Analyst's Upgrade And Raise Price Targets For ITMN - InterMune Inc.

Thomas Weisel Partners More Than Double InterMune (ITMN) Price Target To $55

http://www.benzinga.com/analyst-ratings/analyst-color/166370/thomas-weisel-partners-more-than-doubles-intermune-itmn-price-t

Wells Fargo Upgrades InterMune (ITMN) to Outperform:

http://www.streetinsider.com/Upgrades/Wells+Fargo+Upgrades+InterMune+(ITMN)+to+Outperform/5424826.html

Top 10 Analyst Upgrades and Downgrades (ADI, NLY, BIDU, CVX, ESLR, ITMN, JCG, LMT, SONC, VALE)

Posted: March 10, 2010 at 8:22 am

These are this Wednesday’s top 10 analyst upgrades, downgrades, and initiations seen from Wall Street morning research calls:

Analog Devices Inc. (NYSE: ADI) Raised to Outperform at Bernstein.
Annaly Capital Management (NYSE: NLY) Cut To Neutral at JPMorgan.
Baidu, Inc. (NASDAQ: BIDU) Reiterated Buy but Target raised to $630 from $550 at Citigroup.
Chevron Corp. (NYSE: CVX) Cut to Neutral at BofA/Merrlill Lynch.
Evergreen Solar (NASDAQ: ESLR) Started as Hold at Wunderlich.
InterMune Inc. (NASDAQ: ITMN) Raised to Buy at ThinkEquity; Raised to Outperform at Wells Fargo.
J. Crew Group, Inc. (NYSE: JCG) Cut to Hold at Citigroup.
Lockheed Martin (NYSE: LMT) Raised to Neutral at Macquarie.
Sonic Corp. (NASDAQ: SONC) Raised to Buy at KeyBanc.
Vale SA (NYSE: VALE) Cut to Neutral at UBS.

http://247wallst.com/2010/03/10/top-10-analyst-upgrades-and-downgrades-adi-nly-bidu-cvx-eslr-itmn-jcg-lmt-sonc-vale/

Happy Trading,
zigzagman

ITMN - FDA Panel Favors Approval For Intermune Inc. Drug:

FDA panel favors approval for InterMune drug:

By: The Associated Press | 09 Mar 2010 | 04:47 PM ET

WASHINGTON - Federal health advisers on Tuesday voted in favor of an experimental drug from InterMune Inc., despite mixed evidence of whether it provides significant benefits for patients with a rare lung disease.

The Food and Drug Administration's panel of lung experts voted 9-3 to recommend approval of the company's drug pirfenidone. That recommendation followed a narrower 7-5 vote that the drug provides a "clinically meaningful benefit" for patients with idiopathic pulmonary fibrosis, an often fatal lung disease for which there are no approved drugs.

The FDA is not required to follow the group's advice, though it often does. The agency is scheduled to make its final decision by May 4.

Ultimately, the lack of options for patients with idiopathic pulmonary fibrosis, or IPF, appeared to sway a majority of panelists in the drug's favor.

"IPF is a fatal disease and you have to offer your patients hope," said Karen Gottesman, the panel's patient representative. "If this drug can offer your patients even a smidgen of hope, it's worth approving."

Intermune submitted two studies for its drug to FDA, measuring ability to improve lung function in patients. While one study showed a statistically significant 4.4 percent increase in lung strength, another failed to achieve significance compared with placebo.

The FDA usually requires two placebo-controlled trials showing meaningful results to grant approval, a fact cited by several panelists who voted against the drug's benefits.

"We have two competing studies here," said Dr. Peter Terry, of Johns Hopkins University Medical Institutions. "Based on the agency's requirement for substantial evidence I don't think this meets the criteria for clinically meaningful benefit."

Most panelists agreed the drug's effect was modest and that long-term follow-up would be needed to determine whether it can extend patient survival. While slightly more patients taking pirfenidone survived compared with patients taking placebo, there wasn't an overall survival benefit in the company's studies, according to the FDA.

"Some people were expecting a cure, this is not a cure," said Dr. Richard Honsinger, of Los Alamos Medical Center. "This drug just slows the decline caused by the disease."

In a separate vote, panelists ruled 9-3 that pirfenidone was safe for patients. Most panelists said side effects such as nausea, rash and fatigue were tolerable, considering the fatal nature of the disease.

While some pirfenidone patients experienced abnormalities in liver function, those issues mostly resolved after patients discontinued the drug.

About 200,000 people in the U.S. and Europe have idiopathic pulmonary fibrosis. The disease causes scarring and stiffening of the lungs, which makes it increasingly difficult to breathe over time. The cause of the disease is unknown.

Intermune Chief Medical Officer, Dr. Steven Porter said he was "very excited," by the meeting's outcome.

"I think it was a very productive discussion and the data spoke for itself," said Porter.

If approved, InterMune plans to market the drug in the U.S. under the name Esbriet. The drug was approved in Japan in October 2008, where it is sold under the name Pirespa by Shionogi and Co.

