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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?
Morgan Stanley’s price target of $90 for AXSM suggests a potential upside of 78.83%.
https://beststocks.com/morgan-stanley-analyst-upgrades-axsome-therap/
Good luck and GOD bless,
A rising star in the biotech industry
Prosper Junior Bakiny (Axsome Therapeutics): Sporting a market cap of just $3.3 billion, Axsome Therapeutics is a relatively small and unknown drugmaker. But it would be unwise to ignore this biotech just because of its size. In fact, the market has yet to factor Axsome Therapeutics' full potential into its share price, which makes the stock a no-brainer buy right now.
Over the next year, Axsome expects two phase 3 data readouts, two late-stage study initiations, and two regulatory submissions. These catalysts could send the stock price soaring if all goes according to plan. More importantly, though, Axsome Therapeutics is building a solid portfolio that could drive top-line growth for years.
Right now, the company's lineup includes just Auvelity, a medicine for depression, and Sunosi, which targets daytime sleepiness in narcolepsy patients. Within the next five years, Axsome plans to add label expansions to Auvelity in treating Alzheimer's disease agitation and Sunosi as a treatment for attention-deficit/hyperactivity disorder (ADHD).
That's in addition to three potential new products, AXS-07, AXS-12, and AXS-14. These investigational medicines target migraine, narcolepsy, and fibromyalgia, respectively. Axsome estimates that its late-stage portfolio addresses diseases with a patient population of over 60 million people in the U.S.
The biotech is still in the early innings of its growth story, which could last long before it runs into patent cliffs for any of its lineup and pipeline products. That's why, despite significantly outperforming the market in the past 12 months, Axsome Therapeutics remains an excellent stock to buy and hold for investors.
https://www.fool.com/investing/2023/06/10/3-no-brainer-stocks-to-buy-in-june/
God luck and GOD bless,
Whatever happened to Teva applying to sell generic Auvelity?
Axsome Therapeutics Reports First Quarter 2023 Financial Results and Corporate Update
https://finance.yahoo.com/news/axsome-therapeutics-reports-first-quarter-110000640.html
Good luck and GOD bless,
TOMORROW THURSDAY 27 April 2023
Title: Efficacy of AXS-07 (MOSEIC™ Meloxicam and Rizatriptan) in Patients with Risk Factors for Inadequate Response to Acute Migraine Medications
Poster Session: P13 - Poster Session 13
Presenting Author: Stuart J. Tepper, MD, Professor of Neurology, Geisel School of Medicine at Dartmouth
Date/Time: Thursday, April 27, 2023, from 8 a.m. – 9 a.m. ET
Good luck and GOD bless,
Could Axsome Therapeutics Stock Help You Become a Millionaire?
https://finance.yahoo.com/m/388ef1a6-3490-3185-a753-e5a85b9950ec/could-axsome-therapeutics.html
Good luck and GOD bless,
Axsome Therapeutic presentation THURSDAY with corrected URL
Details for the upcoming AAN presentations are as follows:
Title: Efficacy of AXS-07 (MOSEIC™ Meloxicam and Rizatriptan) in Patients with Risk Factors for Inadequate Response to Acute Migraine Medications
Poster Session: P13 - Poster Session 13
Presenting Author: Stuart J. Tepper, MD, Professor of Neurology, Geisel School of Medicine at Dartmouth
Date/Time: Thursday, April 27, 2023, from 8 a.m. – 9 a.m. ET
https://axsometherapeuticsinc.gcs-web.com/news-releases/news-release-details/axsome-therapeutics-present-five-abstracts-including-new-data
Good luck and GOD bless,
Axsome Therapeutic presentation THURSDAY
Details for the upcoming AAN presentations are as follows:
Title: Efficacy of AXS-07 (MOSEIC™ Meloxicam and Rizatriptan) in Patients with Risk Factors for Inadequate Response to Acute Migraine Medications
Poster Session: P13 - Poster Session 13
Presenting Author: Stuart J. Tepper, MD, Professor of Neurology, Geisel School of Medicine at Dartmouth
Date/Time: Thursday, April 27, 2023, from 8 a.m. – 9 a.m. ET
axsometherapeuticsinc.gcs-w...
