georgejjl
3 월 전
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
Good luck and GOD bless,
Frankestin
8 월 전
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
Frankestin
9 월 전
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
Frankestin
10 월 전
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)
georgejjl
1 년 전
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,
georgejjl
1 년 전
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,
georgejjl
1 년 전
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,
georgejjl
1 년 전
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,
georgejjl
2 년 전
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,
georgejjl
2 년 전
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,
georgejjl
2 년 전
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,
georgejjl
2 년 전
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,
georgejjl
2 년 전
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.
https://www.marketbeat.com/instant-alerts/nasdaq-axsm-sec-filing-2023-04-21/
Good luck and GOD bless,
georgejjl
2 년 전
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."
https://www.fool.com/investing/2023/04/12/can-axsome-hold-out-till-depression-drug-becomes-a/?source=eptyholnk0000202&utm_source=yahoo-host&utm_medium=feed&utm_campaign=article
Max77
2 년 전
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+
georgejjl
2 년 전
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
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