Salix Pharmaceuticals Inc fka SLXP

[OffTheGrid]

Obama’s tax rules claim first casualty

The Hill

[RidingFreeShares]

$SLXP Up Pre-Market on Terminated Merger deal. Loses $25mil in the process. Sounds like management couldn't mesh well... lol.

http://ih.advfn.com/p.php?pid=nmona&article=63908576

[maytepper]

$SLXP Cantor Fitzgerald Reiterates Buy On Salix Pharma, Increases PT To $181 http://t.co/WgMomIv6Va

[Skitradr]

NP........GL

[AnG5640]

Ahhhhh.. Thx!

[Skitradr]

Or I mean " buying" them

[Skitradr]

AGN bought them

[AnG5640]

What's going on here today??

[AnG5640]

Nice volume today!

[Eliot Ness]

Salix bought Santarus. Santarus won a patent infringment case against Par Pharmaceutical. Has Par paid damages? %200,000,000.00?

[RealGenius]

200K shares AH

[W3Research]

Interesting Chart.

[surf1944]

http://www.secform4.com/insider-trading/1009356.htm

short sale prospect

[surf1944]

7:02AM Salix Pharma announced FDA approved Fulyzaq 125 mg delayed-release tablets for the symptomatic relief of diarrhea in patients with HIV/AIDS on anti-retroviral therapy (SLXP) 40.49 : Co announced that the FDA has approved Fulyzaq 125 mg delayed-release tablets for the symptomatic relief of non-infectious diarrhea in adult patients with human immunodeficiency virus (HIV)/ acquired immune deficiency syndrome (AIDS) on anti-retroviral therapy. The FDA approval of Fulyzaq is based on a randomized, double-blind, placebo-controlled and placebo-free, multi-center study of 374 HIV-positive patients on ART, with a history of diarrhea for one month or more. The primary efficacy endpoint was the proportion of patients experiencing less than or equal to two watery bowel movements per week, during at least two of the four weeks of the placebo-controlled phase of the study. Patients who received concomitant anti-diarrheal medications or opiates were counted as clinical non-responders.

[surf1944]

30-Nov-12 Mizuho Initiated Buy

[surf1944]

7:01AM Salix Pharma: FDA continues review of crofelemer New Drug Application beyond PDUFA goal date of September 5, 2012 (SLXP) 43.95 : Co announced that the FDA has advised the Company that its New Drug Application (NDA) for crofelemer 125 mg tablets, for the proposed indication of symptomatic relief of non-infectious diarrhea in patients with HIV/AIDS on anti-retroviral therapy, is still under review and that a final action will not be taken by the scheduled Prescription Drug User Fee Act (PDUFA) goal date of September 5, 2012. "We look forward to this continuing collaboration, and at this time anticipate an action by the FDA on our NDA by the end of the first quarter of 2013

[surf1944]

12:22AM Salix Pharma and Progenics Pharmaceuticals (PGNX) receive Complete Response Letter from FDA for RELISTOR sNDA (SLXP) 53.19 : Salix Pharmaceuticals (SLXP) and Progenics Pharmaceuticals (PGNX) received a Complete Response Letter from the FDA following its review of a Supplemental New Drug Application for RELISTOR injection for subcutaneous use for the treatment of opioid-induced constipation in adult patients with chronic, non-cancer pain. The CRL requests additional clinical data. Salix and Progenics intend to request an End-of-Review meeting with the Division of Gastroenterology and Inborn Errors Products to better understand the contents of the CRL.

[surf1944]

Salix Pharmaceuticals Reports 1Q2012 Results

62% Increase in Year-over-Year 1Q Product Revenue

27% Increase in Year-over-Year 1Q XIFAXAN® Prescriptions on a Milligram Basis

36% Increase in Year-over-Year 1Q APRISO® Prescriptions

Completed Placement of $690 Million of Senior Convertible Notes

Initiated XIFAXAN Retreatment Trial for Irritable Bowel Syndrome with Diarrhea

Business WirePress Release: Salix Pharmaceuticals, Ltd. – Mon, May 7, 2012 4:01 PM EDT

RALEIGH, N.C.--(BUSINESS WIRE)--

Salix Pharmaceuticals, Ltd. (NASDAQ:SLXP - News) today announced financial and operating results for the first quarter ended March 31, 2012 and other business updates.

Total product revenue was $171.1 million for the first quarter of 2012, a 62% increase compared to $105.9 million for the first quarter of 2011. XIFAXAN® revenue for the first quarter of 2012 was $112.9 million, a 40% increase compared to $80.7 million for the first quarter of 2011. APRISO® revenue for the first quarter of 2012 was $15.1 million, a 44% increase compared to $10.5 million for the first quarter of 2011. The revenue contribution of newly-introduced products - RELISTOR®, SOLESTA® and DEFLUX®- contributed to the 62% increase in year-over-year total product revenue for the first quarter of 2012 compared to the first quarter of 2011.

