NEW YORK, NY / ACCESSWIRE / October 11, 2018 / Neovasc Inc. shares and AcelRx Pharmaceuticals shares were both winning big in Wedneday’s session on positive FDA developments. Neovasc headed higher on news that the FDA has granted Breakthrough Device designation to the Neovasc Reducer™. AcelRx Pharmaceuticals jumped after FDA staff had said the company's opioid painkiller was safe and effective for use based on resubmitted data.
RDI Initiates Coverage on:
Neovasc Inc.
https://www.rdinvesting.com/report/?ticker=NVCN
AcelRx Pharmaceuticals, Inc.
https://www.rdinvesting.com/report/?ticker=ACRX
Neovasc Inc. shares were up nearly 14.75% at the close on Wednesday on nearly 32 million shares traded. The stock saw its trading volume skyrocket compared to its average trading volume of just around 425,000 shares. The big commotion came after the developer of minimally invasive transcatheter mitral valve replacement technologies and in the development of minimally invasive devices for the treatment of refractory angina, announced that the U.S. Food and Drug Administration has granted Breakthrough Device designation to the Neovasc Reducer™. This is a medical device for the treatment of refractory angina, which is not currently approved for commercial sale in the U.S. Company CEO Fred Colen, remarked, "We are pleased that the FDA has approved our request for Breakthrough Device designation for the Reducer. We will now start a process of further discussions and filings with the FDA, to obtain further guidance as to the regulatory pathway for entrance into the U.S. market. This designation supports our belief that this technology offers a significant benefit to patients suffering from refractory angina. We look forward to working closely with FDA through this regulatory process."
Access RDI’s Neovasc Inc. Research Report at:
https://www.rdinvesting.com/report/?ticker=NVCN
AcelRx Pharmaceuticals, Inc. shares closed up nearly 35.66% on about 30 million shares traded yesterday with an additional 7.93% in gains seen in extended hours of trading. The jump came after Wall Street learned that FDA staff had said the company's opioid painkiller was safe and effective for use based on resubmitted data. An advisory panel to the FDA will vote on the drug on Friday, before the regulator’s final decision by Nov 3. The staff reviewers are still concerned over the risk of accidental exposure due to misplaced tablets. The FDA's Anesthetic and Analgesic Drug Products Advisory Committee is evaluating the company's new drug application for Dsuvia. The committee said the dosage regimen appear effective in the drug's proposed population and reasonably safe in the context of existing opioid therapy.
Access RDI’s AcelRx Pharmaceuticals, Inc. Research Report at:
https://www.rdinvesting.com/report/?ticker=ACRX
Our Actionable Research on Neovasc Inc. (NASDAQ: NVCN) and AcelRx Pharmaceuticals, Inc. (NASDAQ: ACRX) can be downloaded free of charge at Research Driven Investing.
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SOURCE: RDInvesting.com