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dara biosciences inc (DARA) Key Developments

Dara Biosciences Receives Waiver of Approximately $1.1 Million for Product and Establishment Fees by the FDA

DARA BioSciences Inc. announced that it has been granted a barrier-to-innovation waiver for certain product and establishment fees. The Food and Drug Administration has granted company's request for a barrier-to-innovation waiver of the fiscal year 2012 product and establishment fees, fiscal year 2013 product fee, and fiscal year 2014 product and establishment fees for NDA, 21-807, Soltamox oral solution totaling approximately $1.1 million. A waiver or reduction in PDUFA fees may be appropriate when the product for which the waiver is being requested is innovative or the entity requesting the waiver is otherwise pursuing innovative drug products or technology, and the fee would be a significant barrier to the entity's ability to develop, manufacture, or market innovative products or technology. Specifically, the FDA acknowledged company's development work surrounding its KRN5500 asset during the years relating to the waiver, and determined that the imposition of the fees during those years created a significant financial barrier to the company. The company has requested a similar waiver for 2015. The FDA's Office of Financial Management (OFM) has been directed to refund the fees related to fiscal year 2012 already remitted by the company in the amount of approximately $619,000 which should be processed and refunded within 30 days from the waiver being granted. The fees related to fiscal years 2013 and 2014 which have not been remitted total approximately $480,000.

DARA BioSciences Receives Non-Compliance Notice From NASDAQ

On November 17, 2014, DARA BioSciences, Inc, received a notification letter from the Listing Qualifications Department of The NASDAQ Stock Market (NASDAQ) indicating that, for the last 30 consecutive business days, the bid price for the Company’s common stock has closed below the minimum $1.00 per share requirement for continued listing on The Nasdaq Capital Market under NASDAQ Listing Rule 5550(a)(2). In accordance with NASDAQ Listing Rule 5810(c)(3)(A), the Company has 180 calendar days, or until May 18, 2015, to regain compliance with the minimum $1.00 price per share requirement. To regain compliance, anytime before May 18, 2015, the bid price of the Company’s common stock must close at $1.00 per share or more for a minimum of 10 consecutive business days. NASDAQ’s notification letter has no effect on the listing of the Company’s common stock at this time. On May 18, 2015, if the Company meets The Nasdaq Capital Market initial listing criteria set forth in NASDAQ Listing Rule 5505, except for the minimum bid price requirement, it may be provided with an additional 180 calendar day compliance period to demonstrate compliance. If the Company is not eligible for an additional compliance period at that time, NASDAQ will provide the Company with written notification that its common stock will be delisted. Upon such notice, the Company may appeal the NASDAQ Staff’s determination to a NASDAQ Hearings Panel pursuant to the procedures set forth in the applicable NASDAQ Listing Rules. There can be no assurance that, if the Company appeals the NASDAQ Staff’s determination, such appeal would be successful.

DARA BioSciences, Inc Presents at 7th annual Biotech Showcase Conference 2015, Jan-12-2015 03:00 PM

DARA BioSciences, Inc Presents at 7th annual Biotech Showcase Conference 2015, Jan-12-2015 03:00 PM. Venue: Parc 55 Wyndham San, Francisco - Union Square, San Francisco, CA 94102, United States.

DARA BioSciences, Inc. Reports Earnings Results for the Third Quarter Ended September 30, 2014

DARA BioSciences Inc. reported earnings results for the third quarter ended September 30, 2014. For the quarter, the company reported net revenues of $597,800, as compared to net revenues of $138,900 for the third quarter ended September 30, 2013, a year over year increase of 330%. The company reported a loss attributable to controlling interest of approximately $2.1 million or $0.11 per share, as compared to a loss attributable to controlling interest of approximately $2.5 million, or $0.51 per share for the third quarter ended September 30, 2013.

DARA BioSciences, Inc to Report Q3, 2014 Results on Nov 05, 2014

DARA BioSciences, Inc announced that they will report Q3, 2014 results After-Market on Nov 05, 2014


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