Axsome Therapeutics Inc (AXSM)

[Frankestin]

AXS-05, met the primary and key secondary goals of a late-stage study testing it in Alzheimer’s disease patients

[chainma1l]

Pipeline is long with a lot of things moving simultaneously. I wonder if the market will recognize that before AXSM is bought out.

https://finance.yahoo.com/news/axsome-therapeutics-reports-third-quarter-120000040.html

[chainma1l]

Wow. Gross numbers--relative--are impressive. The image in the report is not great, but is legible enough. It'll be interesting to see the next few weeks.
I think $76 will be laughable shortly. Mizuho is probably going to revise that number soon.

[chainma1l]

Didn't even close 10 bucks higher. Must not be a good stock.

[chainma1l]

https://www.fool.com/investing/2022/11/03/why-axsome-therapeutics-stock-is-soaring-today/

Definitively vague/speculatory.

[chainma1l]

Let the speculation begin.
I'm sure there were shorts from $120, maybe a few decided that $57 was a better exit than $30?
Early acknowledgement of Auvelity possibly being "blockbuster"?
05's multiple indications starting to hit home?
07's multiple indications?
12?
14?
Buyout offers starting to look legitimate?
Leaks?
Could be any/all of the above.
I honestly don't think $10 billion is a fair buyout offer at this stage and I'm hoping the board would work for shareholders, but that doesn't always seem to be the case.
$20 billion today or $50 billion a year from now. At a glance that sounds completely ridiculous, but I think it's not out of the question.

[Frankestin]

Very well!
someone covers up?

[georgejjl]

85 million U.S. adults living with elevated depressive symptoms Mar-Apr 2021

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

Good luck and GOD bless,

[georgejjl]

Auvelity pricing is out

Prices as low as $539.81 for 30 tablets with coupon from GoodRx

https://www.goodrx.com/auvelity

Patients need to take 60 tablets per month at a cost of $1079.62 per month.

Good luck and GOD bless,

[georgejjl]

AXSM is looking very good TODAY!!!

Good luck and GOD bless,

[rosemountbomber]

Possibly.

[georgejjl]

GREAT NEWS on the way NEXT WEEK for TSLA, AXSM and AVXL.

Good luck and GOD bless,

[georgejjl]

Over $7 million of AXSM stock bought (traded) at about 10:02 AM EDT TODAY.

Good luck and GOD bless,

[georgejjl]

TODAY's WEBCAST was EXCELLENT!!!

Everything is right on schedule!!!

Listen when you get time!!!

https://axsometherapeuticsinc.gcs-web.com/webcasts-and-presentations

Good luck and GOD bless,

[georgejjl]

A MUST READ

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 Herriot Tabuteau, MD, Axsome’s Chief Executive Officer, will participate in a fireside chat at the Morgan Stanley 20th Annual Global Healthcare Conference on Monday, September 12, 2022 at 11:40 AM Eastern Time. The conference will be held at the Sheraton Times Square in New York, NY.

A live webcast and archive of the event can be viewed on the “Webcasts & Presentations” page of the “Investors” section of the Company’s website

https://axsometherapeuticsinc.gcs-web.com/news-releases/news-release-details/axsome-therapeutics-present-morgan-stanley-20th-annual-global

Good luck and GOD bless,

[georgejjl]

Expect the AXSM stock price to go up tomorrow Friday 9 September 2022 and possibly exceed $100.00 per share before the end of September 2022.

Good luck and GOD bless,

[georgejjl]

On September 8, 2022, Axsome Therapeutics, Inc. (the “Company”) issued a press release announcing the enrollment of the first patient in the Company’s ADVANCE-2 (Addressing Dementia via Agitation-Centered Evaluation-2) Phase 3 trial of AXS-05 for the treatment of agitation associated with Alzheimer's disease.

https://www.sec.gov/ix?doc=/Archives/edgar/data/0001579428/000095017022018238/axsm-20220908.htm

Good luck and GOD bless,

[georgejjl]

I bought several hundred more shares of AXSM yesterday!!!

Good luck and GOD bless,

[georgejjl]

Buy AXSM stock BEFORE MONDAY 12 Sept. 2022

Expect pricing for Auvelity SOON!!!

Good luck and GOD bless,

[Frankestin]

AXS-07 reminds me of SPPI and the problems they had with Rolontis (eflapegrastim)!
Same problem but in South Korea.
Tomorrow, after a year, we will know the verdict for SPPI

[georgejjl]

Enrollment now complete. Trial completion by or before CHRISTmas 2022.

