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1. adri67 27 februari 2018 11:16

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   Axsome Therapeutics Announces Primary Endpoint Met in Phase 1 Trial of Next Generation Product Candidate AXS-09 Containing Chirally Pure Esbupropion and Dextromethorphan
   GlobeNewswire•February 26, 2018
   
   Chirally pure and stable single enantiomers of bupropion achieved
   
   AXS-09 consists of esbupropion and dextromethorphan for CNS disorders
   
   Esbupropion is the chirally pure S-enantiomer of bupropion
   
   AXS-09 results in substantial increases in dextromethorphan plasma levels (p<0.0001)
   
   NEW YORK, Feb. 26, 2018 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (AXSM), a clinical-stage biopharmaceutical company developing novel therapies for the management of central nervous system (CNS) disorders, today announced positive topline clinical trial results from a Phase 1 pharmacokinetic study of AXS-09, a novel, oral medicine consisting of esbupropion and dextromethorphan being developed for the treatment of CNS disorders. Esbupropion (S-bupropion) is the S-enantiomer of bupropion, a dopamine and norepinephrine reuptake inhibitor and nicotinic acetylcholine receptor antagonist which also serves to increase the bioavailability of dextromethorphan. Results of the Phase 1 trial demonstrated that AXS-09 resulted in substantial increases in dextromethorphan plasma concentrations, the trial’s primary endpoint, into a potentially therapeutic range with repeated dosing (p<0.0001 day 1 versus day 8). AXS-09 was well tolerated with no serious adverse events reported in the trial.
   
   AXS-09 is enabled by Axsome’s technical success at isolating chirally pure and chemically stable single enantiomers of bupropion, and formulating them into dosage forms that maintain their chirality. Enantiomers are molecules which are identical in chemical structure but which differ in the three-dimensional arrangement of the atoms (i.e. mirror images). Based on the results of this Phase 1 trial and preclinical data, Axsome believes that the individual enantiomers of bupropion (R-bupropion and S-bupropion) may each have unique properties that render them potentially useful in different indications. To Axsome’s knowledge, this is the first time that stable, chirally pure single enantiomers of bupropion have been successfully formulated and dosed in a clinical trial.
   
   The increased plasma concentrations of dextromethorphan after dosing with AXS-09, which contains the chirally pure S-enantiomer of bupropion, are comparable to those achieved with dosing of the company’s first generation product candidate AXS-05 (bupropion and dextromethorphan) which contains racemic bupropion (equal amounts of the S- and R-enantiomers). Results of this Phase 1 trial coupled with preclinical data also indicate the potential for enhanced absorption and therapeutic effect of the S-enantiomer as compared to the R-enantiomer.
   
   “We are developing a robust portfolio of novel treatments for CNS disorders, which is an area of high unmet medical needs,” said Cedric O’Gorman, M.D., Senior Vice President, Clinical Development and Medical Affairs of Axsome. “We are actively progressing AXS-05 in our ongoing Phase 3 trial in treatment resistant depression and Phase 2/3 trial in agitation in patients with Alzheimer’s disease, and we look forward to the results of those trials. Based on the positive Phase 1 results, AXS-09 provides us with another attractive product candidate that merits evaluation in future CNS indications.”
   
   “The successful results with AXS-09 reflect Axsome’s continued scientific innovation and are additive to AXS-05 which is already in late-stage clinical trials,” said Herriot Tabuteau, M.D., Chief Executive Officer of Axsome. “With AXS-05 and AXS-09, we are building a franchise of differentiated medicines targeting both glutamatergic and monoaminergic neurotransmission with potential applicability in numerous CNS disorders.”
   
   AXS-09 is yet another product candidate generated using Axsome’s proprietary medicinal chemistry and formulation technologies which allow the design of new and innovative medicines to treat CNS conditions. These capabilities, which have yielded five clinical-stage product candidates, include: 1) chiral chemistry and formulation to identify, isolate and stabilize chirally pure enantiomers, 2) metabolic inhibition as a novel drug delivery method to increase the bioavailability and prolong the half-life of target drug molecules, 3) the MoSEIC™ technology which is designed to substantially increase the solubility and speed the absorption of target drug molecules, and 4) proprietary chemical synthesis and analysis to increase the solubility and enable the oral delivery of target drug molecules.
   
