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  1. #1
    L'avatar di axelvento
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    igxt

    http://www.intelgenx.com/_assets/pdf...-Sept-2009.pdf

    Filed NDA with U.S. Food and Drug Administration (FDA) - on April 3, 2009 the Company and Cary Pharmaceuticals filed a New Drug Application (NDA) under CFR 21 paragraph 505(b)(2) for the CPI-300 antidepressant. CPI-300 is a new strength of a leading antidepressant that will provide a more convenient dosing option to patients with major depressive disorder ("MDD").

    The NDA has been formally accepted by the FDA for standard review. Pursuant to Prescription Drug User Fee Act (PDUFA) guidelines, IntelGenx expects the FDA will complete its review or otherwise respond to the NDA by February 6, 2010.

    ,59

  2. #2
    L'avatar di axelvento
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    IntelGenx Reports Results For the Third Quarter and Nine Months Ended September 30, 2009


    FINANCIAL HIGHLIGHTS:

    Raised approximately $3.9 million in Q3 through private placements.

    Repaid the balance of convertible debt of approximately $1.0 million in September, 2009.

    Total Revenue increased 36% to $383.4 thousand in Q3 and increased 47% to $1,084.8 thousand year-to-date (2008: $282.2 thousand and $738.3 thousand respectively)

    Total Expenses decreased 6% to $1,082.4 thousand in Q3 and 22% to $1,494.4 thousand year-to-date (2008: $1,150.4 thousand and $3,310.3 thousand respectively)

    The Net Loss improved by 22% to $655.8 thousand in Q3 and improved by 44% to $1,364.5 thousand for the year-to-date (2008: loss of $839.2 thousand and $2,454.1 thousand respectively)

    The Basic and Diluted Loss Per Common Share improved by 50% to $0.02 in Q3 and improved by 54% to $0.06 for the year-to-date (2008: Basic and Diluted Loss Per Common Share of $0.04 and $0.13 respectively)

    Commenting on the results, Horst Zerbe, President and Chief Executive Officer of IntelGenx, said: "In the third quarter we substantially strengthened our balance sheet by successfully completing our largest fundraising to date, repaying the balance of convertible debt, and retaining sufficient cash to support ongoing R&D operations. I am also pleased to report that operationally our year-to-date revenue remains 47% above prior year whilst expenses are 22% lower, leading to an improvement of more than $1 million in our net result".

    RECENT HIGHLIGHTS:

    Appointed IR firms - on October 1, 2009 the Company engaged Little Gem Life Science Partners ("Little Gem") and SectorSpeak Inc. ("SectorSpeak") to spearhead the development of the Company's relationships with the investment communities of North America. Although both firms will work closely together, Little Gem, based in New York, has been retained with primary responsibility for Investor Relations activities in the USA whilst SectorSpeak, a Canadian Corporation, will concentrate on the Canadian market. Both firms have been engaged for a term of 12 months.

    Repaid convertible notes outstanding - on September 22, 2009 the Company repaid the balance of the convertible notes outstanding of $976,333. The Company had entered into convertible note agreements with certain institutional and accredited investors on May 22, 2007 for amounts totaling $1,500,000. The convertible notes bore interest at the rate of 8% per annum, payable quarterly and substantially all of the assets of the Company had been pledged as security of the convertible notes. The repayment of the convertible notes strengthens the balance sheet and creates additional cost savings for the Company.

    Raised approximately $3.9 million in Q3 through private placements - on July 13, 2009 the Company closed a private placement offering of approximately 10.5 million special warrants for gross proceeds of approximately $3.6 million. Each special warrant entitles its holder to receive, upon exercise or deemed exercise thereof, one common share of the Company and one common share purchase warrant. Each warrant entitles the holder thereof to purchase one common share of the Company at a price of $0.80 until July 13, 2012.

    On July 22, 2009, as part of a private placement, the Company issued 350,000 units to investors in the United States for gross proceeds of approximately $127.5 thousand. Each unit consists of one common share of the Company and one common share purchase warrant. Each warrant entitles the holder to purchase one common share at an exercise price of $0.80 per common share and expires 36 months after the date of issuance.

    On September 3, 2009, as part of a private placement, the Company issued 250,000 units to investors for gross proceeds of approximately $92.9. Each unit consists of one common share of the Company and one common share purchase warrant. Each warrant entitles the holder to purchase one common share at an exercise price of $0.80 per common share and expires 36 months after the date of issuance.

    ABOUT INTELGENX:

    IntelGenx is a drug delivery company focused on the development of oral controlled-release products as well as novel rapidly disintegrating delivery systems. IntelGenx uses its unique multiple layer delivery system to provide zero-order release of active drugs in the gastro-intestinal tract. IntelGenx has also developed novel delivery technologies for the rapid delivery of pharmaceutically active substances in the oral cavity based on its experience with rapidly disintegrating films. IntelGenx's research and development pipeline includes products for the treatment of pain, hypertension, osteoarthritis, and depressive disorders. More information is available about the company at www.intelgenx.com.

  3. #3
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    Buongiorno Axel!
    IGXT il prossimo Novelis?
    Provo a 0.55 se me le danno.
    Thanks Axel!

  4. #4
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    due farmaci diversi...CPI-300 antidepressant igxt

  5. #5
    L'avatar di axelvento
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    piccolo volume che entra

    ,60

  6. #6
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    Outstanding Shares
    20,850,002 as of Mar 4, 2009

  7. #7
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    vera gemma(se tutto va bene) questo titolo axel!

    cerco di sgranocchiare ....qualcosa

  8. #8
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    uhmmmmm!

    that the Company's board of directors granted options to acquire 125,000 common shares effective November 24, 2009. All options were granted under the 2006 Stock Option Plan with an exercise price of C$0.65 and expire in five years.

    Of the total stock options grant, 25,000 were granted to each of the Company's non employee directors Bernard Boudreau, Ian Troup and Bernd Melchers and vest immediately. The company also granted 25,000 options to purchase common shares to each the CEO and President, Horst G. Zerbe and the CFO, Paul A. Simmons. The officer's options vest over the period of two years at the rate of 25 % every six months.

  9. #9
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    sgranocchiando scattata...

    60x62

  10. #10

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    titolo interessante, ottima segnalazione...

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