Good luck and GOD bless,
Axsome Therapeutic presentation TOMORROW and THURSDAY
Details for the upcoming AAN presentations are as follows:
Title: Effects of Solriamfetol on Cognitive Function in Participants with Cognitive Impairment Associated with Excessive Daytime Sleepiness in Obstructive Sleep Apnea: Results of the SHARP Study
Poster Session: P4 - Poster Session 4
Presenting Author: Eileen Leary, Ph.D., Senior Director of Clinical Development at Axsome
Date/Time: Monday, April 24, 2023, from 8 a.m. – 9 a.m. ET
Title: Preclinical Pharmacology of Solriamfetol: Potential Mechanisms for Wake Promotion
Poster Session: P4 - Poster Session 4
Presenting Author: Gregory S. Parks, Ph.D., Executive Director of Medical Affairs at Axsome
Date/Time: Monday, April 24, 2023, from 8 a.m. – 9 a.m. ET
Title: Solriamfetol Real World Experience Study: Initiation, Titration, Safety, Effectiveness, and Experience During Follow-Up for Patients with Narcolepsy from Germany
Poster Session: P4 - Poster Session 4
Presenting Author: Samantha Floam, DMD, Director of Medical Affairs at Axsome
Date/Time: Monday, April 24, 2023, from 8 a.m. – 9 a.m. ET
Title: Identifying Areas of Unmet Need Among People with Migraine with an Inadequate Response to Prior Acute Therapies: Results from the MOMENTUM trial
Poster Session: P7 - Poster Session 7
Presenting Author: Zachariah Thomas, PharmD, MPH, Executive Director of Medical Affairs at Axsome
Date/Time: Monday, April 24, 2023, from 8 a.m. – 9 a.m. ET
Title: Efficacy of AXS-07 (MOSEIC™ Meloxicam and Rizatriptan) in Patients with Risk Factors for Inadequate Response to Acute Migraine Medications
Poster Session: P13 - Poster Session 13
Presenting Author: Stuart J. Tepper, MD, Professor of Neurology, Geisel School of Medicine at Dartmouth
Date/Time: Thursday, April 27, 2023, from 8 a.m. – 9 a.m. ET
https://axsometherapeuticsinc.gcs-web.com/news-releases/news-release-details/axsome-therapeutics-present-five-abstracts-including-new-data
Good luck and GOD bless,
Resources Investment Advisors LLC. Has $624,000 Stock Holdings in Axsome Therapeutics, Inc. (NASDAQ:AXSM)
Axsome Therapeutics, Inc is a commercial-stage biopharmaceutical company, which engages in the development of novel therapies for the management of central nervous system disorders. Its portfolio consists of Products Overview and Pipeline Overview. The Products Overview includes Auvelity and Sunosi. The Pipeline Overview contain AXS-05, AXS-07, AXS-12, and AXS-14.
Axsome (AXSM) Focuses on Auvelity Launch to Fuel Its Growth
https://www.msn.com/en-us/money/topstocks/axsome-axsm-focuses-on-auvelity-launch-to-fuel-its-growth/ar-AA1aabbm
Good luck and GOD bless,
It's propaganda. Or at least designed for clicks. Pipeline is in good shape. AXS-07 will be resubmitted asap. I'd like to know how many buyout offers they have had. I think $25 billion would take it right now or in the next year or two. After that, $50 billion will be required. Poster on another board mentioned they could raise $600 million in a heartbeat by selling 10 million shares and that isn't terrible considering the low float. I agree with that.
Does the negative tone of the article concerning cash burn concern anyone? Or is it just the Fool's way of scaring people into their 10 Best Stocks to Buy?
According to a market analysis conducted two years ago by Research and Markets, well before the agency's green light, Auvelity (then known as AXS-05) could bring in $1.3 billion in sales in 2029, a significant slice of the anticipated total global market size of $7.9 billion. A more recent general market analysis by The Brainy Insights is slightly lower, putting the MDD market at $6.8 billion.
Auvelity has the potential to become a leading treatment since MDD is notoriously difficult to treat, and doctors often have to try a number of different drugs on the same patient. Citing two published professional journal articles, Axsome says Auvelity "is the first and only rapid-acting oral medicine... [with] statistically significant antidepressant efficacy compared to placebo starting at one week."
AXSM Reg-FD disclosure wrt SVB exposure:
https://www.sec.gov/Archives/edgar/data/1579428/000095017023007250/axsm-20230310.htm
Mizuho
Bullish $axsm on yesterday’s news
Our take: While the news in itself (that a P-IV for Auvelity was filed) is not a surprise, the timing of the news does, as it comes a bit sooner than we have been expecting (note: given that Auvelity was initially filed for approval under the 505() (2) pathway, we had expected that a P4 could come at any point in time.
That said, we had an opportunity to speak with AXSM management this morning, who noted: (1) the P-IV has been expected by the company, and it was only a matter of time; (2) that TEVA filed a P-IV for Auvelity implies to them that TEVA thinks Auvelity will be a significant commercial product, (3) the earliest that a generic could be approved is in 2034, at least 11 years from now, giving Auvelity a sufficient commercial runway; (4) with >100 patents listed in the FDA's Orange Book, we should expect that AXSM will continue to strengthen its Auvelity IP estate; and (5) the company is still evaluating its patent term extension (PTE) strategy for Auvelity, which could potentially add additional patent protection.
Also this morning, we also had an opportunity to speak with an IP expert, a person we frequently use on IP diligence. In his view (and ours), that TEVA is only challenging four method of use patents expiring in 2040 (and not the base '328 and '234 patents which expire in 2033 and '34, respectively) represents a very favorable development for AXSM. That said, we'll be interested in learning more about TEVA's IP strategy (as well as AXSM's strategy in response) once AXSM's patent lawsuit against TEVA becomes available.