Total cost of products sold was $34.2 million for the first quarter of 2012 compared to $18.6 million for the first quarter of 2011. Gross margin on total product revenue was 80.0% for the first quarter of 2012 compared to 82.4% for the first quarter of 2011. Research and development expenses were $26.7 million for the first quarter of 2012 compared to $31.0 million for the prior year period. Selling, general and administrative expenses were $60.4 million for the first quarter of 2012 compared to $46.7 million for the prior year period. The Company reported GAAP net income of $10.0 million, or $0.15 per share, fully diluted, for the first quarter of 2012.

Net income on a non-GAAP basis, excluding the loss on extinguishment of debt and non-cash adjustments related to the repurchase of a portion of our 2028 Notes in March 2012, the difference between income taxes paid and income taxes expensed, and non-cash depreciation, amortization, stock-based compensation and convertible debt interest expense, was $44.7 million, or $0.67 per share, fully diluted, for the three-month period ended March 31, 2012. We believe these non-GAAP measures might provide investors additional relevant information, in part for purposes of historical comparison. In addition, we use these non-GAAP measures to analyze our performance in more detail and with better historical comparability; however, you should be aware that non-GAAP measures are not superior to, nor a substitute for, the comparable GAAP measures. A reconciliation of our non-GAAP measures to the comparable GAAP measures is provided in the accompanying financial table.

Cash and cash equivalents were $665.9 million as of March 31, 2012

Adam Derbyshire, Executive Vice President and Chief Financial Officer, stated, “XIFAXAN 550 mg continued to perform well during the first quarter of 2012. During the quarter our XIFAXAN prescription business, comprised of XIFAXAN 200 mg tablets and XIFAXAN 550 mg tablets, demonstrated impressive growth, on a milligram basis, of 27% compared to the first quarter of 2011. APRISO also demonstrated strong prescription year-over-year growth of 36% for the first quarter of 2012 compared to the first quarter of 2011.

“We are revising our estimate of 2012 financial guidance to reflect the effect of the March 16, 2012 placement of $690 million of convertible senior notes. Additionally, our estimate of 2012 adjusted net income includes adjustments relating to the impact of the following non-cash items: loss on extinguishment of debt, depreciation, amortization, stock-based compensation, convertible debt discount amortization and the difference between income taxes paid and income taxes expensed.
2012 Guidance
(In millions except per share data)





2012

GAAP

Guidance
2012
Adjustments


2012

As

Adjusted
Revenues:
Net product revenues $ 735 $ 735

Costs and Expenses:
Cost of products sold 145 145
Amortization of product rights and intangible assets 42 (42 ) -
Research and development 140 (5 ) 135
Selling, general and administrative 269 (18 ) 251
Total costs and expenses 596 (65 ) 531

Income from operations 139 65 204
Loss on extinguishment of debt (14 ) 14 -
Interest expense (57 ) 37 (20 )
Interest and other income 12 (9 ) 3
Income before income tax 80 107 187
Income tax expense 38 (17 ) 21

Net Income $ 42 $ 124 $ 166

Income per share, basic $ 0.72 $ 2.14 $ 2.86
Income per share, diluted $ 0.66 $ 1.94 $ 2.59
Shares used in computing net income per share, basic 58 58 58
Shares used in computing net income per share, diluted 64 64 64

“The current annualized run rates, based on dollarizing the March 2012 prescription data for XIFAXAN, our bowel cleansing products, APRISO, RELISTOR (U.S.), and our ’other products’, are approximately $442 million, $104 million, $71 million, $28 million, and $44 million, respectively. Based on the full year 2012 guidance provided above, for the second quarter of 2012 we anticipate total Company product revenue should be approximately $180 million and adjusted net income should be approximately $32 million, or $0.51 per share, fully diluted, on the non-GAAP basis described above.”

Carolyn Logan, President and Chief Executive Officer, stated, “XIFAXAN continues to grow sequentially, with prescriptions, on a milligram basis, increasing 5.4% for the first quarter of 2012 compared to the fourth quarter of 2011. APRISO also continued to exceed the Company’s expectations during the quarter. APRISO prescriptions increased 6.3% during the first quarter of 2012 compared to the fourth quarter of 2011. RELISTOR prescriptions increased 22.3% during the first quarter of 2012 compared to the fourth quarter of 2011.

“Salix continued to execute its plan and to progress in the commercial and product development arenas during the first quarter of 2012. A commercial milestone for the period was the March launch of SOLESTA® and DEFLUX® by the Salix sales force. SOLESTA is a first-in-class, biocompatible tissue bulking agent for the treatment of fecal incontinence. Fecal incontinence is estimated to affect approximately 15% of people in the United States over the age of 50 and is the leading reason for admission to assisted living facilities in the United States. In December 2011 the Company submitted an application to the Centers for Medicare and Medicaid Services (CMS) to secure a Healthcare Common Procedure Coding, or HCPC code, for reimbursement purposes for SOLESTA. DEFLUX is the only FDA-approved alternative to major ureteral reimplantation surgery for the treatment of children with vesicoureteral reflux (VUR) grades II-IV. VUR is a malformation of the urinary bladder that can result in severe infections of the kidneys and irreversible kidney damage.

