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Stock Market & Financial Investment News

News Breaks
December 13, 2012
15:08 EDTACRXPerceptive Advisors reports 14.25% passive stake in AcelRx
News For ACRX From The Last 14 Days
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July 29, 2014
10:00 EDTACRXOn The Fly: Analyst Downgrade Summary
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06:38 EDTACRXAcelRx downgraded to Neutral from Overweight at Piper Jaffray
Piper Jaffray downgraded AcelRx to Neutral citing an uncertain regulatory outlook for Zalviso after the company received a Complete Response Letter from the FDA. Piper lowered its price target for shares to $8 from $14.
July 28, 2014
16:32 EDTACRXOn The Fly: Closing Wrap
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12:21 EDTACRXOn The Fly: Midday Wrap
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11:00 EDTACRXHigh option volume stocks:
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10:02 EDTACRXOn The Fly: Analyst Downgrade Summary
Today's noteworthy downgrades include: AcelRx (ACRX) downgraded to Hold from Buy at Canaccord... Anglo American (AAUKY) downgraded to Neutral from Buy at UBS... Aon plc (AON) downgraded to Hold from Buy at Sandler ONeill... Cabot Oil & Gas (COG) downgraded at Oppenheimer... Cisco (CSCO) downgraded to Sector Perform from Outperform at Pacific Crest... Coeur Mining (CDE) downgraded to Market Perform from Outperform at Raymond James... DSW (DSW) downgraded at Sterne Agee... DuPont Fabros (DFT) downgraded to Neutral from Buy at Citigroup... El Paso Electric (EE) downgraded to Hold from Buy at Jefferies... Enphase Energy (ENPH) downgraded to Hold from Buy at Deutsche Bank... GlaxoSmithKline (GSK) downgraded to Neutral from Buy at BofA/Merrill... Horizon Technology (HRZN) downgraded to Hold from Buy at Wunderlich... Lear (LEA) downgraded to Hold from Buy at Deutsche Bank... Life Time Fitness (LTM) downgraded at Wedbush... Monster Beverage (MNST) downgraded to Neutral from Buy at UBS... NRG Energy (NRG) downgraded to Buy from Conviction Buy at Goldman... PG&E (PCG) downgraded to Sell from Neutral at Goldman... Pfizer (PFE) downgraded at BMO Capital... Post Properties (PPS) downgraded to Neutral from Buy at Citigroup... Publicis (PUBGY) downgraded to Sell from Neutral at Citigroup... Selmer Scientific (SMLR) downgraded to Hold from Buy at Aegis... TransCanada (TRP) downgraded to Neutral from Outperform at Credit Suisse... Travelers (TRV) downgraded to Hold from Buy at Sandler O'Neill... Zurich Insurance (ZURVY) downgraded to Underperform from Market Perform at Bernstein.
09:17 EDTACRXOn The Fly: Pre-market Movers
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08:56 EDTACRXAcelRx price target lowered to $12 from $14 at JMP Securities
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07:18 EDTACRXAcelRx price target lowered to $12 from $15 at RBC Capital
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06:32 EDTACRXAcelRx downgraded to Hold from Buy at Canaccord
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05:58 EDTACRXAcelRx to host conference call
Conference call to discuss the Zalviso Complete Response Letter will be held on July 28 at 8:30 am. Webcast Link
July 27, 2014
13:25 EDTACRXFDA issues Complete Response Letter for AcelRx NDA for Zalviso
AcelRx Pharmaceuticals announced that the U.S. Food and Drug Administration, FDA, has issued a Complete Response Letter, CRL, for the company's new drug application, NDA, for Zalviso, sufentanil sublingual tablet system. The company is currently reviewing the FDA's comments and requests contained in the CRL and plans to discuss these requests with the FDA.The CRL contains requests for additional information on the Zalviso System to ensure proper use of the device. The requests include provision of bench data demonstrating a reduction in the incidence of optical system errors which require premature drug cartridge change, changes to the Instructions for Use for the device, and additional data to support the shelf life of the product. We believe some of the requests have been addressed in amendments to the NDA that have been submitted prior to the receipt of the CRL but, as acknowledged by the FDA, have not been reviewed. There is no guarantee that the information previously provided to the FDA will be adequate to address the issues in the CRL. Additional bench testing will be required and human factors testing may be required to address certain items in the CRL. There were no requests to conduct additional human clinical studies. "We believe we can satisfy all of FDA's requests in the CRL and resubmit the NDA by the end of 2014, although we will have more clarity on the process and timing after our conversation with FDA," said Richard King, president and CEO of AcelRx. "We are confident in the Zalviso development program and will work closely with the FDA to address the Agency's concerns as outlined in the CRL to ensure that healthcare professionals and patient communities will have access to Zalviso."
July 25, 2014
17:58 EDTACRXAcelRx trading halted, pending news
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15:43 EDTACRXAcelRx volatility elevated into July 27 PDUFA date for Zalviso
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09:25 EDTACRXOn The Fly: Pre-market Movers
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05:24 EDTACRXAcelRx confirms July 27 PDUFA date for Zalviso
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July 18, 2014
09:00 EDTACRXAcelRx attractive ahead of Zalviso PDUFA, says Roth Capital
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