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Cortex COR gedumpt

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  1. [verwijderd] 3 april 2006 17:34
    FDA Puts Cortex Drug Trials on Hold
    Monday April 3, 10:43 am ET
    FDA Halts Cortex Drug Trials Over Concerns About Animal Tests

    IRVINE, Calif. (AP) -- Cortex Pharmaceuticals Inc. said Monday the Food and Drug Administration has put the company's clinical trials of its flagship drug on hold, over concerns about data from animal tests.

    Cortex's primary drug candidate is CX717, which it is testing for narcolepsy, attention deficit hyperactivity disorder, schizophrenia and Alzheimer's disease.

    The company said the FDA on Friday put its clinical trials of the drug on hold because of concerns over some preclinical animal testing data and not over results from any human clinical trials.

    Cortex said it plans to fully cooperate with the FDA and aims to meet with the agency about the issue.

    Cortex fell $2.49, or 47 percent, to $2.76 in morning trading on the American Stock Exchange. The stock has traded between $1.96 and $5.94 over the past 52 weeks.

  2. [verwijderd] 22 mei 2006 15:25
    Corcept Therapeutics Completes Enrollment in Second Phase 3 Study for Treating Psychotic Major Depression
    Monday May 22, 8:30 am ET

    MENLO PARK, Calif., May 22 /PRNewswire-FirstCall/ -- Corcept Therapeutics Incorporated (Nasdaq: CORT - News) announced today that it completed patient enrollment in Corcept 09, the second of three Phase 3 clinical trials in which CORLUX® (mifepristone) is being evaluated for treating the psychotic features of psychotic major depression (PMD).
    "We recently announced that patient enrollment was completed in our first Phase 3 study, Corcept 07, and that we expect to report the results of that trial in August," said Corcept's Chief Executive Officer Joseph K. Belanoff, M.D. "In addition, we now expect to report the results from Corcept 09 in September 2006. We expect to report the results of our third Phase 3 trial, Corcept 06, in the fourth quarter."

    About Psychotic Major Depression

    PMD is a serious psychiatric disorder that affects about three million people in the United States every year. It is more prevalent than either schizophrenia or manic depression. The disorder is characterized by severe depression accompanied by delusions, hallucinations or both. People with PMD are approximately 70 times more likely to commit suicide than the general population and often require lengthy and expensive hospital stays. There is no FDA-approved treatment for PMD.

    A Description of Study 09

    Study 09 is a randomized, double-blind, placebo-controlled study that is being conducted in Europe. The primary endpoint is the proportion of patients with at least a 50 percent improvement in the Brief Psychiatric Rating Scale Positive Symptom Subscale (BPRS PSS) at both Day 7 and Day 28, a responder analysis. A secondary endpoint is the proportion of patients with at least a 50 percent improvement in the BPRS PSS at both Day 7 and Day 56. The BPRS is an 18-item rating instrument used to assess psychopathology, and the PSS includes the four items in the BPRS that specifically measure psychosis. Patients must have at least mild psychotic symptoms (BPRS PSS greater than or equal to 12) to enter the study. Study enrollees may be either inpatients or outpatients. BPRS PSS assessments are made at Days 14, 42 and 56.

    Patients may not take any antidepressant or antipsychotic medication for at least one week before study randomization. At randomization, they are placed in a one-to-one distribution into either a treatment group or a placebo group. Patients in the treatment group receive 600 mg of CORLUX once daily for a period of seven days. All patients receive antidepressant therapy starting on Day 1 and through Day 56. Treatment with antipsychotic medications or electroconvulsive therapy at any time during the study results in the patient being classified as a non-responder.

    Previously Completed Trials

    The company has completed four studies of CORLUX for treating the psychotic features of PMD. In January 2001, a dose-finding clinical trial evaluated the efficacy, tolerability of and dose response to CORLUX. The results showed that after one week of treatment, approximately two-thirds of the patients in the two higher dosage groups (600 mg and 1200 mg) experienced clinically meaningful reductions in psychosis, as measured by the BPRS PSS. Based on these encouraging results, Corcept conducted two double-blind, placebo-controlled safety and efficacy clinical trials (Study 02 and Study 03) in which a total of 429 patients were enrolled.

