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Insider Ownership 38.12%
Institutional Shares 51.92% (ex 13D/G)
https://fintel.io/sst/us/axsm
BHUAHAHAHAHHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAH
TODAY 9:00 AM EDT
Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company developing and delivering novel therapies for the management of central nervous system (CNS) disorders, today announced that it will host a virtual event on Tuesday, June 28, 2022 at 9:00 AM EDT to provide investors an update on Sunosi® (solriamfetol). Sunosi is the first and only dual-acting dopamine and norepinephrine reuptake inhibitor (DNRI) indicated to improve wakefulness in adult patients with excessive daytime sleepiness (EDS) due to narcolepsy or obstructive sleep apnea (OSA).
The event will include clinical overviews of current and potential future indications provided by invited physician experts. The Axsome senior management team will also provide an overview of Sunosi commercial activities and clinical development plans. The presenters will be available to answer questions at the end of the presentations
https://axsometherapeuticsinc.gcs-web.com/news-releases/news-release-details/axsome-therapeutics-host-sunosir-investor-update-virtual-event
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and today to pump a little more, here:
https://ih.advfn.com/stock-market/NASDAQ/axsome-therapeutics-AXSM/stock-news/88423608/axsome-therapeutics-to-host-sunosi-investor-updat
I would like to take more!
We are full of depressed people who need to be helped!
Life if you think about it is a stupid thing but if you don't think about it it can be wonderful!
took a handful at 34.77
I can't resist!
Latest Axsome Therapeutics Presentation
https://axsometherapeuticsinc.gcs-web.com/static-files/d0beb034-c48d-45c2-8ac3-bfd85f26177f
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The Axsome Therapeutics pipeline
https://www.axsome.com/axs-portfolio/pipeline
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STOCK PRICE TARGET FOR AXSM
High
$162.00
Median
$60.00
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AXSM short squeeze THIS WEEK!!!
A short squeeze is a large, short-term spike in a stock's share price that occurs when a significant number of short sellers are forced to buy shares and exit their positions all at once.
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Thank you for responding
Any guess where the PPS will go?
GLTU
SEC 8k Filing, Congratu;ations! On June 24, 2022, Axsome Therapeutics, Inc. (the “Company”) received from the U.S. Food and Drug Administration (the “FDA”) proposed labeling for the Company’s AXS-05 product candidate with respect to its New Drug Application (the “NDA”) for AXS-05 for the treatment of major depressive disorder. The Company is reviewing the proposed labeling and will reply to the FDA to secure final labeling agreement.
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Axsome Therapeutics Announces Publication of Pivotal GEMINI Phase 3 Trial of AXS-05 in Major Depressive Disorder in The Journal of Clinical Psychiatry
Even before the FDA approves AXS-05 and/or AXS-07 Axsome Therapeutics currently has 10s of millions of dollars of sales of Sunosi
Sunosi had sales of just shy of $58 million in 2021 sales,
Good luck and GOD. bless,
Axsome Therapeutics now has a large sales and marketing team in place and working increase sales.
Sunosi® (solriamfetol):
Sunosi net product sales increased by 104% to $57.9 million in 2021 and increased 71% to $14.9 million in 4Q21 compared to the same periods in 2020.
In 4Q21, U.S. prescriptions increased by 4% compared to 3Q21.
Lori Englebert -- Senior Vice President, Commercial and Business Development
Hey, Ram. Thanks for the question. So, you know, I think it's very important for sales force especially during launch periods, and, in this case, you know, for Sunosi initially viewing this as somewhat of a relaunch coming over to us. You know, they need to stay focused on their priority targets.
And so, they will be deployed to high-prescribing, high-potential, high-value prescribers in the markets, respective markets. The AXS-05 sales force will primarily focus on those targets related to AXS-05, where we believe we will have the highest potential, and the same for the Sunosi. However, we do know that there is a very high overlap between prescribers. And, you know, as appropriate, we will leverage those synergies.
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Axsome Therapeutics AXSM will be a MULTI-BILLION DOLLAR BIG PHARMACEUTICAL WITHIN THE NEXT 5 TO 10 YEARS MAYBE SOONER!!!
See slide #4 and #5
https://axsometherapeuticsinc.gcs-web.com/static-files/d0beb034-c48d-45c2-8ac3-bfd85f26177f
Good luck and GOD bless,
Auvelity: New Antidepressant for Most Severe Depression
Dextromethorphan and bupropion: A powerful drug combination that will help with depression that cannot be treated with standard antidepressants.
https://biopharma.media/auvelity-new-antidepressant-for-most-severe-depression-4068/
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This is the time to buy AXSM stock!!
