42% Plus Ency und die Thelin (TM) Story - 500 Beiträge pro Seite

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Heute 42 % Plus !
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Press Release Source: Encysive Pharmaceuticals Inc.


FDA Grants Class 1 Review to Encysive Pharmaceuticals\\' Complete Response to Thelin(TM) (Sitaxsentan Sodium) New Drug Application
Thursday June 15, 12:41 pm ET
Agency Assigns 60-Day PDUFA Target Action Date


HOUSTON, June 15 /PRNewswire-FirstCall/ -- Encysive Pharmaceuticals (Nasdaq: ENCY - News) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the Company\\'s complete response to the March 24 approvable letter regarding its New Drug Application (NDA) for Thelin(TM) (sitaxsentan sodium) 100 mg tablets. The FDA has designated the review as a Class 1 resubmission and issued a new Prescription Drug User Fee Act (PDUFA) target action date of July 24, 2006 for the Thelin NDA.
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Thelin is currently being evaluated by the FDA as a potential new oral treatment for patients with pulmonary arterial hypertension.

Encysive recently received a positive opinion recommending the approval of Thelin 100 mg tablets by the Committee for Medicinal Products for Human Use (CHMP) of the European Agency for the Evaluation of Medicinal Products (EMEA). A final decision for European approval is expected within 90 days of the CHMP positive opinion.

About Encysive Pharmaceuticals

Encysive Pharmaceuticals Inc. is a biopharmaceutical company engaged in the discovery, development and commercialization of novel, synthetic, small molecule compounds to address unmet medical needs. Our research and development programs are predominantly focused on the treatment and prevention of interrelated diseases of the vascular endothelium and exploit our expertise in the area of the intravascular inflammatory process, referred to as the inflammatory cascade, and vascular diseases. To learn more about Encysive Pharmaceuticals please visit our web site: http://www.encysive.com .

This press release contains "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These forward-looking statements are subject to certain risks, trends and uncertainties that could cause actual results to differ materially from those projected. Among those risks, trends and uncertainties are decisions by the U.S. Food and Drug Administration and other regulatory authorities regarding whether and when to approve our drug applications for Thelin(TM) (sitaxsentan sodium), as well as more specific risks, trends and uncertainties facing Encysive such as those set forth in its reports on Forms 8-K, 10-Q and 10-K filed with the U.S. Securities and Exchange Commission. Given these risks, trends and uncertainties, any or all of these forward-looking statements may prove to be incorrect. Therefore you should not rely on any such forward-looking statements. Furthermore, Encysive undertakes no duty to update or revise these forward-looking statements. The Private Securities Litigation Reform Act of 1995 permits this discussion.
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Source: Encysive Pharmaceuticals Inc.

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2006-06-04 15:33:00
EMEA-Gremium sorgt für Kursexplosion bei Encysive
Biotech/Pharma-Marktbericht von der Wallstreet
Ein Beratergremium der Europäischen Arzneimittelagentur, kurz EMEA (European Agency for the Evaluation of Medicinal Products), dem europäischen Äquivalent zur U.S. Gesundheitsbehörde (FDA), gab am Freitag grünes Licht für das von Encysive (ENCY) entwickelte experimentelle Produkt Thelin. Das Gremium empfahl der Behörde, den Wirkstoffkandidaten gegen kardiovaskuläre Erkrankungen, die Vermarktungsgenehmigung zur erteilen. Innerhalb von 90 Tagen wird nun die EMEA über die Zulassung entscheiden, die wohl schon so gut wie sicher sein dürfte. Der Aktie des Unternehmens Encysive brachte die gute Neuigkeit am vergangenen Freitag einen Kursgewinn von gigantischen 35% auf nun $5,82.

Simone Hörrlein, M.Sc.
Life Scientist (TUM)
Scientific & Medical Editor
Biotech Consultant
Email: [e-mail]
Webseite: http://www.investbionano.com..., http://www.biotech-experte.de...

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Da hatte ich doch den richtigen Riecher :

32 % up heute !!!!!!!!!! Klasse !

Encysive says U.S. accepts response on Thelin

NEW YORK, June 15 (Reuters) - Encysive Pharmaceuticals Inc. (ENCY.O: Quote, Profile, Research) on Thursday said U.S. regulators accepted the company\\'s response regarding its application for its Thelin drug, and that the regulators will act on the application for the product by July 24.

Thelin is under review as a treatment for pulmonary arterial hypertension, a serious lung condition. The U.S. Food and Drug Administration in March deemed Thelin "approvable."


© Reuters 2006. All Rights Reserved.