Shares of the Brisbane, Calif.-based company were halted in trading Tuesday ahead of the FDA's meeting. The stock closed at $23.30 Monday.

Last week shares jumped to their highest point since 2007 after the FDA posted its review of pirfenidone.

http://www.cnbc.com/id/35783566/site/14081545/for/cnbc/

Here is one of the first PR's I saw after the FDA Advisory Panel gave it's decision:

U.S. FDA Panel Backs InterMune Lung Drug:

Tue Mar 9, 2010 3:39pm EST

Final agency decision expected by May 4.

SILVER SPRING, Md., March 9 (Reuters) - U.S. medical advisers backed InterMune Inc's (ITMN.O) experimental drug to treat lung scarring on Tuesday, saying it should be approved for patients with the rare fatal condition.

In a 9-3 vote, the Food and Drug Administration's outside experts said the company's data were strong enough to support use of the drug, pirfenidone, for patients with idiopathic pulmonary fibrosis (IPF).

InterMune is seeking FDA approval of pirfenidone to help mitigate worsening lung function in patients with IPF, a fatal condition in which the lungs scar for no apparent cause.

Trading in shares of InterMune was halted ahead of the panel's vote.

http://www.reuters.com/article/idUSN0924859020100309

Here are two charts showing ITMN's big move up as soon as the trading halt was lifted at 4:30pm ET...It immediately shot up to the $38.00 range, and it's After-Hours high was $38.62

ITMN closed yesterday at $23.30 and the closing price on March 4th was $14.31

CONGRATULATIONS! to ITMN, and it's shareholders.

This is great news for the people who need this drug, since there is currently no approved drug for their condition.

Happy Trading,
zigzagman





ITMN closed yesterday at $23.30 and the closing price on March 4th was $14.31 !!!...

InterMune Inc. - ITMN Shares Hang on FDA Playing the “make or break” event with options:

InterMune (ITMN) Shares Hang on FDA Playing the “make or break” event with options:

by Kevin Cook March 8, 2010 4:06 EST

Kevin Cook is an options instructor for the Options News Network. He was an institutional foreign exchange market maker and arbitrageur for nine years, where he worked with futures.

http://www.onn.tv/buy-and-trade/intermune-itmn-shares-hang-on-fda/

We know that the stocks of young biotech companies with experimental drugs in the works trade “make or break” around FDA approval events. Friday’s action in InterMune (NASDAQ: ITMN), which sent the shares up over 60%, was another classic example and something we had been anticipating since January 4th when the FDA granted “Priority Review” status to ITMN’s idiopathic pulmonary fibrosis drug, pirfenidone.

Last week, I decided to write—for the next 20 weeks—about all 20 stocks in my favorite biotech ETF, the FBT. This week was made for ITMN, one of the top-ten holdings, with its scheduled FDA review date of March 9th and stock-moving news posted Friday in briefing documents on the FDA website. The optimism expressed in ITMN’s rally is built around speculation that the FDA analysis of pirfenidone’s Phase 3 clinical trials may be more favorable than previously expected.

The final word of approval from the FDA for pirfenidone is not due until May 4th, but the company and investors may be hanging their fortunes on the fact that the findings of Advisory Committee meetings, like tomorrow’s, are often the direction the agency is headed. In other words, while the FDA is not held to judgments by its advisory panels, it usually follows them. Before we look at how options traders might be playing the event, let’s review some of the key facts about InterMune and pirfenidone.

Key Facts on ITMN:

InterMune, Inc. is a biotechnology company focused on developing and commercializing innovative therapies in pulmonology and hepatology. Their only drug approved in the U.S. currently is Actimmune, which treats both CGD and severe, malignant osteopetrosis, two rare congenital disorders.

Pirfenidone is the only drug designed to treat idiopathic pulmonary fibrosis (IPF), an unexplained inflammation and scarring of the lungs, which hinders the ability to process oxygen and causes shortness of breath. A progressive disease, symptoms increase in severity and usually result in death within two to five years of diagnosis.

200,000 people are affected by IPF in US and Europe; there are an estimated 30,000 new cases each year.

Pirfenidone is approved and marketed in Japan as Pirespa
FDA granted Fast Track/Priority Review status for the US New Drug Application (NDA) on January 4, 2010.

On Friday March 5, FDA posted a March 9 Review briefings document, signaling that prior criticisms of ITMN research may be alleviating.

Proposed U.S. name for pirfenidone is Esbriet.

Neutral and Bearish Strategies:

For investors and traders who believe that we won’t know enough after tomorrow to take ITMN’s stock above $30 or below $15, this short iron condor offers significantly high implied volatility to temper the risk. We recommended this play in our Trading Ideas section on Friday when it was garnering only $2.50 in total premium. With implied volatility climbing yet again today to over 300%, this iron condor could now collect more than $3.00.



And for those who think that a severe disappointment and pullback is likely after tomorrow, in our OTA Portfolio we looked at a bear ratio put strategy where you could buy a March 17.5 put and sell two 12.5 puts for nearly even money. With essentially zero cash outlay, and a max profit potential of $5.00, this play doesn’t begin to lose money unless the stock falls below $7.50. (The chart below was created with a virtual trading account, something I recommend especially for anyone who wants to experiment with new option strategies).