    Study 02 indicated that CORLUX was well tolerated, and there were no discernible problems with drug interactions between CORLUX and commonly prescribed antipsychotic and antidepressant medications. Study 03 demonstrated with statistical significance that patients in the CORLUX group were more likely than patients in the placebo group to achieve a 50 percent reduction in the BPRS PSS at Day 7, sustained to Day 28. At the request of the FDA, approximately one third of the 221 patients enrolled in this study had efficacy measures taken at Day 56. Of those patients who exhibited at least mild psychotic symptoms on Day 0 (BPRS PSS greater than or equal to 12) Study 03 showed with statistical significance that patients receiving CORLUX were more likely than patients receiving placebo to achieve a 50% reduction in the BPRS PSS at day 7 sustained to day 56.

    A fourth trial involved an open-label study of the safety of retreatment in patients with a favorable response to treatment in Studies 02 and 03. The results indicated that patients tolerated their retreatment well. Twenty-eight patients participated in this study.

    About Corcept Therapeutics Incorporated

    Corcept Therapeutics Incorporated is a pharmaceutical company focused on developing drugs for treating severe psychiatric and neurological diseases. Corcept's lead product, CORLUX, is in Phase 3 clinical trials for treating the psychotic features of PMD. The drug is administered orally to PMD patients once per day for seven days. CORLUX, a potent GR-II antagonist, appears to reduce the effects of the elevated and abnormal release patterns of cortisol seen in PMD. The company has also initiated a proof-of-concept study to evaluate the ability of CORLUX to mitigate weight gain associated with the use of olanzapine. For more information, please visit www.corcept.com.

    Forward-looking Statements

    Statements made in this news release -- other than statements of historical fact -- are forward-looking statements. These include information relating to Corcept's PMD clinical development program, FDA agreements, and the timing of the completion of pivotal Phase 3 trials. Forward-looking statements are subject to a number of known and unknown risks and uncertainties that might cause actual results to differ materially from those expressed or implied here. For example, there can be no assurances on the efficacy, safety, completion or success of clinical trials; the regulatory process or regulatory approvals; or commercial success; in addition, trial timetables may not be accurate. Risk factors are explained in the company's SEC filings, all of which are available from its Web site (www.corcept.com) or from the SEC's Web site (www.sec.gov). The company does not have any intention or duty to update forward-looking statements made in this news release.

    --------------------------------------------------------------------------------
    Source: Corcept Therapeutics Incorporated
  3. [verwijderd] 21 juni 2006 18:30
    Hebben blijkbaar een upgrade gekregen met koersdoel 12 euro.

    Gepikt van Belgisch Cash forum en is al 1 week oud :

    vr 16 jun 2006 19:59 Rodman & Renshaw handhaven koersdoel van 12 USD | Print

    --------------------------------------------------------------------------------
    RODMAN & RENSHAW

    CORTEX PHARMACEUTICALS (COR)
    BIOTECHNOLOGY
    MARKET OUTPERFORM / SPECULATIVE RISK
    COMPANY UPDATE
    JUNE 16, 2006

    COR: PRESENTATIONS AT SLEEP CONFERENCE

    DATA ON CX717 TO BE PRESENTED Next Tuesday, June 20th, Cortex representatives will present data on the activity of CX717, Cortex¿ lead AMPAKINE compound, in sleep deprivation studies at the 20th Anniversary Meeting of the Associated Professional Sleep Societies. The meeting is taking place in Salt Lake City, Utah.

    CX717 is currently under clinical hold; Cortex aims to have the entire data package addressing the FDA¿s concerns submitted to the FDA by the end of August. We reiterate our Market Outperform/Speculative Risk rating and $12 price target.

    CX717 CONTINUES TO SHOW PROMISE Top-line results were presented last year in a press release from a sleep deprivation study involving 16 patients. The sleep deprivation data to be presented at the conference includes further results from a study of healthy volunteers who were deprived of sleep for 27 hours. CX717 showed activity at the highest dose tested (1000mg), enhancing alertness, attention, information processing and sleep latency. (See abstract on Page 3.) These results appear promising and confirm the activity that was seen in studies of CX717 in sleep-deprived monkeys. Coincidentally, according to previous guidance by management, results from the 48-patient shift-work study conducted by DARPA may be released near-term.