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Volume: 7,340,108 at Nasdag

Direktlink:

http://finance.yahoo.com/q?s=ENCY

ENCYSIVE PHARMA (NasdaqNM:ENCY) Delayed quote data

Last Trade: 7.09 Dollar
Trade Time: 1:33PM ET
Change: 2.04 (40.40%)
Prev Close: 5.05
Open: 5.09
Bid: 7.09 x 100
Ask: 7.09 x 400
1y Target Est: 8.07

Day's Range: 5.03 - 7.17
52wk Range: 3.29 - 13.29
Volume: 7,340,108
Avg Vol (3m): 3,533,380
Market Cap: 419.70M
P/E (ttm): N/A
EPS (ttm): -1.50
Div & Yield: N/A (N/A)

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Encysive Pharma upgraded by CE Unterberg Towbin


16-Jun-06 CE Unterberg Towbin Upgrade from Underperform to Buy

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Antwort auf Beitrag Nr.: 22.151.717 von kaktus10 am 16.06.06 17:02:52

3 neue Analysen alle empfehlen: buy !!

Analysen Datum Nachricht Autor

16.06.06 15:27 Update Encysive Pharmaceuticals Inc.: Buy Punk, Ziegel & Co

16.06.06 15:26 Update Encysive Pharmaceuticals Inc.: Buy UBS

16.06.06 15:24 Update Encysive Pharmaceuticals Inc.: Buy CE Unterberg, Towbin

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Antwort auf Beitrag Nr.: 22.151.902 von kaktus10 am 16.06.06 17:13:40

Wieder eine gute Nachricht.

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Ich denke man sollte nun einsteigen. Wenn die endgültige Zulassung der EU kommt, siehe vorherige Posts von mir, gibt es sicher noch einen Kursschub und einen weiteren, wenn am Ende des Monates die Zulassung der FDA/Gesundheitsbehörde der USA kommt. Lest Euch mal in Ruhe die vorherigen Post hier durch und entscheidet dann selber.

Ich bleibe da auf jeden Fall weiter investiert. Eine Aktie für LONGS und mit Geduld und keiner Panikreaktion, wenn es mal 80 oder 90 Cents abwärts geht.

So long :-).

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The Best Small Cap for 2007: Encysive Pharmaceuticals
By Brian Lawler
December 7, 2006

The best place to find undervalued stocks is undoubtedly with small-cap companies with less than $1 billion in market capitalization. Small-cap companies are often so small, though, because they always face the threat of going out of business or having a larger competitor come in and take over their market. If you want to ratchet up the rewards and risks even more, then look no further than small-cap pharmaceutical stocks, whose existence is often riding on the clinical and commercial success of one drug.

This situation perfectly describes Rule Breakers pick and small-cap wonder Encysive Pharmaceuticals (Nasdaq: ENCY). Its fortunes rise and fall on the prospects of its one drug, Thelin, which is used to treat a rare disease called pulmonary arterial hypertension (PAH).

Thelin is awaiting approval in the U.S. (more on that later) and has already been approved in the European Union. It is currently coming to market in the individual countries of the EU as fast as Encysive can set up sales and marketing forces and negotiate reimbursement rates in each EU country.

To get an idea of what sort of sales Thelin will bring in, one only has to look at the level of sales that a competing but inferior treatment for PAH marketed by Swiss-based Actelion (OTC: ALIOF.PK) has enjoyed. After more than five years on the market in both the EU and U.S., Actelion's Tracleer has ramped up sales to more than $500 million in just the first nine months of 2006. Even after being on the market for so long, the drug's sales are still climbing, with 2006's sales up more than 40% compared to 2005.

Based on the growth in Tracleer sales in its first years after EU approval, and the fact that Thelin will be the second PAH drug on the market, sales of Thelin should be around $30 million for 2007, assuming it is only approved in the EU. In 2008 and beyond, sales should continue to ramp up, thanks to its superior side-effect profile and easier dosing regimen compared to Tracleer.

Thelin's route to approval in the U.S. has been much rockier than in the EU, though. The drug has already been turned down twice by the FDA, and a third decision is forthcoming either within the next several weeks or in about five months, depending on how the FDA decides to handle Encysive's response to its approvable letter.

The knock on companies developing drugs to treat PAH has always been that the disease is so rare that it will be too difficult to hammer out profits selling drugs for this indication. For niche diseases like PAH, though, it doesn't take a large sales force to cover all the physicians treating the disease (which keeps overhead low). And since drugs to treat PAH typically cost more than $30,000 annually, it doesn't take a lot of patients on the drug to bring a company in this space to profitability. Pharmas like Gilead Sciences (Nasdaq: GILD) and Actelion seem to agree with me, since they've both acquired companies developing drugs to treat PAH at healthy premiums this year.

