someconcerns
2週前
From the Forbes "Innovation RX" email newsletter:
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In this week’s edition of InnovationRx, we look at Axsome’s growing pipeline, HistoSonics innovative cancer treatment, state litigation over Medicaid work requirements, and more. To get it in your inbox, subscribe here.
Last October, when Forbes profiled Axsome Therapeutics founder and CEO Herriot Tabuteau, the company had three drugs on the market, five in the pipeline and a market cap of $6.1 billion. Since then, the stock has doubled, giving it a market cap of $12.6 billion—and Tabuteau a net worth of $2.2 billion. That performance is far ahead of shares of Alphabet (up 45% in the same time period), Eli Lilly (up 57%) or Nvidia (just 7%), to name just a few fast-growing giants.
Behind the rise: The New York-based company got approval for its drug Auvelity to treat the agitation that often accompanies Alzheimer’s disease. “We literally just launched it a couple of weeks ago. The reception has been tremendous,” Tabuteau, 57, tells Forbes.
When Tabuteau, who was born in Haiti and educated at Yale School of Medicine, started the drug development company in 2012, he decided to do things differently. He focused on drugs for brain disorders, which are notoriously difficult to develop and whose efficacy can be hard to prove. He also shunned venture capital, instead self-funding with help from family and friends. When Axsome went public in 2015, Wall Street was skeptical and the company’s stock puttered along under $10 for years.
But as we detailed last year, its prospects skyrocketed with its first big drug, Auvelity. When the treatment for major depressive disorder gained FDA approval in August 2022, the company’s shares popped 65% in a week, valuing the company at $3 billion.
Getting approval for the drug in Alzheimer’s agitation may be an even bigger deal. More than 7 million people in the U.S. have Alzheimer’s and Axsome figures that up to 76% of them experience agitation. Yet until now the only way to treat their symptoms has been with anti-psychotics, which have serious risks, including death. Scrutiny of antipsychotics’ usage has been increasing. A report from the Health and Human Services Office of the Inspector General in March found “alarming instances of inappropriate uses of antipsychotic drugs,” in a comprehensive review of 40 nursing home inspections, and noted that such inappropriate use has been a “longstanding concern for Congress and others.” Tabuteau points to the FDA’s unusual announcement heralding approval of the drug as the first non-antipsychotic for the indication as a sign of the new drug’s importance for public health.
Now Tabuteau (who Forbes recently named to its Immigrant 250 list) forecasts that the entire Auvelity franchise could reach $8 billion in peak sales, up from an earlier estimate of $6 billion, and he’s cranked up the company’s sales force to sell it. Potentially, Auvelity could be expanded to treat agitation in other forms of dementia, such as Lewy body dementia or vascular dementia, as well.
Axsome’s revenue reached $709 million for the latest 12 months (through the first quarter), up 64% from the same period the previous year. William Blair analyst Myles Minter now projects sales of $975 million for 2026 and $1.7 billion for 2027. In a recent research note, he wrote that not only were sales of the company’s drug for daytime sleepiness growing, but it also had “multiple shots on goal from additional pipeline assets,” including those for treatment of cataplexy (the sudden loss of muscle control) associated with narcolepsy and for fibromyglia.
“With the current pipeline, we are in position to file at least one new [drug application] every year, starting this year through 2030,” Tabuteau says. The company submitted an application for its narcolepsy medication earlier this year.
Tabuteau’s previous experience in finance–including stints at Goldman Sachs, Bank of America Securities and hedge fund Healthco/S.A.C. Capital, as well as managing his own funds–has paid off for Axsome. In late-2021, it bought the daytime sleepiness drug Sunosi for $53 million (plus single-digit royalties), then recouped its money when Tabuteau sold the European, Middle Eastern and North African rights.
That finance experience could pay off going forward as well. Since November, Axsome has acquired two additional therapeutic candidates: one to treat epilepsy, the other for schizophrenia and Tourette syndrome. It snagged the epilepsy drug by purchasing a small biotech that had originally licensed the therapy from AstraZeneca for just $300,000 upfront with potential milestone payments reaching $83 million, plus royalties. It acquired the schizophrenia and Tourette’s drug from Takeda for an undisclosed sum.
“It was not something that Takeda was looking to out-license, but based on our research we thought it was interesting so we did approach them and start a conversation,” Tabuteau says. He now figures that drug will be ready for phase 3 trials in patients with schizophrenia by the end of the year.
“Overall, if you look at our pipeline, it has the potential to generate peak sales of $20 billion-plus,” Tabuteau says. “There’s a lot more growth to be had, and we are very well positioned to deliver on that growth.”
US Market News
4月前
Psychedelic Medicine Advances: Here Are Five Companies Targeting CNS DisordersFebruary 26, 2026 12:07 PM
PR Newswire (US)
Issued on behalf of Helus PharmaVANCOUVER, BC, Feb. 26, 2026 /PRNewswire/ -- USA News Group News Commentary – The first psilocybin compound to achieve two positive Phase 3 results in treatment-resistant depression cleared that milestone this week, signaling a potential shift in how regulators and investors view psychedelic-based psychiatry[1]. The pathway is widening at the federal level, where the Drug Enforcement Administration raised its 2026 psilocybin production quota by 67%[2]. Five companies are working to translate that momentum into approved treatments: Helus Pharma (NASDAQ: HELP), Compass Pathways (NASDAQ: CMPS), Relmada Therapeutics (NASDAQ: RLMD), Alto Neuroscience (NYSE: ANRO), and Axsome Therapeutics (NASDAQ: AXSM).