Unique Protocol ID: AXS-05-AD-302
Brief Title: Assessing Clinical Outcomes in Alzheimer's Disease Agitation (ACCORD)
Official Title: A Double-blind, Placebo-controlled, Randomized Withdrawal Trial to Assess the Efficacy and Safety of AXS-05 for the Treatment of Agitation in Subjects With Dementia of the Alzheimer's

https://clinicaltrials.gov/ct2/show/NCT04797715

Good luck and GOD bless,

[georgejjl]

Axsome Therapeutics Initiates EMERGE Phase 3 Open-Label Trial of AXS-07 for the Acute Treatment of Migraine in Adults with a Prior Inadequate Response to an Oral CGRP Inhibitor

Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company developing and delivering novel therapies for the management of central nervous system (CNS) disorders, announced that it has enrolled the first patient in the EMERGE trial of AXS-07 for the acute treatment of migraine.

EMERGE (Evaluating Outcomes of AXS-07 after Acute Gepant Failures) is a Phase 3, open-label, multicenter trial to assess the efficacy and safety of AXS-07 in the acute treatment of migraine in patients with a prior inadequate response to an oral Calcitonin Gene-Related Peptide (CGRP) inhibitor. Approximately 100 patients experiencing migraine attacks will be treated with AXS-07 for up to eight weeks, following an inadequate response to prior treatment with an oral CGRP inhibitor. The two co-primary endpoints will be pain relief and absence of the most bothersome symptom two hours after dosing. The study is being conducted to further elucidate the clinical profile of AXS-07 and is not a regulatory requirement.

About Migraine

Over 37 million Americans suffer from migraine according to the Centers for Disease Control, and it is the leading cause of disability among neurological disorders in the United States according to the American Migraine Foundation. Migraine is characterized by recurrent attacks of pulsating, often severe and disabling head pain associated with nausea, and sensitivity to light and or sound. It is estimated that migraine accounts for $78 billion in direct (e.g. doctor visits, medications) and indirect (e.g. missed work, lost productivity) costs each year in the United States. Published surveys of migraine sufferers indicate that more than 70% are not fully satisfied with their current treatment, that nearly 80% would try a new therapy, and that they desire treatments that work faster, more consistently, and result in less symptom recurrence.

About AXS-07

AXS-07 is a novel, oral, rapidly absorbed, multi-mechanistic investigational medicine for the acute treatment of migraine, consisting of MoSEIC™ meloxicam and rizatriptan. Meloxicam is a new molecular entity for migraine enabled by Axsome's MoSEIC™ (Molecular Solubility Enhanced Inclusion Complex) technology, which results in rapid absorption of meloxicam while maintaining a long plasma half-life. Meloxicam is a COX-2 preferential non-steroidal anti-inflammatory drug and rizatriptan is a 5-HT1B/1D agonist. AXS-07 is designed to provide rapid, enhances and consistent relief of migraine, with reduced symptom recurrence. AXS-07 is covered by more than 80 issued U.S. and international patents which provide protection out to 2036. AXS-07 is not approved by the FDA.

Good luck and GOD bless,

[georgejjl]

Axsome Therapeutics Inc. (AXSM) Stock: Better Than You Think

https://baxterreport.com/2022/08/29/axsome-therapeutics-inc-axsm-stock-better-than-you-think/

Good luck and GOD bless,

[georgejjl]

FDA Approves First Fact-Acting Oral Drug for Clinical Depression That Works in 1 Week

Trials show it’s fast-acting and well tolerated.

https://www.prevention.com/health/a40983448/fda-approves-first-fact-acting-oral-drug-for-clinical-depression-auvelity/

Good luck and. GOD bless,

[georgejjl]

You need to look at the chart for AXSM. There was huge buying volume and a price increase at the close of trading Friday 26 August 2022.

GOD bless,

[cfoofme]

What does a red -4% pps relate to a huge volume & pps increase at close?

[georgejjl]

Expect AXSM stock price per share and trading volume to increase just before the end of trading TODAY, 26 Aug. 2022!!!

Good luck and GOD bless,

[georgejjl]

When the US stock market drops like a rock, AXSM also goes down.

But when the US stock market recovers NEXT WEEK, AXSM shares will go back UP NEXT WEEK!!!

Good luck and GOD bless,

[georgejjl]

Why Axsome Therapeutics Stock Jumped This Week

Wall Street is optimistic about the company's newly approved depression medication.

KEY POINTS

Axsome's shares have been soaring ever since the FDA approved Auvelity for major depressive disorder.
Wall Street thinks the drug will achieve blockbuster status before the end of the decade.

What happened
Shares of the commercial-stage biotech Axsome Therapeutics (AXSM 5.45%) rose by a stately 17.2% through the first four days of trading this week, according to data from S&P Global Market Intelligence. The biotech's shares have been racing higher of late in response to the Food and Drug Administration's (FDA) approval for the major depressive disorder (MDD) drug Auvelity (formerly AXS-05) late last week.

