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Home  /  Forum  /  BioPharma  /  CHTP - Chelsea Therapeutics International

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CHTP - Chelsea Therapeutics International

790 Posts
Pagina: «« 1 ... 4 5 6 7 8 ... 40 »» | Laatste | Omlaag ↓
  3. svenhedin 31 oktober 2011 17:08
    Re: Short interest keeps rising 28 minutes ago

    No, I don't believe it is rocket fuel. In the old stock market it used to be.
    My insinuation of organized crime is this - the hedge funds and wise guys that are destroying the stock market can put on a short position illegally and take it off illegally.

    Case in point: I own a small bank, symbol PMBC. Some guy put on a short position of 1 million shares or 10% of the float very quickly. The stock is very thinly traded. Recently the short started covering. For such a thinly traded stock this should have created a rise in price.

    Note the period from 9/1 to 9/15 where 400,000 shares were "covered." In that same period only 160,000 shares traded! How were 400,000 shares covered when only 160,000 traded? The stock price actually FELL during this two week period where 4% of the float was "covered."

    I don't know how these guys do it, but they are doing it. They are skirting around legitimately borrowing shares and naked shorting.
    The way they cover is almost as if it is done with a journal entry to make it go away. Thus, they stand to gain on a price drop but are not exposed to any risk in the case of a rising price.

    Mark my words, if CHTP starts rising on great news all of a sudden you may see huge covering but no corresponding huge rise in price as you might expect.

    I believe these funds and wise guys are organized and attack smaller company stocks. The SEC seems to just look the other way.
    I have reached a point where I feel the game is rigged. CHTP is one of my last holdings. I want to see how it plays out because I believe they have a good chance at approval for Northera. Plus, CH-4051 has blockbuster potential.
    www.nasdaq.com/symbol/pmbc/short-...
  4. ludwig mack 2 november 2011 22:26

    Chelsea Therapeutics Reports Third Quarter 2011 Results
    Company to Host Conference Call at 4:30 PM ET

    CHARLOTTE, N.C., Nov. 2, 2011 (GLOBE NEWSWIRE) -- Chelsea Therapeutics International, Ltd. (Nasdaq:CHTP) reported financial results for the third quarter 2011 and presented a quarterly update on the Company's development progress. Chelsea's management team will host a conference call this afternoon at 4:30 PM EDT to discuss these results.

    Recent Highlights:

    Reported unblinded interim safety data from ongoing Phase II trial of CH-4051 demonstrating that a daily 1.0 mg dose of CH-4051 achieved similar efficacy to 20.0 mg weekly dose of methotrexate (MTX) while maintaining better safety and tolerability in patients with an incomplete response to MTX;

    Submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking Priority Review and approval to market NORTHERA™ (droxidopa) for the treatment of symptomatic neurogenic orthostatic hypotension (NOH) in patients with primary autonomic failure, dopamine beta hydroxylase deficiency and non-diabetic autonomic neuropathy;

    Granted new patent related to methods of reducing pain associated with fibromyalgia by administering droxidopa alone, or in combination with other specified medications; and

    Achieved target enrollment in Phase II trial of droxidopa in fibromyalgia.
    "People with symptomatic neurogenic orthostatic hypotension face extraordinary challenges every day," commented Dr. Simon Pedder, President and CEO of Chelsea. "The filing of our new drug application during the third quarter was a significant achievement that has been several years in the making and reflects our team's commitment to these patients. In reaching this goal, we believe we took a significant step toward making a meaningful new treatment option available to patients whose lives have been impacted by the symptoms of NOH. We are highly confident in the effectiveness of Northera, the strength of our filing and the abilities of our sales and marketing team and look forward toward an anticipated U.S. approval and launch of Northera next year."

    Financial Results for the Third Quarter

    Chelsea reported a net loss for the quarter ended September 30, 2011 of $10.9 million or ($0.18) per share versus a net loss of $8.8 million or ($0.22) per share for the same period in 2010. For the first nine months of 2011, Chelsea reported a net loss of $38.0 million or ($0.64) per share compared to a net loss of $24.9 million or ($0.65) per share for the nine months ended September 30, 2010.

    Research and development (R&D) expenses of $7.4 million for the third quarter 2011 remained flat year-over-year. The R&D expenses for the quarter reflect a decrease in clinical expense offset by approximately $1.1 million related to medical affairs activities including the hiring, on a contract basis, of a team of Medical Science Liaisons and approximately $0.7 million related to the preparation and filing of the Northera NDA. For the nine months ended September 30, 2011, R&D expenses were $29.6 million versus $20.7 million for the comparable prior-year period. This year-over-year increase primarily reflects an increase in costs associated with the planned registration and anticipated launch of Northera including expenses related to the manufacturing of commercial drug product, the Northera QTc study and the preparation and filing of the Northera NDA.