All of these March strikes have seen significant trading today with the March 30/35 call spread trading over 10,000 by noon and now edging closer to 20,000 contracts each as the day winds down. On the put side, the March 12.5 and 15 puts have seen more than 12,000 contracts trade in each, while the 17.50, 10, and 7.50 strikes all have close to 5,000 contracts. All of these volumes are well above normal and indicate many players positioning for any possible news tomorrow.

Short Interest and Insider Buying:

Also worth noting about ITMN shares is that since the early January announcement about FDA’s track for approval of pirfenidone, short interest in the stock climbed significantly from around 11% of float to near 16%. This may explain much of the move we saw Friday that vaulted the shares from below $15 to above $25 at one point.

And late January saw significant buying by insiders, with Director Jonathan Leff buying 2.1 million shares at $14.10 and Director James Healy exercising 5,000 options at $4.50 per share.

ITMN - InterMune Inc. - A Stock To Watch Next Week - March 8th-12th, 2010:

ITMN - InterMune Inc. - Healthcare - Biotechnology

Website: http://www.intermune.com/wt/home

Friday's news release from the company website that caused the huge gap up at the opening bell:

http://phx.corporate-ir.net/phoenix.zhtml?c=100067&p=irol-newsArticle&ID=1399323&highlight=

Another news release released on Friday:

InterMune Stock Gets Boost as FDA Staff Questions Lung Drug:

http://blogs.wsj.com/health/2010/03/05/intermune-stock-gets-boost-as-fda-staff-questions-lung-drug/?mod=yahoo_hs

By James A. White

The FDA staff said it has a bunch of questions about InterMune’s new drug to slow deteriorating lung functioning. But investors figure the concerns weren’t as bad as they could have been, sending the biotech’s shares soaring.

The stock jumped as much as 74% after FDA reviewers said only one of InterMune’s two late-stage trails for the experimental drug pirfenidone had met its main goal and added that “the clinical significance of the treatment effect size is uncertain.”

The FDA documents, which were released ahead of an advisory panel meeting to discuss the drug Tuesday March 9th, also had a mix of other things to say.

All things considered, an Oppenheimer analyst noted the “tone was less negative than expected,” all things considered and there was room for the drug to still get FDA approval. The shares settled down in later trading, but still finished up nearly 60% for the day.

InterMune often appears on lists of likely biotech takeover candidates. FDA approval of pirfenidone would give it two drugs on the U.S. market.

The new drug would treat idiopathic pulmonary fibrosis, which affects about 200,000 Americans, the majority of whom eventually die of respiratory failure. The FDA noted that there aren’t any approved drugs to treat IPF, although drugs like corticosteroids and drugs that suppress the immune system are used, according to Dow Jones Newswires.

The company also put out material noting that “the slowing of progression in loss of lung volume constitutes a clear benefit to patients,” Reuters said.

Here’s more news that came out on Friday about ITMN:

http://www.prnewswire.com/news-releases/intermune-announces-posting-of-briefing-documents-for-fda-advisory-committee-meeting-on-pirfenidone-86546937.html

http://www.forbes.com/2010/03/05/intermune-fda-drug-markets-equities-pharma-update.html?partner=yahootix

http://finance.yahoo.com/news/InterMune-Shoots-Higher-On-ibd-3578098094.html?x=0&.v=1

http://www.foxbusiness.com/story/markets/industries/health-care/fda-posts-documents-briefing-new-drug/

The last paragraph of this article mentions ITMN may be a buyout target by a big pharma company:

http://blogs.wsj.com/health/2009/08/21/is-1-billion-is-the-right-price-for-pharma-ma/

Here is some Fundamental Analysis information:

Look at the difference in the numbers shown by the Yahoo Finance and the Finviz.com sites. Notice the differences between the Float numbers, the percentage of shares owned by Institutions, and the percentage of shares owned by Insiders. There is also a large difference in the number and the percentage of shares that are Short.

That's probably due to when each site updates their data. I usually prefer to get my information from Yahoo Finance, because they usually update their data faster than Finviz.com does.

I read on the IHUB message board that Insiders recently purchased 30 million shares, but I haven't been able to verify that yet. That may account for the differences between the Yahoo Finance and the Finviz.com information.

The Yahoo Finance numbers:



The Finviz.com numbers:





Look at all of the Insider Transactions for January 26th, 2010. Insiders started buying again on that date, which is a vote of confidence from the people that run this company:



But here, Yahoo Finance missed Oppenheimer's reiteration of an Outperform rating on January 25th, 2010.

Yahoo Finance:



Finviz.com:



Here is an hourly, daily, and a weekly chart of ITMN. There is a short YouTube video below these chartrs that shows Technical Analysis of these charts.







Here is the Option Chain for ITMN as of the close on Friday March 5th, 2010. These Options expire on the third Friday in March, which is March 19th, 2010:



Here's a nine minute YouTube video that analyzes ITMN's charts:



Happy Trading,
zigzagman