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Axsome Therapeutics

56 Posts
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  1. [verwijderd] 10 januari 2018 18:58
    Axsome Therapeutics (AXSM) got hit hard in trading Tuesday. What hurt the stock is that an independent data monitoring committee has recommended the termination of the company's Phase 3 CREATE-1 study assessing drug candidate AXS-02 in patients with complex regional pain syndrome. This is a chronic pain condition affecting a limb usually after an injury. So let's take a look at Axsome after this trial setback in today's Spotlight feature.

    Company Overview:

    Axsome Therapeutics is a New York based clinical-stage biopharmaceutical company developing novel therapies for the management of central nervous system disorders. CNS disorders are difficult to treat and are often underserved with many disorders having no approved or satisfactory treatments. Axsome’s goal is to fill this void with therapeutics that have novel mechanisms of action, novel delivery approaches, and well-characterized molecules. After today's early declines, the stock trades at around $3.60 a share and has a market capitalization of just under $100 million.



    Pipeline:

    As one can see from the chart above, the company has several 'shots on goal'. This is something I always want to see in a 'Tier 4' stock before taking a small stake in the name within a well-diversified biotech portfolio. While AXS-02 was nixed for complex regional pain syndrome; the same independent data monitoring committee gave the go ahead into Phase 3 testing for knee osteoarthritis associated with bone marrow lesions.

    The company also has two other drug candidates in late stage testing.

    AXS-05:

    AXS-05 is a novel, oral treatment that combines bupropion and dextromethorphan. Dextromethorphan is an NMDA receptor antagonist, sigma-1 receptor agonist, and inhibitor of the serotonin and norepinephrine transporters and bupropion serves to increase the bioavailability of dextromethorphan and is a norepinephrine and dopamine reuptake inhibitor, and a nicotinic acetylcholine receptor antagonist.

    The drug is designed for central nervous disorders, which primary indications include Treatment Resistant Depression {TRD} and Agitation in Patients with Alzheimer’s disease. Patients diagnosed with major depressive disorder are defined as having TRD if they have failed two or more antidepressant therapies. Its estimated that there are 3 million patients with TRD in the United States. The company has received Fast Track Designation from the FDA for both indications.

    AXS-05 is currently being investigated in two separate Phase 3 programs, the STRIDE-1 study and the ADVANCE-1 study. The STRIDE-1 study is a phase 3, multicenter, randomized, double-blind, active-controlled trial to assess the efficacy and safety of AXS-05 in Treatment Resistant Depression. In July 2017, Axsome announced enrollment of the first patient in the ADVANCE-1 study. The ADVANCE-1 study 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. Top line data from the STRIDE-1 study should be disclosed sometime in the first half of this year.

    AXS-06:

    AXS-06 is designed for the relief of the signs and symptoms of OA and Rheumatoid Arthritis, and the reduction in the risk of developing upper gastrointestinal ulcers in patients at risk of developing nonsteroidal anti-inflammatory drug associated upper gastrointestinal ulcers.

    In July 2017, Axsome Therapeutics announced positive topline clinical trial results from a Phase 1 pharmacokinetic study of AXS-06. Furthermore, in the same month, Axsome received, from the FDA, Pre-Investigational New Drug Application written guidance on a proposed clinical developmental program for AXS-06 for the relief of the signs and symptoms of OA and RA, and the reduction in the risk of developing upper gastrointestinal ulcers in patients at risk of developing NSAID associated upper gastrointestinal ulcers. Phase 3 testing should commence at some point in the foreseeable future.

    Analyst Commentary & Balance Sheet:

    The company ended the first half of the year with just under $40 million in cash on the balance sheet. Axsome ended the third quarter with just over $30 million in cash on the balance sheet. The company is burning between $5 to $6 million a quarter, roughly. Management has stated this cash balance should fund all operations into the first quarter of 2019.

    Axsome is a small company with limited coverage, but analysts like the company’s potential. Most price targets in 2017 were in the mid-teens all the way up to the low $20s. Cantor Fitzgerald was the last analyst firm to chime in just over a month ago when it assigned a Buy rating and $13 price target on the stock.