“On February 3, 2012 the FDA granted marketing approval for GIAZO (balsalazide disodium) tablets, 1.1 gm for the treatment of mildly to moderately active ulcerative colitis in male patients 18 years of age and older. The availability of GIAZO will provide an additional aminosalicylate-based option for treating ulcerative colitis.

“During the first quarter we continued to broaden, strengthen and expand our rifaximin intellectual property portfolio. Two additional patents relating to rifaximin - U.S. Patent No. 8,158,644 and U.S. Patent No. 8, 158,781 - issued by the U.S. Patent and Trademark Office in April provide further protection relating to a previously-issued patent that covers several physical states, or polymorphous forms, of rifaximin. These patents should provide protection until June 2024. Salix has an exclusive license to patents 8,158,644 and 8,158,781 from Alfa Wassermann S.p.A. to use, sell, have sold and import licensed rifaximin products, which the Company markets in the United States under the trade names XIFAXAN® (200mg) and XIFAXAN550™ (550mg). These two patents provide protection for all indications currently marketed and being assessed.

“On April 25, 2012 the FDA notified the Company that it requires additional time for review of the supplemental New Drug Application (sNDA) for RELISTOR (methylnaltrexone bromide) injection for subcutaneous use for the treatment of opioid-induced constipation (OIC) in adult patients with chronic, non-cancer pain and has extended the April 27, 2012 goal date by three months. The extended user fee goal date is July 27, 2012. We look forward to working with the FDA to complete the review of the NDA by the extended PDUFA goal date. RELISTOR is a peripherally acting mu-opioid receptor antagonist that counteracts the constipating effects of opioid pain medications in the gastrointestinal tract without affecting their ability to relieve pain. We believe RELISTOR, if approved, should be a welcomed option for physicians and their patients who experience the often debilitating gastrointestinal consequences of the use of opioid analgesics to manage chronic pain.

“On February 7, 2012 the FDA issued an action date of June 5, 2012 under PDUFA and granted Priority Review designation for the NDA for Crofelemer 125 mg tablets for the proposed indication of the control and symptomatic relief of diarrhea in patients with human immunodeficiency virus (HIV)/acquired immune deficiency syndrome (AIDS) on anti-retroviral therapy. The FDA recently notified the Company that it requires additional time for review of the New Drug Application (NDA) for Crofelemer 125 mg tablets and has extended the June 5, 2012 goal date by three months. The extended user fee goal date is September 5, 2012. We look forward to working with the FDA to complete the review of the NDA by the extended PDUFA goal date.

“On February 21, 2012 the Company initiated TARGET 3 - a Phase 3 study to evaluate the 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 who respond to an initial treatment course with rifaximin 550 mg TID for 14 days. We are working to enroll a number of subjects sufficient to randomize approximately 800 subjects (400 subjects per treatment group) into the double blind retreatment phase of the study. The study will be conducted in approximately 250 sites throughout the United States. The Company continues to anticipate that from study initiation it could take approximately 24 months to complete the trial, submit a response to the Complete Response Letter and secure a FDA decision regarding approvability.

“During the first quarter of 2012 the Company also continued to make progress in the development of oral RELISTOR, budesonide foam, the next generation formulation of rifaximin for potential additional indications and Lumacan. Detailed results of the 804-patient Phase 3 trial to evaluate the efficacy and safety of oral methylnaltrexone bromide for the treatment of opioid–induced constipation (OIC) in subjects with chronic, non–cancer pain are to be presented at Digestive Disease Week on May 22, 2012. The highly statistically significant results of this study constitute the basis of the New Drug Application the Company is targeting to submit to the FDA during the third quarter of 2012. We anticipate completing patient enrollment in our two budesonide foam Phase 3 trials by the end of 2012. In December 2011 we initiated a pharmacokinetic study to assist in the characterization of three prototype tablet formulations of rifaximin. The study progressed during the first quarter of 2012 and currently we intend to move forward with a suitable next generation rifaximin candidate or candidates with the initiation of a clinical trial by the end of 2012. Work continued to progress on the development of Lumacan formulation prototypes. We intend to test various formulation prototypes in the clinic during 2012. We believe that Lumacan, if approved, has the potential to significantly improve the earlier detection and diagnosis of colon cancer.

“As reflected in our revised 2012 selling, general and administrative expense guidance, over the next several months we intend to expand our selling capacity by increasing our GE-focused sales force from its current size of 160 sales representatives to 192 sales representatives. Additionally, over the past several quarters we have expanded our institutional sales force from 25 key account managers (KAMs) to its current size of 40 KAMs.