Buy low sell much much higher!!!
https://www.prnewswire.com/news-releases/jazz-pharmaceuticals-completes-us-divestiture-of-sunosi-solriamfetol-to-axsome-therapeutics-301542221.html
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Jazz Pharmaceuticals Completes U.S. Divestiture of Sunosi® (solriamfetol) to Axsome Therapeutics
https://www.prnewswire.com/news-releases/jazz-pharmaceuticals-completes-us-divestiture-of-sunosi-solriamfetol-to-axsome-therapeutics-301542221.html
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Can't be in 2 places at one time. Especially if one of theos3e places is possibly discussions with FDA.
At noon TODAY, Wednesday 4 May 2022 before the FED raised interest rates some institution bought $4 million worth of AXSM. Institutions are continuing to accumulate AXSM stock.
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Ok so one in the George pumping echo chamber.
But many interested investors! Keep it going George.
Who are you telling? Not many posters left here.
See TODAY's webcast transcript including the Q & A toward the end
https://www.fool.com/earnings/call-transcripts/2022/05/02/axsome-therapeutics-axsm-q1-2022-earnings-call-tra/?source=eptyholnk0000202&utm_source=yahoo-host&utm_medium=feed&utm_campaign=article
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Seekingalpha regarding Axsome Therapeutics
https://seekingalpha.com/article/4505697-axsome-and-axs-05-special-situation
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Hope this doesn’t end like your predictions for NRXP, IPIX, & others which have lost 95% of their value.
"Axsome is poised to transform into a commercial entity potentially as early as this month, a direct result of our dedicated team's focused execution. Between pending FDA action on our NDA for AXS-05 in depression and the expected closing of our acquisition of Sunosi, Axsome is well-positioned to potentially make two important new medicines available to patients living with serious CNS disorders in the coming months," said Herriot Tabuteau, MD, Chief Executive Officer of Axsome. "With regards to AXS-07 for migraine, we look forward to engaging with the FDA to address the issues in the recent complete response letter, with the goal of an expeditious resubmission of that NDA. The rest of our rich pipeline continues to progress with an NDA filing for AXS-14 in fibromyalgia, and topline results from our Phase 3 trials of AXS-12 in narcolepsy and AXS-05 in Alzheimer's disease agitation anticipated in 2023.
Business Update
Axsome is committed to developing medicines that meaningfully improve the lives of patients living with CNS disorders. The Company is advancing a portfolio of differentiated, patent-protected, CNS product candidates with four in active clinical development.
AXS-05
AXS-05 (dextromethorphan-bupropion) is Axsome's novel, oral, investigational NMDA receptor antagonist with multimodal activity being developed for the following indications: major depressive disorder (MDD), Alzheimer's disease (AD) agitation, and smoking cessation. AXS-05 has been granted U.S. Food and Drug Administration (FDA) Breakthrough Therapy designations for MDD and for AD agitation.
Depression: Axsome's New Drug Application (NDA) for AXS-05 for the treatment of MDD was granted Priority Review and is currently under review by the FDA. The Company has received and agreed to Postmarketing Requirements/Commitments proposed by the FDA. Based on this interaction, the Company anticipates potential FDA action on the NDA in the second quarter of 2022.
Alzheimer's Disease Agitation: Axsome is conducting the ACCORD study, a Phase 3, double-blind, placebo-controlled, multicenter, randomized withdrawal trial to evaluate the efficacy and safety of AXS-05 in the treatment of Alzheimer's disease (AD) agitation. The Company is evaluating the design of the study and will provide an update following consultation with the FDA.
Smoking Cessation: Axsome plans to proceed to a pivotal Phase 2/3 trial in this indication. The Company intends to provide information on the timing of initiation of this study in 2022.
AXS-07
AXS-07 (MoSEIC™ meloxicam-rizatriptan) is Axsome's novel, oral, rapidly absorbed, multi-mechanistic, investigational medicine for the acute treatment of migraine.
Migraine: Axsome received a Complete Response Letter (CRL) from the FDA regarding its NDA for AXS-07 for the acute treatment of migraine. The CRL did not identify or raise any concerns about the clinical efficacy or safety data in the NDA and the FDA did not request any new clinical trials to support the approval of AXS-07. The principal reasons given in the CRL relate to chemistry, manufacturing, and controls (CMC) considerations. The Company believes that the issues raised in the CRL are addressable, and intends to provide potential timing for a resubmission following consultation with the FDA.