    Outlook:

    Obviously Tuesday's news was a disappointment for Axsome shareholders. However, the company still has multiple ‘shots on goal’, some upcoming catalysts, funding visibility as well as sparse but positive analyst support. Once I establish my desired stake in a Tier 4 name, I rarely average down as I consider them binary plays. Therefore, I am not adding to my holdings on Axsome on today's decline. However, I am not selling either as the company still has some 'arrows' in its 'quiver'.
  2. [verwijderd] 19 januari 2018 14:25
    quote:

    peebee schreef op 19 januari 2018 08:37:


    Ik ga dit bedrijf volgen...

    Heerlijk om onontdekte pareltjes in biotech-land proberen te vinden...

    Een vaak voorkomend "probleem" bij upcoming biotech bedrijven is dat er dikwijls gesponsord dient te worden omdat er nog geen/weinig omzet behaald word.


    Hier de realtime koersen.
    Ben benieuwd of het bericht over smoking cessation trial van vandaag de start omhoog wordt.
    finance.yahoo.com/quote/AXSM/communit...
  3. MVo_ 19 januari 2018 15:29
    quote:

    peebee schreef op 19 januari 2018 08:37:


    Ik ga dit bedrijf volgen...

    Heerlijk om onontdekte pareltjes in biotech-land proberen te vinden...

    Een vaak voorkomend "probleem" bij upcoming biotech bedrijven is dat er dikwijls gesponsord dient te worden omdat er nog geen/weinig omzet behaald word.


    Ik zit er een tijdje in, maar heb ook wel al wat moeten lijden helaas. Toevallig begin van dit jaar een gefailde trial gemeld, de koers klapte 25% ineen binnen een paar minuten. Nu hopelijk de downtrend gestopt, het aandeel lijkt zwaar oversold te zijn.
  4. [verwijderd] 19 januari 2018 20:46
    Axsome Therapeutics Inc (NASDAQ:AXSM) And Duke University Team Up For Phase 2 Trial Of AXS-05
    SHARE ON:FacebookTwitter

    Axsome Therapeutics Inc (NASDAQ:AXSM) announced late last year that it would be working hand in hand with Duke University In Phase 2 Trial Of AXS-05.



    The two have joined forces to carry out the investigative trials on the AXS-05 to find out whether the treatment is an effective solution for smoking cessation. The Phase 2 trial will evaluate smokers who are attempting to quit their smoking habit. The treatment is a fixed-dose compound made up of bupropion and dextromethorphan and it is administered orally. The research from the partnership will add to the preclinical investigations carried out at Duke in which dextromethorphan as one of the components demonstrated positive effects.

    Duke University is currently considered the best Nicotine research center and its research is aimed at creating solutions for smoking cessation. This is a sensitive area because smoking is currently considered the leading cause of deaths that could have been prevented. Researchers at the university have been hard at work trying to come up with treatments that make it easier for smokers to quit. Dr. James M. Davis, the Medical Director of the Duke Center for Smoking Cessation believes that AXS-05 might usher in a new category of tobacco treatments that provide more advantages over the currently existing payments.

    Axsome and Duke University will jointly carry out the Phase 2 and Phase 3 trials involving AXS-05. If the trials demonstrate good safety and efficacy levels, then it will mean that it can potentially be used to boost the treatment as a good option for smoking cessation. The evaluation of AXS-05 will involve a double-blind, randomized and controlled trial to investigate the impact of the treatment compound on smoking behavior.

    This kind of research is vital considering that the smoking cessation treatments or solutions that are currently in the market have low success with the rate of quitting below 25 percent after six months. The nicotine patch is one of the treatment options that are available in the market. Duke University and Axsome believe that their joint efforts could fast-track the development of a viable solution that can solve the tobacco addiction problem.
  5. adri67 22 januari 2018 17:43
    AXSM= Market Cap $75 M / $41 Million or untill end 2019 / 6x Phase 3 Programs in different Indications . Shares Outstanding 25.4 Million more than 16 Millione of these shares held by Insiders and Institutions alone Ceo is largest shareholder with over 7.3 million Shares . Very experienced Management who brought many Products to market . AXSM is definitely one of the most attractive and massive undervalued Biotech you can get at this time .Dont let trolls mislead you always do your own dd thanks and good luck to all . More infos below


    Latest Presentation :
    media.corporate-ir.net/media_files/IR...


