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CHTP - Chelsea Therapeutics International

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Omlaag ↓

[verwijderd] 13 juli 2011 21:13

Tussen 10 en 20 duizend. Eerste kleine koop 2,80 circa anderhalf jaar geleden.Regelmatig bijgekocht tot 7,50. Gemiddelde 4.50.
Blijf met minstens tienduizend enkele jaren zitten.

junkbond 23 juli 2011 12:11

Ik heb er inmiddels 7500. Ik wil er nog 2500 bijkopen maar ik wacht even de CC af. Dus ik koop waarschijnlijk woensdag nog 2500 stukken .

[verwijderd] 23 juli 2011 22:20

Ik laat mij niet door het koersverloop beinvloeden. Hooguit wat vertraging voor fase 2 ADHD. Misschien toch bekendmaking bij cijfers en CC.

junkbond 26 juli 2011 14:41

quote:
oudje schreef op 23 juli 2011 22:20:
Ik laat mij niet door het koersverloop beinvloeden. Hooguit wat vertraging voor fase 2 ADHD. Misschien toch bekendmaking bij cijfers en CC.

finance.yahoo.com/news/Preliminary-Da...

[verwijderd] 26 juli 2011 15:11

Een uitstekend bericht over ADHD!!
Natuurlijk zijn er nog een aantal jaren te gaan, voordat, naast Parkinson, hier het product de markt haalt. Maar dan praten we over 4% van de bevolking in de VS. We gaan dus te maken krijgen met een "blockbuster".

svenhedin 26 juli 2011 16:18

Preliminary Data From Exploratory Phase II Study Demonstrates Significant Activity of Droxidopa in Adult Attention Deficit Hyperactivity Disorder (ADHD)

CHARLOTTE, N.C., July 26, 2011 (GLOBE NEWSWIRE) -- Chelsea Therapeutics International, Ltd. (Nasdaq:CHTP) announced positive top-line results of an investigator-led Phase II clinical study of droxidopa in combination with carbidopa in adults with attention deficit hyperactivity disorder (ADHD).

The single-center, 12-week study enrolled 20 patients diagnosed with adult ADHD. The top-line results showed that droxidopa dramatically improved the patients' mean score on the adult ADHD Investigator Symptom Rating Scale (AISRS). The AISRS is a standardized, validated rating scale for assessing symptoms of adult ADHD and for measuring response to treatment.

Upon enrollment, patients in the study had a mean AISRS score of 34. After three weeks of open-label droxidopa monotherapy (titration from 200mg-600mg TID), the mean AISRS score decreased by approximately 47% to 19 (p<0.0001). The reduction in AISRS score was maintained with the addition of carbidopa (25mg or 50mg) for another three weeks.

Interpretation of the data in the following two-week double-blind, placebo-controlled withdrawal period of the study is limited due to the small number of patients who continued in the study (5 patients received placebo; 6 patients received the droxidopa/carbidopa combination). Furthermore, as seen in prior studies with a limited washout period, patients withdrawn to placebo after prolonged droxidopa treatment continued to experience therapeutic benefits and no statistically significant difference was observed between treatment and placebo arms at the end of the two-week randomized period. Droxidopa was well tolerated with no serious adverse events observed. The most common adverse events observed throughout both the open-label and double-blind portions of the study were headache (n=5; 25%) and drowsiness (n=5; 25%), both of which were mild.

"This exploratory study showed that droxidopa rapidly improved ADHD symptoms during open-label treatment," commented Dr. Lenard A. Adler, professor of psychiatry at New York University Langone Medical Center and the study's lead investigator. "The magnitude of the treatment effect combined with the marked safety and tolerability of the medication is of interest and clearly warrants future study of droxidopa in adult ADHD."

"While exploratory in nature, this is the first study to demonstrate the potential therapeutic benefits of droxidopa outside its traditional hypotension-related indications and underscores the potential for norepinephrine replacement therapy across a broad range of indications," stated Dr. Art Hewitt, Chelsea's Chief Scientific Officer. "We are especially encouraged by the excellent safety data which was not suggestive of meaningful blood pressure elevations in this normotensive patient population. We look forward to working with Dr. Adler to further analyze these exciting results and continuing our work with additional independent investigators to more fully characterize the potential benefit of droxidopa in other norepinephrine related conditions."

