Axsome Therapeutics Inc (AXSM) 옵션

axsome therapeutics to report fourth quarter and full year 2024 financial results on February 18, 2025

10K submitted to the US SEC.

https://axsometherapeuticsinc.gcs-web.com/news-releases/news-release-details/axsome-therapeutics-report-fourth-quarter-and-full-year-2024

Good luck and GOD bless,

AXSM stock price should go up near the close of trading today and tomorrow!!!

Good luck and GOD bless

"...Teva Pharmaceuticals is a major pharmaceutical company that produces over-the-counter (OTC) drugs. Teva is the world's largest generic drug supplier and has a wide range of products, including generics, OTC drugs, and specialty treatments. ...

https://en.wikipedia.org/wiki/Teva_Pharmaceuticals#:~:text=Teva%20Pharmaceuticals%20is%20the%20largest,to%20inflate%20prices%20for%20drugs.

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still going up, wow!

Secured patent protection for AUVELITY until at least September 2038
Resolution of all outstanding patent litigation
Protected market exclusivity for 14+ years

https://www.stocktitan.net/news/AXSM/axsome-therapeutics-announces-settlement-agreement-resolving-8uzudzwdqmke.html

Good luck and GOD bless,

That is an ABSOLUTELY GREAT DEAL WITH TEVA!!!

https://axsometherapeuticsinc.gcs-web.com/news-releases/news-release-details/axsome-therapeutics-announces-settlement-agreement-resolving

Good luck and GOD bless,

Holy shit. Yeah, great announcement, but didn't change a whole heck of a lot. I guess it really just educated a lot of people on how well-positioned AXSM is. I was expecting $120 after 07 approval. Should be at $150.

Good deal with Teva!
It would be fantastic if there were more… maybe to sell outside the US market.

https://www.marketbeat.com/instant-alerts/strategic-financial-concepts-llc-acquires-new-position-in-axsome-therapeutics-inc-nasdaqaxsm-2025-02-10/

"This outcome is better than our base case, which assumed exclusivity through 2037"- brokerage Truist Securities
https://www.tradingview.com/news/reuters.com,2025:newsml_L4N3P110M:0-axsome-therapeutics-rises-on-settlement-with-teva-for-depression-drug/

unexpected good news!
Very good!
https://www.stocktitan.net/news/AXSM/axsome-therapeutics-announces-settlement-agreement-resolving-8uzudzwdqmke.html

maybe they communicate it like this... it seems to me that there is something different compared to the November presentation... Maybe it has been presented and now we are waiting for an acceptance response?

https://www.axsome.com/axs-portfolio/pipeline/

They are doing ok with sunosi, but I think they may have gotten that for it salesforce help

I don't think HT is going to sell anytime soon, but I think it would take 25 billion to even get his attention right now. 2 years it'll be 50 billion. Somewhere in the middle next year. And one of the big ones is going to have to pony up strictly as a defensive maneuver. The acquirer will obviously get a massive portfolio, but I think the main impetus is to not lose market share. AXS-05 would make AXSM profitable just off the number of indications coming. 07 has the potential for blockbuster. Migraine sufferers are all going to want to try it. 8 other indications in late stage. I'm a little bothered that they spent the money to acquire Sunosi, but HT knows what he's doing. I think one of their other drugs may end up as an off-label weight loss drug.

EMERGE Ph 3 trial of AX-07 in CGRP non-responders (4Q 2024)
ENGAGE Ph 3 trial of solriamfetol in BED (2025)
PARADIGM Ph 3 trial of solriamfetol in MDD (1Q 2025)
FOCUS Ph 3 trial of solriamfetol in ADHD (1Q 2025)
AND
Chief Executive Officer Herriot Tabuteau indicated that the company plans to swiftly advance towards filing a New Drug Application (NDA) for AXS-12. The company intends to request a pre-NDA meeting with the U.S. Food and Drug Administration (FDA).
Axsome to File NDA Following Positive Phase 3 Results of AXS-12 in Narcolepsy
AXS-12 significantly reduced cataplexy attacks and improved excessive daytime sleepiness, cognition, and work productivity in narcolepsy patients.
The ENCORE trial showed a 77% reduction in cataplexy attacks at 6 months, with sustained improvements in concentration and narcolepsy symptoms.
AXS-12 was well-tolerated, with no new safety signals, and demonstrated a favorable long-term safety and tolerability profile.
Axsome Therapeutics plans to file a new drug application for AXS-12, supported by positive results from the ENCORE and SYMPHONY trials.
Over the 6-month treatment period, patients saw improvements in cataplexy frequency, excessive daytime sleepiness, cognition, and work productivity with AXS-12.