AXS-12
AXS-12 (reboxetine) is Axsome's novel, oral, potent, and highly selective norepinephrine reuptake inhibitor for the treatment of narcolepsy. AXS-12 has been granted FDA Orphan Drug designation for the treatment of narcolepsy.
Narcolepsy: Axsome is conducting the SYMPHONY study, a Phase 3 randomized, multicenter, double-blind, placebo-controlled, parallel-group trial of AXS-12 in the treatment of narcolepsy. Enrollment in the trial is progressing and topline results are anticipated in the first half of 2023.
AXS-14
AXS-14 (esreboxetine) is Axsome's novel, oral, potent, and highly selective norepinephrine reuptake inhibitor for the management of fibromyalgia. Esreboxetine, the SS-enantiomer of reboxetine, is more potent and selective than racemic reboxetine.
Fibromyalgia: Manufacturing and other activities related to the planned submission of an NDA for AXS-14 for the management of fibromyalgia are ongoing. The Company expects to submit the NDA in 2023. AXS-14 has previously met the primary endpoints and demonstrated positive and statistically significant results in a Phase 3 and in a Phase 2 trial for the management of fibromyalgia.
Corporate
In March 2022, Axsome announced that the Company entered into a definitive agreement to acquire Sunosi® (solriamfetol) from Jazz Pharmaceuticals (NASDAQ: JAZZ). Sunosi is a dual-acting dopamine and norepinephrine reuptake inhibitor (DNRI) indicated to improve wakefulness in adult patients with excessive daytime sleepiness (EDS) due to narcolepsy or obstructive sleep apnea (OSA). Sunosi net sales were $57.9 million in 2021, representing year-over-year growth of 104%.
The waiting period applicable to the acquisition under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 has expired. The transaction is structured to be completed in sequential closings for the U.S. and ex-U.S. territories. The Company expects the U.S. transaction to close in the second quarter of 2022, and the ex-U.S. transaction to close within 60 days following the U.S. transaction close.
Commercial and Launch-Readiness Activities
Axsome is prepared for a commercial launch of AXS-05 for the treatment of MDD, if approved, and is ready to assume commercialization of Sunosi upon closing of that acquisition:
The AXS-05 field force team build is complete with all signed offers contingent upon approval. The Company anticipates having all field representatives for the product candidate on-board by launch.
Activities are underway to ensure a timely and seamless transition of Sunosi into the Axsome infrastructure upon closing of the transaction.
Axsome's first-in-class Digital Centric Commercialization™ (DCC) platform will be used to augment commercialization of both AXS-05 and Sunosi.
https://finance.yahoo.com/news/axsome-therapeutics-reports-first-quarter-110500377.html
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No clinical efficacy or safety issues raised and no additional clinical studies required by FDA to support approval
Company plans to engage with FDA toward expeditious resolution of outstanding items
NEW YORK, May 2, 2022 /PRNewswire/ -- Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company developing novel therapies for the management of central nervous system (CNS) disorders, today announced that the Company has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding its New Drug Application (NDA) for AXS-07 for the acute treatment of migraine. The CRL did not identify or raise any concerns about the clinical efficacy or safety data in the NDA, and the FDA did not request any new clinical trials to support the approval of AXS-07.
The principal reasons given in the CRL relate to chemistry, manufacturing, and controls (CMC) considerations. The CRL identified the need for additional CMC data pertaining to the drug product and manufacturing process. Axsome believes that the issues raised in the CRL are addressable and intends to provide potential timing for a resubmission following consultation with the FDA.
"It is our goal to work with the FDA to fully understand and adequately address their comments, so that we can make this important new medicine available to patients with migraine as quickly as possible," said Herriot Tabuteau, MD, Chief Executive Officer of Axsome. "The approval of AXS-07 would offer a much-needed new multi-mechanistic treatment option for the millions of people living with this debilitating neurological condition."
The NDA is supported by results from two Phase 3 randomized, double-blind, controlled trials of AXS-07 in the acute treatment of migraine, the MOMENTUM and INTERCEPT trials, which demonstrated statistically significant elimination of migraine pain with AXS-07 compared to placebo and active controls.
https://finance.yahoo.com/news/axsome-therapeutics-receives-fda-complete-110000340.html
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Yup biggest pumper on iHub with a terrible record of making predictions.
Buyer be ware.