    CLINICAL HOLD COULD BE REMOVED IN SEPTEMBER In
    response to the FDA¿s request for additional acute preclinical work on CX717, Cortex has hired regulatory consultants, initiated Maximum Tolerated Dose (MTD) studies in primates; begun
    assessment of tissue from the previous primate study; and will begin work on the rat MTD study in mid-May. A data package will be completed by August and the FDA has indicated that it would
    respond within 30 days. The clinical hold on CX717 could thus be lifted in September.

    EFFICACY ENCOURAGING CX717 showed encouraging results in the Phase II study in patients with attention deficit hyperactivity disorder (ADHD). Results were comparable to those obtained with
    the Eli Lilly (LLY, Not Rated) drug Strattera in a pivotal trial. A repeated measures statistical test showed that CX717 provoked a statistically significant response on the overall ADHD Rating Scale as well as both the hyperactivity and attentiveness subscales. No safety issues were seen. Cortex should receive the data on CX717
    performance in the DARPA-sponsored shift-work study shortly.

    KEY RISK Our recommendation for Cortex takes into account that memory/cognition-related disorders represent one of the most difficult-to-treat, and thus highest risk, therapeutic categories.
    Cortex will need to partner its drugs to continue their development in the absence of additional financing.

    Bron: Yahoo Cortex-MB

    Volgende week dinsdag worden dus de resultaten met CX-717 i.v.m. sleep deprivation bekend gemaakt, later volgen de resultaten i.v.m. shiftwerk en in september valt dus de beslissing i.v.m. het al dan niet opheffen van de clinical hold op CX-717. Volgende week dinsdag zal alleszins een behoorlijke koersreactie veroorzaken (maar in welke richting valt helaas niet te voorspellen).


  4. [verwijderd] 22 juni 2006 10:07
    RODMAN & RENSHAW

    First Take

    Cortex Pharmaceuticals
    COR, Price: $2.89 (6/22/06, intraday); Market Cap: $95MM (6/22/06, intraday);
    Market Outperform, Target Price: $12

    Update on Results of CX717 Shift Work Clinical Trial
    · Cortex Pharmaceuticals announced today that the top-line findings from the simulated night shift-work study on its lead AMPAKINEâ compound CX717, funded by the Defense Advanced Research Projects Agency (DARPA), would be presented at the Sleep 2006 meeting in Salt Lake City, UT.
    · That study assessed the effect of CX717 on cognitive performance and alertness across 4 nights of simulated night shift work and restricted daytime sleep.
    · The primary finding from the study was that CX717 did not enhance cognitive performance relative to treatment with placebo. However, similar to the observations in the previously reported UK sleep deprivation study, CX717 did alter the recovery sleep architecture as measured by electroencephalogram (EEG) in a dose-related manner.
    · The 1000 mg dose of CX717 statistically (p<0.05) reduced the amount of slow wave sleep during each of the 4 recovery sleep periods and increased (p<0.05) the minutes of wake time after sleep onset during 2 of the 4 recovery sleep periods.
    · CX717 was well tolerated, and no serious adverse events or other significant safety concerns were observed.
    · While there were indications of a signal for CX717, the efficacy profile of the compound
    suggests that it is not likely to be developed further for treatment of sleep deprivation once partnered with a large pharmaceutical firm. The principal indications that will be explored, based on previously reported trial results, are likely to be attention deficit/hyperactivity disorder (ADHD) and potentially Alzheimer’s disease.
    · Cortex will most likely pursue the sleep deprivation indication with a next-generation
    AMPAKINE molecule that would have greater potency.
    · We regard the announcement of the results of the shift-work study with CX717 as neutral, since these results will not affect partnering discussions on the compound that will likely center on ADHD and Alzheimer’s disease. Furthermore, Cortex will continue to explore application of the AMPAKINEâ technology in treatment of sleep deprivation
    with other compounds.
    · We believe Cortex is firmly on track to meet the objectives set by the FDA to remove the current clinical hold on its lead compound, which should pave the way for further exploration of the potential for CX717 in multiple neurological disease indications. We reiterate our Market Outperform rating and price target of $12 on Cortex shares.

    De Darpa-resultaten met CX-717 i.v.m. sleep deprivation waren dus niet goed, de koers van COR werd (bijgevolg) gisteren teruggezet tot zo'n 2.88 USD. R& R blijven optimistisch en handhaven hun KD van 12 USD. Ze verwachten dat CX-717 beter zal scoren op het vlak van ADHD en Alzheimer. Afwachten.
  5. [verwijderd] 25 augustus 2006 17:03
    Corcept Therapeutics (CORT) shares plummeted Friday after the company announced negative results from a clinical trial on its experimental psychotic depression drug Corlux.

