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Encysive Pharmaceuticals Inc. - ENCY

718 Posts
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  1. [verwijderd] 9 maart 2007 20:39
    quote:

    DieGroeneGigant schreef:

    [quote=elmono]
    ik stap pas in na emissie, zo eind feb begin maart denk ikzelf. Voorlopige nog genoeg andere fondsen om mee te spelen. Denk zelf dat we nog wel een stukkie lager kunnen, maar voor jou hoop ik dat natuurlijk niet :-). Succes met gestaffeld naar beneden kopen.
    [/quote]

    goed gezien..
    Nog steeds even wachten maar. Kan nog wel een tikkie lager. Net als INSM trouwens. Stond op het punt om bij te kopen, maar ook daar hangt going concern en financiering als een loden deken boven het aandeel en heb na de overeenkomst te hebben bestudeerd, toch maar even daar vanaf gezien. Verwacht binnekort positief nieuws omtrent NFLD
  2. [verwijderd] 15 maart 2007 18:27
    ach, als je een kleine week geleden als bedrijf aangeeft dat je van een onafhankelijke auditeur (lees: accountant) een 'going concern' aan je broek krijgt, dan moet je je toch achter de oren gaan krabben :-)
  3. Dereek 15 maart 2007 20:07
    begrijp ik goed dat ze nu bezig zijn met nieuwe financiering of komt dat in de nabije toekomst?
  4. [verwijderd] 15 maart 2007 21:30
    ik weet het niet, maar als door een externe auditeur wordt getwijfeld aan het voortbestaan aan het bedrijf als het niet op korte termijn cash aantrekt of zijn uitgaven drastisch terugsnoeit, wat zou je dan doen??
  5. [verwijderd] 15 maart 2007 21:46
    ze hebben net een emmissie achter de rug... ik geloof was iets van 40 of 60 milj. is het niet vreemd dat ze nu ineens weer geld nodig hebben???
  6. [verwijderd] 19 maart 2007 14:10
    Encysive Beaten Down to a Possible Buy
    Monday March 19, 3:43 am ET

    Andrew Vaino submits: On a few occasions since last November I wrote how I thought Encysive pharmaceuticals (NasdaqGM: ENCY) was a good short. Encysive had been having some problems getting its pulmonary arterial hypertension [PAH] treatment Thelin on the market in the U.S.
    So far it has only received approvable letters from the FDA. That is, the FDA wanted more data. Encysive's CEO stated that there was one issue the FDA still had a problem with, but wouldn't specify what that issue was. While the CEO stated the issue had been addressed, I was mistrustful of his lack of transparency.

    The Monday after I suggested shorting the stock (November 6), it was at $5.76. The stock closed Friday (March 16) at $2.77, a 52% decline (note, in the BC tracking portfolio I covered on December 29 at $4.17, a gain of 27.6%: I guess bulls make money, bears make money, and chemists cover too soon!).

    So, while I clearly had no respect for ENCY in the past, I think the stock has been beaten down enough that some money can be made going long. Encysive expects to hear from the FDA on June 15 about its application for Thelin. There is no guarantee it will be approved, and, indeed, I wouldn't even count on it. The drug has, however, been approved in other parts of the world, and has been launched in the UK, Germany, and Australia. So, even without the U.S. market, it will be selling to a combined population of over 160 million. To be clear, pricing controls in these countries does diminish the attractiveness of these markets.

    Now, a kicker in all this is that Gilead (NasdaqGS: GILD) expects to hear from the FDA about its PAH drug Ambrisenstan (acquired when it purchased Myogen) on June 18, three days after Encysive should hear about Thelin.

    Clinical results for both Thelin (J. Am. Coll. Cardiol, 2006, 47, 2049) and for Ambrisenstan (J. Am. Coll. Cardiol, 2005, 46, 529) have been published. The primary endpoints for these studies was improvement in 6 minute walking distance (6MWD, a benchmark for cardiopulmonary function) after 12 weeks. In the Ambrisenstan case, patients displayed on average an improvement of 40m in the 6MWD test. The Thelin study reported an improvement of 25m. In another publication about Thelin (Journal of Heart and Lung Transplantation, 2007, 26, 63) one third of patients experienced improvements of >15% on the 6MWD. As the baseline value was 325m, this represents an improvement of 49m.