Whether Encysive is fated to be the one stock you must buy depends partially on whether it can get U.S. approval to market Thelin before Gilead's competing drug starts to take over some of the market. Even if this U.S. approval doesn't happen in a timely fashion, though, investors in shares of Encysive can at least wait for EU sales to start ramping up to meaningful levels in 2008.

Based on the risk-reward profile for Encysive and the possibility of U.S. approval in the upcoming months, Encysive has the potential to be one of the best small-cap investments of 2007. If you agree with me -- or if you want to tell the rest of the world why I'm wrong -- come join the Fool's brand-new community-intelligence database, Motley Fool CAPS, and rate the stock as an "outperform" or an "underperform." CAPS is free to join and play, and is a great way to check in on what investors think about the stocks you're interested in. Based on what you have to say, we'll declare the best small cap for 2007 early next week -- so come on out and vote for Encysive.

Seen our other contenders for best small cap? If not, click here.

Fool contributor Brian Lawler does not own shares of any company mentioned in this article. The Fool has a disclosure policy.

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Nach Börsenschluss USA bereits 16% plus

Encysive Pharmaceuticals Inc. has added a news release to its Investor Relations website.

Title: Encysive Pharmaceuticals Receives FDA Clearance to Resume Clinical Studies With TBC3711
Date: 12/7/2006 6:45:15 PM

For a complete listing of our news releases, please click here

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AP
Encysive's Thelin Gets Aussie Nod
Friday December 15, 5:50 pm ET
Encysive Pharmaceuticals Gets Positive Recommendation for Thelin by Australian Committee


HOUSTON (AP) -- Encysive Pharmaceuticals said late Friday an Australian review panel recommended approval of the company's Thelin treatment for pulmonary arterial hypertension.
The committee's recommendation will be weighed by Australian regulators. The drug is also under review by the U.S. Food and Drug Administration.

Shares of Encysive rose 36 cents, or 6.5 percent, to close at $5.89 on the Nasdaq.

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Super, Zulassung in Deutschland !!!!!!

Encysive Pharmaceuticals Announces Launch of Thelin in Germany
Monday December 18, 2:30 am ET
First Selective, Once-Daily Oral Endothelin A Receptor Antagonist Now Commercially Available for Pulmonary Arterial Hypertension Patients


HOUSTON, Dec. 18, 2006 (PRIME NEWSWIRE) -- Encysive Pharmaceuticals (NASDAQ:ENCY - News) today announced that THELIN(r)(1) (sitaxentan sodium(2)) 100 mg tablets are now commercially available in Germany for the treatment of pulmonary arterial hypertension (PAH). The Company received European Union 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.

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Encysive Pharmaceuticals Announces Launch of THELIN (Sitaxentan Sodium) in the Netherlands
Monday April 16, 2:00 am ET
First Selective, Once-Daily Oral Endothelin A Receptor Antagonist Now Commercially Available for Pulmonary Arterial Hypertension Patients

HOUSTON, April 16, 2007 (PRIME NEWSWIRE) -- Encysive Pharmaceuticals (NasdaqGM:ENCY - News) today announced the commercial availability of THELIN(r)(1) (sitaxentan sodium(2)) 100 mg tablets in the Netherlands for the treatment of pulmonary arterial hypertension (PAH). The Company received European Union 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.

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THELIN is indicated for improving exercise capacity in PAH patients classified as World Health Organization (WHO) functional class III. Efficacy has been shown in primary pulmonary hypertension(3) and pulmonary hypertension associated with connective tissue disease (CTD).

``As a once-daily oral therapy, THELIN may provide PAH patients with effective symptom management in a convenient, non-invasive route of administration,'' said Anco Boonstra, M.D., Ph.D., pulmonologist, Vrije Universiteit Medical Center, Amsterdam. ``THELIN is a welcome new treatment option for patients with primary disease and also those with CTD-related PAH, where THELIN has demonstrated a therapeutic benefit.''

The European Commission's centralized licensing procedure permits Encysive to market THELIN in all 27 member states of the European Union. THELIN has been launched in three member states to date, and will be commercialized in successive EU countries as local government approval for reimbursement is obtained.

