[Frankestin]

https://www.symbravo.com/
https://www.symbravohcp.com/

[Frankestin]

The RTF for AXS-14 was not unexpected — fibromyalgia has always been a tougher regulatory path. What really matters now are the more promising opportunities ahead: the potential NDA acceptance for Alzheimer's-related agitation and the commercial launch of Sunbravo expected this June. Momentum is building where it counts.
if it drops I'll add

[Frankestin]

The RTF for AXS-14 was not unexpected — fibromyalgia has always been a tougher regulatory path. What really matters now are the more promising opportunities ahead: the potential NDA acceptance for Alzheimer's-related agitation and the commercial launch of Sunbravo expected this June. Momentum is building where it counts.
if it drops I'll add

[Frankestin]

[Paullee]

Wm Blair out with a new target 198 after presentation today


Valuation. We rate shares of Axsome Outperform, based on net present value assumptions for Auvelity (AXS-05) in depression, AD-A, and smoking cessation; Sunosi in excessive daytime sleepiness; AXS-07 in migraine; and AXS-12 in narcolepsy. We view Auvelity as a best-in-class dextromethorphan-based therapy considering that it is anchored to an active stabilizing agent in bupropion, an approved antidepressant marketed as Wellbutrin. In our opinion, the mechanism of Auvelity is de-risked but is significantly differentiated from pipeline products in the neurology space, and we view the therapy as uniquely positioned to compete against atypical antipsychotics in the depression markets. AXS-05 has also demonstrated a sound risk/benefit profile in AD-A, in our view, ahead of a near-term regulatory submission. For Symbravo, we see an effective combination therapy for treatment-refractory migraineurs, with the MOMENTUM dataset demonstrating superiority over rizatriptan alone. Our sum-of-the-parts fair value for Axsome is $197.85 per share.

[Frankestin]

Blackstone purchased $15 million of Axsome common stock at the 30-day volume weighted average price per share equal to $107.14. + 3.524.411

[Frankestin]

total net product revenues reaching $121.5 million, a 62% increase compared to $75.0 million during the same period in 2024.
BUT
The company reported a net loss of $59.4 million for the first quarter of 2025, compared to a net loss of $68.4 million during the same period in 2024. Axsome Therapeutics highlighted that the loss includes $26.2 million in non-cash charges, with stock-based compensation expense accounting for $23.3 million.

Significant business updates include the approval of SYMBRAVO for the acute treatment of migraine, with a commercial launch scheduled for June 2025.

The company submitted a New Drug Application (NDA) for AXS-14 for managing fibromyalgia and is on track for a supplemental NDA submission for AXS-05 in Alzheimer's disease agitation in the third quarter of 2025.

[Frankestin]

[Frankestin]

just added!💪

[Frankestin]

Their drugs are manufactured through contract manufacturers. For example, in 2022, the company reported that the FDA might delay an inspection of a contract manufacturing facility in the United States for their migraine drug... All made in USA

[chainma1l]

Yes.

[Paullee]

Do you know where their drugs are manufactured ?

[Frankestin]

If it drops a bit more I'll add! They'll be launching Symbravo soon... Aside from the delay in the AXS-14 NDA. AXS-05 sales can only increase until everyone has kissed Trump's ass... and let's hope they hurry! Nothing is imported or exported here!

[Frankestin]

[Frankestin]

[Frankestin]

[Frankestin]

It's almost the end of March, something should be coming out soon on AXS - 14 or am I wrong again?

[someconcerns]

Mizuho Securities Adjusts Axsome Therapeutics Price Target to $216 From $212, Maintains Outperform Rating

[Paullee]

No, it means it is more effective for tougher cases

[chainma1l]

From a functional drug perspective, that's good news. Simply taking more doesn't make a difference. I'm guessing "the market" sees it as "well, they can't sell the higher dose for more money". That part makes no sense. Price the 150mg dose at whatever the theoretical price would have been for the 300mg dose.

[Paullee]

It seems the market didn't like the results of the 300 dose

[Frankestin]

The drug helps with focus, but today the market chose not to pay attention.
The market seems distracted by AXS-14’s silence.

