) saw its shares crater by as much as 62% today on exceptionally high volume. This drop was triggered by the announcement that the FDA issued a Complete Response Letter (CRL) in response to AcelRx’s New Drug Application (NDA) for DSUVIA.
DSUVIA is designed to reduce moderate-to-severe acute pain and dosing errors associated with IV administration via its non-invasive single-dose applicator (SDA) in medically supervised settings.
The CRL states that the FDA determined it cannot approve the NDA in its present form and provides recommendations needed for resubmission. The two primary recommendations within the CRL are: first, while the safety database was suitable in number of patients, the collection of additional data was requested on at least 50 patients to assess the safety of DSUVIA dosed at the maximum amount described in the proposed labelling; second, to ensure proper administration of the tablet with the single-dose applicator, the FDA recommended certain changes to the Directions for Use to address use-related errors, including dropped tablets, to be validated through a human factors study.
AcelRx CEO Vincent J. Angotti commented, “We believe the recommendations stated in the CRL are manageable and plan to fully cooperate with the FDA. We remain focused on the NDA resubmission and our mission to provide physicians and patients with precise and efficient non-invasive pain management options for moderate-to-severe acute pain within medically supervised settings.”
AcelRx will request a meeting with the FDA to discuss the topics covered in the CRL, and confirm plans to move towards resubmission of the DSUVIA NDA. AcelRx ended the third quarter with an estimated $67.9 million in cash and we will provide further financial updates on our third quarter earnings call.
On the ratings front, ACRX stock has been the subject of a number of recent research reports. In a report issued on August 25, RBC analyst Randall Stanicky reiterated a Buy rating on ACRX, with a price target of $6.00, which represents a potential upside of 186% from where the stock is currently trading. Similary, on August 7, H.C. Wainwright’s Ed Arce reiterated a Buy rating on the stock and has a price target of $7.00.
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Randall Stanicky and Ed Arce have a yearly average loss of 11% and a return of 33.2% respectively. Stanicky has a success rate of 26% and is ranked #4643 out of 4694 analysts, while Arce has a success rate of 54% and is ranked #104.
Overall, 2 research analysts have assigned a Hold rating and 4 research analysts have given a Buy rating to the stock. When considering if perhaps the stock is under or overvalued, the average price target is $7.00 which is 233.3% above where the stock opened today.
AcelRx Pharmaceuticals is a specialty pharmaceutical company, which engages in the development and commercialization of innovative therapies for the treatment of moderate-to-severe acute pain. Its product candidates is comprised of DSUVIA, and ZALVISO, which both contains sufentanil as a therapeutic ingredient.