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News Breaks
August 4, 2014
08:31 EDTIPXLImpax reports FDA re-inspected its manufacturing facility in California
Impax Laboratories announced that the FDA performed a re-inspection of the Company's Hayward, California manufacturing facility from June 16 to July 31. At the conclusion of the inspection, the FDA issued a Form 483 with seven inspectional observations, two of which are designated as repeat observations. The FDA did not provide any status or classification to these observations and, pursuant to its established regulatory process, will defer classification until it has reviewed the Company's response to the inspection.
News For IPXL From The Last 14 Days
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May 11, 2015
19:15 EDTIPXLOn The Fly: After Hours Movers
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16:43 EDTIPXLImpax performs GMP, pre-approval inspections of Impax Hayward facility
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16:15 EDTIPXLImpax says FDA issued Form 483 after facility inspection
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16:14 EDTIPXLImpax reaffirms outlook for 2015
Impax still sees 2015 adjusted gross margins as a percent of total revenue are expected to be in the mid 50% range, adjusted total research and development expenses across the generic and brand divisions of $80M-$85M and capital expenditures of $45M-$50M.
16:13 EDTIPXLImpax reports Q1 adjusted EPS 9c, consensus 18c
Reports Q1 revenue $143.1M, consensus $146.13M. The company said, "This quarter's revenues were negatively impacted by the later than anticipated close of the Tower acquisition, the delayed launch of lamotrigine ODT, which was launched in April due to delayed receipt of inventory from our supplier, and the deferred recognition of product sales from the launch of RYTARY. In addition, product sales mix in the combined portfolio as well as costs related to successfully launching RYTARY and the financing of the Tower acquisition led to a reduction in our first quarter earnings."
15:00 EDTIPXLNotable companies reporting after market close
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