[someconcerns]

Axsome Therapeutics Announces FOCUS Phase 3 Trial of Solriamfetol in Adults with Attention Deficit Hyperactivity Disorder (ADHD) Achieves Primary Endpoint

GlobeNewswire - 7:00 AM ET 3/25/2025 Investment News

Email Facebook. Twitter. LinkedIn. Print

Demonstrated substantial and statistically significant improvement in ADHD symptoms as measured by the AISRS total score compared to placebo (p=0.039, primary endpoint, 150 mg solriamfetol)

Statistically significant reduction in overall ADHD disease severity as measured by the CGI-S score compared to placebo (p=0.017, key secondary endpoint, 150 mg solriamfetol)

Statistically significant rate of clinical response on the AISRS compared to placebo (p=0.024, 150 mg solriamfetol)

Onset of action as early as Week 1 compared to placebo (p=0.036, AISRS, 150 mg solriamfetol)

Well tolerated with safety profile generally consistent with prior solriamfetol trials

NEW YORK, March 25, 2025 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. ( AXSM ) , a biopharmaceutical company leading a new era in the treatment of central nervous system (CNS) disorders, today announced that the FOCUS Phase 3 trial of solriamfetol in the treatment of attention deficit hyperactivity disorder (ADHD) achieved its primary and key secondary endpoints demonstrating statistically significant improvements in ADHD symptoms and disease severity with solriamfetol compared to placebo. The FOCUS study was a randomized, double-blind, placebo-controlled, multicenter, U.S. trial, in which 516 adults with ADHD were randomized to receive solriamfetol 150 mg, solriamfetol 300 mg, or placebo, once daily, for 6 weeks.

The study achieved the primary endpoint by demonstrating a statistically significant reduction in the Adult ADHD Investigator Symptom Rating Scale (AISRS) total score compared to placebo at Week 6, with mean reductions from baseline of 17.7 points for solriamfetol 150 mg and 14.3 points for placebo (p=0.039). Overall, the improvement with solriamfetol at Week 6 represents a 45% mean reduction from baseline in ADHD symptoms. Improvements in the AISRS total score were greater with solriamfetol compared to placebo starting at Week 1 (p=0.036). Clinical response, defined as ≥30% improvement from baseline in the AISRS total score, was achieved by a statistically significantly greater percentage of patients treated with solriamfetol 150 mg (53.5%) compared to those treated with placebo (41.3%) at Week 6 (p=0.024).

The study also achieved the key secondary endpoint by statistically significantly reducing overall ADHD disease severity compared to placebo, as assessed by the Clinical Global Impression of Severity (CGI-S) for ADHD, at Week 6 (p=0.017). Results on the primary and key secondary endpoints for the exploratory 300 mg solriamfetol dose were numerically superior compared to placebo but were not statistically significant.

Gregory Mattingly, M.D., Associate Clinical Professor of Psychiatry at the Washington University School of Medicine and President of the American Professional Society for ADHD and Related Disorders, commented, “ADHD substantially impairs social, academic, and occupational functioning, while negatively impacting patient quality of life and increasing the risk of morbidity and mortality. The results of the FOCUS trial demonstrate that solriamfetol was able to reduce mean ADHD symptom burden by nearly fifty percent, which contributed to significant reductions in disease severity. These results are especially promising as part of a comprehensive wellness plan for individuals with ADHD. The symptom improvements observed with solriamfetol were accompanied by a favorable safety and tolerability profile. Based on these compelling data, solriamfetol has the potential to be an important new treatment option for adult patients living with ADHD.”

Herriot Tabuteau, MD, Chief Executive Officer of Axsome, said, “We are pleased with the positive results of the FOCUS trial which provide the first evidence from a multicenter controlled trial of the efficacy of solriamfetol in the treatment of ADHD. ADHD is a serious, heterogenous, and prevalent condition. We look forward to advancing the development of solriamfetol as a new, differentiated potential treatment for the millions of patients living ADHD. With these results in the adult population in hand, we plan to initiate a trial in pediatric patients this year.”

Solriamfetol was safe and well tolerated in the trial, with a side effect profile that was consistent with the established safety profile of solriamfetol. Rates of adverse events were dose dependent. There were no serious adverse events reported in the trial.

About the FOCUS Trial

FOCUS (Forward Treatment of Attention Deficit and Hyperactivity Using Solriamfetol) was a Phase 3, randomized, double-blind, placebo-controlled, multicenter, 6-week, parallel group trial to evaluate the efficacy and safety of solriamfetol in adults with ADHD in the United States. A total of 516 adult patients with a primary diagnosis of ADHD were randomized 1:1:1 to treatment with solriamfetol 150 mg, solriamfetol 300 mg, or placebo, once daily for 6 weeks. The primary endpoint was the change from baseline in the Adult ADHD Investigator Symptom Rating Scale (AISRS) total score at Week 6. Total scores on the AISRS range from 0 to 54, with 0 corresponding to total absence of symptoms and higher scores corresponding to greater symptom severity. Mean baseline AISRS total scores for the solriamfetol 150 mg, solriamfetol 300 mg, and placebo groups were 39.1, 38.3, and 37.9 respectively. The key secondary endpoint was the change from baseline in the Clinical Global Impression of Severity (CGI-S) for ADHD at Week 6.