    While Ambrisenstan does appear to have greater efficacy, differing safety profiles for the two drugs means there is still a place for Thelin. For example, in the clinical trials mentioned above, 13 of 64 (20.3%) patients taking Ambrisenstan experienced clinical worsening, compared with only 4 out of 61 (6.5%) patients taking Thelin.

    Encysive also has a phase 2 study underway, on BC3711, to treat resistant hypertension. While good results from this trial might push the stock up a bit, most of Encysive's value is in Thelin.

    The other issue facing Encysive - its extended FDA plight - has seriously strained its balance sheet. In releasing the 2006 10K, it expressed potential difficulties in continuing as a going concern - never a good thing. This also raises the possibility of further dilution.

    My take is ENCY has been beaten down to a point were it may be worth a buy. To be clear, this is still highly speculative, and I still wish management was more transparent about Thelin's FDA troubles. The launch of its product in a market of substantial size is encouraging. While Ambrisenstan does appear to offer greater efficacy, differing safety profiles may mean some patients will respond better to Thelin. At a price of under $3, even modest revenue for Thelin will afford a rise in price.

    I don't recommend buying ENCY until the VIX decreases a bit and until its technicals start to improve. The stock just broke through support at ~$3.30 and could keep falling. If it hits $2.50 I'd consider buying.

    biz.yahoo.com/seekingalpha/070319/299...
  7. [verwijderd] 21 maart 2007 14:21
    Encysive Pharmaceuticals Announces Patient Enrollment Initiated for TBC3711 Phase II Study
    Wednesday March 21, 8:00 am ET

    HOUSTON, March 21, 2007 (PRIME NEWSWIRE) -- Encysive Pharmaceuticals Inc. (NasdaqGM:ENCY - News) today announced that the first patient has been enrolled into its Phase II dose-ranging study of oral TBC3711, the Company's next-generation, highly selective endothelin receptor antagonist, in resistant hypertension. The 12-week, multi-center, randomized, double-blind, placebo-controlled study will evaluate four once-daily oral doses of TBC3711 in approximately 150 patients with diagnosed resistant hypertension.
    ``With the commercialization of our lead product THELIN(tm) well underway in the European Union, we're able to focus on advancing our product pipeline,'' commented Bruce D. Given, M.D., President and Chief Executive Officer of Encysive Pharmaceuticals. ``This study is the crucial next step for TBC3711 development and we eagerly await the results.''

    Study Details

    Resistant hypertension patients enrolled in the Phase II study will be randomized to one of four double-blind TBC3711 treatment arms or a placebo arm. Each arm will consist of approximately 30 patients. All study arms will receive once-daily doses of either TBC3711 or placebo. TBC3711 or placebo will be given concomitantly with each patient's current anti-hypertensive regimen. Primary outcome data will consist of blood pressure measurements taken pre-dose and two hours post-dose.

    ``A selective endothelin receptor antagonist may prove effective in improving persistent vasoconstriction, a hallmark finding of resistant hypertension,'' said Domenic Sica, M.D., Professor of Internal Medicine and Nephrology, Virginia Commonwealth University, Richmond, Virginia. ``I look forward to the study of TBC3711 in the resistant hypertension population, a group of patients who, despite three drug therapy, are still presenting with poorly controlled high blood pressure.''

    About TBC3711 and Resistant Hypertension

    TBC3711 is a small molecule that blocks the action of endothelin, a potent mediator of blood vessel constriction and growth of smooth muscle in vascular walls. TBC3711 is a next-generation endothelin A antagonist which possesses high oral bioavailability and is more selective and potent than THELIN(tm) (sitaxsentan sodium) Encysive's oral treatment for pulmonary arterial hypertension. TBC3711 is greater than 100,000-fold selective in the targeting of the endothelin A receptor versus the endothelin B receptor.

