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ELN - Sector: Healthcare - Industry: Biotechnology & Drugs

Started by AustinPowers, June 09, 2005, 09:56:38 PM

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bula

Buying large position at $8.08 and accumulating dips into Wednesday.  We'll see if this pays off, but the price is off its highs so risk seems worthwhile.

/Bula



DUBLIN (Dow Jones)--Elan Corp. PLC (ELN) is hoping a U.S. Federal Drug Administration decision due next week at the earliest will give priority review for its multiple sclerosis drug Tysabri, observers said Friday.

Elan and joint partner Biogen Idec PLC (BIIB) last month requested priority review status for Tysabri, which could result in action by the FDA 6 months from last month's submission date, rather than 10 months.

This could see Tysabri back on the market by March, rather than mid-summer 2006, say analysts, who expect the FDA to make a response by Wednesday though the FDA could also take another 30 days, an Elan spokeswoman said.

NCB Stockbrokers analyst Orla Hartford, who has a buy on Elan, said she's "hopeful" that the FDA will grant a priority review aimed at fast-tracking Tysabri's return to market "due to the unmet medical need in MS."

Elan and Biogen Idec suspended Tysabri in the U.S. Feb. 28 after two patients contacted the rare neurological disease PML. A third case was confirmed later. All affected patients were on combination therapy.

Before Elan's third-quarter results next Thursday, NCB's Hartford said focus will remain firmly on Elan's approximate $870 million net debt and, crucially, on priority status for Tysabri by the FDA.

In August, Elan said a safety study found no new PML cases in MS Tysabri patients and, this week, confirmed no new cases in those with Crohn's disease and rheumatoid arthritis, completing its safety review of 3,000 patients.

Still, while most analysts who hold the stock are betting on Tysabri returning to market, some fund managers are still skeptical, saying Tysabri needs to be the much-hoped for blockbuster drug.

Anne Marieke Ezendam, who runs the global healthcare fund at Threadneedle Investments in London, said she's "convinced" Tysabri will come back to market, "but to a smaller market and not before summer of 2006."

"Elan's underlying cash burn on sales force and research is very high," she said. "Tysabri needs around $550 million per year in sales to offset Elan's current spending. I'm not sure if the market will support that."

Elan has also submitted Tysabri's two-year Phase III data, safety review data and its proposals for labelling/monitoring of Tysabri patients to the European Medicines Agency. No timeline has yet been given.

At 1626 GMT, Elan's shares were down 27 cents, or 3.8%, at EUR6.73 on the Irish Stock Exchange. The ISEQ Overall Index was down 1.2%. The shares have fallen from EUR20.30 after Tysabri was suspended in February.

After a volatile few years, the company seems to be continuing a focus on reducing costs and simplifying its business model and balance sheet, while also focusing on its key drugs, Tyasbri and pain drug Prialt, analysts say.

The safety review comes after a long and arduous recovery, which began with a change of senior management in 2002, when Elan's late former CEO and Chairman Donal Geaney resigned amid accounting troubles and a falling share price.

Company Web site: http://www.elan.com

-By Quentin Fottrell, Dow Jones Newswires; +353 1 676 2189; [email protected]


(END) Dow Jones Newswires

10-21-05 1229ET

Copyright (c) 2005 Dow Jones & Company, Inc.


bula

Now $8.27 and climbing.  ELN should continue to rise into BIIB earnings on Wednesday.  I expect $8.5-$9.  Expectations that Tysabri will get some good news from FDA or Biogen.If FDA gives fast track return to market, ELN will be $15 by Friday.

Tracking the bidders closely for insider moves.  But so far, I love my buy in.

Bula

akclide

I do not think it will move that high that fast,as this fda decission will only confirm the results in 6 months or 10 and not weather the drug is back in or not.

bula

from the article I posted above ..

"This could see Tysabri back on the market by March"

That would be huge news and justify a big pop.

bula

ELN hitting $9.5+ now.  FDA review due within a week or 2.  This has been a great 3 week hold for me (up +1.5).  I still say $15 will happen quick if the FDA given a positive output on Tysabri.

Bula

bula

NEWS - FDA gives Tysabri a priority review .. as I mentioned would occur. This was EASY money folks. I hoped to see a bigger pop on the news AH - ELN got to about $11.50.   Not bad for a 4 week play.

We may still see a nice move at the open, but in any case.  Selling the news is always best.  I'll watch close and if it doesn't pop to yesterdays AH highs, i'll take my profits.

Happy trading all,
Bula

calven

#36
There was already an ELN thread created in the forum...

Please go to SEARCH on the top of this page and type in "ELN" you should be able to find it from there....

That is why nobody is replying to you, its because there is already a 7 page thread on ELN - http://www.3stocksonfire.org/trading/index.php?topic=1660.90

Thanks,
Cal
StockGravity.com - The Forces that Move Stocks!
http://www.stockgravity.com

bula

Sold at $11.02 almost +3

Thanks for the info on the other thread.  Didn't know that.

I'm out so this thread is done.

kslifka

After a few months of consolidatin ELN is breaking out of an ascending triangle.  Volume is slowly picking up, ahead of likely re-introduction of MS blockbuster drug Tysabri.


kslifka

ELN continues to move up on good volume.  ELN printed 16.87, a 52 week high.  It broke an ascending triangle last Friday and appears to have formed a 5 month cup.  Could we see a handle form??  News about FDA re-introduction of MS drug,Tysabri, is right around the corner and will be out, at the latest, by mid-June.  This one has a huge gap to fill up to $25 from just over a year ago.

kslifka

Updated chart on ELN.  Broke a 52 week high today with increasing volume and 3 consecutive white candles.  Still waiting FDA news regarding MS drug, Tysabri, re-introduction.

kslifka

ELN...would be nice to get a nice big white candle surrounding the red one from yesterday  ;D

kslifka

ELN has held up well, even against adverse market conditions.  Is something up??  Waiting on FDA re-intro of blockbuster MS drug Tysabri.  Question is what will the pre-cautions be??
Gap to $26.

kslifka

ELN started off very promising this morning, even when the stock market with going negative, ELN hit a 52 week high at 18.47 in high volume.  Unfortunately it fell in afternoon trading there fore it may start negative tomorrow AM but it may provide a buying opportunity.  A small triangle is setting up and the ascending line will be around 17.10.  Still an open gap to $25 from last year.

kslifka

ELN started off very promising this morning, even when the stock market with going negative, ELN hit a 52 week high at 18.47 in high volume.  Unfortunately it fell in afternoon trading there fore it may start negative tomorrow AM but it may provide a buying opportunity.  A small triangle is setting up and the ascending line will be around 17.10.  Still an open gap to $26 from last year.