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Stock Market & Financial Investment News

News Breaks
June 23, 2014
04:55 EDTACRX, ACRX, BLRX, BLRX, CRIS, CRIS, NEO, NEO, PRTA, PRTA, PTCT, PTCT, LGND, LGND, GALE, GALE, IPCI, IPCIRoth Capital to hold a conference
ROTH Healthcare Corporate Access Day to be held in London, England on June 23-24.
News For ACRX;BLRX;CRIS;NEO;PRTA;PTCT;LGND;GALE;IPCI From The Last 14 Days
Check below for free stories on ACRX;BLRX;CRIS;NEO;PRTA;PTCT;LGND;GALE;IPCI the last two weeks.
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July 28, 2014
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 23, 2014
09:33 EDTLGNDGlaxoSmithKline reports record Promacta/Revolade Q2 revenue of $92M
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08:57 EDTIPCIIntellipharmaceutics management to meet with Brean Capital
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July 22, 2014
15:46 EDTGALEGalena in-license of Zuplenz makes sense, says Piper Jaffray
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13:17 EDTLGNDLigand reports partner SAGE receives fast track designation for SAGE-547
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10:00 EDTPTCTOn The Fly: Analyst Initiation Summary
Today's noteworthy initiations include: Abengoa Yield (ABY) initiated with an Equal Weight at Morgan Stanley... Actinium Pharmaceuticals (ATNM) initiated with a Buy at Canaccord... Axys Technologies (AXYS) initiated with a Buy at Dougherty... Chambers Street Properties (CSG) initiated with a Neutral at SunTrust... Enphase Energy (ENPH) initiated with a Buy at Dougherty... Minerals Technologies (MTX) initiated with an Outperform at Wedbush... NextEra Energy Partners (NEP) initiated with a Buy at BofA/Merrill... PTC Therapeutics (PTCT) initiated with a Buy at BofA/Merrill... QIWI (QIWI) initiated with a Positive at Susquehanna... Quality Systems (QSII) initiated with a Buy at Topeka... Sarepta (SRPT) initiated with a Neutral at BofA/Merrill... Trinseo S.A. (TSE) initiated with a Buy at BofA/Merrill... Washington Prime Group (WPG) initiated with a Neutral at SunTrust... Zhaopin (ZPIN) initiated with a Buy at UBS.
09:55 EDTGALEGalena 'stands little chance' of improving Zuplenz sales, TheStreet says
After Galena BioPharma entered into a license agreement with MonoSol Rx for Zuplenz, TheStreet's Adam Feuerstein predicted that the company "stands little chance of delivering higher sales of Zuplenz than its previous marketer," calling the drug one that "no one wants" and "something to promote while waiting for the phase III study of NeuVax in breast cancer to inevitably fail." Reference Link
07:21 EDTGALEGalena enters into licensing agreement with MonoSol Rx
MonoSol Rx announced that it has licensed Zuplenz to Galena Biopharma. Zuplenz is an oral soluble film, or OSF, for the prevention of chemotherapy-induced, radiotherapy-induced, and postoperative nausea and vomiting. The licensing agreement includes an undisclosed upfront payment from Galena, as well as double digit royalty payments from sales of Zuplenz. Zuplenz is the first oral soluble lingual film product approved by the FDA as a prescription medication, based on MonoSol Rx's proprietary PharmFilm technology.
07:11 EDTPTCTPTC Therapeutics initiated with a Buy at BofA/Merrill
Target $37.
July 18, 2014
09:00 EDTACRXAcelRx attractive ahead of Zalviso PDUFA, says Roth Capital
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07:30 EDTPTCTPTC Therapeutics management to meet with JPMorgan
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