ADHD is a neurobiological disorder characterized by lifelong issues of inattention, distraction, organizational difficulties, forgetfulness, restlessness, and other disruptive behavioral issues. ADHD is the second most common neuropsychiatric disorder affecting 4.4% of the US adult population, or between 8-9 million individuals. As adult ADHD is characterized as a disorder of decreased norepinephrine (NE) activity in the pre-frontal cortex, the NE-increasing effect of droxidopa could help improve ADHD symptoms.

Partial funding for this study was provided by Chelsea Therapeutics.

About droxidopa

Droxidopa, the lead investigational agent in Chelsea Therapeutics' broad pipeline, is currently in Phase III clinical trials for the treatment of symptomatic neurogenic orthostatic hypotension (NOH) in patients with primary autonomic failure -- a group of diseases that includes Parkinson's disease, multiple system atrophy (MSA) and pure autonomic failure (PAF). Droxidopa is a synthetic catecholamine that is directly converted to norepinephrine (NE) via decarboxylation, resulting in increased levels of NE in the nervous system, both centrally and peripherally. Droxidopa is also being studied for the treatment of fibromyalgia in an ongoing Phase II trial and completed a Phase II trial in intradialytic hypotension (IDH) study with positive results.

About Chelsea Therapeutics

Chelsea Therapeutics is a biopharmaceutical development company that acquires and develops innovative products for the treatment of a variety of human diseases. Chelsea's most advanced drug candidate, NORTHERA™ (droxidopa), is an orally active synthetic precursor of norepinephrine initially being developed for the treatment of neurogenic orthostatic hypotension. In addition to Droxidopa, Chelsea is also developing a portfolio of metabolically inert oral antifolate molecules engineered to have potent anti-inflammatory and anti-tumor activity to treat a range of immunological disorders, including two clinical stage product candidates: CH-1504 and CH-4051. Preclinical and clinical data suggest superior safety and tolerability, as well as increased potency versus methotrexate (MTX).

This press release contains forward-looking statements regarding future events. These statements are just predictions and are subject to risks and uncertainties that could cause the actual events or results to differ materially. These risks and uncertainties include risks and costs of drug development, risk of regulatory approvals, our reliance on our lead drug candidates droxidopa and CH-4051, reliance on collaborations and licenses, intellectual property risks, our need to raise additional operating capital in the future, our history of losses, competition, market acceptance for our products if any are approved for marketing, and reliance on key personnel including specifically Dr. Pedder.

CONTACT: Investors:
Kathryn McNeilChelsea Therapeutics
704-973-4231
mcneil@chelseatherapeutics.com

Media:
Lauren Tortorete
Hill & Knowlton
212-885-0348
lauren.tortorete@hillandknowlton.com

Source: Chelsea Therapeutics

Read more: www.nasdaq.com/aspx/company-news-stor...

ludwig mack 26 juli 2011 18:05

ik ben aan het kijken, en ziet er interessant uit;
ga een plukje overwegen voor l.t.

leuk clubje posters ook ;-)

gr

svenhedin 27 juli 2011 14:49

Chelsea Therapeutics Reports Second Quarter 2011 Results

Northera™ (droxidopa) New Drug Application for the Treatment of Symptomatic Neurogenic Orthostatic Hypotension on Track for Submission in Third Quarter 2011
Unblinded Interim Efficacy Data From CH-4051 Phase II Trial in Rheumatoid Arthritis Expected in September 2011
Company to Host Conference Call at 4:30 PM EDT
CHARLOTTE, N.C., July 26, 2011 (GLOBE NEWSWIRE) -- Chelsea Therapeutics International, Ltd.(Nasdaq:CHTP) today reported financial results for the second 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 significant benefit of droxidopa in rapidly improving symptoms of adult attention deficit hyperactivity disorder in investigator-led Phase II study
Completed Northera dedicated thorough QTc study showing no cardiac safety concerns including no prolongation of QTc interval
Opened enrollment in 3.0 mg dose arms of CH-4051 Phase II trial in rheumatoid arthritis after review of data from 0.3 mg and 1.0 mg arms confirmed safety
Presented new data from Northera Study 306A highlighting the reduction of falls associated with Northera treatment in patients with neurogenic orthostatic hypotension (NOH) associated with Parkinson's disease (PD) during MDS 15th International Congress of Parkinson's Disease and Movement Disorders
"During the second quarter of 2011, we made significant advancements toward our near-term objectives of completing our new drug application for Northera and reporting the first efficacy data for our novel-antifolate, CH-4051, in rheumatoid arthritis," commented Dr. Simon Pedder, president and CEO of Chelsea. "Having completed our QTc study ahead of schedule and having completed enrollment for our interim RA analysis, we look forward to achieving both of these goals later this quarter."