   Phase 1 Trial Design
   
   The study was a randomized, multiple-dose, parallel group pharmacokinetic trial. A total of 40 healthy adult subjects were randomly assigned to treatment with AXS-09 (esbupropion and dextromethorphan), R-bupropion and dextromethorphan, single-entity S-bupropion, or single-entity R-bupropion tablets, for 8 days under fasting conditions. Plasma concentrations of dextromethorphan, bupropion, and their metabolites were measured. The primary endpoint was the change in dextromethorphan plasma concentrations from day 1 to day 8.
   
   About AXS-09
   
   AXS-09 is a novel, oral medicine consisting of chirally pure esbupropion and dextromethorphan being developed for the treatment of central nervous system disorders. Esbupropion is the S-enantiomer of bupropion, a dopamine and norepinephrine reuptake inhibitor and nicotinic acetylcholine receptor antagonist which also serves to increase the bioavailability of dextromethorphan. Dextromethorphan is an NMDA receptor antagonist, sigma-1 receptor agonist, an inhibitor of the serotonin and norepinephrine transporters, and a nicotinic acetylcholine receptor antagonist. AXS-09 is an investigational drug product not approved by the FDA.
   
   About AXS-05
   
   AXS-05 is a novel, oral medicine under development for the treatment of central nervous system (CNS) disorders. AXS-05 utilizes Axsome’s technology of combining bupropion and dextromethorphan. Dextromethorphan is an NMDA receptor antagonist, sigma-1 receptor agonist, an inhibitor of the serotonin and norepinephrine transporters, and a nicotinic acetylcholine receptor antagonist. Bupropion serves to increase the bioavailability of dextromethorphan, and is a norepinephrine and dopamine reuptake inhibitor, and a nicotinic acetylcholine receptor antagonist. AXS-05 is an investigational drug product not approved by the FDA.
2. adri67 26 april 2018 16:39

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   Axsome Therapeutics Announces Positive Outcome of Interim Analysis of STRIDE-1 Phase 3 Trial of AXS-05 in Treatment Resistant Depression
   
   Independent Data Monitoring Committee recommends trial continuation
   
   Second interim analysis anticipated second half of 2018 for efficacy
   
   NEW YORK, April 26, 2018 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (AXSM), a clinical-stage biopharmaceutical company developing novel therapies for the management of central nervous system (CNS) disorders, today announced a positive outcome of the interim futility analysis for the STRIDE-1 Phase 3 trial of AXS-05 in treatment resistant depression. An independent data monitoring committee (IDMC) conducted the unblinded, pre-specified interim analysis. Based on the results of the analysis, the IDMC recommended that the trial continue. The IDMC also reviewed the available safety information from the study and indicated that, based on the interim results, AXS-05 appeared safe and well-tolerated.
   
   AXS-05 is a novel, oral, fixed-dose combination of dextromethorphan and bupropion. AXS-05 combines glutamatergic and monoaminergic mechanisms of action, which have been associated with antidepressant effects, and Axsome’s metabolic inhibition technology. Pharmacokinetic data with AXS-05 and clinical observations with the dextromethorphan component indicate that AXS-05 increases dextromethorphan concentrations into a potentially therapeutic range. AXS-05 has been granted U.S. Food and Drug Administration (FDA) Fast Track designation for the treatment of treatment resistant depression.
   
   “The positive outcome of this interim futility analysis combined with the multiple mechanisms of action of AXS-05 support its continued development for treatment resistant depression,” said Herriot Tabuteau, MD, Chief Executive Officer of Axsome. “We look forward to the next and final interim analysis of the STRIDE-1 trial, anticipated in the second half of this year, which will be conducted to assess efficacy.”
   
   The STRIDE-1 interim futility analysis was performed on the first approximately 40% of the target number of subjects. A second interim analysis will be performed on the first approximately 60% of the target number of subjects to assess efficacy.
   
   “The IDMC’s recommendation for continuation of the STRIDE-1 trial and its findings of an overall favorable clinical safety profile for AXS-05 are encouraging,” said Cedric O’Gorman, MD, Senior Vice President of Clinical Development and Medical Affairs of Axsome. “A significant proportion of patients with major depressive disorder are treatment resistant, having previously failed two or more therapies. There are limited available treatment options for these patients. AXS-05’s multiple mechanisms, targeting glutamatergic, monoaminergic and anti-inflammatory pathways, may offer a unique therapeutic approach for this serious condition.”
   
