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    AXSM (Mkap $83 M) (Cash $40 M) 4 x Phase 3 Studien /erste Daten im 2H 2017 (Seite 16)

    eröffnet am 21.03.17 23:52:12 von
    neuester Beitrag 19.08.22 13:09:24 von
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     Ja Nein
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      schrieb am 04.08.17 10:39:57
      Beitrag Nr. 118 ()
      Eine neue Präsentation vom 2. August ist online. :)

      http://phx.corporate-ir.net/phoenix.zhtml?c=254022&p=irol-pr…
      Avatar
      schrieb am 26.07.17 14:06:04
      Beitrag Nr. 117 ()
      Nettes Kursziel

      Axsome Therapeutics (AXSM) PT Raised to $31 at Ladenburg Thalmann
      https://www.streetinsider.com/Analyst+Comments/Axsome+Therap…

      Ladenburg Thalmann raised its price target on Axsome Therapeutics (NASDAQ: AXSM) to $31.00 (from $28.00) while maintaining a Buy rating.

      Analyst Matt Kaplan comments "Interim Phase 3 data for CRPS is expected in 4Q17, with AXS-02 potentially being initially launched in the US in 2019, and other indications following in later years. We estimate AXS-02 can achieve $150 million in revenue in CRPS, with other pain indications also adding materially. At peak, we estimate AXS-02 can reach $600 million."
      Avatar
      schrieb am 25.07.17 20:43:32
      Beitrag Nr. 116 ()
      Antwort auf Beitrag Nr.: 55.390.506 von Biohero am 25.07.17 13:31:38Auch von mir erst mal Danke für den guten Tipp .
      Da du von Übernahme-Kanidat sprichst . Was denkst du währe die Firma bei einer Übernahme ( positive Daten natürlich vorausgesetzt ) wert ?
      Avatar
      schrieb am 25.07.17 15:03:24
      Beitrag Nr. 115 ()
      Ja, auch hier wars ein toller Tip von Biohero, vielen Dank. Eine tolle Performance seit Threaderöffnung und die Zukunftsperspektiven sind sehr gut.
      Avatar
      schrieb am 25.07.17 13:32:38
      Beitrag Nr. 114 ()
      Antwort auf Beitrag Nr.: 55.390.473 von Aurum2010 am 25.07.17 13:17:02Oha...dieses Unternehmen könnte sich als wahre Goldgrube herausstellen! Klasse News.

      Trading Spotlight

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      Was die Börsencommunity nach Ostern auf keinen Fall verpassen willmehr zur Aktie »
      Avatar
      schrieb am 25.07.17 13:31:38
      Beitrag Nr. 113 ()
      Antwort auf Beitrag Nr.: 55.390.473 von Aurum2010 am 25.07.17 13:17:02Jetzt sind es 6 x Phase 3 Studien die AXSM in der Pipeline hat 4 davon aktiv und 2 bereit für Phase 3 wirklich klasse für ein Unternehmen das gerade mal mit rund $134 million bewertet ist und davon fast $50 million in cash hält .AXSM wird als potentieller Übernahme kandidat immer hübscher .
      1 Antwort
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      schrieb am 25.07.17 13:17:02
      Beitrag Nr. 112 ()
      Axsome Therapeutics Announces AXS-06 (MoSEIC™ Meloxicam and Esomeprazole) Meets Primary Endpoint in Phase 1 Clinical Trial

      XS-06 is an oral, rapidly-absorbed, once-daily, non-opioid, COX-2 preferential pain therapeutic with a gastroprotectant

      Primary endpoint met with 9 times faster time to maximum plasma concentration (Tmax) of meloxicam versus Mobic® (p<0.0001)

      Therapeutic plasma levels of meloxicam achieved within 15 minutes of oral dosing of AXS-06

      Gastroprotective concentrations of esomeprazole achieved

      Phase 3-ready based on FDA Pre-IND guidance

      AXS-06 utilizes Axsome’s MoSEIC™ delivery technology

      AXS-06 to complement commercialization of AXS-02 in development for complex regional pain syndrome

      NEW YORK, July 25, 2017 (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-06, a novel, oral, non-opioid, fixed-dose combination of meloxicam and esomeprazole being developed for the treatment of osteoarthritis and rheumatoid arthritis. Axsome has received, from the U.S. Food and Drug Administration (FDA), Pre-Investigational New Drug Application (Pre-IND) written guidance on a proposed clinical developmental plan for AXS-06. Based on this guidance, Axsome believes that AXS-06 is Phase 3-ready. AXS-06 is now Axsome’s third product candidate in clinical development and its second differentiated oral, non-opioid product candidate for the management of chronic pain.

      The clinical trial results demonstrated, for the first time, rapid achievement of peak plasma levels of meloxicam after oral administration. Meloxicam is a long-acting nonsteroidal anti-inflammatory drug (NSAID) with COX-2 preferential inhibition and potent pain relieving efficacy. However standard meloxicam has an extended time to maximum plasma concentration (Tmax) which delays its onset of action. AXS-06 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. AXS-06 also incorporates esomeprazole, a proton pump inhibitor, to reduce the risk of NSAID-associated gastrointestinal ulcers which can occur with chronic NSAID use.

