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ENCY

Started by dennis67, June 02, 2006, 09:15:39 AM

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dennis67

way up in pre market

Encysive Pharmaceuticals Gets Postive EMEA Thelin Opinion

Jun 2, 2006 06:41:00 (ET)


DOW JONES NEWSWIRES

Encysive Pharmaceuticals (ENCY) said that the Committee for Medicinal Products for Human Use of the European Agency for the Evaluation of Medicinal Products issued a positive opinion recommending Thelin 100 milligram tablets as a once daily oral treatment for patients with pulmonary arterial hypertension.

The CHMP's positive opinion will now be considered by the European Commission, which is expected to issue a final decision regarding marketing approval within approximately 90 days.


D&Data

Hey Dennis...
I hope you were in !

Good pick man

dennis67

sold all at 6.80, made a real nice profit on it. :D now im buying more hom.

la-onda

probably sold too early ?

feedback is appreciated
cheers
Oliver

ENCY: Leerink Swann Ups to Mkt Perform from Underperform; Sets Tgt @ $9; Analyst Notes
Friday , June 16, 2006 11:00 ET

Issuer: Encysive Pharmaceuticals, Inc. (NasdaqNM: ENCY)
Analyst Firm:  Leerink Swann & Company
Ratings Action: UPGRADE
Current Rating: Mkt Perform (from Underperform)
Target Price Action: INITIATE
Target Price: $9.00

Analyst Comments: According to the firm, the FDA accepted ENCY's complete response to Thelin's March 24 approvable letter and that based on the positive momentum they are upgrading their rating to Market Perform from Underperform. They see a US launch of Thelin to come sometime in Q3 2006. They raised revenue estimates for '06 to $24M from 15M, '07 to $99M from $34M, '08 to $184M from $58M, and '09 to $297M from $153M. They also raised EPS estimates for '06 to ($1.84) from ($1.92), '07 to (68c) from (80c), '08 to 35c from (41c), and '09 to $1.73 from 36c.

&

Encysive Meets FDA Requests Without Costly Delays
Friday , June 16, 2006 00:39 ET

Jun 16, 2006 (financialwire.net via COMTEX) -- June 16, 2006 (FinancialWire) Shares of Encysive Pharmaceuticals (NASDAQ: ENCY) skyrocketed up to 43 percent Thursday before falling slightly to end the day at $6.89, a 36 percent increase on news that the Food and Drug Administration (FDA) would not require expensive new clinical trials for Encysive's Thelin drug.
Thelin is designed to treat pulmonary arterial hypertension but was only labeled "approvable" by the FDA in Encysive's initial application. The FDA could have required new trials that would have substantially delayed approval.
The fear of delays caused Encysive shares to plummet earlier in the year.
The company said the drug could be approved by July 24 in the U.S. and expects European regulators to rule on its application by the end of September. A European panel recommended approval of Thelin earlier this month.
Thelin is estimated to achieve $200 million in annual sales and if Encysive can get to shelves fast, it could corner the market before other companies have a chance to enter.

&

A Second Look: Encysive Pharmaceuticals
Friday , June 16, 2006 13:37 ET

By Staff Reporter

HOUSTON, Jun 17, 2006 (XFN-ASIA via COMTEX) -- Shares of Encysive Pharmaceuticals Inc. fell Friday, giving back some gains made off of news the U.S. Food and Drug Administration will render a decision on its latest drug candidate by July.

The drug developer's stock lost 13 cents, or nearly 2 percent, hitting $6. 88 on the Nasdaq in midday trading. It closed Thursday at $7.01 after gaining 39 percent. The FDA said it will make a decision on approving the company's pulmonary arterial hypertension drug, Thelin, by July 24. The drug treats chronic high blood pressure in the blood vessel carrying oxygen-poor blood to the lungs.

The company received an "approvable" letter in March, in essence requesting more data in the submission and the company expects European approval of the drug within 90 days.

News of the decision date sparked several analyst moves, with several reaffirming or upgrading the stock's rating.

C.E. Unterberg, Towbin analyst Andrew S. Fein upgraded the stock to "Buy" from "Underperform" with a price target of between $9 and $11 per share. In a note to investors, he cites the news as the catalyst and said the stock should eventually gain enough ground to return to its trading price prior to the approvable letter. The stock, which hit a 52-week high of $13.29 on Sept. 5, lost 47 percent the day the approvable letter was announced, and slumped to a low of $3.29 on May 19.

The slight decline in morning trading is most likely a matter of profit taking, he said, as investors mull how long to hold on to the stock.

"The question some people are asking is, if we hold at this point, what's my potential upside," Fein said.

He also cites the company's move to reform its Scientific Advisory Board, overlooked by Wall Street, as a key to the company's future success with Thelin. The board is made up of top physicians in the field and would have a solid influence on how well the drug does in the market.

Competition concerns include Myogen's ambrisentan, though Thelin would most likely have a sizable head-start in the market if approved.

Needham Co. analyst Mark Monane took a more cautious stance on the stock, reaffirming his "Hold" rating citing the good news, but warning of possible pitfalls.

Though the news is positive, he said, the FDA could require additional trials, leaving room for uncertainty. He noted the FDA's approvable letter in March most likely dealt with safety concerns or issues.

"While we are impressed by the recent recommendation regarding Thelin, we note that the FDA has been very cautious lately especially around any safety issues," he wrote.

422fwhp

I believe it has found the bottom, imo.

In at $3.36

422fwhp

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

News should help today...

Encysive Places $60M Senior Notes
Tuesday February 6, 8:29 pm ET 
Encysive Closes $60M Senior Note Placement


HOUSTON (AP) -- Encysive Pharmaceuticals Inc. said Tuesday its newly formed, wholly owned subsidiary has closed a $60 million senior note placement to institutional investors.
The notes will bear interest at a rate of 12 percent annually beginning March 30. Royalties on the notes will be paid from sales of Argatroban, a drug which Encysive licenses to British drug maker GlaxoSmithKline plc.

Encysive shares climbed 18 cents, or 5.3 percent, to $3.60 in after-hours trading after closing up a penny to $3.42 on the Nasdaq.




422fwhp

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

I sold the gap up for a small profit (got a ways to go to make up for recent dung).  Now I'm just unsure...pretty much for the entire market. :( 

opinions?

GLTA...Jody


Ares

Volume up as price made a higher high.
Go in with upside momentum or wait for stock to tank and buy close to support.

Ares

Positive 5 minute MACD near zero with 1 minute stochastics near oversold conditions.
Price is currently above the 5 minute 8ma.
Daily pivot at 4.64.
Go in with upside momentum or wait for stock to tank and buy close to support.

wrangler

ENCY : might be ready to make a move up.
JMO
I have no position
wrangler