   The Company recently held a research and development (R&D) day focusing on AXS-05. Of relevance to treatment resistant depression were presentations by key opinion leaders Stephen M. Stahl, MD, PhD, DSc (Adjunct Professor of Psychiatry, University of California San Diego), and Maurizio Fava, MD (Executive Vice Chair of the Department of Psychiatry, Massachusetts General Hospital). Dr. Stahl discussed the psychopharmacology of AXS-05 and its potential clinical implications. Dr. Fava discussed approaches that target multiple mechanisms of action to address treatment resistant depression, and the potential utility of AXS-05 for this condition. An archived webcast of this event, with slides, can be accessed on the investor page of Axsome’s website at www.axsome.com.
   
   The R&D day also featured presentations from key opinion leaders Marc Agronin, MD (Vice President of Behavioral Health and Clinical Research at Miami Jewish Health), who discussed the potential of AXS-05 for the treatment of agitation associated with Alzheimer’s disease, and James Davis, MD (Medical Director of the Duke Center for Smoking Cessation, Duke University School of Medicine), who discussed unmet needs in smoking cessation and the potential for AXS-05.
   
   About the STRIDE-1 Study
   
   STRIDE-1 (Symptom Treatment in Resistant Depression 1) is a Phase 3, randomized, double-blind, active controlled trial to assess the efficacy and safety of AXS-05 in the treatment of treatment resistant depression (TRD). Patients with major depressive disorder (MDD) who have previously failed one or two antidepressant treatments are treated in an open-label fashion with bupropion during a 6-week lead-in period. Patients who fail to respond to bupropion during this lead-in period are randomly assigned in a 1:1 ratio to receive bupropion or AXS-05 in a double-blind fashion for 6 weeks. The primary endpoint is the change in the Montgomery-Åsberg Depression Rating Scale (MADRS) after 6 weeks of treatment.
   
   About Treatment Resistant Depression (TRD)
   
   Patients diagnosed with major depressive disorder (MDD) are defined as having TRD if they have failed two or more antidepressant therapies. MDD is a serious condition characterized by depressed mood or a loss of interest or pleasure in daily activities consistently for at least a two-week period, and which impairs social, occupational, educational, or other important functioning. According to the National Institute of Health, an estimated 6.7% of U.S. adults experience MDD each year. Nearly two-thirds of diagnosed and treated patients do not experience adequate treatment response with first-line therapy, and the majority of these initial failures also fail second-line treatment.
   
   About AXS-05
   
   AXS-05 is a novel, oral, investigational drug product under development for the treatment of central nervous system (CNS) disorders. AXS-05 consists of bupropion and dextromethorphan and utilizes Axsome’s metabolic inhibition technology. Dextromethorphan is an NMDA receptor antagonist, sigma-1 receptor agonist, nicotinic acetylcholine receptor antagonist, and inhibitor of the serotonin and norepinephrine transporters. Bupropion serves to increase the bioavailability of dextromethorphan, and is a norepinephrine and dopamine reuptake inhibitor, and a nicotinic acetylcholine receptor antagonist. AXS-05 is an investigational drug product not approved by the FDA. The safety and efficacy of AXS-05 have not yet been established.
   
   About Axsome Therapeutics, Inc.
   
   Axsome Therapeutics, Inc. is a clinical-stage biopharmaceutical company developing novel therapies for the management of central nervous system (CNS) disorders for which there are limited treatment options. Axsome’s product candidate portfolio includes five clinical-stage candidates, AXS-02, AXS-05, AXS-06, AXS-07, and AXS-09. AXS-05 is currently in a Phase 3 trial in treatment resistant depression (TRD), a Phase 2/3 trial in agitation associated with Alzheimer’s disease (AD), and a Phase 2 trial in smoking cessation. AXS-02 is currently in a Phase 3 trial in knee osteoarthritis (OA) associated with bone marrow lesions (BMLs) with an additional Phase 3 trial planned in chronic low back pain (CLBP) associated with Modic changes (MCs). AXS-07 is being developed for the acute treatment of migraine. AXS-06 is being developed for the treatment of osteoarthritis and rheumatoid arthritis and for the reduction of the risk of NSAID-associated gastric ulcers. AXS-02, AXS-05, AXS-06, AXS-07, and AXS-09 are investigational drug products not approved by the FDA. For more information, please visit the company website at www.axsome.com. The company may occasionally disseminate material, nonpublic information on the company website.
3. bionerd 30 april 2018 17:41

