Santarus Inc (SNTS)

[surf1944]

4:18AM Santarus and Pharming provides new data on treatment with the investigational drug RHUCIN; treatment response rates founded to be 90% or greater (SNTS) 3.29 : Co and Pharming announce new data on 62 patients with Hereditary Angioedema who received repeat treatment with the investigational drug RHUCIN for 168 acute angioedema attacks. The median time to beginning of relief of symptoms across treatments for repeat attacks was ~60 minutes with response rates that were consistently 90% or greater. Time to beginning of relief was assessed by patients using a 100 mm visual analog scale (VAS). Of the 168 attacks, 90% were treated with a single dose of 50 U/kg of RHUCIN. More than 90% of the attacks responded within four hours of treatment. In addition, there were no relapses of attacks following treatments. In the safety analysis of the adverse events, 39 (63%) of the patients reported at least one AE; most of the AEs were considered mild to moderate in severity and 7 patients experienced an AE that was considered severe. None of the AEs were considered to be probably or definitely related to the study drug. The overall incidence of AEs was similar to those in the placebo groups in previously conducted clinical studies with RHUCIN. The frequency of adverse events did not increase upon repeat administrations.

[sevenOdouble]

http://www.businesswire.com/news/home/20110303006629/en/Santarus-Reports-Fourth-Quarter-Full-Year-2010

[mlkrborn]

SNTS $3.16 on letter to file refusal? Its partner now 0.15 euro in europe..
Shares of partners Santarus Inc. (SNTS 3.18, -0.01, -0.21%) and Netherlands-based Pharming Group N.V. (NL:PHARM 0.15, -0.04, -18.62%) took a hit Monday on news that U.S. regulators have refused to accept their market application for the drug Rhucin due to insufficient data.

The companies are seeking to have Rhucin approved to treat the rare condition hereditary angioedema. Santarus and Pharming intend to meet regulators to discuss what will be needed to re-file the application.

Pharming shares sank almost 20% to 15 cents, while Santarus shares dipped 8% to $2.99.

[pimpbot4000]

Seems today might be a good day to add or start a position. I am looking to do the latter. I am looking/hoping for an over reaction and drop to 2.60 - 2.65 but based on pre-market that might not happen.

My personal opinion is if the company can show they are turning the corner by increasing sales and getting back to being profitable, todays news will be a big nothing burger.

[sevenOdouble]

Thank you Deniseaan for this useful information.
Good luck to ya...

[deniseann]

STNS Actuality, the fda response is to a stns (Pharming, STNS Dutch counter part) application for a Biologics License, and not a jump through hoops kind of a deal... see below...

>>>>>
Pharming lodged its Biologics License Application (BLA) for Rhucin to the FDA in late December and the FDA has 60 days to accept the application, triggering the start of the regulatory approval process -- a process which is likely extend into 2012.

Keegan said he expects the FDA to accept the BLA application by the end of the month, triggering a new $5 million milestone payment from Santarus.
>>>>>
Relative Article...
http://www.reuters.com/article/2011/02/22/pharming-idUSLDE71L05F20110222?feedType=RSS&feedName=companyNews&rpc=43

STNS, Yahoo.
http://finance.yahoo.com/q?s=SNTS

There's quite a bit of stuff out on stns now, but they are still struggling financially.
http://seekingalpha.com/symbol/snts

[sevenOdouble]

Hi deniseann, do you know what the FDA response scheduled for Feb 28th is about?

[deniseann]

Santarus Inc (SNTS) down from $3.69 to $3.40 in the last two days

[deniseann]

Santarus to Webcast Analyst Day and Investor Briefing Presentation on January 19

PR Newswire
SAN DIEGO, Jan. 19, 2011
SAN DIEGO, Jan. 19, 2011 /PRNewswire/ -- Santarus, Inc. (Nasdaq: SNTS) announces that a live audio webcast and accompanying slide presentation will be provided for its Analyst Day and Investor Briefing.
Details of the event are as follows:
What: Santarus Analyst Day and Investor Briefing

When: Today, Wednesday, January 19, 2011 at 4:15 p.m. Eastern time

Where: www.santarus.com (under the Investor Relations link)


