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CHTP - Chelsea Therapeutics International

1. ludwig mack 6 september 2011 18:42

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   Chelsea Therapeutics Receives New Patent for Use of Droxidopa in Fibromyalgia
   
   CHARLOTTE, N.C., Sept. 6, 2011 (GLOBE NEWSWIRE) -- Chelsea Therapeutics International, Ltd. (Nasdaq:CHTP) announced today that the United States Patent and Trademark Office has issued U.S. Patent No. 8,008,285 entitled "Droxidopa and pharmaceutical composition thereof for the treatment of fibromyalgia." The claims of the patent are related to methods of reducing pain associated with fibromyalgia by administering droxidopa alone, or in combination with other specified medications, to patients diagnosed with fibromyalgia.
   
   Chelsea recently completed enrollment of 120 patients in its Phase II trial of droxidopa for the treatment of fibromyalgia. Top-line results of the trial are expected by the end of the year.
   
   Fibromyalgia is a chronic and debilitating condition that is characterized by widespread pain and stiffness throughout the body, accompanied by severe fatigue, insomnia and mood symptoms. While the precise etiology of fibromyalgia remains unknown, current research has focused on the role of norepinephrine (NE) reuptake and availability in the central nervous system. NE, a widely used neurotransmitter in the central and peripheral nervous systems has long been linked to both chronic pain and depression. Droxidopa, a synthetic amino acid, is converted by the body into norepinephrine and, as a prodrug of NE, provides replacement therapy for NE deficiency. While NE, as a catecholamine does not penetrate the blood-brain barrier, droxidopa, as a neutral amino acid, is able to do so thus providing both a peripheral and central affect on circulating NE levels.
   
   About Droxidopa
   
   Droxidopa, the lead investigational agent in Chelsea Therapeutics' broad pipeline, is currently in Phase III clinical trials for the treatment of symptomatic neurogenic orthostatic hypotension (NOH) in patients with primary autonomic failure -- a group of diseases that includes Parkinson's disease, multiple system atrophy (MSA) and pure autonomic failure (PAF). Droxidopa is a synthetic catecholamine that is directly converted to norepinephrine (NE) via decarboxylation, resulting in increased levels of NE in the nervous system, both centrally and peripherally. Droxidopa is also being studied for the treatment of fibromyalgia in an ongoing Phase II trial and completed a Phase II trial in intradialytic hypotension (IDH) study with positive results.
   
   About Chelsea Therapeutics
   
   
2. ludwig mack 7 september 2011 15:55

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   Chelsea Therapeutics to Present at the 13th Annual Rodman & Renshaw Global Healthcare Investment Conference
   
   CHARLOTTE, N.C., Sept. 7, 2011 (GLOBE NEWSWIRE) -- Chelsea Therapeutics International, Ltd. (Nasdaq:CHTP) is scheduled to present at the 13th Annual Rodman & Renshaw Global Healthcare Investment Conference at 11:15 AM on September 13, 2011 at the Waldorf-Astoria in New York.
   
   Keith Schmidt, Chelsea's vice president for marketing and sales, will provide a brief overview of the company's product pipeline, clinical development status and upcoming milestones.
   
   Mr. Schmidt's presentation will be webcast live and archived for 30 days on Chelsea's website, www.chelseatherapeutics.com.
   
   About Chelsea Therapeutics
   
   
   
3. [verwijderd] 11 september 2011 00:16

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   Hi Oudje ik verneem net dat je een maand geleden een rotsmak hebt gemaakt.
   Hoop dat je weer de oude bent.
   
   Heb inmiddels ook een porsje CHTP voor 4,02.
   
   Now we wait.
   
   De beste wensen.
   Louis
   
   
4. [verwijderd] 12 september 2011 15:15

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   Hi, Louis.
   
   Dank je. Ben weer helemaal "de oude".
   Wat de presentatie van morgen bij Rodman & Renshaw betreft: Dr. Pedder laat het over aan de vice-president. Zou Dr. Pedder op zijn plaats blijven om vragen over het verschenen bericht met betrekking tot de NDA te beantwoorden? Of komt dat later in deze maand of zou er een lichte vertraging optreden? Het valt niet mee, geduldig te blijven.
   In een vorig leven zorgde ik er altijd voor, zeer tijdig op bepaalde zaken vooruit te lopen, en ik leek gelijk te krijgen, maar na een oplopende koers tot boven de 8 kwam toch weer de terugval naar circa 3.50. Sterke beinvloeding door shorters, met hulp van de MM's. Op dit moment heb ik de indruk, dat de MM's ongemerkt tegen zo laag mogelijke prijzen een voorraadje aanleggen om binnen niet te lange tijd een stormloop van indekkende shorters te kunnen opvangen.
   Hoop ik!!!
5. svenhedin 13 september 2011 19:35