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   •    bionerd

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   Mensen beginnen langzaam te begrijpen dat dit een parel is. Heeft een koersdoel van 13 dollar. Gaat vandaag helemaal los. 10% er bij. De trein is vertrokken.
   
4. bionerd 30 april 2018 19:05

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   www.analystratings.com/articles/axsom...
   
5. [verwijderd] 8 november 2018 10:54

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   Als er ooit een moment was om dit pareltje te kopen is het nu wel.
   Op clinicaltrials.gov vind je nu volgende informatie :
   
   1.
   clinicaltrials.gov/ct2/show/NCT035955...
   Randomized, Double-Blind, Active-Controlled Study of AXS-05 for MDD.
   Estimated Primary Completion Date : October 2018
   Estimated Study Completion Date : October 2018
   
   2.
   clinicaltrials.gov/ct2/show/NCT034717...
   Research study is designed with the purpose of evaluating AXS-05 for its effects on smoking behavior.
   Estimated Primary Completion Date : December 31, 2018
   Estimated Study Completion Date : January 21, 2019
   
   3.
   clinicaltrials.gov/ct2/show/NCT027417...
   To evaluate the efficacy and safety of AXS-05 relative to bupropion in subjects with treatment resistant major depressive disorder (MDD).
   Estimated Primary Completion Date : January 2019
   Estimated Study Completion Date : March 2019
   
   Verder kan je lezen in hun "Corporate Presentation" dd. 17 oktober 2018 (link : axsometherapeuticsinc.gcs-web.com/eve... dat volgende catalysten er nog dit jaar aankomen :
   *** Interim Analysis AXS-05 in AD agitation
   *** Start Ph 3 trial AXS-07 in migraine
   *** Start Ph 2 trial AXS-12 in narcolepsy
   
   Morgen komen de cijfers van Q3 uit, weinig nieuws op dat front te verwachten (nog geen inkomsten) maar mogelijk dus een update AXS-05 in MDD. En meerdere updates in de komende maanden. Market cap belachelijk laag IMO.
   Succes!
   
6. [verwijderd] 8 november 2018 12:15

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   axsometherapeuticsinc.gcs-web.com/eve... deze link naar de presentatie zou wel moeten werken :)
7. [verwijderd] 8 november 2018 12:18

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   Catalysten voor AXSM in de komende maanden in bijlage. Ziet er goed uit.

   Bijlage:
8. adri67 2 januari 2019 20:23

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   Er komen op korte termijn veel fase 2/3 resultaten:
   
   NEW YORK, Dec. 27, 2018 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ: AXSM), a clinical-stage biopharmaceutical company developing novel therapies for the management of central nervous system (CNS) disorders, today provided the following clinical update for its robust CNS pipeline:
   
   AXS-05
   
   Axsome is evaluating AXS-05 (dextromethorphan/bupropion) in the following indications: treatment resistant depression, major depressive disorder, Alzheimer’s disease agitation, and smoking cessation.
   
   Treatment Resistant Disorder
   
   To date, just under 90% of the target number of subjects have been randomized in the Phase 3 STRIDE-1 trial in treatment resistant depression (TRD), with topline results anticipated in the first quarter of 2019. STRIDE-1 is a multicenter, randomized, double-blind, controlled trial in which subjects with TRD are randomized to treatment with AXS-05 or bupropion. A positive interim futility analysis was previously announced for the STRIDE-1 trial. The interim analysis was conducted by an independent data monitoring committee (IDMC) which recommended continuation of the study. Axsome has received U.S. Food and Drug Administration (FDA) Fast Track designation for AXS-05 for the treatment of TRD.
   