Financial Results for the Second Quarter

Chelsea reported a net loss for the quarter ended June 30, 2011 of $13.3 million or ($0.21) per share versus a net loss of $9.9 million or ($0.25) per share for the same period in 2010. For the first six months of 2011, Chelsea reported a net loss of $27.1 million or ($0.46) per share compared to a net loss of $16.2 million or ($0.43) per share for the first half of 2010.

Research and development (R&D) expenses for the second quarter 2011 were $10.7 million, compared to $8.4 million for the same period in 2010. The increase in R&D expense during the second quarter reflects increases in costs associated with the planned commercialization of Northera and included approximately $1.6 million related to the manufacturing and process validation of commercial drug product, $1.3 million related to the completion of a dedicated QTc study to support the application for marketing approval in the U.S. and approximately $0.9 million related to the preparation of the Northera new drug application (NDA). An overall decrease of approximately $2.0 million year-over-year in clinical trial expenses was further offset by the initiation of medical affairs planning that accounted for approximately $0.9 million during the quarter.

For the six months ended June 30, 2011, research and development expenses were $22.1 million versus $13.3 million for the comparable prior-year period. Similar to R&D expense for the quarter, R&D expense for the first half of 2011 was primarily driven by increased costs associated with the planned registration and anticipated launch of Northera in the first half of 2012 including approximately $3.8 million related to the manufacture of commercial drug product, $2.6 million related to the Northera QTc study and $0.9 million related to the implementation of a medical affairs program.

Selling, general and administrative (SG&A) expenses of $2.6 million for the three months ended June 30, 2011 increased from $1.6 million for the same period in 2010. This increase in SG&A is primarily related to increased compensation and related expenses as well as increases in market research, promotional activities such as conference sponsorships and presentations, and legal expenses related to our intellectual property. Similarly, for the six months ended June 30, 2011, SG&A expenses of $5.1 million reflect an increase from $3.0 million for the prior-year period reflecting an increase in compensation and related expenses to support the planned commercialization of Northera as well as an overall increase in costs associated with implementing pre-launch sales and marketing initiatives.

Chelsea ended the quarter with $67.1 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 $47 million and SG&A expenses continuing to ramp through commercialization with a 2011 total of approximately $17 million. 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.

Conference Call Today at 4:30 PM EDT

Chelsea will discuss its second quarter results and provide an update on its clinical development programs in a conference call today at 4:30 PM Eastern Time. Interested investors may participate in the conference call by dialing 877-638-9567 (domestic) or 720-545-0009 (international). A replay will be available for one week following the call by dialing 855-859-2056 for domestic participants or 404-537-3406 for international participants and entering passcode 84867259 when prompted. Participants may also access both the live and archived webcast of the conference call on Chelsea's web site at www.chelseatherapeutics.com.

About Chelsea Therapeutics

Chelsea Therapeutics is a biopharmaceutical development company that acquires and develops innovative products for the treatment of a variety of human diseases. Chelsea's most advanced drug candidate, droxidopa, is an orally active synthetic precursor of norepinephrine initially being developed for the treatment of neurogenic orthostatic hypotension. In addition to droxidopa, Chelsea is also developing a portfolio of metabolically inert oral antifolate molecules engineered to have potent anti-inflammatory and anti-tumor activity to treat a range of immunological disorders, including two clinical stage product candidates: CH-1504 and CH-4051. Preclinical and clinical data suggest superior safety and tolerability, as well as increased potency versus methotrexate (MTX).