      “AXS-06 provides the benefits of oral administration and demonstrates a more rapid meloxicam Tmax than that reported with intramuscular administration, highlighting the potential for faster pain relief. In addition, AXS-06 maintains the long half-life of meloxicam which enables once-daily dosing and sustained effect,” said Herriot Tabuteau, M.D., Chief Executive Officer of Axsome. “These results indicate that AXS-06 has a potentially best-in-class NSAID profile based on the differentiated pharmacokinetic profile of MoSEIC™ meloxicam and the potentially enhanced gastrointestinal safety from the esomeprazole component. The potential efficacy and safety advantages of AXS-06 as compared to currently available NSAIDs could provide significant benefit to patients.”

      The study compared the pharmacokinetics of meloxicam and esomeprazole after oral administration of AXS-06 tablets (meloxicam 15 mg, esomeprazole 40 mg), and commercially available Mobic® tablets (15 mg meloxicam) and Nexium® capsules (40 mg esomeprazole) in healthy volunteers. The median Tmax for meloxicam, the trial’s primary endpoint, was 9 times faster for AXS-06 as compared to Mobic® (0.5 hour versus 4.5 hours for AXS-06 and Mobic, respectively, p<0.0001). AXS-06 also demonstrated higher mean maximum plasma concentration (Cmax) (p=0.0018), faster time to therapeutic plasma concentration (p<0.0001), and time to half-maximal plasma concentration (p<0.0001) as compared to Mobic®. Terminal half-lives for meloxicam were similar for AXS-06 and Mobic® at approximately 20 and 22 hours, respectively. Plasma concentrations and terminal half-lives of esomeprazole after AXS-06 and Nexium® administration were comparable. AXS-06 was well tolerated with reported adverse events being similar across the three treatment arms. There were no serious adverse events in the study.

      “With its differentiated profile and Phase 3-ready status, AXS-06 complements AXS-02 which is currently in Phase 3 trials in complex regional pain syndrome and knee osteoarthritis,” continued Dr. Tabuteau. “The overlapping patient and physician audiences for AXS-02 and AXS-06 should allow Axsome to leverage our commercialization efforts. We look forward to the further development of AXS-06 and to a data readout for AXS-02 in complex regional pain syndrome anticipated in the fourth quarter.”

      Phase 1 Trial Design

      The study was a randomized, parallel group trial to evaluate the pharmacokinetics and safety of meloxicam and esomeprazole after single and multiple dose administration of AXS-06 in healthy volunteers. A total of 30 subjects were randomly assigned in a 1:1:1 ratio to treatment with AXS-06 tablets (15 mg meloxicam, 40 mg esomeprazole), Mobic® tablets (15 mg meloxicam), or Nexium® capsules (40 mg esomeprazole), once daily for 6 days under fasting conditions. The primary endpoint was the Tmax of meloxicam. Secondary endpoints included Cmax, time to half maximum concentration, and time to therapeutic concentration.

      About the NSAID Market

      Nonsteroidal anti-inflammatory drugs (NSAIDs) are widely used for the treatment of pain and arthritis. Approximately 120 million prescriptions were written for NSAIDs overall in the U.S. in 2016, of which approximately 25% were written for meloxicam. Chronic use of NSAIDs has been reported to be associated with the development of gastrointestinal ulcers in as many as 25% of patients.

      About AXS-06

      AXS-06 is an oral, non-opioid, fixed-dose combination of MoSEIC™ meloxicam and esomeprazole which is being developed for the treatment of chronic pain. Meloxicam is a long-acting nonsteroidal anti-inflammatory drug (NSAID) with COX-2 preferential inhibition and potent pain-relieving efficacy. AXS-06 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. Esomeprazole is a proton pump inhibitor which lowers stomach acidity and which has been shown to reduce the occurrence of NSAID-induced gastrointestinal ulcers. AXS-06 is designed to provide rapid, effective pain relief, and to reduce the risk of NSAID-induced ulcers, with convenient once-daily dosing.

      https://finance.yahoo.com/news/axsome-therapeutics-announces…
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      schrieb am 17.07.17 13:59:39
      Beitrag Nr. 111 ()
      Die Phase 3 Studie in AD agitation hat begonnen ...

      Axsome Therapeutics Initiates Phase 2/3 Trial of AXS-05 for Alzheimer’s Disease Agitation
      https://globenewswire.com/news-release/2017/07/17/1047310/0/…
      Avatar
      schrieb am 17.07.17 13:57:20
      Beitrag Nr. 110 ()
      First patient enrolled in the ADVANCE-1 study

      Agitation reported in nearly 50% of patients with Alzheimer’s disease

      FDA Fast Track designation previously received for AXS-05 for Alzheimer’s disease agitation

      Second indication for AXS-05 in late-stage clinical trials

      NEW YORK, July 17, 2017 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (AXSM), a clinical-stage biopharmaceutical company developing novel therapies for the management of central nervous system (CNS) disorders, enrolled the first patient in the ADVANCE-1 (Addressing Dementia Via Agitation-Centered Evaluation 1) study, a Phase 2/3 trial evaluating the efficacy and safety of AXS-05 for the treatment of Alzheimer’s disease (AD) agitation. AXS-05 is a combination of dextromethorphan (an NMDA receptor antagonist, sigma-1 receptor agonist, and serotonin and norepinephrine reuptake inhibitor) and bupropion (a norepinephrine and dopamine reuptake inhibitor, which also increases the bioavailability of dextromethorphan).

