Key Developments: Salix Pharmaceuticals Ltd (SLXP.OQ)

SLXP.OQ on NASDAQ Stock Exchange Global Select Market

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21 Nov 2014
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Latest Key Developments (Source: Significant Developments)

Morgan & Morgan files class action lawsuit against Salix Pharmaceuticals
Monday, 10 Nov 2014 11:40am EST 

Morgan & Morgan:Files a class action lawsuit in the United States District Court for the Southern District of New York on behalf of purchasers of Salix Pharmaceuticals Ltd securities between Nov. 8, 2013 and Nov. 6.Complaint alleges that the company and certain of its officers and/or directors violated Sections 10(b) and 20(a) of the Securities Exchange Act of 1934.Complaint also alleges that defendants made certain false and misleading statements and allegedly concealed certain material information regarding deteriorating demand for Salix's top-selling drug XIFAXAN (rifaximin) and other Salix drugs.  Full Article

Salix Pharmaceuticals Ltd gives Q4 2014 guidance below analysts' estimates; lowers FY 2014 guidance
Thursday, 6 Nov 2014 04:13pm EST 

Salix Pharmaceuticals Ltd:Expects Q4 2014 total net product revenue of about $325 million.Expects Q4 2014 EBITDA, excluding expenses associated with the acquisition of Santarus and the terminated merger with Cosmo Technologies Limited, of about $120 million.Expects Q4 2014 non-GAAP net income of about $92 million, or $1.16 per diluted share.Expects FY 2014 total net product revenue of about $1.4 billion.Expects FY 2014 EBITDA, excluding expenses associated with the acquisition of Santarus and the terminated merger with Cosmo Technologies Limited, of about $573 million.Excepts FY 2014 Non-GAAP net income of about $400 million, or $5.20 per diluted share.Q4 2014 revenue of $436 million, EBITDA of $192 million, net income of $157 million and EPS of $1.95 - Thomson Reuters I/B/E/S.FY 2014 revenue of $1.60 billion, EBITDA of $674 million, net income of $473 million and EPS of $6.17 - Thomson Reuters I/B/E/S.  Full Article

Salix Pharmaceuticals appoints acting Chief Financial Officer
Thursday, 6 Nov 2014 04:01pm EST 

Salix Pharmaceuticals Ltd:Announces that the appointment of Timothy J. Creech as Acting Chief Financial Officer of the company, effective immediately.Timothy J. Creech succeeds Adam C. Derbyshire, who resigned his position at the company.  Full Article

Salix Pharmaceuticals grants final approval for UCERIS
Wednesday, 8 Oct 2014 08:30am EDT 

Salix Pharmaceuticals Ltd:Says FDA approves UCERIS (Budesonide) 2mg Rectal Foam for the Induction of Remission of Mild-to-Moderate Distal Ulcerative Colitis.Says Food and Drug Administration (FDA) has granted final approval for UCERIS (budesonide) rectal foam for induction of remission in patients with active mild-to-moderate distal ulcerative colitis (UC) extending up to 40cm from anal verge.The foam is rectally administered corticosteroid that overcomes treatment limitations associated with currently approved therapies which are often ineffective due to insufficient distribution of active drug to distal colon.On Sept. 15 the FDA tentatively approved UCERIS rectal foam pending expiration of 45-day waiting period.Waiting period has expired and FDA has granted UCERIS rectal foam final approval as of Oct. 7.  Full Article

Salix Pharmaceuticals Ltd and Cosmo Pharmaceuticals SpA announce termination of merger agreement
Friday, 3 Oct 2014 12:01am EDT 

Salix Pharmaceuticals Ltd and Cosmo Pharmaceuticals SpA:Agree to terminate their previously-announced merger agreement pursuant to which Salix would have combined with, and become wholly owned subsidiary of, Cosmo Technologies Limited, subsidiary of Cosmo.Under terms of termination, which is effective immediately, Salix will make $25 million payment to Cosmo.  Full Article