    Selling, general and administrative (SG&A) expenses of $3.5 million for the three months ended September 30, 2011 increased from $1.4 million for the same period in 2010. This increase of approximately $2.1 million reflects an increase in compensation related to the hiring of a marketing and sales leadership team, increased prelaunch market research and the implementation of key sales and marketing initiatives to support the planned commercialization of Northera in 2012. SG&A expenses of $8.6 million for the nine months ended September 30, 2011 compared to $4.4 for the prior-year period and, similar to third quarter expense, reflects an increase in compensation and costs related to market research, sales force strategy and planning, as well as planning for advertising and promotional campaigns.

    Chelsea ended the quarter with $57.6 million in cash, cash equivalents and short-term investments compared to $47.6 million at December 31, 2010.

    2011 Financial Guidance

    Chelsea anticipates 2011 R&D expense to remain near current levels with full year R&D expenses of approximately $42 million and SG&A expenses continuing to ramp through commercialization with a 2011 total of approximately $16 million. Based on these expenses, Chelsea anticipates ending the year with approximately $35 — 40 million in cash, cash equivalents and short-term investments. The Company anticipates that available cash, cash equivalents and short-term investments should fund the company's current development programs and launch initiatives through anticipated commercialization of Northera in the second quarter of 2012.


    bron: persbericht
  5. ludwig mack 2 november 2011 22:28
    Chelsea Therapeutics Announces Preliminary Results of Interim Analysis of CH-4051 Phase II Trial in Rheumatoid Arthritis

    Mid-Range Dose of CH-4051 Demonstrates Similar Comparable Efficacy and Improved Safety and Tolerability Compared to Standard Dose of Methotrexate

    Data From 0.3 mg and 1.0 mg CH-4051 Arms Suggest Dose Effect

    High-Dose Arms Now Fully Enrolled With Topline Results Expected in Second Quarter 2012

    met hier een enkel citaat:

    "We are encouraged that the results of our interim analysis not only continue to show the safety, tolerability and efficacy of a metabolically inert antifolate such as CH-4051 but do so in a treatment resistant population," commented Dr. Art Hewitt, Chief Scientific Officer of Chelsea Therapeutics. "As we look toward the full study results, we are very optimistic that our two more recently activated 3.0 mg CH-4051 treatment arms will demonstrate more potent therapeutic activity while retaining the improved safety and tolerability profile compared to methotrexate. We are eagerly looking forward to full dataset from this trial, anticipated in the second quarter 2012."

    zie verder tekst van dit separate persbericht v/d company.

    gr

  8. ludwig mack 3 november 2011 16:33
    Chelsea Therapeutics Internatio
    (NasdaqCM: CHTP )

    Real Time 4.84 Up 0.37 (8.28%) 11:30AM EDT
    Last Trade: 4.78
    Trade Time: 11:17AM EDT
    Change: Up 0.31 (6.94%)
    Prev Close: 4.47
    Open: 4.58
    Bid: 4.78 x 500
    Ask: 4.79 x 300
    1y Target Est: 11.20
    Day's Range: 4.50 - 4.79
    52wk Range: 3.25 - 8.20
    Volume: 80,371
    Avg Vol (3m): 423,388
    Market Cap: 295.63M
    P/E (ttm): N/A
    EPS (ttm): -0.94
    Div & Yield: N/A (N/A)
  11. ludwig mack 4 november 2011 16:54
    We are eagerly looking forward to the anticipated approval and launch of Northera for the treatment of NOH. This transition from our clearly development stage company to a commercial organization as one we have been working towards for sometime. It will not be overnight and it will not be without some challenges along the way. But I’m confident we have a team uniquely capable of successfully executing this transformation

    zie: seekingalpha.com/article/304755-chels...
  13. junkbond 13 november 2011 21:13
    Chelsea Therapeutics (CHTP) is trading around $4.50. CHTP is a biotechnology company based in North Carolina. These shares have traded in a range between $3.25 to $8.20 in the last 52 weeks. The 50-day moving average is $4.30 and the 200-day moving average is $4.46. Chelsea is pursuing an orphan drug strategy for a drug called Northera (Droxidopa) which is for the treatment of hypotension. (Yes, that's hypotension -- low blood pressure -- not hypertension.) This treatment has been approved and marketed in Japan for over 15 years, and generates about $50 million in revenue in that country. Recently, Chelsea released positive data on this drug and it caused an analyst to raise the price target to $18 due to their belief this will be approved early in 2012. I believe Chelsea is a low-risk, high-potential biotech stock

