Tuesday, July 25, 2017 2:29:11 PM
ACRX... It would be nice if price had some pullback ahead of earnings report....
July 14 was given a $7 price target...
Reports earnings Aug. 2nd or 3rd ? not sure correct date
FDA Calendar has 07/31 listed as looking at phase 3 trial...?
AcelRx Pharmaceuticals, Inc.'s Jefferies analyst Matthew Andrews assumed coverage on the stock. Andrews has put a $7.00 price target on AcelRx which had traders pretty excited.
According to Andrews, the company's DSUVIA, which is for the treatment of moderate to severe acute pain, will be approved on its October 12th, 2017 PDUFA date. Andrews said, "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.
In Europe... 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 also noted, "ACRX is under-valued due to potent oral opioid Dsuvia's promise in medically supervised acute pain markets (~92M patients) and we see a high likelihood of U.S./EU approvals in Q4'17/H1'18.
AcelRx Pharmaceuticals, Inc. is a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of moderate-to-severe acute pain. A New Drug Application (NDA) for DSUVIA™ (sufentanil sublingual tablet, 30 mcg), known as ARX-04 outside the United States, with a proposed indication for the treatment of moderate-to-severe acute pain in medically supervised settings, was accepted for filing by the United States Food and Drug Administration (FDA) and has been given a PDUFA date of October 12, 2017. In the EU, the European Medicines Agency (EMA) has notified the company that the ARX-04 (sufentanil sublingual tablet, 30 mcg) Marketing Authorisation Application (MAA) has passed validation and that the scientific review of the MAA is underway.
The company's follow on product candidate, ZALVISO® (sufentanil sublingual tablet system), is designed for the management of moderate-to-severe acute pain in adult patients in the hospital setting. The company has completed enrollment in a Phase 3 clinical trial, IAP312, for which it anticipates top-line data results in mid-2017. ZALVISO delivers 15 mcg sufentanil sublingually through a non-invasive delivery route via a pre-programmed, patient-controlled analgesia device. ZALVISO is approved in the EU and is investigational and in late-stage development in the U.S.
ACRX
July 14 was given a $7 price target...
Reports earnings Aug. 2nd or 3rd ? not sure correct date
FDA Calendar has 07/31 listed as looking at phase 3 trial...?
AcelRx Pharmaceuticals, Inc.'s Jefferies analyst Matthew Andrews assumed coverage on the stock. Andrews has put a $7.00 price target on AcelRx which had traders pretty excited.
According to Andrews, the company's DSUVIA, which is for the treatment of moderate to severe acute pain, will be approved on its October 12th, 2017 PDUFA date. Andrews said, "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.
In Europe... 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 also noted, "ACRX is under-valued due to potent oral opioid Dsuvia's promise in medically supervised acute pain markets (~92M patients) and we see a high likelihood of U.S./EU approvals in Q4'17/H1'18.
AcelRx Pharmaceuticals, Inc. is a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of moderate-to-severe acute pain. A New Drug Application (NDA) for DSUVIA™ (sufentanil sublingual tablet, 30 mcg), known as ARX-04 outside the United States, with a proposed indication for the treatment of moderate-to-severe acute pain in medically supervised settings, was accepted for filing by the United States Food and Drug Administration (FDA) and has been given a PDUFA date of October 12, 2017. In the EU, the European Medicines Agency (EMA) has notified the company that the ARX-04 (sufentanil sublingual tablet, 30 mcg) Marketing Authorisation Application (MAA) has passed validation and that the scientific review of the MAA is underway.
The company's follow on product candidate, ZALVISO® (sufentanil sublingual tablet system), is designed for the management of moderate-to-severe acute pain in adult patients in the hospital setting. The company has completed enrollment in a Phase 3 clinical trial, IAP312, for which it anticipates top-line data results in mid-2017. ZALVISO delivers 15 mcg sufentanil sublingually through a non-invasive delivery route via a pre-programmed, patient-controlled analgesia device. ZALVISO is approved in the EU and is investigational and in late-stage development in the U.S.
ACRX
Join the InvestorsHub Community
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
