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Attention Biotech Investors: Mark Your Calendar For These November PDUFA Dates
Thursday, November 1, 2018 - 9:26am | 1612October was a volatile month for the markets, and biotech stocks were no exception. The iShares NASDAQ Biotechnology Index (NASDAQ: IBB) had slipped about 17 percent in the period. This compares to S&P 500's 7 percent retreat. As we enter the last leg of the year, here are a few PDUFA...
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AcelRx Shares React Positively To FDA Committee Briefing On Painkiller Candidate Dsuvia
Wednesday, October 10, 2018 - 12:32pm | 572A day after Trevena Inc (NASDAQ: TRVN) shares suffered a setback in reaction to a FDA committe's briefing document, another stock is trading higher following the release of a briefing document pertaining to its adcom review. What Happened The briefing document released by FDA's...
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Early FDA Approval Speculation Sends AcelRX Pharma Shares Soaring
Monday, October 2, 2017 - 3:55pm | 511AcelRx Pharmaceuticals Inc (NASDAQ: ACRX) shares have been on a tear and are trading near a two-year high after speculation started doing the rounds that its pain treatment candidate DSUVIA is poised to get early approval. About 3.25 million shares exchanged hands, roughly 2.5 times the average...
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Born On The Battlefield: AcelRx Awaits FDA Ruling On Device That Delivers Potent Opioid To Wounded Soldiers
Wednesday, August 30, 2017 - 12:07pm | 999It isn't easy being a small pharmaceutical company banking on FDA approval of a painkiller product in a nation gripped by an opioid epidemic. Consider AcelRx Pharmaceuticals Inc (NASDAQ: ACRX), which has developed a fast, under-the-tongue delivery system for the opioid called sufentanil. It...
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AcelRx CFO Shares Update On DoD Relationship And More After FDA Accepted NDA For DSUVIA
Tuesday, February 28, 2017 - 6:45pm | 774Micro-cap specialty pharmaceutical company AcelRx Pharmaceuticals Inc (NASDAQ: ACRX) announced Monday the FDA accepted its New Drug Application for DSUVIA, its treatment for moderate-to-severe acute pain in medically supervised settings. In addition, the federal agency set a PDUFA date of Oct. 12,...
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Exclusive: AcelRx Pharma Execs Discuss Stock Performance, Catalysts And Financial Position
Thursday, February 16, 2017 - 1:16pm | 810AcelRx Pharmaceuticals Inc (NASDAQ: ACRX) is a micro-cap company focused on the development and commercialization of therapies for the treatment of moderate-to-severe acute pain in medically supervised settings. What’s particularly interesting here is that the development of its lead product...
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AcelRx: Replacing Morphine With Department Of Defense Funding
Wednesday, February 15, 2017 - 12:08pm | 1007AcelRx Pharmaceuticals Inc (NASDAQ: ACRX) is a micro-cap company focused on the development and commercialization of therapies for the treatment of moderate-to-severe acute pain in medically supervised settings. Benzinga recently learned that the U.S. Department of Defense (DoD) had funded the...