    seekingalpha.com/article/307274-6-bio...
  14. [verwijderd] 13 november 2011 22:08
    Het voorgaande verdient, wat omzet betreft, een nadere verklaring.
    Omzet in Japan circa $ 50 miljoen. Dit is gebaseerd op een "normale" prijs, omdat hier de ontwikkelingskosten al lang terugverdiend zullen zijn.
    De drug gaat in de USA de "orphan drug status" krijgen. Dus gedurende zeven jaar een beschermde prijs. Deze is vastgesteld op $ 30.-- per dag, ofwel $ 11.000.-- per jaar per patient. Het aantal patienten in de USA wordt geschat op 180.000. De onderneming voorspelt over 3 tot 5 jaar een omzet van $ 300 tot 375 miljoen te kunnen bereiken.
    Volgens mij geen overdreven voorspelling, omdat hier "slechts" 27.000 tot 34.000 patienten voor nodig zijn.
    Zie verder het betoog van Keith Schmidt tijdens de conference call. Niet onvermeld mag blijven, dat midodrine wegens bijwerkingen een afkeuring van de FDA aan de broek had, die 14 dagen later werd hersteld wegens protesten van gebruikers, die kennelijk geen last hadden van de bijwerkingen.
    Bedenk, dat de goedkeuring nog moet komen. Verwacht wordt in maart a.s.
  15. [verwijderd] 17 november 2011 13:47
    Chelsea Therapeutics announces FDA acceptance of NDA for priority review
    Chelsea Therapeutics International announced that the U.S. Food and Drug Administration has accepted for filing the New Drug Application for NORTHERA, an orally active synthetic precursor of norepinephrine, for the treatment of symptomatic neurogenic orthostatic hypotension in patients with primary autonomic failure, dopamine beta hydroxylase deficiency and non-diabetic autonomic neuropathy. The FDA also granted Chelsea's request for Priority Review, and, under the Prescription Drug User Fee Act, the FDA's goal is to review and act on the NDA by March 28, 2012. The FDA grants priority review to drugs offering major advances in treatment, or providing a treatment where no adequate therapy exists. In addition, the FDA has indicated its intent to discuss the Northera NDA at a February 2012 meeting of its Cardiovascular and Renal Drugs Advisory Committee. Advisory committees provide independent, expert advice to the agency and are often held as part of the review process for first-in-class drugs. :theflyonthewall.com
  18. ludwig mack 17 november 2011 17:09
    * FDA sets March 28, 2012 as action date on Northera

    * FDA to discuss Northera NDA at a Feb advisory panel

    Nov 17 (Reuters) - Chelsea Therapeutics said U.S. health regulators granted a priority review status to its hypotension drug Northera and will review it by next March.

    The Charlotte, North Carolina-based company said the FDA also indicated its intent to discuss the drug's marketing application at an advisory committee meeting in February 2012.

    Chelsea is testing Northera for symptomatic neurogenic orthostatic hypotension (NOH) -- a chronic and often debilitating drop in blood pressure upon standing up and most often associated with Parkinson's disease.

    Northera has an orphan status, which is granted by the U.S. health regulator to drugs that treat a rare condition affecting less than 200,000 Americans and guarantees a marketing exclusivity of seven years in the country.

    Shares of the company, valued at about $282 million, closed at $4.56 on Wednesday on Nasdaq.

    www.reuters.com/article/2011/11/17/ch...
  19. ludwig mack 17 november 2011 18:46
    Chelsea Therapeutics Internatio
    (NasdaqCM: CHTP )

    Real Time 4.74 Up 0.18 (3.95%) 12:46PM EST
    Last Trade: 4.79
    Trade Time: 12:30PM EST
    Change: Up 0.23 (5.04%)
    Prev Close: 4.56
    Open: 4.80
    Bid: 4.79 x 100
    Ask: 4.80 x 700
    1y Target Est: 11.00
    Day's Range: 4.64 - 4.85
    52wk Range: 3.25 - 8.20
    Volume: 382,405
    Avg Vol (3m): 356,443
    Market Cap: 296.25M
    P/E (ttm): N/A
    EPS (ttm): -0.89
    Div & Yield: N/A (N/A)
790 Posts
Pagina: «« 1 ... 4 5 6 7 8 ... 40 »» | Laatste |Omhoog ↑

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