CHELSEA THERAPEUTICS INTERNATIONAL, LTD. AND SUBSIDIARY
(A Development Stage Company)
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(unaudited)

CONTACT: Investors:
Kathryn McNeilChelsea Therapeutics
704-973-4231
mcneil@chelseatherapeutics.comNick RiehleChelsea Therapeutics
704-973-4201
Riehle@chelseatherapeutics.com

Media:
Lauren Tortorete
Hill & Knowlton
212-885-0348
lauren.tortorete@hillandknowlton.com

Source: Chelsea Therapeutics

svenhedin 27 juli 2011 14:51

Voor betere leesbaarheid: zie nasdaq.com (CHTP)

CHELSEA THERAPEUTICS INTERNATIONAL, LTD. AND SUBSIDIARY
(A Development Stage Company)
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(unaudited)

For the three months ended June 30, For the six months ended June 30,
2011 2010 2011 2010

Operating expenses:
Research and development $ 10,681,032 $ 8,394,276 $ 22,139,974 $ 13,274,749
Sales and marketing 1,324,217 508,420 2,435,347 918,967
General and administrative 1,317,454 1,088,171 2,650,170 2,063,758
Total operating expenses 13,322,703 9,990,867 27,225,491 16,257,474

Operating loss (13,322,703) (9,990,867) (27,225,491) (16,257,474)
Interest income 51,316 101,923 85,898 169,474
Interest expense -- (35,381) -- (68,334)

Net loss $ (13,271,387) $ (9,924,325) $ (27,139,593) $ (16,156,334)

Net loss per basic and diluted share of common stock $ (0.21) $ (0.25) $ (0.46) $ (0.43)

Weighted average number of basic and diluted common shares outstanding 61,847,065 40,200,406 58,373,101 37,831,345

CHELSEA THERAPEUTICS INTERNATIONAL, LTD. AND SUBSIDIARY
Condensed Consolidated Balance Sheet Data
(unaudited)

June 30,

2011 December 31,

2010
(in thousands)

Cash and cash equivalents $ 10,967 $ 47,593
Short-term investments 56,145 --
Total assets 68,250 48,374
Total liabilities 12,682 13,186
Deficit accumulated during the development stage (160,013) (132,873)
Stockholders' equity 55,567 35,188

This press release contains forward-looking statements regarding future events. These statements are just predictions and are subject to risks and uncertainties that could cause the actual events or results to differ materially. These risks and uncertainties include our need to raise operating capital, our history of losses, risks and costs of drug development, risk of regulatory approvals, our reliance on our lead drug candidates droxidopa and CH-4051, reliance on collaborations and licenses, intellectual property risks, competition, market acceptance for our products if any are approved for marketing and reliance on key personnel including specifically Dr. Pedder. We refer you to documents we file from time to time with the Securities and Exchange Commission.

CONTACT: Investors:
Kathryn McNeilChelsea Therapeutics
704-973-4231
mcneil@chelseatherapeutics.comNick RiehleChelsea Therapeutics
704-973-4201
Riehle@chelseatherapeutics.com

Media:
Lauren Tortorete
Hill & Knowlton
212-885-0348
lauren.tortorete@hillandknowlton.com

Source: Chelsea Therapeutics

ludwig mack 28 juli 2011 16:30

wat ik ervan begrijp, is droxidopa een precursur (voorloper) van epinefrine (=adrenaline) en kan worden toegepast bij vertigo (duizeligheid) en lage bloeddruk bij verschillende aandoeningen, zoals de ziekte van parkinson en andere aandoeningen.ook dat laatste is erg interessant.
het is dus géén middel tegen de eigenlijke ziekte van parkinson, waarbij in bepaalde hersenkernen te weinig dopamine wordt gemaakt.

klopt dit?
en is ondanks dat de markt groot dat ze mooie cashflow en winsten kunnen maken?

gr.

junkbond 28 juli 2011 20:50

Hahaha het spookte ff, bijgekocht op 4.88. 10K in totaal nu

[verwijderd] 28 juli 2011 21:40

quote:
ludwig mack schreef op 28 juli 2011 16:30:
wat ik ervan begrijp, is droxidopa een precursur (voorloper) van epinefrine (=adrenaline) en kan worden toegepast bij vertigo (duizeligheid) en lage bloeddruk bij verschillende aandoeningen, zoals de ziekte van parkinson en andere aandoeningen.ook dat laatste is erg interessant.
het is dus géén middel tegen de eigenlijke ziekte van parkinson, waarbij in bepaalde hersenkernen te weinig dopamine wordt gemaakt.

klopt dit?
en is ondanks dat de markt groot dat ze mooie cashflow en winsten kunnen maken?

gr.