“The expanded 192-member sales force will continue to focus primarily on gastroenterologists, colorectal surgeons and hepatologists. One 96-member division of the GE sales force will promote XIFAXAN 550 for hepatic encephalopathy, RELISTOR and APRISO. The second 96-member division of the GE sales force will promote SOLESTA for fecal incontinence, XIFAXAN 550 for hepatic encephalopathy, MOVIPREP/OSMOPREP – our bowel cleansing products – and APRISO. The KAMs will promote XIFAXAN 550 for hepatic encephalopathy, RELISTOR and DEFLUX.

“Our core business is strong and growing. In the near term we believe we can generate $1 billion in revenue in 2013, assuming the July 27, 2012 approval of subcutaneous injection RELISTOR for OIC in chronic, non-cancer pain and excluding the potential XIFAXAN IBS indication. Our portfolio of marketed products is complemented by our impressive pipeline of product candidates in development that should drive additional revenue growth over the long term as they are commercialized. Additionally, the Company continues to actively pursue additional product opportunities to expand and broaden our product portfolio. We are extremely pleased with the success we have achieved to date and we believe the Company is well-positioned to continue to succeed in our mission of being the leading specialty pharmaceutical company licensing, developing and marketing innovative products to healthcare professionals to prevent or treat gastrointestinal disorders.”

The Company will host a conference call at 5:00 p.m. ET, on Monday, May 7, 2012. Interested parties can access the conference call by way of web cast or telephone. The live web cast will be available at www.salix.com. A replay of the web cast will be available at the same location. The telephone numbers to access the live conference call are [phone] (U.S. and Canada) or [phone] (international.) The telephone numbers to access the replay of the call are [phone] or [phone] (U.S. and Canada) or [phone] (international). The access code for the replay is 71128117

[surf1944]

4:16PM Salix Pharma announces offering of $500 mln of convertible senior notes due 2019 (SLXP) 48.75 -0.55 : Co announced its intention to offer, subject to market and other customary conditions, $500 million aggregate principal amount of convertible senior notes due 2019 to qualified institutional buyers. In connection with the offering of the notes, Salix expects to enter into privately negotiated convertible note hedge transactions with counterparties that may include one or more of the initial purchasers. Salix intends to use the net proceeds from the offering, together with the proceeds from its entrance into the warrant transactions, to repurchase at closing from a holder a portion of their outstanding 5.5% Convertible Senior Notes due 2028 and, at the holder's option within a certain period after closing, to repurchase at the same price an additional portion of their outstanding 5.5% Convertible Senior Notes due 2028, both in privately negotiated transactions, to pay the cost of the convertible note hedge transactions, to repurchase up to $50 million of its outstanding common stock in privately negotiated, off-market transactions, which may be effected through one or more of the initial purchasers of the notes or their respective affiliates, concurrently with the offering, and for business development activities and other general corporate purposes, including potential additional repurchases of its outstanding debt, commercialization of product candidates, clinical trials, research and development expenses and general and administrative expenses.

[Penny Roger$]

~ Monday! $SLXP ~ Earnings posted, pending or coming soon! In Charts and Links Below!

~ $SLXP ~ Earnings expected on Monday *
Want more like this? Search Keyword: MACMONEY >>> http://tinyurl.com/MACMONEY <<<
One or more of many earnings sites has alerted this security has or will be posting earnings on or around the day of this message.








http://stockcharts.com/h-sc/ui?s=SLXP&p=D&b=3&g=0&id=p88783918276&a=237480049




http://stockcharts.com/h-sc/ui?s=SLXP&p=W&b=3&g=0&id=p54550695994



~ Google Finance: http://www.google.com/finance?q=SLXP
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~ Yahoo! Finance ~ Profile: http://finance.yahoo.com/q/pr?s=SLXP
Finviz: http://finviz.com/quote.ashx?t=SLXP
~ BusyStock: http://busystock.com/i.php?s=SLXP&v=2


<<<<<< http://www.earningswhispers.com/stocks.asp?symbol=SLXP >>>>>>



http://investorshub.advfn.com/boards/post_prvt.aspx?user=251916

*If the earnings date is in error please ignore error. I do my best.

[surf1944]

7:01AM Salix Pharma announces FDA granting of Priority Review designation for the crofelemer NDA for treatment of diarrhea in patients with HIV/AIDS on anti-retroviral therapy (SLXP) 48.54 : Co announced that the FDA has granted Priority Review designation for the co's New Drug Application for crofelemer 125 mg tablets for the proposed indication for the control and symptomatic relief of diarrhea in patients with human immunodeficiency virus (HIV)/acquired immune deficiency syndrome (AIDS) on anti-retroviral therapy. The FDA grants a Priority Review designation to drugs offering major advances in treatment, or providing a treatment where no adequate therapy exists. Based on this review classification, the FDA has issued an action date for the NDA of June 5, 2012 under the Prescription Drug User Fee Act.

[surf1944]

The stock price of Salix Pharmaceuticals , a gastrointestinal drug manufacturer headquartered in north Raleigh, has plateaued. At least for the time being, according to stock analysts.