AGENDA
• Strategic Overview and 2011 Financial Outlook
Gerald T. Proehl, President, Chief Executive Officer & Director, Santarus, Inc.
• CYCLOSET® - Clinical/Medical Background
Dr. J. Michael Gaziano, Chief, Division of Aging, Brigham & Women’s Hospital,
Professor of Medicine, Harvard Medical School
• ULTESA™ (Budesonide MMX®) – Overview and Top-line Phase III Clinical Study Results
Dr. Simon P.L. Travis, Consultant Gastroenterologist,
Translational Gastroenterology Unit, John Radcliffe Hospital, Oxford, UK
• Ulcerative Colitis – Treatment Perspective
Dr. William J. Sandborn, Professor of Clinical Medicine and Chief of the Division of Gastroenterology, University of California, San Diego
• RHUCIN® and Hereditary Angioedema (HAE)
Dr. Bruce L. Zuraw, Professor of Medicine and Chief, Allergy and Immunology, University of California, San Diego, Research Scientist, San Diego VA Healthcare
• SAN-300 (anti-VLA-1 antibody)
Dr. Mark C. Totoritis, Senior Vice President, Biologics, Santarus, Inc.
• Wrap-up/Question & Answer Session
Gerald T. Proehl, President, Chief Executive Officer & Director, Santarus, Inc.
How: Live over the Internet – Simply log on to the Investor Relations section of the company's website at www.santarus.com


Contact:


Lippert/Heilshorn & Associates
Narine Darbinyan
310-691-7100

[deniseann]

$3.69 HOD and also high since Apr 2010.
FDA response scheduled for Feb 28th.

[deniseann]

Tomorow Jan 19th 4:15pm est

What: Santarus Analyst Day and Investor Briefing

When: Wednesday, January 19, 2011 at 4:15 p.m. Eastern time

Where: www.santarus.com (under the Investor Relations link)

AGENDA

* Strategic Overview and 2011 Financial Outlook
* CYCLOSET® - Clinical/Medical Background
* ULTESA™ (Budesonide MMX®) – Overview and Top-line Phase III Clinical Study Results
* Ulcerative Colitis – Treatment Perspective
* RHUCIN® and Hereditary Angioedema (HAE)
* SAN-300 (anti-VLA-1 antibody)
* Wrap-up/Question & Answer Session

How: Live over the Internet – Simply log on to the Investor Relations section of the company's website at www.santarus.com

Contact:

Lippert/Heilshorn & Associates
Narine Darbinyan
310-691-7100

[YoungShark]

I don't like how the indices are acting today but if they hold up, I will look into getting back into SNTS as the chart is starting to show a bottom is forming. A strong green volume day would confirm those indicators but if the indices hold up, I feel its safe enough to re-enter and accumulate more if it acts healthy over the coming days/weeks.

The indices are more concerning as the volume is non-supportive of the price action, it appears.

[Topgun21]

Well, good thing I never hold anything into earnings, took a nice profit at $3.53 this a.m.

Monitoring to see if it goes back to low 2's!

Tim
SNTS

[kookiekook]

I hear you, I also got out this morning at slightly over $3.50. If it goes low enough I may buy for a bounce. If nothing else, it should go up some when Cycloset 500mg re-release is announced and when (if) Pharmin announces the BLA submission for RHUCIN®, so a mid-term buy around Thanksgiving maybe worth looking at.

[kookiekook]

I personally look for to open around $2.80 drop in the first half hour to just above $2.50 and then rise the rest of the day to about $2.90.

[Cryptics]

I have to agree 100% and glad I got out first thing this morning. I will not hold bio's through earnings for this reason alone.

[powerade1]

yeah it is horrible...what do u look for in a price range tomorrow

[kookiekook]

Even if you count one-time restructuring costs of $7.3 million and a $15 million upfront payment to acquire rights to RHUCIN®, as unusual events, Santarus would have loss about $.06/share. And while Pharming plans to submit a Biologic License Application (BLA) to the FDA in December 2010 or January 2011 and a NDA is expected to be filed for Budesonide MMX in the 2nd half of 2011, neither drug candidate will have an affect on earnings near-term. The relaunch of Cycloset will help but many users just had their dosage change while the problems were resolved. Anyway, I look at it this quarterly report was a disaster.

[powerade1]

and awful earnings...

[Topgun21]

Awesome news here with SNTS!!

Fantatic!

Tim
SNTS

[Superfly15]

'Grats to people playing, I know there are many on $heffs board in it.

November 8, 2010

Santarus Announces Positive Top-Line Results in E.U. Phase III Clinical Study Evaluating Budesonide MMX in Ulcerative Colitis


NDA filing planned in second half of 2011 following completion of extended use study

Conference call to begin at 4:30 p.m. Eastern time today

ir.santarus.com/releaseDetail.cfm?ReleaseID=527724

[Topgun21]

Cryptics, here's to a hefty payday this week for us with snts!

$heff has some awesome dd post and charts on the $heff station, so be sure to check it out along with investor 100 posts on his board to!