    Many individuals can successfully lower blood pressure through lifestyle modifications and/or treatment with one or more approved hypertension drugs. Resistant hypertension is defined as the failure to reach goal blood pressure (less than 140/90 mmHg) in patients who are adhering to a regimen of full doses of three anti-hypertensive drugs, including a diuretic. A direct relationship exists between increased blood pressure and risk of heart attack, stroke, kidney disease and heart failure.

    biz.yahoo.com/pz/070321/115877.html
  8. [verwijderd] 2 april 2007 15:38
    Encysive Pharmaceuticals Announces Launch of Thelin (Sitaxentan Sodium) in Republic of Ireland
    Monday April 2, 3:00 am ET
    First Selective, Once-Daily Oral Endothelin a Receptor Antagonist Now Commercially Available for Pulmonary Arterial Hypertension Patients

    HOUSTON, April 2, 2007 (PRIME NEWSWIRE) -- Encysive Pharmaceuticals (NasdaqGM:ENCY - News) today announced the commercial availability of THELIN(r)(a)(sitaxentan sodium(b)) 100 mg tablets in the Republic of Ireland for the treatment of pulmonary arterial hypertension (PAH). The Company received European Union (EU) marketing authorization for THELIN from the European Commission in August 2006. THELIN is the first selective endothelin A receptor antagonist and the first once-daily oral treatment available for patients with PAH. THELIN will be available through the High Tech Scheme in Ireland.

    biz.yahoo.com/pz/070402/116527.html
  9. Dereek 4 april 2007 19:09
    van 2,60 naar 3,60 in een paar dagen
    helaas vergeten in te stappen of eerlijk gezegd: niet gedurfd)
  10. [verwijderd] 8 mei 2007 20:12
    On May 7, Encysive Pharmaceuticals (Nasdaq: ENCY) released first-quarter earnings for the period ended March 31.

    Thelin had just $1 million in sales in its first full quarter on the European market. This is not an encouraging sign for future prospects, and sales must pick up considerably in coming quarters.
    The company achieved regulatory approval for Thelin100mg tablets in Australia and is now seeking reimbursement approval in that country.
    Commercial availability of Thelin was recently announced for PAH in the Republic of Ireland and in The Netherlands.
    Encysive re-initiated a Phase II dose ranging study of TBC3711, Encysive's next-generation, highly selective endothelin A antagonist.
    The most important event for the company occurs next month when the FDA decides whether or not to approve Thelin in the U.S. The company has not had good luck with the FDA in prior attempts to obtain approval for Thelin.

    tinyurl.com/yr6old
  11. [verwijderd] 8 mei 2007 20:45
    MORNING MEETING COMMENTS
    Encysive Pharmaceuticals Inc. (NASDAQ: ENCY)
    May 8, 2007
    Matthew Kaplan • 212.891.5247
    mkaplan@pzk.com

    Encysive Reports 1Q 2007 Results, EU Thelin Sales Increase Revenue
    We maintain our BUY rating and price target of $12.

    • Thelin launch continues in the EU. Thelin pricing has been negotiated in the
    Netherlands, Ireland, the UK and in Germany, with pricing approval pending in
    several other EU nations. The Company estimates Thelin is being used in about 40%
    of new patients (new ETRA starts in naïve patients and patients returning to ETRA
    treatment following failure on Tracleer). They expect to increase this percentage as
    the market begins to accept Thelin. Additionally, as doctors become more familiar
    with Thelin, they may start switching patients from Tracleer over to Thelin. EU sales
    added about $1 million to Encysive’s top line in the first quarter 2007.
    • Additional Thelin approvals expected in 2007. Thelin was approved in Australia
    in early March 2007. Encysive launched Thelin in Ireland and the Netherlands in
    April. The Company expects an approval in Canada during 2Q 2007, a launch in
    Australia, and launches in additional EU countries to come throughout 2007.
    Additionally, the Thelin PDUFA date with the FDA is June 15, 2007.
    • We continue to strongly believe the market potential for Thelin in Europe is not
    reflected in the Company’s current market cap of only $232 million. Based on
    conservative projections, we believe Thelin could be a $180 million and a $257
    million product in Europe by 2009 and 2010, respectively. We estimate if a
    Company were to purchase this franchise from ENCY, the European market potential
    of $180 million to $257 million for Thelin represents roughly a $380 million to $715
    million, or $6.10 to $11.45 per share, of present value for ENCY. We arrive at our
    Thelin present value (PV) estimate for Europe using a 3-4x multiple of our 2009 or
    2010 revenue projections and apply a 20% discount rate for two or three periods.
    Additionally, the market is currently awarding no value at all to Thelin in the US
    market. Based on the strength of the product’s therapeutic profile we believe this is a
    mistake.
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