About Attention Deficit Hyperactivity Disorder

Attention deficit hyperactivity disorder (ADHD) is a chronic neurobiological and developmental disorder characterized by a persistent pattern of inattention, hyperactivity, or impulsivity, that interferes with functioning or development.1 Impairments in cognition are apparent in attention, planning and problem solving, working memory, and behavioral inhibition.2,3 An estimated 15.5 million adults and 7 million children in the U.S. are affected by ADHD,4,5 with approximately two-thirds or more of children with ADHD continuing to experience symptoms into adulthood.6 The total annual societal excess cost associated with adult ADHD in the U.S. has been estimated at over $120 billion.7

[georgejjl]

Expect millions of AXSM shares to be purchased today!!!

Good luck and GOD bless,

[chainma1l]

Good find. Assuming "Axsome Malta Ltd" is related to AXSM. Cataplexy and conjunction with other bio certainly sounds like it. HT's name not on it, which is not a bad thing.
For the size of the jump, I can't think of any other catalyst that would cause it other than institutions finally thinking this may be the cheapest it gets.
Offering prior to forward split? I realize they said they are good on cash until they are cash flow positive, but it may be necessary or simply prudent to raise a billion dollars off of 10 million shares or preferably 5 million at $200. I think a split prior to them becoming cashflow positive is unlikely, but we'll see.

[georgejjl]

The AXSM earning’s call

https://finance.yahoo.com/news/axsome-therapeutics-inc-axsm-q4-070314761.html

Good luck and GOD bless,

[georgejjl]

Axsome Therapeutics, Inc. (AXSM): the Best Performing Healthcare Stock So Far in 2025

https://finance.yahoo.com/news/axsome-therapeutics-inc-axsm-best-194803676.html

Good luck and GOD bless,

[Frankestin]

it's finally going up! it can't be this:

[georgejjl]

Listen to the Axsome Fourth Quarter 2024 Financial Results and webcast

https://event.choruscall.com/mediaframe/webcast.html?webcastid=R5kRW9qc

Good luck and GOD bless,

[georgejjl]

New AXSM Corporate Presentation

https://axsometherapeuticsinc.gcs-web.com/static-files/c585f159-fd40-44e3-8e01-137afc2cab0c

Good luck and GOD bless,

[Frankestin]

Anticipated Milestones
Regulatory and Commercial:
* AXS-14 for fibromyalgia, NDA submission (1Q 2025)
* AXS-05 for Alzheimer’s disease agitation, NDA submission (2H 2025)
* AXS-12 for narcolepsy, NDA submission (2H 2025)
Clinical Trial Topline Results:
* Phase 3 EMERGE trial of AXS-07 in migraine in patients with inadequate response to oral CGRP inhibitors (1Q 2025)
* Phase 3 FOCUS trial of solriamfetol in ADHD in adults (1Q 2025)
* Phase 3 PARADIGM trial of solriamfetol in major depressive disorder (1Q 2025)
* Phase 3 ENGAGE trial of solriamfetol in binge eating disorder (2026)
* Phase 3 SUSTAIN trial of solriamfetol in shift work disorder (2026)
Clinical Trial Initiations and Progress:
* Pivotal Phase 2/3 trial of AXS-05 in smoking cessation, initiation (2025)

[georgejjl]

AXSM expect NEWS TOMORROW!!!

Good luck and GOD bless,

[georgejjl]

Axsome Therapeutics will report its financial results for the fourth quarter and full year of 2024 on Tuesday, February 18, 2025, before the opening of the U.S. financial markets. Axsome management will then host a conference call at 8:00 a.m. Eastern Time to discuss these results and provide a business update.

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

Good luck and GOD bless,

[georgejjl]

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,

[georgejjl]

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

Good luck and GOD bless

[georgejjl]

"...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.

Good luck and GOD bless,

[gail]

still going up, wow!

[georgejjl]

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,

[georgejjl]

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,

[chainma1l]

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.

[Frankestin]

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

[Frankestin]

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

[Frankestin]

"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/

[Frankestin]

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

[Frankestin]

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/

[Paullee]

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

[chainma1l]

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.

[Frankestin]

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.

[Frankestin]

AXS-07 🤪😁😁🤩🤩🤪

[Frankestin]

🔥 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