Gltu
Tim

[Topgun21]

Well, I am looking for a big pop to the $5 share etc.
I know this company I way undervalued, and will be properly valued very soon!

Here's to the above for Tuesday!!

Tim
Snts. Also the 15 h and eu for phase 3 etc

[Cryptics]

I really feel this will be around $3.50 by end of week. That will be a 4% gain for the week.

[luvn socal]

Just got a position at $3.36...any idea of what kind of pop we can expect Mon AH and then on the 15th?

[Cryptics]

I'm with ya Tim! Good Luck to us all!

[Topgun21]

SNTS. GOING TO BE BIG THIS WEEK!!

Tim

[luvn socal]

Great article-

http://biomedreports.com/2010110559545/short-and-long-term-catalysts-likely-to-move-santaurus-stock-higher.html

[Cryptics]

$3.50 x $3.60

[Cryptics]

It's popping in PM. $3.35 x $3.40

[Topgun21]

I haven't seen one yet. Will have to check with $heff and see whats cooking!

I love what they did in the conference in LA!

Cyclomax is going to be huge!

Tim
SNTS

[Icanslim]

Agreed. if you check on Sheff's ibox he has a section which shows his entry price and exit price. he's still holding SNTS from '$3.23 buy on 10/25/10'

Has there been any pro forma regarding the Nov 8th financials?

thanks

[Topgun21]

No when $heff sales he puts alerts out!

He is upfront, and lots of integrity.

They have the best, solid DD on $heff board!

Tim
SNTS

[Stock H.O.G.]

They daily short volume yesterday was 49.24%. Looks like a war right at the 200 day.

[rickochey]

I noticed last night (wednesday) that there was another Bear Raid just before close. So I am believing that good things are right around the corner

[Cryptics]

I agree. and with the increase in volume it should show up on investors stock screeners tonight and more should be jumping in this. I saw that Sheff mentioned this but he hasn't discussed it at all since he purchased. Thought maybe he sold or something.

[Topgun21]

SNTS---

$heff, and I100 from the Sheff board have excellent DD on this company!!

Very big turnaround here, and the news today is huge, pps should follow!

Tim

[Cryptics]

I can wait. I think it's been about 2 weeks since I got in. I expect a steady climb going forward.

[RichieRich49]

Volume is 3 times higher than the average for the last 10 days.

We have presentation today, 3Q earning on Nov. 8th, rollout of Cycloset, and other drugs in pipeline.

Good things to come.

[Cryptics]

Well with my $3.23 avg cost basis, that will be just fine with me! I'd be happy with $4/share.

[Topgun21]

$5.80-$8 share in my opinion

Tim

[Dollar Bill]

I am convinced on this one. In at $3.28. Rock and Roll.

[Chimaera]

Joined the team here, looked like a great time to jump in! Best of luck to all.

[Cryptics]

Volume is high based on it's MA but for a $3 stock this volume is pitiful IMO. I'd rather this stock churn in a range and not be manipulated and daytraded like AVNR was/is!!!!

[RichieRich49]

We have very high volume today but share price not going up much.

What gives?

They have forward looking events, presentation today, production of Cycloset and clinical trials for another drug.

Is anybody attending the presentation today in LA?

[powerade1]

whats the upside from here after crossing that

[Topgun21]

We are over the 200 dma!!!

Snts
Tim

[Cryptics]

Wow! a 25k share lot trade just hit the tape.

[Topgun21]

SNTS HUGE NEWS!!! Courtesy of kei:

http://finance.yahoo.com/news/Cycloset-Data-to-Be-Presented-bw-3004757244.html?x=0&.v=1

Tim
SNTS

[kookiekook]

Target Price History

Current 1 Week Ago
High Target Price Estimate 5.50 8.00
Low Target Price Estimate 3.50 2.00
Mean Target Price Estimate 4.50 4.67
Standard Deviation 1.00 3.06
Date of Most Recent Estimate 10/17/10

Consensus EPS Estimates Trend

Qtr (09/10) Qtr (12/10) FY (12/10) FY (12/11)
Current Estimate -0.21 -0.03 -0.08 0.13
7 Days Ago -0.21 -0.03 -0.08 0.13
30 Days Ago -0.16 -0.01 -0.02 0.13
60 Days Ago -0.16 -0.01 -0.02 0.11
90 Days Ago -0.10 -0.02 0.02 0.13

Earnings Surprise

06/10 N/A N/A
EPS Estimate 0.04 N/A N/A
EPS Actual 0.10 N/A N/A
EPS Difference 0.06 N/A N/A
% EPS Surprise 150.00% N/A N/A