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News Breaks
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."
News For ACRX From The Last 14 Days
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September 26, 2014
16:15 EDTACRXOn The Fly: Closing Wrap
Stocks on Wall Street were higher, regaining much of their losses from yesterday, after GDP data showed the U.S. economy grew at its fastest pace in more than 2 years during the second quarter. Also helping improve sentiment was the significant earnings beat from Dow member Nike (NKE). ECONOMIC EVENTS: In the U.S., second quarter real GDP growth was revised up to 4.6% in the government's third estimate. This was raised from the prior 4.2% growth estimate, though the upward revision had been expected by analysts. The final University of Michigan consumer sentiment index for September came in at 84.6, which was unchanged from the preliminary print but up from the final August reading of 82.5. COMPANY NEWS: Shares of Nike climbed $9.75, or 12.23%, to $89.50 after the company reported stronger than expected results and provided better than expected profit guidance. Following last night's report, a number of analysts reacted positively in notes this morning, including Janney Capital, which upgraded the stock to Buy from Neutral. Meanwhile, Deutsche Bank upgraded Under Armour (UA) to Buy, citing continued sector strength evidenced in Nike's results. Under Armour gained $2.27, or 3.36%, to $69.82 following the report from the industry leader and Deutsche's ratings action. MAJOR MOVERS: Among the notable gainers was Janus Capital (JNS), which surged $4.60, or 41.43%, to $15.72 after the company unexpectedly announced that "Bond King" Bill Gross, formerly of PIMCO, will join as a fund manager this Monday. Afterward, Citigroup upgraded Janus to Neutral from Sell, citing Gross' hiring. Also higher was Yahoo (YHOO), which jumped $1.71, or 4.39%, to $40.66 after activist investor Starboard Value announced it has acquired a significant ownership stake in the company and urged it to explore a strategic combination with AOL (AOL). Shares of AOL also rose $1.58, or 3.68%, to $44.55 following Starboard's public disclosure of its recommendation to Yahoo. Among the noteworthy losers was Finish Line (FINL), which was left out of the Nike-fueled rally in the sneaker sector and fell $4.30, or 14.62%, to $25.11 after the company reported second quarter earnings and revenue that missed expectations. Following Finish Line's Q2 report, the stock and peer Foot Locker (FL) were both downgraded to Neutral from Buy at Bank of America Merrill Lynch. Also lower were shares of AcelRx (ACRX), which fell $1.31, or 19.49%, to $5.41 and was downgraded to Neutral at Roth Capital after the company said it has to resubmit for FDA approval of its Zalviso drug. INDEXES: The Dow advanced 167.35, or 0.99%, to 17,113.15, the Nasdaq gained 45.45, or 1.02%, to 4,512.19, and the S&P 500 rose 16.86, or 0.86%, to 1,982.85.
12:40 EDTACRXAcelRx downgraded to Neutral from Buy at Roth Capital
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07:03 EDTACRXAcelRx provides update on resubmission of Zalviso NDA
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