   Major Depressive Disorder
   
   Axsome has completed enrollment in the Phase 2 ASCEND study in major depressive disorder (MDD), and is on track to announce topline results in early January 2019, as previously disclosed. ASCEND is a multicenter, randomized, double-blind, controlled trial in which subjects with MDD are randomized to treatment with AXS-05 or bupropion.
   
   Alzheimer’s Disease Agitation
   
   In December 2018, Axsome announced positive results of an interim futility analysis for the Phase 2/3 ADVANCE-1 trial of AXS-05 in Alzheimer’s disease (AD) agitation. ADVANCE-1 is a multicenter, randomized, double-blind, controlled trial in which subjects with agitation associated with Alzheimer’s disease are randomized to treatment with AXS-05, bupropion or placebo. The interim analysis was conducted by an IDMC which recommended continuation of the AXS-05 treatment arm and no further randomization of subjects to the bupropion treatment arm. Axsome intends to follow the IDMC’s recommendation. Axsome has received FDA Fast Track designation for AXS-05 for the treatment of AD agitation.
   
   Smoking Cessation
   
   AXS-05 is being evaluated in a Phase 2, randomized, double-blind, controlled trial for smoking cessation treatment. In the trial, smokers are randomized to treatment with AXS-05 or bupropion. The trial is being conducted under a research collaboration between Duke University and Axsome. Top-line results are anticipated in the first quarter of 2019, as previously disclosed.
   
   AXS-07
   
   Axsome is developing AXS-07 (MoSEIC meloxicam/rizatriptan) for the acute treatment of migraine.
   
   Axsome anticipates initiation of its planned Phase 3 trial of AXS-07 in patients with migraine in the first quarter of 2019, as previously disclosed, with topline results expected within approximately one year from trial initiation. The Phase 3 trial will be a multicenter, randomized, double-blind, controlled trial in which subjects with migraine are randomized to treatment with AXS-07, meloxicam, rizatriptan, or placebo.
   
   AXS-12
   
   Axsome is developing AXS-12 (reboxetine) for the treatment of narcolepsy.
   
   In December 2018, Axsome received Investigational New Drug Application (IND) clearance to proceed with its planned Phase 2 trial of AXS-12 (reboxetine) in narcolepsy from the FDA. The planned Phase 2 trial is a multicenter, randomized, double-blind, placebo-controlled, crossover study in patients with narcolepsy. Axsome anticipates initiation of this study in January 2019, with topline results in the first half of 2019. Axsome has received FDA Orphan Drug Designation for AXS-12 for the treatment of narcolepsy.
   
   Anticipated Clinical Trial Readouts
   
   Phase 2 ASCEND trial of AXS-05 in MDD, topline data (early January 2019)
   
   Phase 3 STRIDE-1 trial of AXS-05 in TRD, topline data (1Q 2019)
   
   Phase 2 trial of AXS-05 in smoking cessation, topline data (1Q 2019)
   
   Phase 2 trial of AXS-12 in narcolepsy, topline data (1H 2019)
   
   Phase 2/3 ADVANCE-1 trial of AXS-05 in AD agitation, interim efficacy analysis (2019)
   
   Phase 2/3 ADVANCE-1 trial of AXS-05 in AD agitation, topline data (2H 2019 – 1H 2020)
   
   Phase 3 trial of AXS-07 in the acute treatment of migraine, topline data (2019)
   
   About AXS-05
   
   AXS-05 is a novel, oral, investigational medicine under development for the treatment of central nervous system (CNS) disorders. AXS-05 consists of bupropion and dextromethorphan and utilizes Axsome’s metabolic inhibition technology. Dextromethorphan is an NMDA receptor antagonist, sigma-1 receptor agonist, nicotinic acetylcholine receptor antagonist, and inhibitor of the serotonin and norepinephrine transporters. Bupropion serves to increase the bioavailability of dextromethorphan, and is a norepinephrine and dopamine reuptake inhibitor, and a nicotinic acetylcholine receptor antagonist. AXS-05 is an investigational drug product not approved by the FDA. The safety and efficacy of AXS-05 have not yet been established.
   
   About AXS-07
   
   AXS-07 is a novel, oral, rapidly absorbed, investigational medicine consisting of MoSEIC™ meloxicam and rizatriptan. AXS-07 utilizes Axsome’s proprietary MoSEIC™ (Molecular Solubility Enhanced Inclusion Complex) technology to substantially increase the solubility and speed the absorption of meloxicam while maintaining durability of action.
   