    The stock plunged 70% in premarket trading to $1.05. The results, which came from one of three phase III trials involving a condition known as psychotic major depression, showed that 30.5% of patients receiving Corlux and 28.6% of those getting the placebo responded to treatment.

    RT 1.33

    tinyurl.com/kyxxm
  6. [verwijderd] 25 augustus 2006 17:38
    Is weer wat gestegen naar $1,80. $0,77 per aandeel cash in handen op 23 miljoen aandelen. Bijna geen omzet. 10 man personeel op de payroll..denk dat er anderen zijn waar je je centen beter in kan steken. Als je ze vanmorgen onder de $1 had gekocht dan had je een mooie deal gemaakt.
  7. [verwijderd] 9 oktober 2006 16:36
    +17%

    Cortex Pharmaceuticals Says FDA Clinical Hold on Ampakine Lifted

    IRVINE, Calif. (AP) -- Drug developer Cortex Pharmaceuticals Inc. said Monday that the Food and Drug Administration has lifted its clinical hold on Cortex's experimental Alzheimer's disease treatment.
    The company expects a formal letter from the FDA within 10 days. The action means that the company can now continue clinical trials on the drug.

    In March, the FDA instituted a clinical hold stopping a study of Ampakine CX717.

    Cortex said it agreed to an FDA-specified dose range of the treatment, and that it has already conducted three months of toxicology studies in animals. Cortex expects more toxicology information by the end of the year.

    Cortex is developing a class of drugs called Ampakine compounds that act to strengthen signals at the connections between brain cells. The connection are thought to play a role in the memory and behavior problems in Alzheimer's patients.

    Shares of Cortex rose 57 cents, or 18.5 percent, to $3.65 on the American Stock Exchange. The stock has ranged between $2.02 and $5.94 over the past year.

    biz.yahoo.com/ap/061009/cortex_pharma...
  8. [verwijderd] 9 oktober 2006 20:23
    Dat is positief nieuws, maar niet superpositief (vandaar dat de koers na de eerste explosie richting 3,64 USD in de loop van de beurssessie terugviel): COR moet van de FDA nog bijkomende toxicologische testen doen op apen en ratten, begin januari zullen wschl. de resultaten daarvan bekend zijn. Normaliter kan er pas dan een of ander samenwerkingsakkoord met een groot farmabedrijf worden afgesloten. Cortex heeft dus nog een héél lange weg af te leggen ...
  9. [verwijderd] 19 januari 2007 18:24
    Bedrijf heeft weer aandelen uitegegeven. De koers is 20% gedaald. Nieuw 52 weeks low, naar mijn smaak te laag. Heb een plukje gekocht in verwachting op herstel.
  10. forum rang 4 Nel 19 januari 2007 18:58
    ga met je mee,zie idd kansen ,news is onderweg.

    succes
  11. [verwijderd] 20 januari 2007 01:50
    Kansen??? De situatie is momenteel kritiek voor COR, als de FDA binnenkort (eind februari?) weigert de dosis-beperkingen op CX-717 (m.b.t. ADHD) op te heffen is het over en uit voor CX-717 en dus wschl. ook voor COR. Met de opgehaalde 5,6 miljoen USD zullen ze niet in staat zijn andere ampakines in de pijplijn te brengen en te ontwikkelen. Wie nu koopt, gokt er dus op dat de FDA de beperkingen op CX-717 zal opheffen én dat COR dan een akkoord kan sluiten met een farma-bedrijf om CX-717 en/of andere ampakines verder te ontwikkelen. Nogal magertjes om een aankoop op te baseren ...
  12. [verwijderd] 20 januari 2007 14:12

    Scholle,

    De hold op CX-717 speelt al sinds april 2006. De recente daling van van 20% is dus alleen ingegeven door de uitgifte van aandelen van nog geen $ 6kk, hetgeen mi een overreactie is.

    FDA zal niet in februari uitsluitsel geven. Cortex zal eind februari begin maart nieuwe data aan de FDA overleggen dat vervolgens bestudeerd zal worden.
    Wanneer geken wordt naar de potentie van dit medicijn zullen zeker beleggers weer instappen. Dit aandeel volg ik al een tijdje en in de VS is een aantal hardcore COR believers die zeker richting het oordeel van FDA zullen bijkopen.