Bottom line: TEVA is not challenging the earlier expiring patents for Auvelity, and seeing this as a potential best case scenario for AXSM with respect to a potential loss of exclusivity/LOE for Auvelity (where recall, we currently model LOE in 2034), we're not terribly concerned about the news
Hence, on any_potential weakness, we recommend being opportunistic on AXSM shares today.
Graig Suvannavejh, Ph.D.
Managing Director
+1 212 282 4019
Graig.Suvannavejh@mizuhogroup.com
Please refer to the linked full report for important disclosure and analyst certification information
99+
Truist $AXSM BUY $150PT We polled 43 psychiatrists who have prescribed Auvelity since launch and overall feedback is highly positive. Based on positive initial real-world psychiatrist feedbacks, we think Auvelity may outpace our sales forecast of ~$1BN by 2034.
Truist $AXSM Encouragingly, 98% of psychiatrists have stated that, based on their experience with Auvelity, they would prescribe Auvelity to other MDD patients under their care.
News today from Motley Fool regarding AXSM
Axsome soared more than 100% last year. But the average Wall Street estimate calls for more than a 60% gain in the coming 12 months from today's level.
Why should gains continue? Investors applauded Axsome's move from clinical-stage company to commercial-stage company. But the gains don't price in revenue growth from those products and potentially others to come this decade. Axsome is at the very beginning of its growth story.
The company launched Sunosi, a sleep disorders drug it acquired from Jazz Pharmaceuticals, in spring of last year. Then it gained approval of its own antidepressant, Auvelity, and launched it later in the year. The drug is fast-acting, so it could stand out from rivals. In fact, Auvelity may reach revenue of $1.3 billion by 2029, according to GlobalData.
Axsome also recently reported positive phase 3 trial results from its candidate to treat Alzheimer's disease agitation. An eventual approval here could be big. That's because there currently aren't any approved treatments in this area. The company also plans to submit its candidate for migraine treatment to regulators in the third quarter.
So, there's a lot of news -- and potential earnings growth -- on the horizon for Axsome.
https://www.fool.com/investing/2023/01/19/3-unstoppable-stocks-to-keep-buying-in-2023/?source=eptyholnk0000202&utm_source=yahoo-host&utm_medium=feed&utm_campaign=article
AXSM #50
Good trader. Bouncy.
And good outlook.
Sub 70 PM. I guess it’s a waiting game now.
Buyout is no less than $200 and likely closer to $500 when it's all said and done. Obviously $77 wasn't the perfect entry point, but it's going to make money.
Oh wow! took my order at $77!
Now I hope to grasp well the return ....
AXSM Exactly. Confusing and not helpful to the SP.
A little confused with the comment of discussing the findings with the FDA in the context of ongoing clinical development of AXS-05. Why not file for approval? It was a phase 3.
AXSM AXSOME THERAPEUTICS INC
In just now at 73.36
Presently $74.09
+$17.275 (+30.40%)
https://stockcharts.com/h-sc/ui?s=AXSM
Why Axsome Therapeutics Stock Is Soaring Today
by BENZINGA 55 mins ago
Axsome Therapeutics Inc (NASDAQ:AXSM) shares are trading higher Monday morning after the company announced AXS-05 achieved its primary endpoint in the ACCORD Phase 3 trial in Alzheimer's disease agitation.
AXS-05 is Axsome's novel, oral, investigational NMDA receptor antagonist with multimodal activity. It met its primary endpoint as well as key secondary endpoints in the ACCORD (Assessing Clinical Outcomes in Alzheimer's Disease Agitation) Phase 3 trial by substantially and statistically significantly delaying the time to relapse and preventing relapse of agitation in patients with Alzheimer's disease.
"The ACCORD results complement, and are consistent with, those from the previously completed positive ADVANCE-1 trial. We intend to discuss these findings with the FDA in the context of the ongoing clinical development of AXS-05 in this indication," said Herriot Tabuteau, CEO of Axsome.
Axsome is a biopharmaceutical company developing and delivering novel therapies for the management of central nervous system disorders.
AXSM Price Action: Axsome has a 52-week high of $71.98 and a 52-week low of $20.63.
The stock was up 17.1% at $66.55 at time of publication, according to Benzinga Pro.
AXS-05, met the primary and key secondary goals of a late-stage study testing it in Alzheimer’s disease patients
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
Didn't even close 10 bucks higher. Must not be a good stock.
https://www.fool.com/investing/2022/11/03/why-axsome-therapeutics-stock-is-soaring-today/
Definitively vague/speculatory.
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.
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,
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,
AXSM is looking very good TODAY!!!
Good luck and GOD bless,
GREAT NEWS on the way NEXT WEEK for TSLA, AXSM and AVXL.
Good luck and GOD bless,
Over $7 million of AXSM stock bought (traded) at about 10:02 AM EDT TODAY.
Good luck and GOD bless,
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,
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,
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,
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,
I bought several hundred more shares of AXSM yesterday!!!
Good luck and GOD bless,
Buy AXSM stock BEFORE MONDAY 12 Sept. 2022
Expect pricing for Auvelity SOON!!!
Good luck and GOD bless,
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