NEW YORK, NY / ACCESSWIRE / November 5, 2018 / AcelRx Pharmaceuticals saw big gains this past Friday after announcing third quarter results and an update on DSUVIA receiving FDA approval. Shares of Sage Therapeutics were halted after its treatment Zulresso, was recommended by an FDA approval for postpartum depression.
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AcelRx Pharmaceuticals, Inc.
Sage Therapeutics, Inc.
AcelRx Pharmaceuticals, Inc. shares closed up 15.66% on about 20 million shares traded on Friday. Trading volume was tremendous compared to usual as the stock's average trading volume is just under 2.3 million shares. The stock hit a new high of $5.05 despite missing estimates in third quarter results. Traders were excited as the pharmaceutical company’s opioid pain drug got a nod from the U.S. FDA. It was in October that the Anesthetic and Analgesic Drug Products Advisory Committee of the U.S. Food and Drug Administration (FDA) voted 10-3 in favor of recommending the approval of DSUVIA™. DSUVIA is indicated for use in adults in a certified medically supervised healthcare setting, such as hospitals, surgical centers, and emergency departments, for the management of acute pain in adult patients severe enough to require an opioid analgesic, and for which alternative treatments are inadequate. "The FDA's previously announced approval of DSUVIA is a notable achievement for all AcelRx stakeholders, which we anticipate will lead to improved care for patients in acute pain," said Vince Angotti, Chief Executive Officer of AcelRx. He added, "Our third-quarter results demonstrate sustained discipline in our financial management, which we expect to continue as we plan for the commercial launch of DSUVIA, targeted for the first quarter of next year." The Company reported loss of $12.5 million or 21 cents per share in its third quarter. Analysts were hoping for a loss per share of 20 cents. Company’s revenue of $377,000 were also below street’s expectations.
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Sage Therapeutics, Inc. shares were halted this past Friday as an advisory panel to the FDA has recommended the company's experimental treatment for postpartum depression. In an overwhelming 17-1 vote, the panel was in favor of Zulresso, an injectable treatment as the benefits outweigh the risk. The treatment is aimed to treat major episodes of depression during pregnancy or within four weeks after delivery. Panel member Felipe Jain stated, "I believe that (Zulresso) may be a game changer in the treatment of postpartum depression. This is what hope looks like." The panel has however applied a risk evaluation and mitigation strategy (REMS) program to improve the safety of the product. Another panel member, Steven Meisel has said there is a need for a "black box" warning which highlights the risks of patients hurting themselves or their babies because of losing consciousness. Certain patients on the treatment had lost consciousness.
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