So far this year, Salix (Nasdaq: SLXP) has reported almost only good news, and seen its stock price climb more or less steadily since September. At least two pharma analysts say that stock has hit a ceiling for now.

“Though Salix is very well positioned for long-term growth and has an attractive and well-protected business, we believe that 2012 will be a quieter year for the company,” wrote a group of three analysts for Stifel Nicolaus.

This means that those who own stock in Salix should not expect the stock to double in value again, like it did during 2011 when it ranged from $26 to $50.

Technically, the analysts downgraded Salix shares from Buy to Hold, as did at least one other research analyst company, but made sure to point out that does not mean they don’t believe in the company’s future growth. They are just saying that exponential growth won’t happen early this year.

“... We do not expect outsized share performance given the already impressive move coming out of 2011,” they wrote.

Salix shares were down by about 7 percent from a close of $49 on Thursday but still trading well above the 52-week low of $26. A Salix spokesman did not return a request for comment. Through the first three quarters of 2011, Salix was on pace to break the $500 million mark for net sales.

http://www.bizjournals.com/triangle/blog/2012/01/analysts-salix-price-rise-at-a-peak.html?ana=yfcpc

[surf1944]

7:09AM Salix Pharma Previews data slated for presentation at 62nd annual meeting of the American Association for the Study of Liver Diseases (SLXP) 35.08 : "Hepatic encephalopathy signifies a poor prognosis, with one-year and three-year mortality rates of 58 % and 77 %, respectively, after presentation of the first episode of acute HE. The 2010 introduction of XIFAXAN 550 mg, the first new therapy approved for overt HE in over 30 years, is providing physicians a much-needed therapy to manage their patients and to help patients break the cycle of relapse. Additionally, the availability of this tolerable and efficacious treatment for overt HE continues to challenge the HE research community and health care providers to more aggressively approach overt HE therapy with the intention of improving treatment success and long-term outcomes." In the clinical study of XIFAXAN 550 mg , the most common adverse reactions occurring in greater than eight % of patients were edema peripheral (15 %), nausea (14 %), dizziness (13 %), fatigue (12 %), ascites (11 %), muscle spasms (nine %), pruritus (nine %) and abdominal pain (nine %).

[surf1944]

http://www.form4oracle.com/company/salix-pharmaceuticals-ltd-slxp/company-transactions?id=327

[surf1944]

Salix Pharmaceuticals (SLXP): Zacks Rank Buy

Chart for Salix Pharmaceuticals, Ltd.
Bill Wilton, On Thursday October 13, 2011, 1:00 am EDT

Salix Pharmaceuticals (NasdaqGS: SLXP - News) analysts have been raising estimates since the latest earnings surprise back in August. Those moves have left the stock with impressive growth rates and a Zacks #1 Rank (Strong Buy).

Company Description

Salix Pharmaceuticals make prescription pharmaceuticals to prevent and treat gastrointestinal diseases.

Revenue Up 42%

The last quarterly report from Salix was back on Aug 8, but it was a good one. Product revenue was up 42%, to $133.2 million for the second quarter. That puts the year-to-date sales growth at 73%.

Earnings per share came out to $0.54, which was 6 cents higher than the Zacks Consensus Estimate. Salix has now topped expectations in each of the past 10 quarters.

Estimates Rising

Estimates have been up nicely in recent months. This year's Zacks Consensus Estimate rose 8 cents, to $2.07, thanks in part an upward revision in the past few days.

Projections for 2012 are up 11 cents on average, to $2.31. Last year the company brought in $0.27 per share, so the expected growth rates are now 668% and 11%, respectively.

Priced Right

Shares of SLXP are going for about 15 times forward estimates and have a PEG ratio near 0.7 times. Both metrics showing a solid value to go along with the earnings growth.

The Chart

Shares have been on a roll lately as bargain hunters flocked to SLXP during the recent optimism. So, right now it looks like the stock has growth, value, and momentum.

Salix Pharmaceuticals - ticker SLXP> <P ALIGN=

Bill Wilton is the Aggressive Growth Stock Strategist for Zacks.com. He is also the Editor in charge of the Zacks Small Cap Trader service

SALIX PHARM-LTD (SLXP): Free Stock Analysis Report

[surf1944]

Salix Pharma SLXP JMP Securities Mkt Outperform $48 » $40

Read more: http://www.briefing.com/investor/calendars/upgrades-downgrades/#ixzz1bSAnMnvM

[surf1944]

7:05AM Salix Pharma and Progenics (PGNX) announce FDA acceptance of sNDA filing for RELISTOR in patients with non-cancer pain (SLXP) 29.88 : Progenics Pharmaceuticals (PGNX) and co announce that the FDA has accepted for filing a supplemental New Drug Application for RELISTOR Subcutaneous Injection to treat opioid-induced constipation in patients with non-cancer pain. The FDA has issued a PDUFA date of April 27, 2012. The most common adverse reactions reported with RELISTOR compared with placebo in clinical trials were abdominal pain (28.5% vs 9.8%), flatulence (13.3% vs 5.7%), nausea (11.5% vs 4.9%), dizziness (7.3% vs 2.4%), diarrhea (5.5% vs 2.4%), and hyperhydrosis (6.7% vs 6.5%). Safety and efficacy of RELISTOR have not been established in pediatric patients.