    NB! koers voor de hold tegen de $6 geweest.
    quote:

    scholle schreef:

    Kansen??? De situatie is momenteel kritiek voor COR, als de FDA binnenkort (eind februari?) weigert de dosis-beperkingen op CX-717 (m.b.t. ADHD) op te heffen is het over en uit voor CX-717 en dus wschl. ook voor COR. Met de opgehaalde 5,6 miljoen USD zullen ze niet in staat zijn andere ampakines in de pijplijn te brengen en te ontwikkelen. Wie nu koopt, gokt er dus op dat de FDA de beperkingen op CX-717 zal opheffen én dat COR dan een akkoord kan sluiten met een farma-bedrijf om CX-717 en/of andere ampakines verder te ontwikkelen. Nogal magertjes om een aankoop op te baseren ...
  13. [verwijderd] 20 januari 2007 18:54
    Ik volg COR al zo'n jaar of 7, de situatie van het bedrijf is momenteel heel penibel. Het gaat hem niet zozeer om de potentie van CX-717, maar vooral om de reden waarom de FDA de clinical hold oplegde (en slechts gedeeltelijk ophief begin oktober 2006): weefselafwijkingen in de onderzochte stalen van apen die men CX-717 had gegeven. Als na de nieuwe toxicologische proeven met CX-717 blijkt dat die weefselafwijkingen vorige keer geen toeval of een accident de parcours waren, dan zal de FDA-beslissing in april of mei uiteraard negatief zijn en dan is CX-717 (en vermoedelijk alle andere low impact ampakines) 'toast'.

    Dan zal COR, wschl. in juni 2007, met CX-701, een high impact ampakine, fase I trials starten. Met hun huidige cashpositie kunnen ze CX-701 onmogelijk doorheen de pijplijn krijgen. Of ze al in een fase I trial een samenwerkingsakkoord met een farmabedrijf kunnen afsluiten is nog maar de vraag.

    Hoe dan ook, er zal normaliter inderdaad pas echt nieuws zijn ten vroegste april 2007, als de FDA zal beslissen of de ban op de hoge dosering met CX-717 blijft behouden of opgeheven. In geval 1 crasht de koers (opnieuw), in geval twee stijgt ze, maar je moet geen wonderen verwachten, tenzij er dan snel een deal met een farma-bedrijf komt.

    NB Dat de koers vóór de hold 6 USD benaderde is niet echt relevant, omdat de koers toen de goede fase II resultaten met CX-717 m.b.t. ADHD weerspiegelde (goede resultaten die het gevolg waren van de toen toegelaten hoge dosering die NU nog altijd verboden is). Merk tevens op dat het management van COR ook bij de huidige lage koers blijkbaar niet geneigd is aandelen COR te kopen!

    Je kan COR het best volgen op het COR-MB van Investors Hub, waar een aantal COR-specialisten van het eerste uur posten.
  14. [verwijderd] 22 januari 2007 12:02
    Bedankt voor de uitgebreide weergave van je visie, en hiermee ben ik het mee eens. Derhalve zijn we beide van mening dat op lange termijn de toekomst onzeker is , maar ik zie zeker mogelijkheden op de korte termijn. De koersdaling (20%)op basis van de bekendmaking van de uitgifte van slecht $5.6m aan aandelen is een overreactie. De koers zal zich op korte termijn herstellen tot de hoogte van voor de bekendmaking van dit nieuws.
    De reden dat ik vermeld dat de koers voorheen bij $6 stond, is om aan te geven dat speculanten nu de koers zo laag staat zeker een gokje zullen wagen met als gevolg koersstijging.
    Er zijn dus twee redenen om te verwachten dat de koers zal stijgen.

    Concluderend: kt kans op neerwaartse beweging klein en de kans op opwaartse beweging reeel. Dus een perferct fonds voor ritje (15 a 20%).

  15. [verwijderd] 22 februari 2007 19:34

    Blijft maar doorstijgen.

    Laatste koers Verschil

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    Laagste v/d dag Hoogste v/d dag
    1.19 1.66

    Laatste koers Verschil

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    Laagste v/d dag Hoogste v/d dag
    1.19 1.70






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