Ga naar www.chelseatherapeutics.com. In de bovenbalk naar News & Events, daarna News, scrollen naar beneden, pak daar pagina 2 en lees dan het bericht van 20 september 2010.
Op basis van de vermelde conclusies met nog enkele kleine wijzigingen gaan ze binnen enkele maanden voor de NDA.
Op www.seekingalpha.com vind je een transcript van de conference call van de 26e juli. Lezen is altijd nog iets makkelijker dan luisteren.
Succes.
Bij een prijs van 30 dollar per dag (!!!) per patient schat men een omzet van 300 miljoen á 375 miljoen drie jaar na introductie te bereiken.

[verwijderd] 28 juli 2011 21:41

quote:
junkbond schreef op 28 juli 2011 20:50:
Hahaha het spookte ff, bijgekocht op 4.88. 10K in totaal nu

Mij een raadsel, wat ze daar allemaal uitspoken.

junkbond 28 juli 2011 21:52

quote:
oudje schreef op 28 juli 2011 21:41:
[...]

Mij een raadsel, wat ze daar allemaal uitspoken.

Tja, Misschien stop-losses trickeren ? Dat is mijn beste verklaring.

[verwijderd] 28 juli 2011 22:28

quote:
junkbond schreef op 28 juli 2011 21:52:
[...]Tja, Misschien stop-losses trickeren ? Dat is mijn beste verklaring.

Denk het niet.Dan zie je niet die lange lijsten met heel veel transacties van 100 stuks. Meestal is de daling dan veel groter met vaak verschillen van 10 tot 30 cent per transactie en net zo hard weer naar boven en dat allemaal in soms 10 tot 30 seconden.

Mooi bijgekocht, mijn complimenten. Ik miste de hele reut.

[verwijderd] 29 juli 2011 15:47

quote:
oudje schreef op 28 juli 2011 22:28:
[...]

Denk het niet.Dan zie je niet die lange lijsten met heel veel transacties van 100 stuks. Meestal is de daling dan veel groter met vaak verschillen van 10 tot 30 cent per transactie en net zo hard weer naar boven en dat allemaal in soms 10 tot 30 seconden.

Mooi bijgekocht, mijn complimenten. Ik miste de hele reut.

Een mogelijkheid is ook, dat speculanten hoog in de 5 op de pof gekocht hebben. Die worden nu uitgerookt, uiteraard met medewerking van mm-s en shorters.
Over shorters gesproken: of de kansen nu goed of slecht zijn met een NDA: ze gaan per definitie short!!
Maar gewoon niet getreurd. Dit alles geeft beste mogelijkheden een positie op te bouwen bij dips.

junkbond 29 juli 2011 16:30

Ja goed mogelijk Oudje, Ik ga ook proberen mijn gemiddele omlaag te krijgen door met een +- een kwart van mijn positie te day/swingtrade.

ludwig mack 29 juli 2011 17:21

oudje bedankt;
ik ga mijn huiswerk een dezer dagen verder doen.
gr

junkbond 29 juli 2011 18:30

Chelsea Therapeutics:Likely to Double on Safe, Proven Asset..

seekingalpha.com/article/283109-chels...

ludwig mack 30 juli 2011 12:09

The drug has been approved for decades in Japan and millions have used it over there.

The real risk to Chelsea is the FDA refusing to approve droxidopa for neurogenic orthostatic hypotension.

junkbond, die twee citaten uit het artikel vind ik moeilijk: waarom al tientallen jaren in japan, en voor meerdere toepassingen en nog niet in de usa: pending approval; waarom niet eerder toestemming gevraagd?

gr

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