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Hurra, die Zulassung in Kanada ist da. Kurs bereits vorbörslich um 25% gestiegen :


After Hours: 4.50 Up 0.91 (25.35%) as of May 30 on 05/30/07

Canadian Health Authority Approves THELIN (Sitaxsentan Sodium) for Pulmonary Arterial Hypertension
Wednesday May 30, 5:46 pm ET
First Selective Endothelin A Receptor Antagonist, First Once-Daily Oral Treatment

HOUSTON, May 30, 2007 (PRIME NEWSWIRE) -- Encysive Pharmaceuticals (NasdaqGM:ENCY - News) today announced that Health Canada's Therapeutic Products Directorate has approved THELIN(tm) (sitaxsentan sodium) 100 mg tablets.

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Canadian Health Authority Approves THELIN (Sitaxsentan Sodium) for Pulmonary Arterial Hypertension
Wednesday May 30, 5:46 pm ET
First Selective Endothelin A Receptor Antagonist, First Once-Daily Oral Treatment

HOUSTON, May 30, 2007 (PRIME NEWSWIRE) -- Encysive Pharmaceuticals (NasdaqGM:ENCY - News) today announced that Health Canada's Therapeutic Products Directorate has approved THELIN(tm) (sitaxsentan sodium) 100 mg tablets.

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THELIN is indicated for the treatment of primary pulmonary arterial hypertension (PAH) and pulmonary hypertension secondary to connective tissue disease, in patients with World Health Organization (WHO) functional class III who have not responded to conventional therapy. THELIN is also indicated in patients with WHO functional class II who did not respond to conventional therapy and for whom no appropriate alternative can be identified.

THELIN is the first selective endothelin A receptor antagonist (ETRA) available, and the only once-daily oral treatment approved for PAH.

PAH is estimated to afflict approximately 100,000 to 200,000 people in North America and Europe. The disease is characterized by high blood pressure and structural changes in the walls of the pulmonary arteries, the blood vessels that connect the right side of the heart to the lungs. As these arteries become increasingly constricted, blood flow and oxygenation may be inadequate to meet the body's demands. The heart must then pump harder to overcome the resistance, and patients become susceptible to heart failure.

``The approval of THELIN represents an advance in the treatment options available for PAH patients in Canada,'' commented David Langleben, M.D., Professor of Medicine, McGill University and Director of the Center for Pulmonary Vascular Disease, Jewish General Hospital, Montreal. ``THELIN's safety and efficacy profile and once-a-day oral formulation make it an attractive therapeutic option, and I look forward to its commercial availability.''

``THELIN has demonstrated a unique benefit for individuals who have developed PAH as a result of a connective tissue disease, such as scleroderma,'' said Janet Pope, M.D., Professor of Rheumatology, University of Western Ontario and Director, Division of Rheumatology, St. Joseph's Health Centre, London, Ontario. ``As a clinician, I welcome any new treatment that may help these particular patients, as they are a more difficult group to treat.''

THELIN's approval is based on the largest database of patients with PAH ever assembled in an original Canadian New Drug Submission, with more than 1,000 PAH patients receiving THELIN. Encysive received European Union marketing authorization for THELIN in August 2006, marketing approval from the Australian Therapeutic Goods Administration in March 2007 and the drug is currently under evaluation by the Food and Drug Administration (FDA) in the United States.

``This approval is another important step in our effort to commercialize THELIN worldwide,'' stated Bruce D. Given, M.D., President and Chief Executive Officer of Encysive Pharmaceuticals. ``We're extremely proud to have achieved this milestone and look forward to bringing THELIN to PAH patients in Canada.''

THELIN(tm) (Sitaxsentan Sodium) Canadian Marketing Authorization Highlights

The Canadian market authorization was based on submitted data from quality (chemistry and manufacturing) studies, as well as data from non-clinical and clinical studies. Two randomized, double-blind, multi-centre, placebo-controlled studies (n=425) were conducted to demonstrate efficacy and safety. Compared to placebo, treatment with THELIN resulted in a significant increase in exercise capacity. The placebo-corrected increases in six-minute walk distance compared to baseline were 35 meters and 31 meters for the two pivotal studies. Compared to placebo-treatment, THELIN demonstrated improvements to the cardiac index, pulmonary vascular resistance, and systemic vascular resistance after 12 weeks of treatment. Compared to placebo-treatment, THELIN improved functional class. A significant reduction in the rate of clinical worsening was also reported in patients treated with THELIN.

In the STRIDE program, THELIN 100 mg was shown to significantly improve exercise capacity, as measured by improvement in six-minute walk distance, including in patients with connective tissue disease. THELIN was also shown to reduce patients' PAH symptoms (improvement in WHO/NYHA functional class) and improve PAH hemodynamic status. Survival of patients was 96% at one year in the overall patient population and 98% in patients with PAH secondary to connective tissue disease.