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February 27, 2014
07:46 EDTSLXP, RDHLSalix, RedHill Biopharma announce exclusive license agreement for RHB-106
Salix Pharmaceuticals (SLXP) and RedHill Biopharma (RDHL) announced that they have entered into an exclusive agreement by which Salix has licensed the worldwide exclusive rights to RedHill's RHB-106 encapsulated formulation for bowel preparation and rights to other purgative developments. Financial terms of the transaction include an upfront payment of $7M and $5M in subsequent milestone payments to RedHill. Salix also has agreed to pay RedHill tiered royalties on net sales, ranging from low single-digit up to low double-digits. Under the worldwide license agreement, the parties also agreed on potential strategic collaboration with regard to certain other Salix products in specific territories.
News For SLXP;RDHL From The Last 14 Days
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December 18, 2014
15:23 EDTSLXPSalix stake taken by Paulson & Co., Reuters reports
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15:12 EDTSLXPSalix stake taken by Paulson & Co., some holders urging sale, Reuters says
06:18 EDTRDHLRedHill Biopharma acquires techonology from University of Minnesota
RedHill Biopharma (RDHL) has entered into a license agreement with the University of Minnesota to acquire the rights to a patented technology to support the development of a commercial diagnostic test for detection of Mycobacterium avium subspecies paratuberculosis bacterium. RedHill's Crohn's disease program RHB-104, currently undergoing a first Phase III study, is based on evidence that Crohn's disease is caused by MAP infection in susceptible patients. As part of development for RHB-104, RedHill is developing, in collaboration with Quest Diagnostics (DGX), a diagnostic test to aid in detecting the presence of MAP in whole blood. RedHill will pay the University of Minnesota a one-time upfront payment and an additional potential milestone payment for the licensed technology. A pre-submission meeting with the FDA to discuss the development path for the diagnostic test is scheduled for January 2015.
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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06:14 EDTRDHLRedHill Biopharma enrolls first patients in Phase III study of RHB-102
Red Hill announced that the randomized, double-blind, placebo-controlled Phase III study with RHB-102 for acute gastroenteritis and gastritis is underway in the U.S., with a planned enrollment of 320 patients. Top-line results from the Phase III GUARD study are expected during 2H15. RedHill recently submitted a European Marketing Authorization Application seeking approval of RHB-102 for cancer patients suffering from chemotherapy and radiotherapy-induced nausea and vomiting. Results are intended to support potential future submissions of marketing applications in both the U.S. and Europe for this indication. In parallel, RedHill is pursuing marketing approval for RHB-102 for the indications of chemotherapy and radiotherapy-induced nausea and vomiting in Europe and the U.S.
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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