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   Overgenomen van Yahoo forum:
   
   Presentation - 9/13 5 minutes ago
   Every-time I hear the presentation I get more positive and believe the
   $18+ price target is very likely. We seem to have a universal type
   drug in Drox. which has many possibilities. Lets not forget the RA
   results coming and this could really be the big one for CHTP.
   Looking out a few yrs. for those willing to wait I see $30+ a share
   if we are not bought out buy then - another real possibility.
   Textbook!!!!!!!!!!!!!
   
   Sentiment : Strong Buy
   
   
6. [verwijderd] 22 september 2011 13:10

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   Het wordt langzamerhand kort dag voor indiening NDA bij de FDA. Het schijnt gebruikelijk te zijn, dat ondernemingen tot publicatie overgaan als de ontvangst door de FDA is bevestigd. Kan dus ietsjes uitlopen tot begin oktober.
   Door de slechte economische situatie is het uitgangspunt niet zo best. Jammer.
7. svenhedin 27 september 2011 20:10

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   JMP Healthcare Conference 27-Sep-11 08:39 am
   
   I can't find any informaiton that indicates Celsion itself is presenting today. Info below looks to be just a general list of upcoming POSSSIBLE events. Anybody else find something? TIA
   
   Sept. 27-28
   JMP Securities Healthcare Conference
   
   Biotech events expected before the end of September:
   Chelsea Therapeutics(CHTP): Complete FDA approval filing for Northera as treatment for neurogenic orthostatic hypotension.
   Amarin(AMRN): Complete FDA approval filing for AMR101 for treatment of patients with high triglyceride levels.
   Celsion(CLSN): Interim analysis of phase III study of Thermodox in primary liver cancer.
   Exelixis(EXEL): Top-line results of phase III study of cabozantinib in medullary thyroid cancer.
   Vertex Pharmaceuticals(VRTX): Top-line results of phase II study of VX-509 in rheumatoid arthritis.
   Gilead Sciences(GILD): Top-line results from phase III "103" study of experimental Quad HIV pill versus Reyataz and Truvada.
   
8. [verwijderd] 28 september 2011 13:45

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   chtp.client.shareholder.com/releasede...
   
   Chelsea Therapeutics Submits New Drug Application for NORTHERA(TM) (droxidopa) for the Treatment of Symptomatic NOH
   
   CHARLOTTE, N.C., Sept. 28, 2011 (GLOBE NEWSWIRE) -- Chelsea Therapeutics International, Ltd. (Nasdaq:CHTP) announced that it submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking approval to market NORTHERA™ (droxidopa), an orally active synthetic precursor of norepinephrine, for the treatment of symptomatic neurogenic orthostatic hypotension (NOH) in patients with primary autonomic failure (Parkinson's disease, multiple system atrophy and pure autonomic failure), dopamine beta hydroxylase deficiency and non-diabetic autonomic neuropathy. In its application, Chelsea requested Priority Review of the NDA, which if granted could lead to a decision for marketing approval from the FDA for Northera in the first quarter of 2012.
   
   NOH is a chronic neurogenic disorder resulting from deficient release of norepinephrine that predominantly affects patients with primary autonomic failure, a group of diseases which includes Parkinson's disease (PD), multiple system atrophy (MSA) and pure autonomic failure (PAF). Symptoms of NOH include: dizziness, lightheadedness, blurred vision, fatigue, poor concentration, and fainting episodes when a person assumes a standing position, often severely limiting a person's ability to perform routine daily activities that require standing or walking for both short and long periods of time.
   
   "The NDA submission for Northera marks a significant milestone for Chelsea," commented Dr. Simon Pedder, president and CEO of Chelsea Therapeutics. "We believe the robust clinical data generated by our Phase III program clearly demonstrates that Northera is safe and effective for the treatment of symptomatic NOH. If approved, Northera would be the first treatment that specifically improves symptoms of NOH and reduces their impact on a patient's ability to perform daily activities that require standing or walking. We look forward to working closely with FDA on this application while progressing other clinical studies currently underway for Northera and our phase II anti-inflammatory program with CH-4051."
   
   The clinical portion of the NDA filing includes combined safety and efficacy data from Chelsea's two completed Phase III efficacy studies in NOH (Studies 301 and 302), two long-term open-label extension studies, a dedicated thorough QTc study, and a 24-hour ambulatory blood pressure monitoring safety study.
   