So what
Auvelity's regulatory process took well over a year to complete. As a direct result of the prolonged regulatory review, the stock was trading at a mere fraction of the drug's commercial potential at the time of its official approval last Friday. Investors were clearly taking the FDA's lengthy review as a sign that a Complete Response Letter (a rejection) was on the way. But with an approval now in hand, Wall Street appears to be making up for lost time, evinced by Axsome's sizable uptick this week.

What's all the fuss about? Auvelity is widely expected to be a big seller as a rapid-onset option for patients with MDD. For instance, the pharma data analytics firm Globaldata came out with a note earlier this week saying that the drug ought to hit a whopping $1.3 billion in annual sales by 2029. To put this figure into the proper context, Axsome was being valued at well under $2 billion prior to Auvelity's approval.

Now what
Despite Axsome's surging share price this week, this mid-cap biotech stock could have a lot more room to run. The FDA approval still isn't priced in to the stock based on the large unmet need in MDD. Investors, in turn, might want to consider buying this growth stock soon.

https://www.fool.com/investing/2022/08/25/why-axsome-therapeutics-stock-jumped-this-week/?source=eptyholnk0000202&utm_source=yahoo-host&utm_medium=feed&utm_campaign=article

Good luck and GOD bless,

[Frankestin]

poor shorts
I see it hard, the sooner you get out the better

[georgejjl]

NEW PATENT

https://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO1&Sect2=HITOFF&d=PALL&p=1&u=%2Fnetahtml%2FPTO%2Fsrchnum.htm&r=1&f=G&l=50&s1=11,419,867.PN.&OS=PN/11,419,867&RS=PN/11,419,867

United States Patent 11,419,867
Tabuteau August 23, 2022
Bupropion as a modulator of drug activity

Abstract
Dosage forms, drug delivery systems, and methods related to sustained release of dextromethorphan or improved therapeutic effects are disclosed. Typically, bupropion or a related compound is orally administered to a human being to be treated with, or being treated with, dextromethorphan.

Inventors: Tabuteau; Herriot (New York, NY)

Good luck and GOD bless,

[Nelson2]

Put my $64 stop loss in place for the balance of my shares owned. Will increase as the PPS increases
May there be many more increases!

GLTA!

[Frankestin]

Matt Kaplan -- Ladenburg Thalmann and Company -- Analyst
Hi. Good morning, and thanks for taking the questions. I just wanted to dig into AXS-07 a little bit. Where are you with respect to addressing the CMC questions detailed in the CRL? And when do you think you could resubmit the NDA?
Mark Jacobson -- Chief Operating Officer
Hey, Matt. It's Mark. So as you can imagine, the team is doing its work in the background. The CMC team is doing its work following the CRL.
And this morning, we did announce that we've requested and submitted a request for a Type A meeting with FDA. And what we plan to do is once that meeting is held, which we would expect this quarter -- we'd expect it to be held this quarter. Once it's held, then we'll be able to -- we'll be in a position to provide a clear update for our expectations around timing of the resubmission and if there are any nuances about the package or anything like that. But right now, it's status quo in terms of the last update where we think everything is addressable, and that we either have the information on hand or are able to -- in a position to provide it prior to our, or in connection with, our resubmission.
So we'll hopefully have more for you in the not-too-distant future.

[Paullee]

From Truist _target 150

We conducted a Doc call with Dr. Sanjay Mathew M.D., Vice Chair of Research and Professor of Psychiatry at Baylor College of Medicine.



High level, Dr. Mathew was enthusiastic about Auvelity based on:

Rapid onset of action within a week
Good safety with no REMS or DEA scheduling
Overall psychiatrist familiarity with bupropion (Wellbutrin) and comfort with dealing with its DDI related issues


Dr. Mathew added that, in an ideal world, where there are no payor restrictions, he would probably use Auvelity as first-line therapy in the vast majority of his MDD patients, primarily due to its rapid antidepressant effects. However, Dr. Mathew anticipates payor pushback, pending pricing of Auvelity and given cheap generics, though they may not be as effective.