      “Agitation is one of the most distressing and difficult-to-treat behavioral symptoms in patients with Alzheimer’s disease,” said Jeffrey Cummings, M.D., Sc.D., Professor of Neurology, and Director of the Center for Neurodegeneration and Translational Neuroscience, at the Cleveland Clinic Lerner College of Medicine. “It is common, being reported in about half of patients, is one of the primary reasons for early nursing home placement, and is associated with increased mortality. NMDA receptor antagonism, sigma-1 receptor agonism, and serotonin and norepinephrine reuptake inhibition may be relevant mechanisms in this condition. New treatments are needed for agitation and progress in this area is a welcome advance.”

      “Agitation places a heavy burden on patients with Alzheimer’s disease and their caregivers,” said Marc Agronin, M.D., Vice President of Behavioral Health and Clinical Research at Miami Jewish Health, and Affiliate Associate Professor of Psychiatry and Neurology at University of Miami Miller School of Medicine. “Unfortunately there is currently no FDA-approved medication for this condition. The mechanisms of action of AXS-05 may hold promise in treating Alzheimer’s agitation. We look forward to learning more about AXS-05 and its potential to relieve the symptoms of agitation through the ADVANCE-1 trial.”

      “The initiation of the ADVANCE-1 trial reflects Axsome’s continued commitment to developing treatments for serious CNS disorders for which there are limited treatment options,” said Herriot Tabuteau, M.D., Chief Executive Officer of Axsome. “The unique pharmacology of AXS-05 lends itself to the potential treatment of a variety of CNS disorders. With the STRIDE-1 trial in treatment resistant depression also underway, AXS-05 is now being evaluated in late-stage clinical trials in two separate CNS indications.”

      About the ADVANCE-1 Study

      ADVANCE-1 (Addressing Dementia Via Agitation-Centered Evaluation 1) is a Phase 2/3 multicenter, randomized, double-blind, controlled trial to evaluate the efficacy and safety of AXS-05 in patients with agitation associated with Alzheimer’s disease. Approximately 435 patients will be randomized in a 1:1:1 ratio to receive AXS-05, bupropion, or placebo for 5 weeks. The primary efficacy measure is the Cohen-Mansfield Agitation Inventory (CMAI). This trial incorporates a planned interim analysis by an independent data monitoring committee to assess the assumptions used to determine the sample size of the trial.

      About Alzheimer’s Disease (AD) Agitation

      Alzheimer’s disease (AD) is a progressive neurodegenerative disorder that manifests initially as forgetfulness advancing to severe cognitive impairment and memory loss. It afflicts an estimated 5 million individuals in the United States, a number that is anticipated to increase to approximately 14 million by 2050. In addition to cognitive decline, individuals diagnosed with AD typically experience behavioral and psychological symptoms including agitation which is reported in approximately 45% of patients. Agitation is characterized by emotional distress, aggressive behaviors, disruptive irritability, and disinhibition. Agitation in patients with AD has been associated with increased caregiver burden, decreased functioning, earlier nursing home placement, and increased mortality. There are currently no therapies approved by the FDA for the treatment of agitation in patients with AD.

      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 utilizes Axsome’s technology of combining bupropion and dextromethorphan. Dextromethorphan is an NMDA receptor antagonist, sigma-1 receptor agonist, 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.
      https://finance.yahoo.com/news/axsome-therapeutics-initiates…" target="_blank" rel="nofollow ugc noopener">
      https://finance.yahoo.com/news/axsome-therapeutics-initiates…
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      schrieb am 12.07.17 08:44:15
      Beitrag Nr. 109 ()
      Der Kurs von AXSM hat sich in den letzten Wochen sehr positiv entwickelt.

      Die hochkarätigen Zugänge im Management wurden vom Markt positiv aufgenommen.

      Wir sind nun im Q3 d.h die Daten der COAST-1 von AXS-02 "Knee osteoarthritis (OA) with bone marrow lesions (BML)" können täglich kommen.

      Dies ist der erste Catalyst von AXSOME, weitere 2x PIII Daten folgen in nächsten 6-12 Monate.

      Ich könnte mir vorstellen, dass der Kurs spekulativ auf eine MK von gegen 200 Mio. steigen könnte, aktuell sind wir bei 135 Mio. Das wären dann Kurse über USD 8.00.
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      AXSM (Mkap $83 M) (Cash $40 M) 4 x Phase 3 Studien /erste Daten im 2H 2017