   Northera was previously granted Orphan Drug Designation and received Fast Track designation from the FDA. Fast Track designation is designed to facilitate the review of products that address serious or potentially life-threatening conditions for which there is an unmet medical need.
   
   About Neurogenic Orthostatic Hypotension (NOH)
   
   NOH is a chronic neurogenic disorder resulting from deficient release of norepinephrine, the neurotransmitter used by sympathetic autonomic nerves to send signals to the blood vessels and the heart to regulate blood pressure. This deficiency results in lightheadedness, dizziness, blurred vision, fatigue, poor concentration and fainting episodes when a person assumes a standing position. Symptoms of chronic NOH can be incapacitating, not only putting patients at high risk for falls and associated injuries, but also severely affecting the quality of life of patients.
   
   About NORTHERA™ (droxidopa)
   
   NORTHERA™ (droxidopa), the lead investigational agent in Chelsea Therapeutics' pipeline, has been studied in two Phase III clinical trials for the treatment of symptomatic neurogenic orthostatic hypotension (NOH) in patients with primary autonomic failure -- a group of diseases that includes Parkinson's disease, multiple system atrophy (MSA) and pure autonomic failure (PAF). Droxidopa is a synthetic catecholamine that is directly converted to norepinephrine (NE) via decarboxylation, resulting in increased levels of NE in the nervous system, both centrally and peripherally. Droxidopa previously demonstrated clinical benefits in treating both intradialytic hypotension and adult attention deficit hyperactivity disorder in Phase II trials and is currently being evaluated in an ongoing Phase II trial for the treatment of fibromyalgia.
   
   Droxidopa, developed by and licensed from Dainippon Sumitomo Pharma Co., Ltd. (DSP), initially received Japanese approval in 1989 for the treatment of frozen gait and dizziness on standing associated with Parkinson's Disease and for the treatment of orthostatic hypotension, syncope or dizziness on standing associated with Shy-Drager syndrome and Familial Amyloidotic Polyneuropathy. In 2000, Droxidopa received expanded marketing approval to include prevention of vertigo, dizziness and weakness associated with orthostatic hypotension in hemodialysis patients.
   
9. [verwijderd] 28 september 2011 19:10

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   Tja, en dan een diep teleurstellend koersverloop. Ten prooi vallen aan shorters, die dit aandeel hebben uitverkoren voor hun activiteiten.
   En, er zit weinig anders op, nu dan maar wachten op de goedkeuring (half jaar) en marktintroductie 2e kwartaal 2012. En daarnaast uiteraard de verdere ontwikkelingen met betrekking tot droxidopa voor fibromyalgia en vooral ook adhd. Binnenkort komen nog interimresultaten 2e fase RA (project 4051). Zeker met betrekking tot de verdere toepassingen van droxidopa kunnen we positief zijn. Het vergt alleen een langere adem dan ik verwacht had.
10. ludwig mack 28 september 2011 22:18

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    kijk ook elke dag, maar moet je eigenlijk niet doe;
    bericht vandaag niet echt uitschietend dan in de koers ....
12. svenhedin 3 oktober 2011 19:56

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    quote:

    oudje schreef op 28 september 2011 19:10:

    Tja, en dan een diep teleurstellend koersverloop. Ten prooi vallen aan shorters, die dit aandeel hebben uitverkoren voor hun activiteiten.
    En, er zit weinig anders op, nu dan maar wachten op de goedkeuring (half jaar) en marktintroductie 2e kwartaal 2012. En daarnaast uiteraard de verdere ontwikkelingen met betrekking tot droxidopa voor fibromyalgia en vooral ook adhd. Binnenkort komen nog interimresultaten 2e fase RA (project 4051). Zeker met betrekking tot de verdere toepassingen van droxidopa kunnen we positief zijn. Het vergt alleen een langere adem dan ik verwacht had.
    

    Ben onlangs gestart met inname Levodopa, is geen volmaakt medicijn maar momenteel het sterkst werkende medicijn in NL tegen symptomen van Parkinson. Hoop op beter doet leven...
    