[surf1944]

Salix Pharma SLXP Brean Murray Buy $50

http://www.briefing.com/Investor/Public/Calendars/UpgradesDowngrades.htm

[dealorfx]

nobody jumping on board here????????//

[surf1944]

7:02AM Salix Pharma receives Complete Response Letter from FDA; deems the XIFAXAN 550 mg sNDA for non-C IBS is not ready for approval (SLXP) 31.86 : Co announces that the FDA issued a Complete Response Letter for the supplemental New Drug Application for XIFAXAN 550 mg tablets for the proposed indication of treatment of non-constipation irritable bowel syndrome and IBS-related bloating. The CRL reconfirms the co's understanding that the FDA deems the XIFAXAN 550 mg sNDA for non-C IBS is not ready for approval primarily due to a newly expressed need for retreatment information. At this time, the co intends to request a Type A meeting with the Agency to discuss the XIFAXAN 550 mg sNDA for non-C IBS.

[momentum74]

Links.They have earnings in 4 days 13% of the float is short so I'm looking for a bounce going into earnings. Stock was 49.00 in dec 2010 now 32.12 . High shortinterest can often keep a bid on stock as they cover and take profits.

http://finviz.com/quote.ashx?t=slxp

http://www.earningswhispers.com/stocks.asp?symbol=slxp

[stocktrader001]

Salix Anticipates Receipt of FDA Complete Response Letter on XIFAXAN® 550 Mg Tablets Supplemental New Drug Application
Salix (NASDAQ:SLXP)
Intraday Stock Chart
Heute : Thursday 24 February 2011


Salix Pharmaceuticals, Ltd. (NASDAQ:SLXP) today announced that based on a telephone conversation with the U.S. Food and Drug Administration (FDA) held last evening, the Company anticipates receiving a Complete Response Letter (CRL) on or before the March 7, 2011 PDUFA goal date for the supplemental New Drug Application (sNDA) for XIFAXAN® (rifaximin) 550 mg tablets for the proposed indication of treatment of non-constipation irritable bowel syndrome (Non-C IBS) and IBS-related bloating. Until the Company is in receipt of the CRL, the Company has limited information as to its complete content.

The FDA issues a Complete Response Letter to indicate that the review cycle for an application is complete and that the application is not ready for approval. Based on the telephone conversation referenced above, the Company is of the understanding that the FDA deems the XIFAXAN 550 mg sNDA is not ready for approval primarily due to a newly expressed need for retreatment information. The Company will consider next steps with respect to the XIFAXAN 550 mg sNDA for non-C-IBS following receipt of a Complete Response Letter.

Salix will host a conference call at 7:30 a.m. ET on Thursday, February 24, 2011 to provide an update regarding the FDA review of the supplemental New Drug Application (sNDA) for XIFAXAN® (rifaximin) 550 mg tablets for the proposed indication of treatment of non-constipation irritable bowel syndrome (Non-C IBS) and IBS-related bloating.

Interested parties can access the Thursday, February 24, 2011, 7:30 a.m. ET conference call by way of web cast or telephone. The live web cast will be available at www.salix.com. A replay of the web cast will be available at the same location. The telephone numbers to access the live conference call are [phone] (U.S. and Canada) or [phone] (international.) The telephone numbers to access the replay of the call are [phone] (U.S. and Canada) or [phone] (international). The access code for the replay is 8909507.

[HDOGTX]

SLXP News: Salix Pharmaceuticals to Present at Jefferies Conference
Date : 09/29/2010 @ 7:00AM
Source : Business Wire
Stock : Salix Pharmaceuticals, Ltd. (SLXP)
Quote : 41.64 -0.12 (-0.29%) @ 7:22AM


Salix Pharmaceuticals to Present at Jefferies Conference
Salix (NASDAQ:SLXP)
Intraday Stock Chart
Today : Wednesday 29 September 2010
Salix Pharmaceuticals, Ltd. (NASDAQ:SLXP) today announced that the Company will present at the Jefferies 2010 Global SpecPharma and European Healthcare Conference in London, UK on Wednesday, October 6 at 10:00 a.m. ET.

Interested parties can access a live audio web cast of the presentation at http://www.salix.com. A replay of the presentation will be available at the same location.

Salix Pharmaceuticals, Ltd., headquartered in Raleigh, North Carolina, develops and markets prescription pharmaceutical products for the prevention and treatment of gastrointestinal diseases. Salix’s strategy is to in-license late-stage or marketed proprietary therapeutic drugs, complete any required development and regulatory submission of these products, and market them through the Company’s gastroenterology specialty sales and marketing team.