A MUST READ
MONDAY 2 MAY AXSOME THERAPEUTICS WILL HOST A CONFERENCE CALL AND WEBCAST AT 8:00AM EDT BEFORE THE STOCK MARKET OPENS FOR TRADING.
YOU MAY WANT TO BUY AXSM STOCK TOMORROW FRIDAY 29 APRIL 2022 BEFORE THE CLOSE OF TRADING.
BUY LOW; SELL HIGH.
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Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company developing novel therapies for the management of central nervous system (CNS) disorders, today announced that it will report its financial results for the first quarter of 2022 on Monday, May 2, 2022 before the opening of the U.S. financial markets. Axsome's management team will host a conference call at 8:00 AM Eastern Time on May 2, 2022 to discuss these results and provide a business update.
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You’re pumping this just like IPIX.
Chill out brother. What will be will be.
SVB Leerink analyst Marc Goodman expressed surprise in a note to clients that the biotech stock crashed. Investors are much more interested in Axsome's efforts in depression and Alzheimer's disease with its AXS-05 drug, he said. Last Tuesday, shares surged 25% after Axsome said it finished FDA negotiations ahead of approval for that treatment.
"The focus has been consistently on AXS-05 for depression, and the news from management on that asset has been incrementally positive given the post-marketing requirement discussions, and approval seems much more likely now in the second quarter," he said. "We look at this sell-off as a good buying opportunity."
AXS-07 is a novel, oral, rapidly absorbed, multi-mechanistic, investigational medicine. AXS-07 consists of MoSEIC™ (Molecular Solubility Enhanced Inclusion Complex) meloxicam and rizatriptan.
Interestingly both meloxicam and rizatriptan are FDA approved drugs currently on the market.
Therefore, the FDA may only have minor questions about the chemistry, manufacturing, and controls (“CMC”) issues identified during the FDA’s review of the Company’s New Drug Application (“NDA”) for its AXS-07.
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So far the NDA filing process for AXS-07 is quite similar as the NDA for AXS-05.
The CRL is a delay in approval for AXS-07 by ? months.
Good luck and GOD bless,
On April 22, 2022, Axsome Therapeutics, Inc. (the “Company”) was informed by the U.S. Food and Drug Administration (the “FDA”) that chemistry, manufacturing, and controls (“CMC”) issues identified during the FDA’s review of the Company’s New Drug Application (“NDA”) for its AXS-07 product candidate for the acute treatment of migraine are unresolved. Based upon the time remaining in the NDA review cycle, the Company expects to receive a Complete Response Letter with respect to this NDA on or about the Prescription Drug User Fee Act target action date of April 30, 2022.
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EXPECT ABSOLUTELY GREAT NEWS FROM THE FDA REGARDING AXSM THIS WEEK!!!
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$78 BILLION$
What is the commercial opportunity for AXS-07? Axsome estimates that there are more than 37 million people in the U.S. who suffer from migraines, and the annual direct and indirect costs of these in the U.S. amount to $78 billion. Further, more than 70% of people within this patient population are not fully satisfied with current treatments, and about 80% of them would try a new medicine.
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Why This Stock Could Double Your Money in 2022
https://www.fool.com/investing/2022/04/22/why-this-biotech-stock-could-double-your-money-in/?source=eptyholnk0000202&utm_source=yahoo-host&utm_medium=feed&utm_campaign=article
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A MUST READ
Read everything especially slide #5
https://axsometherapeuticsinc.gcs-web.com/static-files/d0beb034-c48d-45c2-8ac3-bfd85f26177f
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Sales for AXS-05 and AXS-07 and Sunosi are projected to be in the $BILLION$
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A MUST SEE
Axsome Therapeutics, Inc. (the “Company”) today announced that it has received and agreed to Postmarketing Requirements/Commitments proposed by the U.S. Food and Drug Administration (the “FDA”) with respect to the New Drug Application (“NDA”) for its AXS-05 product candidate for the treatment of major depressive disorder.
Based on this interaction, the Company anticipates potential FDA action on the NDA in the second quarter of 2022.
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EXPECT ABSOLUTELY GREAT NEWS BY OR BEFORE NEXT FRIDAY 29 APRIL 2022 REGARDING AXSM FROM THE FDA.
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Mechanism of action of AXS-05
https://www.axsome.com/axs-pipeline/about-axs-05
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Mechanism of action of AXS-07
https://www.axsome.com/axs-pipeline/about-axs-07
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43.04 up 5% > Another awesome day!
AXSM
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