    Wel mooie instapmomenten.
13. svenhedin 4 oktober 2011 16:59

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    $300MM Sales? 3-Oct-11 02:40 pm There are 100.000 users of Midodrine. But there are far more Parkinson patients in the USA only.
    In the Netherlands (16 million inhabitants) there are about 40.000 Parkinson patients.
    It seems to me, that Chelsea's estimate ($300 million in 3 to 5 years) is easy to reach
    
14. svenhedin 4 oktober 2011 17:15

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    Re: $300MM Sales? 3-Oct-11 01:45 pm Here is another article that summarises the situation better, I think. Note they say there are about 100,000 patients currently. If that is correct, then if CHTP can charge $3000/year and capture that market or expand it so that their piece is 100,000 patients you've got your $300M.
    
    articles.philly.com/2011-09-25/bu...
    
    Sentiment : Hold
    
    
15. ludwig mack 4 oktober 2011 21:10

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    Chelsea Therapeutics Internatio
    (NasdaqCM: CHTP )
    
    Real Time 3.65 Up 0.28 (8.31%) 3:02PM EDT
    Last Trade: 3.63
    Trade Time: 2:52PM EDT
    Change: Up 0.26 (7.72%)
    Prev Close: 3.37
    Open: 3.37
    Bid: 3.63 x 100
    Ask: 3.64 x 400
    1y Target Est: 11.20
    Day's Range: 3.25 - 3.74
    52wk Range: 3.25 - 8.20
    Volume: 259,797
    Avg Vol (3m): 514,547
    Market Cap: 224.50M
    P/E (ttm): N/A
    EPS (ttm): -0.94
    Div & Yield: N/A (N/A)
16. ludwig mack 4 oktober 2011 21:32

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    Re: one way UP FOR CHELSEA 4-Oct-11 11:05 am
    does ANYONE know why austin quit buying?he could turn this chelsea oround
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    Re: one way UP FOR CHELSEA 17 minutes ago
    that guy is broke.....if this tanks hill hang himself
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    dit haal ik van board; zo zie je dat men daar de keste dingen post, echt ziek.
    
    
17. [verwijderd] 4 oktober 2011 22:26

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    Vandaag 16% erbij, zijn we eindelijk los?
    
    CHTP Chelsea Therapeutics I... 3.91 +0.54 16.02%
    
    Traders Get Bullish on Shares ofChelsea Therapeutics International, Shares Up 10.2% (CHTP)Published on Tue, 10/04/2011 - 12:24
    By Adrienne Chilton in Market movers, CHTP, chelsea therapeutics international, nasdaq:chtp, penny stocks
    
    Chelsea Therapeutics International (NASDAQ:CHTP) is one of today's best performing low-priced stocks, up 10.2% to $3.71 on 0.6x average daily volume.Thus far today, Chelsea Therapeutics International has traded 202,000 shares, vs. average volume of 356,000 shares per day. The company traded 503,000 shares yesterday.
    
    In the past 52 weeks, Chelsea Therapeutics International share prices have been bracketed by a current low of $3.25 and a high of $8.20 and are now at $3.71. The 200-day and 50-day moving averages have moved 0.52% lower and 2.48% lower over the past week, respectively.
    
    Chelsea Therapeutics International has overhead space with shares priced $3.71, or 67.0% below the average consensus analyst price target of $11.25. The stock should run into initial resistance at its 50-day moving average (MA) of $4.21 and subsequent resistance at its 200-day MA of $4.84.
    
    Chelsea Therapeutics International Ltd. is a biopharmaceutical company developing a pipeline of low toxicity antifolate compounds engineered to have anti-inflammatory and anti-tumor activity. The Company's lead candidate is in development as a metabolically inert treatment alternative to Methotrexate for rheumatoid arthritis, psoriasis, and other disorders.
18. svenhedin 14 oktober 2011 14:31

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    bron: Yahoo
    
    Chelsea Therapeutics added to Focus List at Roth Capital
    
    14-Oct-11 06:57 am 06:29 EDT Chelsea Therapeutics added to Focus List at Roth Capital
    
    Roth Capital added Chelsea to its Focus List based on expected FDA approval of Northera, for the treatment of neurogenic orthostatic hypotension, in Q1 2012. Shares are Buy rated with a $18 price target. (CHTP)
    
19. [verwijderd] 19 oktober 2011 22:37

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    Je blijft aardig bezig, Junkbond!!
20. [verwijderd] 20 oktober 2011 18:02

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    quote:

    oudje schreef op 19 oktober 2011 22:37:

    Je blijft aardig bezig, Junkbond!!
    

    hehehe ja Oudje, ik ben andere positie aan het sluiten en ik ga vol voor Chelsea. Of dat een slimme actie zal spoedig blijken . Maar het voelt goed, we zullen zien
21. [verwijderd] 20 oktober 2011 18:43

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    Op 1000 aandelen na zit ik bomvol.