Salix markets XIFAXAN® (rifaximin) tablets 200 mg and 550 mg, MOVIPREP® (PEG 3350, Sodium Sulfate, Sodium Chloride, Potassium Chloride, Sodium Ascorbate and Ascorbic Acid for Oral Solution), OSMOPREP® (sodium phosphate monobasic monohydrate, USP and sodium phosphate dibasic anhydrous, USP) Tablets,), VISICOL® (sodium phosphate monobasic monohydrate, USP, and sodium phosphate dibasic anhydrous, USP) Tablets, APRISO™ (mesalamine) extended-release capsules 0.375 g., METOZOLV® ODT (metoclopramide HCl), PEPCID® (famotidine) for Oral Suspension, Oral Suspension DIURIL® (Chlorothiazide), AZASAN® Azathioprine Tablets, USP, 75/100 mg, ANUSOL-HC® 2.5% (Hydrocortisone Cream, USP), ANUSOL-HC® 25 mg Suppository (Hydrocortisone Acetate), PROCTOCORT® Cream (Hydrocortisone Cream, USP) 1% and PROCTOCORT® Suppository (Hydrocortisone Acetate Rectal Suppositories) 30 mg. Budesonide foam, crofelemer and rifaximin for additional indications are under development.

For full prescribing information, including BOXED WARNINGS for VISICOL, OSMOPREP and METOZOLV, on Salix products, please visit www.salix.com or contact the Company at 919 862-1000.

Salix trades on the NASDAQ Global Select Market under the ticker symbol “SLXP.”

For more information please visit our web site at www.salix.com . Information on our web site is not incorporated in our SEC filings.

[surf1944]

9:58AM Salix Pharma announces FDA acceptance for filing and priority review designation for XIFAXAN550 sNDA for the treatment of non-constipation irritable bowel syndrome (SLXP) 41.59 +0.20 :

[surf1944]

New 52 week high for SLXP...

[surf1944]

12:00PM Salix Pharma announces issuance of U.S. patent for Rifaximin pending until 2019 (SLXP) 35.97 -0.75

[surf1944]

5:34PM Salix Pharma: XIFAXAN 550 mg (rifaximin) demonstrated acute and sustained relief of non-constipation irritable bowel syndrome symptoms; data from target 1&2 presented at Digestive Disease Week (SLXP) 41.06 +0.91

[surf1944]

8:45AM Salix Pharma announced the FDA has issued a complete response letter regarding the New Drug Application for GIAZO (SLXP) 38.55 : Co announced the Food and Drug Administration (FDA) has issued a complete response letter regarding the New Drug Application (NDA) for GIAZO Tablets 1.1 g. for the treatment of mild-to-moderate active ulcerative colitis in patients 18 years and older. In this complete response letter there are no requests for new pre-clinical or clinical trials. The sole issue raised in this letter concerns a deficiency of the manufacturing facility for this application. The manufacturer has responded to the FDA and continues to work with the FDA to resolve the matter. The facility only manufactures COLAZAL Capsules and GIAZO Tablets for Salix.

[surf1944]

Salix Pharma SLXP Thomas Weisel Overweight $52

[surf1944]

Salix Pharma SLXP Caris & Company Buy $40 » $47

[surf1944]

Salix Pharma SLXP Jefferies Buy $38 » $42

The shorts are going to have a hard time getting out unless the volume is very heavy in the coming week:

Average Volume (3 month)3: 1,400,130
Average Volume (10 day)3: 1,451,420
Shares Outstanding5: 56.47M
Float: 54.47M
% Held by Insiders1: 2.75%
% Held by Institutions1: 99.00%
Shares Short (as of 26-Feb-10)3: 5.79M
Short Ratio (as of 26-Feb-10)3: 3.3
Short % of Float (as of 26-Feb-10)3: 21.50%
Shares Short (prior month)3: 5.55M

[Fastmandoo]

FDA Approves XIFAXAN® 550 MG Tablets for Reduction in Risk of Overt Hepatic Encephalopathy (HE) Recurrence
Salix Pharmaceuticals, Ltd. (NASDAQ:SLXP) today announced the U.S. Food and Drug Administration (FDA) has granted marketing approval for XIFAXAN® (rifaximin) 550 mg tablets for reduction in risk of overt hepatic encephalopathy (HE) recurrence in patients 18 years of age or older. HE is a serious disorder caused by chronic liver failure, resulting in cognitive, psychiatric and motor impairments.i This approval was supported by findings from the largest randomized trial of maintenance therapy in HE conducted to date, which assessed the efficacy and safety of XIFAXAN 550 mg tablets and demonstrated a statistically significant and clinically meaningful reduction in the risk of overt HE recurrence.ii The labeling for XIFAXAN 550 mg tablets includes data on both the risk reduction of overt HE recurrence as well as risk reduction of HE-related hospitalization.

