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News Breaks
July 14, 2014
07:07 EDTPGNX, SLXPFDA says RELISTOR can be approved on data submitted in sNDA
Salix Pharmaceuticals (SLXP) and Progenics Pharmaceuticals (PGNX) announced that the Food and Drug Administration has informed Salix that RELISTOR can be approved on the data submitted in the sNDA. The FDA Office of Drug Evaluation III responded to the company’s formal appeal filed in response to the Complete Response Letter of July 27, 2012 to the supplemental NDA ) for RELISTOR. The Agency’s letter stated that, “Salix’s request that FDA approve the supplemental NDA for RELISTOR subcutaneous injection for the treatment of opioid-induced constipation in patients with chronic non-cancer pain based on the submitted data is granted.” This request for a proposal for a post-marketing observational study is in accordance with recommendations of the June 11-12, 2014 meeting of the Anesthetic and Analgesic Drug Product Advisory Committee. Salix will work with the DGIEP in an effort to provide information to the division that will enable the division to approve RELISTOR for use by patients with chronic non-cancer pain and experiencing OIC.
News For SLXP;PGNX From The Last 14 Days
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December 17, 2014
10:02 EDTSLXPOn The Fly: Analyst Downgrade Summary
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09:05 EDTSLXPSalix reinstated with a Market Perform from Outperform at JMP Securities
After Salix provided an updated plan for an expedited inventory work-down, issued 2015-2016 guidance,and announced a three month extension of its Xifaxan IBS PDUFA, JMP Securities thinks the company's guidance reflects unsustainable low tax rates. The firm believes the PDUFA delay may indicate that there are higher odds that the company will have to face another Advisory Committee meeting which Salix does not expect. The firm does not expect the company to be bought in the near-term.
08:41 EDTSLXPSalix price target raised to $127 from $108 at Leerink
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07:54 EDTSLXPSalix price target raised to $147 from $117 at Canaccord
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07:38 EDTSLXPSalix price target raised to $136 from $116 at UBS
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07:27 EDTSLXPSalix price target raised to $123 from $103 at Jefferies
Jefferies raised its price target for Salix Pharmaceuticals shares to $123 saying the company's accelerated inventory drawdown is one year ahead of expectations. It also notes that while the PDUFA was extended for Xifaxan IBS-D, not complete response letter was issued. Jefferies still expects FDA approval in FY15 and keeps a Buy rating on Salix.
07:24 EDTSLXPSalix price target raised to $130 from $119 at Piper Jaffray
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December 16, 2014
12:46 EDTSLXPSalix still ideal takeover target as destocking accelerated, says Brean Capital
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09:16 EDTSLXPOn The Fly: Pre-market Movers
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07:07 EDTSLXPSalix expects to achieve wholesale inventory targets by year-end 2015
07:07 EDTSLXPSalix sees FY16 EPS $8.50-$9.50
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07:06 EDTSLXPSalix sees FY15 EPS $3.10-$4.10, consensus $4.49
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07:04 EDTSLXPSalix says FDA extends PDUFA data for Xifaxan 550 to May 27, 2015
Salix announced that on December 15, 2014, the FDA provided written notice to the company that it has extended the Prescription Drug User Fee Act Action Date for XIFAXAN 550 for the treatment of irritable bowel syndrome with diarrhea, or IBS-D, to May 27, 2015. The company remains confident that FDA approval for XIFAXAN 550 for the treatment of IBS-D will be obtained, and it maintains its previously-announced peak year sales estimate for this product of approximately $2.1B. However, there is no assurance that FDA approval will be obtained in a timely manner or at all.
07:03 EDTSLXPSalix accelerating reduction of wholesale inventory levels of Xifaxan 550
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07:02 EDTSLXPSalix withdraws previously issued guidance for Q4, FY14
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December 10, 2014
13:59 EDTSLXPSalix shares defended at Sterne Agee
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December 4, 2014
14:49 EDTSLXPSalix, Shire rise after analyst says merger would be 'attractive'
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