   About AXS-12
   
   AXS-12 (reboxetine) is a novel, oral, investigational medicine in development for the treatment of the symptoms of narcolepsy. AXS-12 is a highly selective and potent norepinephrine reuptake inhibitor. AXS-12 is an investigational drug product not approved by the FDA.
   
   About Axsome Therapeutics, Inc.
   
   Axsome Therapeutics, Inc. is a clinical-stage biopharmaceutical company developing novel therapies for the management of central nervous system (CNS) disorders for which there are limited treatment options. Axsome’s core CNS product candidate portfolio includes four clinical-stage candidates, AXS-05, AXS-07, AXS-09, and AXS-12. AXS-05 is currently in a Phase 3 trial in treatment resistant depression (TRD), a Phase 2/3 trial in agitation associated with Alzheimer’s disease (AD), a Phase 2 trial in Major Depressive Disorder (MDD), and a Phase 2 trial in smoking cessation. AXS-07 is being developed for the acute treatment of migraine. AXS-12 is being developed for the treatment of the symptoms of narcolepsy. The Axsome Pain and Primary Care business unit (Axsome PPC) houses Axsome’s pain and primary care assets, including AXS-02 and AXS-06, and intellectual property which covers these and related product candidates and molecules being developed by Axsome and others. AXS-02 is being developed for osteoporosis, the pain of knee osteoarthritis, and chronic low back pain. AXS-06 is being developed for osteoarthritis and rheumatoid arthritis. AXS-02, AXS-05, AXS-06, AXS-07, AXS-09, and AXS-12 are investigational drug products not approved by the FDA. For more information, please visit the Company’s website at axsome.com. The Company may occasionally disseminate material, nonpublic information on the company website.
9. 25GTi 3 januari 2019 15:00

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   Op 27 dec jl. nog $2,0 (ATL) nu $2,7-$2,8.
   Misschien toch binnenkort maar eens instappen door een kooporder met limiet in te geven.
10. adri67 7 januari 2019 15:03

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    Axsome's stock nearly triples on heavy volume after positive trial of depression treatment
    
    Published: Jan 7, 2019 8:23 a.m. ET
    
    
    Shares of Axsome Therapeutics Inc. AXSM, +193.92%rocketed 164% in very active premarket trade Monday, after the biopharmaceutical company developing therapies to treat central nervous system disorders said a phase 2 trial of its AXS-05 met its primary endpoint, and "significantly improved symptoms of depression." Trading volume ballooned to about 1.5 million shares, already about 5-times the full-day average of about 306,000 shares, and enough to make the stock the most actively traded ahead of the open. The company said AXS-05 met the primary endpoint by demonstrating a "highly statistically significant reduction" in the Montgomery-Asberg Depression Rating Scale total score. The company said ASX-05 was also safe and well tolerated, with no serious adverse events. The stock had tumbled 28% over the past three months through Friday, while the iShares Nasdaq Biotechnology ETF IBB, +5.03%had lost 12.0% and the S&P 500 SPX, +3.43%had declined 12.3%.
11. 25GTi 7 januari 2019 21:30

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    Adri, gefeliciteerd met deze uitzonderlijke mooie stijging. Ik neem tenminste aan dat je de aandelen bezit.
    Helaas heb ik ze niet bemachtigd in de laatste dagen.....
12. adri67 8 januari 2019 20:32

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    quote:

    25GTi schreef op 7 januari 2019 21:30:

    Adri, gefeliciteerd met deze uitzonderlijke mooie stijging. Ik neem tenminste aan dat je de aandelen bezit.
    Helaas heb ik ze niet bemachtigd in de laatste dagen.....
    