HE occurs frequently in patients with cirrhosis as a result of end-stage liver disease. Typically, cirrhosis is caused by a number of factors, such as alcohol and/or drug abuse, chronic viral hepatitis and autoimmune disease. Currently, there are more than 600,000 cases of cirrhosis in the United States. Cirrhosis is the third most common cause of death, after heart disease and cancer, in people 45-65 years of age in the United States. An estimated 25,000 people die of cirrhosis each year in the United States. The number of cases of liver disease worldwide is rapidly increasing, with the prevalence of chronic liver disease in the United States estimated to be between six and seven million cases.iii, iv There are reported to be approximately 200,000 patients in the United States who suffer from episodic overt HE. v,vi,vii

“HE is a growing health issue among adults suffering from liver disease in the U.S. The imminent availability of XIFAXAN 550 mg tablets signals an important advancement for overt HE patients, their caregivers and the health care community supporting these patients," said Bill Forbes, Pharm.D., Executive Vice President of Research and Development and Chief Development Officer, Salix Pharmaceuticals. “An episode of overt HE can result in a patient losing cognitive function or even death. These symptoms, in a number of incidences, necessitate a clinic or emergency room visit or hospital admission. We are pleased to bring XIFAXAN 550 mg tablets to market and believe the utilization of this treatment should serve to reduce the recurrence of overt HE as well as the number of hospitalizations associated with this serious condition.”

Salix anticipates XIFAXAN 550 mg tablets to be available for physicians and patients by the end of May 2010. In preparation for the launch, the Company is targeting to begin shipping product to wholesalers in early May and to complete the training of its 160-member sales force during the week of May 17.

XIFAXAN has been granted Orphan Drug designation by the FDA for use in hepatic encephalopathy. With XIFAXAN 550 mg tablets now approved by the FDA, Salix believes this designation should provide seven years of marketing exclusivity in the United States.

FDA approval of XIFAXAN 550 mg tablets was based on a 299 subject, double-blind, placebo-controlled, multinational, Phase 3 clinical trial, the largest randomized trial of maintenance therapy in HE conducted to date. Trial results demonstrated a statistically significant and clinically meaningful reduction in the risk of overt HE recurrence.viii The primary endpoint – the risk of experiencing a breakthrough overt HE episode – was reduced by 58 percent in XIFAXAN 550 mg-treated subjects compared with placebo (p 25, and only 8.6% of patients in the controlled trial had MELD scores over 19. There is increased systemic exposure in patients with more severe hepatic dysfunction. Therefore, caution should be exercised when administering XIFAXAN to patients with severe hepatic impairment (Child-Pugh C).

XIFAXAN is contraindicated in patients with a hypersensitivity to rifaximin, any of the rifamycin antimicrobial agents, or any of the components in XIFAXAN. Hypersensitivity reactions have included exfoliative dermatitis, angioneurotic edema, and anaphylaxis.

Clostridium difficile-associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including XIFAXAN, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon which may lead to overgrowth of C. difficile. If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued.

The most common adverse reactions occurring in >8% of patients in the clinical study were edema peripheral (15%), nausea (14%), dizziness (13%), fatigue (12%), ascites (11%), muscle spasms (9%), pruritus (9%), and abdominal pain (9%).

About XIFAXAN® (rifaximin)

Rifaximin is a gut-selective antibiotic with negligible systemic absorption and broad-spectrum activity in vitro against both gram-positive and gram-negative pathogens. Rifaximin has a similar tolerability profile to that of placebo.

Rifaximin tablets 200 mg, which Salix markets in the United States under the trade name XIFAXAN® (rifaximin) tablets 200 mg, currently is approved for the treatment of patients, 12 years of age or older, with travelers' diarrhea (TD) caused by non–invasive strains of Escherichia coli. XIFAXAN should not be used in patients with diarrhea complicated by fever or blood in the stool or diarrhea due to pathogens other than Escherichia coli. XIFAXAN should be discontinued if diarrhea symptoms get worse or persist more than 24–48 hours, and alternative antibiotic therapy should be considered. In clinical trials, XIFAXAN was generally well-tolerated. The most common side effects (vs. placebo) were flatulence 11.3 percent (versus 19.7 percent), headache 9.7 percent (versus 9.2 percent), abdominal pain 7.2 percent (versus 10.1 percent) and rectal tenesmus 7.2 percent (versus 8.8 percent).

[barefootrunner]

Agree. I don't think this is a "sell on the news" situation. Particularly in AH!

[The_Bull]

I would NOT let the AH fool ya, those that want out will sell at any price now especially that it is high, but tomorrow brings in a load of investors, and those that purchased today expect to bring in more then they purchased their stock for !! ..........tomorrow hopefully will bring in a nice return for all of you SLXP investors......glty

[Abashiii]

anyone know what the usual price trends are with pharma's that announce in AH? will the prices be better in the morning?

[Neil_B]

SLXP trading resumes 18:25

[Abashiii]

hold for AH and sell in tomorrow? or sell in AH, any opinions?

[Abashiii]

hold for AH and sell in tomorrow? or sell in AH, any opinions?

[kookiekook]

In approximately 20 minutes

[The_Bull]

thanks will be interesting.....glty