AXS-07 🤪😁😁🤩🤩🤪

🔥 FDA APPROVES SYMBRAVO! 🔥

Axsome Therapeutics ($AXSM) is changing the game in CNS treatments once again with another breakthrough approval! SYMBRAVO is now officially approved for the acute treatment of migraines, delivering a faster, more effective, and longer-lasting option than existing therapies.

💊 Single dose ? Pain relief in 2 hours, sustained up to 48 hours
📊 85% of patients did not need rescue medication
⚡ MoSEIC™ technology ? 5x faster absorption
🚀 Clinically superior to rizatriptan

With over 39 million migraine sufferers in the U.S. alone, Axsome is gearing up to capture a multibillion-dollar market. Commercial launch expected in ~4 months… time to load up before Wall Street catches on?
Relax, they’re keeping it low… After all, why would a company with a newly FDA-approved drug and a multibillion-dollar market go up, right? Maybe it’ll climb slowly… unless, of course, those who want in keep pretending they don’t like it.

https://axsometherapeuticsinc.gcs-web.com/news-releases/news-release-details/axsome-therapeutics-announces-fda-approval-symbravor-meloxicam

Tomorrow The News
financial results for the fourth quarter and full year of 2024 on Tuesday, February 18, 2025,
I would see something else in the middle

Truist Securities raises PT to $180 from $150 😮
The next two weeks will be eventful
AXS-07, a candidate for the acute treatment of migraines, with expectations for regulatory approval
NDA for AXS-14 for fibromyalgia... maybe yes or maybe no

And I'm not going to say AXS-05 for AA is a given/slamdunk, but since the best existing option basically says on the label "people have died from taking this medication, so be aware of that" and the medication doesn't even work as well as AXS-05, there is no LOGICAL reason the FDA should not approve it for that indication.
From RickSanders9 on StockTwits:
"There appear to be 6 PDUFA's in January.
1/2: Decision already rendered.
1/7: Decision already rendered.
1/15: ATRA
1/25: BIIB
1/30: Decision already rendered.
1/31: Axsome

FDA shockingly is ahead of schedule...could be an early call on 07."

With the CRL being about manufacturing process and Axsome having gone through the same thing with ASX-05, I don't think an early decision is far fetched.

AXS-07, with a PDUFA action goal date of January 31st, 2025.
Launch preparations are underway to ensure timely commercialization if approved.
AXS-14 for the management of fibromyalgia, we are completing preparations for the NDA submission and expect to submit the NDA to the FDA this month.
they will have presented it around the end of November so they will have an answer near another catalist...

Someone said... With respect to AXS-14 for the management of fibromyalgia, we are completing preparations for the NDA submission and expect to submit the NDA to the FDA this month.
… was he wrong?
🧐

Wells Fargo Initiates Coverage of Axsome Therapeutics (AXSM) with Overweight Recommendation

https://fintel.io/news/wells-fargo-initiates-coverage-of-axsome-therapeutics-axsm-with-overweight-recommendation-290

Good luck and GOD bless,

xsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company developing and delivering novel therapies for the management of central nervous system (CNS) disorders, today announced that the U.S. Food and Drug Administration (FDA) has acknowledged the resubmission of the Company’s New Drug Application (NDA) for AXS-07 for the acute treatment of migraine. The FDA designated the resubmission as a Class 2 resubmission and set a Prescription Drug User Fee Act (PDUFA) action goal date of January 31, 2025.

https://finance.yahoo.com/news/axsome-therapeutics-announces-fda-acceptance-110000999.html

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Cramer is the kiss of death.

AXSM stock price should be much higher after Jim Cramer said that AXSM stock price should double.

Good luck and GOD bless,

Jim Cramer Thinks Axsome Therapeutics Inc (NASDAQ:AXSM) Stock Can Double

https://finance.yahoo.com/news/jim-cramer-thinks-axsome-therapeutics-094318378.html

Good luck and GOD bless,

"I think free InvestorsHub gets you better info than $9/mo for InvestorVillage."