    Mega Pipeline of 6 Phase 3 Programs :

    AXS-02 COAST-1 Knee Osteoarthritis Associated with Bone Marrow Lesions in Phase 3 (SPA & Fast Track) ---7M patients in the U.S.


    AXS-02 Chronic Low Back Pain Associated with Modic Changes in Phase 3 ---1.6M patients in the U.S.


    AXS-05 Agitation in patients with Alzheimer’s disease(AD) in Phase 2/3 ---No approved medication = unmet medical need. 2M patients in the U.S.


    AXS-05 STRIDE-1 Treatment resistant depression in Phase 3 ---Only 1 approved drug for TRD = unmet medical need. 3M patients in the U.S.


    AXS-06(MoSEIC™ Mx + Eso) Acute and Chronic Pain Phase 3 Ready = 120M NSAID TRx per year in the U.S.


    AXS-07 (meloxicam and rizatriptan) for the Treatment of Migraine Phase 3 Ready = Migraine attacks are disabling and affect more than 37 million Americans


    MAJOR SHAREHOLDERS :

    Herriott Tabuteau, MD 7 351 729 31,1%
    Fidelity Management & Research Co. 1 516 212 6,42%
    JPMorgan Asset Management (UK) Ltd. 1 432 456 6,07%
    Sabby Capital LLC 1 408 000 5,96%
    Laurence W. Lytton 1 300 692 5,51%
    Royce & Associates LP 881 000 3,73%
    Mark Coleman, MD 647 998 2,75%
    Sphera Funds Management Ltd. 501 000 2,12%
    The Vanguard Group, Inc. 418 022 1,77%
    Stifel Trust Co., NA 415 279 1,76%

    thx to Bernstein
  6. [verwijderd] 22 januari 2018 17:57
    +5% Het gaat nu weer mooi worden:

    Van het US forum:
    AXSM= Market Cap $75 M / $41 Million or untill end 2019 / 6x Phase 3 Programs in different Indications . Shares Outstanding 25.4 Million more than 16 Millione of these shares held by Insiders and Institutions alone Ceo is largest shareholder with over 7.3 million Shares . Very experienced Management who brought many Products to market . AXSM is definitely one of the most attractive and massive undervalued Biotech you can get at this time .Dont let trolls mislead you always do your own dd thanks and good luck to all . More infos below


    Latest Presentation :
    media.corporate-ir.net/media_files/IR...


    Mega Pipeline of 6 Phase 3 Programs :

    AXS-02 COAST-1 Knee Osteoarthritis Associated with Bone Marrow Lesions in Phase 3 (SPA & Fast Track) ---7M patients in the U.S.


    AXS-02 Chronic Low Back Pain Associated with Modic Changes in Phase 3 ---1.6M patients in the U.S.


    AXS-05 Agitation in patients with Alzheimer’s disease(AD) in Phase 2/3 ---No approved medication = unmet medical need. 2M patients in the U.S.


    AXS-05 STRIDE-1 Treatment resistant depression in Phase 3 ---Only 1 approved drug for TRD = unmet medical need. 3M patients in the U.S.


    AXS-06(MoSEIC™ Mx + Eso) Acute and Chronic Pain Phase 3 Ready = 120M NSAID TRx per year in the U.S.


    AXS-07 (meloxicam and rizatriptan) for the Treatment of Migraine Phase 3 Ready = Migraine attacks are disabling and affect more than 37 million Americans


    MAJOR SHAREHOLDERS :

    Herriott Tabuteau, MD 7 351 729 31,1%
    Fidelity Management & Research Co. 1 516 212 6,42%
    JPMorgan Asset Management (UK) Ltd. 1 432 456 6,07%
    Sabby Capital LLC 1 408 000 5,96%
    Laurence W. Lytton 1 300 692 5,51%
    Royce & Associates LP 881 000 3,73%
    Mark Coleman, MD 647 998 2,75%
    Sphera Funds Management Ltd. 501 000 2,12%
    The Vanguard Group, Inc. 418 022 1,77%
    Stifel Trust Co., NA 415 279 1,76%
  7. [verwijderd] 22 januari 2018 17:59
    quote:

    adri67 schreef op 22 januari 2018 17:43:


    AXSM= Market Cap $75 M / $41 Million or untill end 2019 / 6x Phase 3 Programs in different Indications . Shares Outstanding 25.4 Million more than 16 Millione of these shares held by Insiders and Institutions alone Ceo is largest shareholder with over 7.3 million Shares . Very experienced Management who brought many Products to market . AXSM is definitely one of the most attractive and massive undervalued Biotech you can get at this time .Dont let trolls mislead you always do your own dd thanks and good luck to all . More infos below


    Latest Presentation :
    media.corporate-ir.net/media_files/IR...


    Mega Pipeline of 6 Phase 3 Programs :

    AXS-02 COAST-1 Knee Osteoarthritis Associated with Bone Marrow Lesions in Phase 3 (SPA & Fast Track) ---7M patients in the U.S.


    AXS-02 Chronic Low Back Pain Associated with Modic Changes in Phase 3 ---1.6M patients in the U.S.


    AXS-05 Agitation in patients with Alzheimer’s disease(AD) in Phase 2/3 ---No approved medication = unmet medical need. 2M patients in the U.S.


    AXS-05 STRIDE-1 Treatment resistant depression in Phase 3 ---Only 1 approved drug for TRD = unmet medical need. 3M patients in the U.S.


    AXS-06(MoSEIC™ Mx + Eso) Acute and Chronic Pain Phase 3 Ready = 120M NSAID TRx per year in the U.S.


    AXS-07 (meloxicam and rizatriptan) for the Treatment of Migraine Phase 3 Ready = Migraine attacks are disabling and affect more than 37 million Americans


    MAJOR SHAREHOLDERS :

    Herriott Tabuteau, MD 7 351 729 31,1%
    Fidelity Management & Research Co. 1 516 212 6,42%
    JPMorgan Asset Management (UK) Ltd. 1 432 456 6,07%
    Sabby Capital LLC 1 408 000 5,96%
    Laurence W. Lytton 1 300 692 5,51%
    Royce & Associates LP 881 000 3,73%
    Mark Coleman, MD 647 998 2,75%
    Sphera Funds Management Ltd. 501 000 2,12%
    The Vanguard Group, Inc. 418 022 1,77%
    Stifel Trust Co., NA 415 279 1,76%

    thx to Bernstein



    Lol, 2 zielen 1 feestje ;-)
  8. adri67 30 januari 2018 20:47
    Van het US forum:

    AXS-02 COAST-1 Knee Osteoarthritis Associated with Bone Marrow Lesions in Phase 3 (SPA & Fast Track) ---7M patients in the U.S.

    It's not a pain killer per se. It's using biphosphonate which strengthens bone for treatment of osteoarthritis. Based on studies with animal models, it slows the PROGRESSION of osteoarthritis. Currently, only treatment available for osteoarthritis is controlling the pain, but does nothing to stop the progression of disease. Steroid injections also controls the pain by decreasing the inflammation. Knee replacement is the only curative treatment for osteoarthritis. This drug, if approved, will halt the progression of osteoarthritis. This drug will offer a new treatment modality.

    I am getting tired of people overlooking AXS-02 as "just a pain killer" that did not work for CRPS. CRPS is a neurological disease (based on what we understand so far), and giving DZT (biphosphonate) would do nothing for treating it, even in theory. I was surprised this even made it to phase 3. The real value of DZT is in COAST-1 trial (knee osteoarthritis), which was given green light after the interim analysis. In animal models, biphosphonates have shown to slow the PROGRESSION of arthritis. If AXS-02 passes phase 3, this will offer a new way of treating osteoarthritis. Currently, all drugs can only treat the pain, and make you more functional by decreasing the pain. They do nothing to slow the progression of the decease. AXS-2 will slow the disease progression. It will offer a new treatment modality, and it could be huge.
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