On Wednesday, Shares of Pernix Therapeutics Holdings, Inc. (NASDAQ:PTX), dropped -0.67% to $7.44.
Pernix Therapeutics Holdings, declared that Pediatric Exclusivity has been granted by the U.S Food and Drug Administration (FDA) for studies conducted on Treximet® (sumatriptan/naproxen sodium), effective April 16, 2015, under section 505A of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355a). Based on this decision, an additional six months of U.S. market exclusivity will attach to the patents that are listed in FDA’s Orange Book for Treximet, or until February 14, 2018.
The approval of pediatric exclusivity does not mean that Treximet is approved for use in pediatric patients. Treximet is FDA-approved only for use in adults aged 18 and older. As formerly stated, on November 14, 2014, Pernix presented a sNDA seeking approval for Treximet for use in adolescent patients, age 12 – 17, for the acute treatment of migraine, with or without aura. Comprised of 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. The Company anticipates approval for Treximet in adolescent patients in the second quarter of 2015, based on the anticipated Prescription Drug User Fee Act (PDUFA) action date.
Pernix Therapeutics Holdings, Inc., a specialty pharmaceutical company, develops, manufactures, markets, and sells branded and generic pharmaceutical products. The company’s product comprise CEDAX, an oral cephalosporin used for the treatment of mild to moderate acute bacterial exacerbations of chronic bronchitis, middle ear infection due to haemophilus influenza, or streptococcus pyogene.
Shares of Rowan Companies plc (NYSE:RDC), declined -0.66% to $19.42, during its last trading session.
Rowan Companies, declared that its report of drilling rig status and contract information has been updated as of April 22, 2015.The report titled “Fleet Status Report” can be found on the Company’s website at www.rowan.com.
The Company continues to estimate planned out-of-service time for the first quarter and full-year of 2015 to range from 3% to 6% for its jack-ups and drillships, subject to fleet repositioning and market conditions.
Rowan Companies plc provides offshore oil and gas contract drilling services. It operates a fleet of 30 self-elevating mobile offshore jack-up drilling units, in addition to 3 ultra-deepwater drill ships.
At the end of Wednesday’s trade, Shares of Envision Healthcare Holdings, Inc. (NYSE:EVHC), dwindled -0.61% to $39.20.
Envision Healthcare Holdings, plans to release its 2015 first quarter operating results Thursday, April 30, 2015, after the securities market close, with a conference call to follow at 5 p.m. Eastern Time.
Envision Healthcare Holdings, Inc. provides physician-led, outsourced medical services to consumers, hospitals, healthcare systems, health plans, and government entities in the United States.
Finally, Sunstone Hotel Investors Inc. (NYSE:SHO), ended its last trade with -0.61% loss, and closed at $16.34.
Sunstone Hotel Investors, declared that it will report financial results for the first quarter 2015 on Monday, May 4, 2015 after the market closes. Administration will hold its quarterly conference call the next day, on Tuesday, May 5, 2015 at 12:00 p.m. Eastern Time (9:00 a.m. Pacific Time).
Sunstone Hotel Investors, Inc. operates as a real estate investment trust. The firm engages in the acquisition, ownership, asset administration, renovation, and sale of luxury, upper upscale, and upscale full-service hotels in the United States.
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