    @25GTi,
    
    Dank voor de felicitatie. Ik heb inderdaad een pluk aandelen Axsome in portefeuille.
13. 25GTi 8 januari 2019 20:39

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    Wie weet wat het je morgen nog maals gaat opleveren.
    Ik heb helaas geen cash vrij anders zou ik een gokje kunnen wagen, gisteren 200%, vandaag 30%. dan zal het morgen toch nog eens 10% kunnen zijn.
14. [verwijderd] 8 januari 2019 21:02

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    Lees nu voor het eerst dit draadje, heb het aandeel ook al een tijdje in het bezit, gisteren een flinke stijging en vandaag weer..... mooi aandeel...! Succes iedereen....!
15. adri67 9 januari 2019 12:43

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    Axsome Therapeutics, Inc. (AXSM) announced yesterday that its drug candidate, AXS-05, met the prespecified primary endpoint and significantly improved symptoms of depression in the ASCEND Phase 2 trial targeting major depressive disorder (MDD). AXS-05 met the prespecified primary endpoint by demonstrating a highly statistically significant reduction in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score, averaged over the 6-week treatment period as compared to bupropion.
    
    “The clinically meaningful improvements in depressive symptoms seen with AXS-05 in this study were achieved versus an active comparator that is a well-established antidepressant, as early as only one week after initiation of treatment,” said Professor Maurizio Fava, MD, Executive Vice Chair, Department of Psychiatry, Massachusetts General Hospital and Associate Dean for Clinical & Translational Research, Harvard Medical School. “As an oral NMDA receptor antagonist with multimodal activity, AXS-05 could provide a new approach to treating this potentially life-threatening condition.”
16. adri67 9 januari 2019 12:49

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    The ASCEND study of AXS-05 was a six-week study in major depressive disorder (MDD) that set a very high bar for success, as while the study was controlled, the control group was treated with bupropion alone (which is known to be active in depression) rather than placebo. Further, the trial only enrolled 80 patients which would usually run a high risk of failing to achieve a statistically significant improvement when comparing the drug (AXS-05) to the control group (bupropion). AXSM also put the endpoint of the ASCEND study at 6 weeks, even though separation between the arms of the study tends to increase further at 8 weeks (although most the benefit of an antidepressant is usually seen by six weeks if one intends to enroll just 80 patients, then an endpoint at six weeks might be viewed as reducing the chance of a statistically significant result even further). Trials of several hundred patients are often needed to avoid the risk of a false negative when working with antidepressants (Figure 2). Even then, marginal p-values (such as 0.01 < p < 0.05) which are sometimes seen.
    
    Despite the limitations of the ASCEND study (80 patients, six-week endpoint, active comparator instead of placebo control) on January 7, 2019, AXSM announced positive results from the study. I believe the magnitude of the reduction in MADRS score, coupled with a statistically significant beat of an approved antidepressant, speaks to the efficacy of the drug in depression and increases my confidence in the readout of the STRIDE-1 study.
    
    seekingalpha.com/article/4231865-axso...
17. [verwijderd] 9 januari 2019 16:00

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    Nou. T was even bagholder spelen, maar mijn centjes verdrievoudigd in 1 jaar.
    Nu mag meip nog even vlammen en mijn jaar begint goed. Feli allen met de winst.
18. [verwijderd] 9 januari 2019 18:31

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    quote:

    Madebeliefje schreef op 9 januari 2019 16:00:

    Nou. T was even bagholder spelen, maar mijn centjes verdrievoudigd in 1 jaar.
    Nu mag meip nog even vlammen en mijn jaar begint goed. Feli allen met de winst.
    

    Wou dat ik dat ook kon zeggen. Vanwaar MEIP Madeliefje?
    
19. holenbeer 9 januari 2019 20:07

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    quote:

    Madebeliefje schreef op 9 januari 2019 16:00:

    Nou. T was even bagholder spelen, maar mijn centjes verdrievoudigd in 1 jaar.
    Nu mag meip nog even vlammen en mijn jaar begint goed. Feli allen met de winst.
    

    Gefeliciteerd! Ik was helaas net te vroeg uitgestapt, duurde te lang en zag andere kansen. Gelukkig maar met een kleine positie.
    
    nog interessante dingen over MEIP te melden, pijplijn, verwachte resultaten?
20. [verwijderd] 10 januari 2019 12:01

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    Meip heeft een market cap van 100mm, 100mm cash, en de trials worden betaald door partners. Resultaten zijn goed, en ze hebben milestone payments van partners van 100en miljoenen. Maar doe je eigen huiswerk. Het ziet er allemaal goed uit in mijn optiek, koers is van 5 naar 2 gegaan door sentiment denk ik, maar gaat nu weer hard omhoog.