While Auvelity label comes with numerous warnings, mostly related to DDI, Dr. Mathew did not see anything particularly concerning in terms of safety. He did not find anything particularly onerous that would act as a hindrance for prescribers. In fact, heviewed the lack of REMS requirement and DEA scheduling as possibly having a commercial edge against some of the other drugs in development that are likely to have DEA scheduling, at least at first, if approved



Also, while some investors have historically pointed out that AXS-05 (Auvelity) is a combination of DM and BUP, which can be compounded, Dr. Mathews mentioned that "astronomically small proportion" of psychiatrists would send patients to compounding pharmacy due to associated liabilities and availability of an FDA approved drug



We spoke with AXSM management today, who expressed commercial readiness of Auvelity, come 4Q22, based on highly differentiated drug profile. Management reiterated that Auvelity satisfied two key conditions necessary to qualify as rapid-acting antidepressant, as defined per FDA draft guidance on MDD drug products (HERE). The draft guidance defines rapid-acting antidepressant as those that demonstrate efficacy within a week with durable effects. Management reiterated that Auvelity has fullfilled both prespecified conditions in a prospective trial.



Net-net we came away incrementally positive on the commercial outlook for Auvelity and see significant upside to current share price of AXSM. Reiterate BUY

[Frankestin]

AXSOME THERAPEUTICS INC - PRO-FORMA CASH AS OF JUNE 30, 2022 OF $243 MILLION
CASH BALANCE AND AVAILABLE LOAN PROCEEDS ARE SUFFICIENT TO FUND ANTICIPATED OPERATIONS INTO 2025

[georgejjl]

Extended release formulations can be complicated especially when there are two or more active drug compounds in the capsule. The two active drug compounds (dextromethorphan/bupropion) each compound can have different extended release timeframes.

GOD bless,

[someconcerns]

sounds reasonable

[chainma1l]

Yes, but it appears it's basically an update to their previous ATM option. Went from $200m to $250m. Either way, the amount of shares isn't going to be outrageous. And that's only if they all were to be sold.

[someconcerns]

Are you referring to their filing for permission to sell up to $250 million in added shares? Showed up in my brokerage feed this morning.

[rosemountbomber]

“AUVELITY is a proprietary extended-release oral tablet containing dextromethorphan HBr (45 mg) and bupropion HCl (105 mg).”

[chainma1l]

I guess you want to strike while the iron is hot, but I expected them to wait a LITTLE longer to pick up some cash.
Hoping that the lessons from 05 help the 07 approval to move faster.

[Frankestin]

Axsome Therapeutics Inc (AXSM.O): Jefferies raises target price to $92 from $63
Axsome Therapeutics Inc (AXSM.O): SVB Securities raises target price to $75 from $50
Axsome Therapeutics Inc (AXSM.O): Truist Securities raises target price to $150 from $100

[georgejjl]

> The FDA has approved AUVELITY for the treatment of major depressive disorder (MDD) in adults
o Breakthrough Therapy Designation for MDD, and Priority Review for the NDA, from the FDA
> AUVELITY is the first and only oral NMDA receptor antagonist, and the first and only rapid-acting oral antidepressant, labeled with efficacy starting at one week, approved for MDD
> AUVELITY represents the first new oral mechanism of action approved for MDD in over 60 years
> Approval is timely for patients in need given recent sharp increase in depression prevalence:
o More than 80 million U.S. adults estimated with elevated depressive symptoms as of 2021
> Commercial launch of AUVELITY is planned for early fourth quarter
> AUVELITY is protected by a robust patent estate extending out at least to 2037-2040

[georgejjl]

AXSM Truist analyst Joon Lee raised the firm's price target on Axsome Therapeutics to $150 from $100 and keeps a Buy rating on the shares. Axsome's AXS-05, branded Auvelity, is now approved for major depressive disorder with a broad label, Lee tells investors in a research note. The label has no restrictions on prior failures, rapid onset of effect in a week and no Drug Enforcement Administration scheduling, says the analyst. Lee adds that major depressive disorder, an already large commercial opportunity, is now three-times larger due to pandemic related mental health issues. Shares of Axsome Therapeutics are up 42% to $60.33 in afternoon trading.

[georgejjl]

rosemountbomber,

Neither you or your doctor even know the price of Auvelity yet.

The ratio of dextromethorphan/bupropion is a proprietary trade secret.

GOD bless,

[rosemountbomber]

I am just wondering how many patients and docs will put their heads together and figure an alternative plan to take the two generic drugs instead hence saving a bunch of money.

I know my doc has always worked with me to find cheaper alternatives

[Rensenbrink]

thanks!

[georgejjl]

AXSM target price
$97.22
63.26% Upside
High Prediction $180.00
Average Prediction $97.22

https://www.marketbeat.com/stocks/NASDAQ/AXSM/price-target/

Good luck and GOD bless,

[georgejjl]

Sales Projections

https://seekingalpha.com/article/4354880-axsome-looks-extremely-undervalued-after-recent-share-price-decline

Good luck and GOD bless,

[georgejjl]

Current Career Opportunities at Axxome Therapeutics

https://www.axsome.com/careers/current-opportunities

Good luck and GOD bless,