FDA approves Salix Pharmaceuticals Inc's Relistor Subcutaneous Injection for the treatment of opioid-induced constipation in patients with chronic non-cancer pain
Monday, 29 Sep 2014 05:30pm EDT 

Salix Pharmaceuticals Ltd:Says the company and Progenics Pharmaceuticals, Inc announced that the Food and Drug Administration has approved RELISTOR (methylnaltrexone bromide) Subcutaneous Injection, 12 mg/0.6ml, for the treatment of opioid-induced constipation in patients taking opioids for chronic non-cancer pain.RELISTOR subcutaneous injection is currently the only available peripherally acting mu opioid receptor antagonist (PAMORA) that is approved for treating OIC at the cause without interfering with the centrally acting analgesic properties of the opioid.  Full Article

Salix Pharmaceuticals Inc announces FDA user fee goal date of Feb. 28, 2015 for XIFAXAN 550mg sNDA for Treatment of Irritable Bowel Syndrome with Diarrhea
Thursday, 18 Sep 2014 01:42pm EDT 

Salix Pharmaceuticals Inc:Says the Food and Drug Administration (FDA) considers the Company's Aug. 29, resubmission of its supplemental New Drug Application (sNDA) for XIFAXAN 550 mg tablets for the proposed indication of the treatment of irritable bowel syndrome with diarrhea or IBS-D to be complete.The resubmission is considered a class 2 response to the FDA's March 7, 2011 action letter and has been assigned a user fee goal date of February 28, 2015.  Full Article

Salix Pharmaceuticals Inc's UCERIS (budesonide) 2mg Rectal Foam for Induction of Remission of Mild-to-Moderate Distal Ulcerative Colitis Granted Tentative Approval by FDA
Monday, 15 Sep 2014 05:31pm EDT 

Salix Pharmaceuticals Inc:Says the FDA has granted tentative approval for UCERIS (budesonide) rectal foam for the induction of remission in patients with active mild-to-moderate distal ulcerative colitis (UC) extending up to 40cm from the anal verge.The foam is a rectally administered corticosteroid that overcomes treatment limitations associated with currently approved therapies which are often ineffective due to insufficient distribution of active drug to the distal colon.The FDA's tentative approval of this product means that Salix's product meets all of the FDA's manufacturing quality and clinical safety and efficacy standards and will be granted final approval upon the resolution of patent issues.Salix anticipates resolution of patent issues early in the fourth quarter of 2014 and the launch of UCERIS rectal foam during the first quarter of 2015.  Full Article

Salix Pharmaceuticals Inc submits response to XIFAXAN 550mg complete response letter regarding repeat treatment for irritable bowel syndrome with diarrhea
Tuesday, 2 Sep 2014 07:19am EDT 

Salix Pharmaceuticals Inc:Says it submitted its response to the March 7, 2011, FDA Complete Response Letter (CRL) regarding the company's supplemental New Drug Application (sNDA) for XIFAXAN(reg) 550 mg tablets for proposed indication of treatment of irritable bowel syndrome with diarrhea or IBS-D.Says upon receipt of Salix's response, the FDA will have six months to issue a response.  Full Article

Salix Pharmaceuticals Ltd announces important topline results for microbiome, culture & susceptibility, and key secondary efficacy results for TARGET 3, Rifaximin IBS-D Repeat treatment study
Monday, 11 Aug 2014 02:00pm EDT 

Salix Pharmaceuticals Ltd:Says topline results from analysis of microbiome, culture and susceptibility, and two key secondary efficacy endpoints from data collected in TARGET 3-Phase 3 randomized, double-blind, placebo-controlled study.To evaluate efficacy and safety of repeat treatment with rifaximin 550 mg TID (three times daily) for 14 days in subjects with irritable bowel syndrome with diarrhea, or IBS-D, who respond to initial treatment course with rifaximin 550 mg TID for 14 days.  Full Article

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