I think the National Enquirer gives you better info than InvestorVillage, which was always an iHub copycat but only allows favorable posts and is moderated by paid pimps.

Sadly the new iHub regime with its unfettered personal attacks and off-topic posts is not much better nowadays.

I tried to log in with my free account yesterday and the site said they were forced to go paid subscription only because of some hack/breach/problem. I think free InvestorsHub gets you better info than $9/mo for InvestorVillage.

Right now the IV site is closed because of a hack they haven't been able to solve. IF and when they come back it may or may not only be subscription. Too early to tell yet.

Anybody with an account on InvestorVillage mind posting weekly script numbers here? Too bad they went subscription only. A lot of good posters and boards over there. Maybe some will move over here.

Axsome Therapeutics Inc (AXSM.O): RBC $128 from $123

NDA resubmission for AXS-07!!!
Who knows how long it will take them to give the answer on this?
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.
🥒🥒🥒🥒🥒🥒🥒

AXS-12 statistically significantly reduced cataplexy attacks compared to placebo (p=0.018, primary endpoint)
AXS-12 achieved statistically significant remission of cataplexy compared to placebo (p=0.008)
AXS-12 statistically significantly reduced excessive daytime sleepiness (EDS) severity compared to placebo (p=0.027, CGI-S for EDS)
AXS-12 statistically significantly improved concentration and memory compared to placebo (p=0.004, Cognitive Function items of FOSQ-10)
AXS-12 statistically significantly reduced overall severity of narcolepsy compared to placebo (p=0.007, CGI-S for narcolepsy)
AXS-12 statistically significantly improved overall function and quality of life compared to placebo (p=0.005, FOSQ-10 total score)
Company to host conference call and webcast today at 8:00 AM ET

Leerink Partners Global Biopharma Conference on Wednesday, March 13, at 9:20
Too!

When does it start? 1Q is about to end 🤞
Cowen 44th Annual Healthcare Conference on Wednesday, March 6, from 9:50-10:20 a.m. Eastern Time at the Marriott Copley Place in Boston, Massachusetts.

Axsome Therapeutics Inc (AXSM.O): Piper Sandler raises price target to $115 from $113

Total 4Q and full year 2023 net product revenue of $71.5 million and $204.9 million, respectively, representing year-over-year growth of 193% and 309%
Cash and cash equivalents totaled $386.2 million at December 31, 2023, compared to $200.8 million at December 31, 2022.
Net loss for the fourth quarter of 2023 was $98.7 million or $(2.08) per share
Financial Guidance * Axsome believes that its current cash is sufficient to fund anticipated operations into cash flow positivity, based on the current operating plan.

NDA submission for AXS-14 in fibromyalgia and NDA resubmission for AXS-07 in migraine, both anticipated in 1H 2024
Topline results of the SYMPHONY Phase 3 trial in narcolepsy anticipated in 1Q 2024
Topline results of the ADVANCE-2 Phase 3 trial in Alzheimer’s disease agitation and the FOCUS Phase 3 trial in ADHD expected in 2H 2024
Initiation of Phase 3 trials of solriamfetol in major depressive disorder MDD, binge eating disorder BED, and shift work disorder SWD expected 1Q 2024

* Pivotal Phase 2/3 trial of AXS-05 for smoking cessation (2024) Conference Call Information

TIC TOC TIC TOC TIC TOC TIC TOC TIC TOC TIC TOC TIC TOC TIC
June is around the corner!
Axsome Therapeutics Inc (AXSM.O): Mizuho raises target price to $112 from $90

AXSM new 52 week high

POO PO PO PO PO POOOO POO

AXSM new 52 week high

https://www.streetinsider.com/New+Coverage/UBS+Starts+Axsome+Therapeutics+%28AXSM%29+at+Buy/22723904.html
What will the shorts do?

Shares Outstanding 47,319,547 shares
Insider Shares 15,231,463 shares
Insider Ownership 32.19 %
Total Insiders 12
Istitutional Shares (Long) 40,227,033 - 85.01% (ex 13D/G) - change of 2.82MM shares 7.55% MRQ
Short Interest 8,319,949 shares - source: NASDAQ
Short Interest Ratio 19.14 Days to Cover
Short Interest % Float 23.89 % - source: NASDAQ (short interest), Capital IQ (float)

Axsome Therapeutics, Inc. (NASDAQ:AXSM)

Latest Share Price Upside: 85%

Number of Q3 2023 Hedge Fund Investors: 31

Axsome Therapeutics, Inc. (NASDAQ:AXSM) is a biotechnology firm developing treatments for nervous system diseases and disorders. Like several other stocks on our list, the shares are also rated Strong Buy on average and analysts have set an average share price target of $115.45.

