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News Breaks
April 1, 2014
08:32 EDTPTXPernix Therapeutics agrees to divest Houston manufacturing operations
Pernix Therapeutics Holdings announced that it has signed a definitive agreement to divest its Houston, TX-based manufacturing operations, Pernix Manufacturing, LLC to Woodfield Pharmaceutical LLC. Woodfield will acquire the entire PML operation and will assume the mortgage associated with the facility. Pernix expects to receive approximately $1.2M in net proceeds at closing and realize approximately $5M in annualized cost savings from the divestiture. As part of the agreement, Woodfield will continue to manufacture the existing Pernix products under a long-term supply agreement. Pernix anticipates a closing of April 15. Closing of the transaction is subject to standard closing conditions and deliveries. In addition, closing on the sale of certain of the real estate assets may extend beyond the anticipated closing date.
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January 20, 2015
08:31 EDTPTXPernix Therapeutics sees Q4 net revenue in excess of $52M, consensus $46.26M
08:31 EDTPTXPernix Therapeutics sees FY14 net revenue in excess of $120M, consensus $114.16M
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January 15, 2015
15:45 EDTPTXPernix Therapeutics announces sNDA for Treximet accepted by FDA
Pernix Therapeutics Holdings announced that its supplemental New Drug Application, sNDA, for Treximet has been accepted by the FDA. Approval is expected in 2Q 2015, based on the anticipated Prescription Drug User Fee Act, PDUFA, action date. The company’s sNDA, submitted on November 14 seeks approval for Treximet for use in adolescent patients, age 12–17, for the acute treatment of migraine with or without aura. Included in the filing are safety and efficacy data sets from three trials conducted to evaluate the pharmacokinetic, efficacy, and long-term safety of Treximet for the acute treatment of adolescent migraine. To date, there is no sumatriptan or combination prescription medication for the treatment of acute migraine attacks with or without aura approved for use in this population. Presently, Treximet is approved in the U.S. for the acute treatment of migraine with or without aura in adults.

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