Insider Monkey scoured 910 hedge fund portfolios for this year's third quarter to find 31 stakeholders in the company. Axsome Therapeutics, Inc. (NASDAQ:AXSM)'s largest hedge fund investor is Mark Lampert's Biotechnology Value Fund / BVF Inc due to its $148 million investment.

https://finance.yahoo.com/news/11-best-upside-stocks-buy-145018690.html

Good luck and GOD bless,

AXSM price per share catalysts on the horizon or imminent

Axsome: Leading Neuroscience Portfolio

> Axsome is committed to developing novel therapies for the millions of patients living with
serious central nervous system disorders

> Axsome’s industry-leading neuroscience portfolio ? 5 commercial or late-stage product
candidates, 8 different indications:
o 2 FDA-approved, differentiated commercial products each with blockbuster potential
(AUVELITY™ for MDD, and SUNOSI® for EDS in narcolepsy and OSA)
o 1 NDA-stage product candidate (AXS-07 for migraine)
o 2 Phase 3-stage product candidates with potential NDA filings in 2023 (AXS-12 for
narcolepsy, and AXS-14 for fibromyalgia)
o 3 follow-on indications in or ready to enter Phase 3 (Alzheimer’s disease agitation, smoking
cessation for AXS-05; ADHD for solriamfetol)

See slide #7

https://axsometherapeuticsinc.gcs-web.com/static-files/c43e73fb-f3d7-4f3d-b614-d18143abe31c

Good luck and GOD bless,

Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company developing and delivering novel therapies for the management of central nervous system (CNS) disorders, today announced a presentation of data from its ACCORD Phase 3 clinical trial of AXS-05, a novel, oral NMDA receptor antagonist and sigma-1 receptor agonist, in patients with Alzheimer’s disease agitation (ADA), at the 16th Clinical Trials on Alzheimer’s Disease (CTAD) Conference, being held in Boston from Oct. 24-27.

“Agitation associated with Alzheimer's dementia is a common and impactful behavioral symptom causing significant distress for patients and their care partners,” said George Grossberg, MD, study author, Professor and Director of the Division of Geriatric Psychiatry at the Saint Louis University School of Medicine. “Agitation is also a significant risk factor for early admission to long term care facilities. The outcome of the ACCORD trial with AXS-05 demonstrating positive efficacy results in agitation associated with Alzheimer's dementia, while being generally well-tolerated, is welcome news."

Results of the trial demonstrated rapid and sustained clinical response in patients with ADA during the open-label AXS-05 treatment phase. During the placebo-controlled randomized withdrawal phase, AXS-05 statistically significantly delayed the time to relapse of agitation symptoms as compared to placebo. AXS-05 was generally well-tolerated in the trial with no new safety signals identified.

“Agitation, which is seen in up to 70% of people with Alzheimer’s disease, is among the most complex, challenging and costly aspects of care and is associated with multiple negative outcomes such as increased caregiver burden, morbidity, mortality, earlier nursing home placement, and overall functional impairment,” said Cecilia Brain, MD, PhD, Vice President of Medical Affairs at Axsome. “The detailed efficacy and safety results of the ACCORD trial support the potential of AXS-05 in this area of significant unmet medical need.”

The poster will be available for viewing in the Poster Hall from 7:30 a.m. Eastern Time on Wednesday, Oct. 25 to 4:30 p.m. Eastern Time on Friday, Oct. 27. Poster presenters will be on hand for discussion from 7:30-8:30 a.m. Eastern Time as well as during the morning and afternoon coffee breaks each day during the CTAD conference. The poster will also be available through the CTAD digital platform.

https://finance.yahoo.com/news/axsome-therapeutics-presents-results-accord-110000892.html

Good luck and GOD bless,

Per Fidelity:

BY Benzinga
— 6:18 AM ET 07/17/2023
HC Wainwright & Co. analyst Raghuram Selvaraju maintains Axsome Therapeutics NASDAQ:AXSM with a Buy and lowers the price target from $200 to $190.

New mid term topic $100.00 by or before the end of 2023.

Their target has been reached. Now what?