The World Health Organization estimates that depression and anxiety cost the global economy more than $1 trillion annually in lost productivity[3]. The pipeline is moving to meet it, and the capital is following.Helus Pharma (NASDAQ: HELP) is a clinical-stage pharmaceutical company developing treatments for depression and anxiety. Its approach centers on novel serotonergic agonists, synthetic molecules designed to activate serotonin pathways believed to promote neuroplasticity.Originally founded as Cybin in 2019, the company rebranded to Helus Pharma in January 2026, pronounced "Heal-Us," and began trading on the NASDAQ under the ticker HELP. The name reflects its transition toward a commercial-ready pharmaceutical operation.The company holds over 350 filed patents with more than 100 already granted, providing protection around its lead programs through at least 2041. It operates across Canada, the United States, the United Kingdom, and Ireland.Recently, Nature Medicine published results from a randomized, placebo-controlled Phase 2a trial of SPL026 in patients with moderate-to-severe major depressive disorder. The study enrolled 34 participants across three clinical sites in the United Kingdom.The study met its primary endpoint. Participants receiving a single 21.5 mg dose showed a mean MADRS difference of -7.35 versus placebo (p=0.023), with effects appearing within one week (p=0.002).Response rates at two weeks reached 35% versus 12% for placebo. Remission rates were 29% versus 12%.Effects were sustained for up to three months, with some participants maintaining improvements for up to six months. No treatment-related serious adverse events were reported."The findings provide clinical proof-of-concept for short-acting serotonergic modulation and further support our conviction that our novel serotonergic agonist molecules, such as HLP004, can potentially deliver meaningful outcomes with greater consistency and commercial feasibility," said Michael Cola, CEO of Helus Pharma.HLP004, a proprietary intramuscular compound informed by the SPL026 clinical insights, is now in Phase 2 for generalized anxiety disorder. Helus expects topline data from that study this quarter.The company's lead asset HLP003, a proprietary oral compound granted FDA Breakthrough Therapy Designation, is advancing through two pivotal Phase 3 studies for the adjunctive treatment of major depressive disorder.Phase 2 data on HLP003 demonstrated 100% response rates and 71% remission at 12 months after just two 16 mg doses, with an approximately 23-point reduction in MADRS scores.The APPROACH pivotal Phase 3 study has topline data anticipated in Q4 2026, while the complementary EMBRACE Phase 3 study and EXTEND long-term extension study continue to progress.Helus reported US$195.1 million in cash as of December 31, 2025, supporting continued advancement across its multi-asset clinical pipeline.CONTINUED… Read this and more news for Helus Pharma at:https://usanewsgroup.com/2026/02/24/this-fda-breakthrough-depression-drug-just-hit-nature-medicine-wall-street-says-its-worth-22-share/ In other industry developments:Compass Pathways (NASDAQ: CMPS) this week reported positive results from two pivotal Phase 3 trials evaluating COMP360, a synthetic psilocybin compound, in patients with treatment-resistant depression. The larger trial, COMP006, enrolled 581 participants across international sites and demonstrated a highly statistically significant reduction in symptom severity, with a p-value below 0.001 and a mean treatment difference of 3.8 points on the MADRS depression scale at Week 6.The company has submitted a request to the FDA to discuss a rolling submission and review, a pathway that could shorten the timeline to a potential approval filing. Across both Phase 3 studies, 39% of participants receiving the 25 mg dose achieved a clinically meaningful reduction in depression scores at Week 6, with durable effects observed through 26 weeks after just one or two administrations.COMP360 is the first classic psychedelic to achieve two highly statistically significant Phase 3 readouts in treatment-resistant depression, a condition that affects roughly one-third of patients who do not respond to standard antidepressants. Most treatment-emergent adverse events were mild or moderate, with the vast majority resolving within 24 hours. The company expects 26-week durability data from COMP006 in early Q3 2026.Relmada Therapeutics (NASDAQ: RLMD) in January confirmed that the FDA has aligned on the registrational development pathway for NDV-01, a sustained-release intravesical formulation of gemcitabine and docetaxel for non-muscle invasive bladder cancer. The agency indicated that a single-arm, open-label pivotal trial is appropriate for second-line refractory high-grade patients with carcinoma in situ, one of the most treatment-resistant bladder cancer populations."A single-arm pivotal study in this setting represents a meaningful opportunity to advance an in-office, bladder-sparing therapy for patients who have few if any effective alternatives," said Raj S. Pruthi, MD, Chief Medical Officer at Relmada Therapeutics. "This study represents the fastest path to approval for NDV-01."The company anticipates initiating both registrational trials in the first half of 2026. NDV-01 is designed to be administered in-office in under five minutes without anesthesia or specialized equipment, with bladder retention and gradual drug release over ten days. Non-muscle invasive bladder cancer represents 75% to 80% of all bladder cancer cases, with over 744,000 prevalent cases in the United States and recurrence rates of 50% to 80% over five years.Alto Neuroscience (NYSE: ANRO) recently completed enrollment in its Phase 2 proof-of-concept trial of ALTO-101, a novel transdermal PDE4 inhibitor for cognitive impairment associated with schizophrenia. The randomized, double-blind, placebo-controlled crossover study enrolled 83 patients across 13 clinical sites in the United States, with topline data expected around the end of Q1 2026."This milestone brings us closer to potentially delivering a first-of-its-kind treatment for the millions of patients suffering from the debilitating cognitive effects of schizophrenia," said Amit Etkin, MD, PhD, founder and CEO of Alto Neuroscience. "Our baseline results have already replicated findings from three independent datasets, reinforcing our confidence in ALTO-101's mechanism and our biomarker-driven approach."There are currently no approved pharmacologic treatments for cognitive impairment in schizophrenia, a condition affecting nearly all patients with the disorder and a primary driver of long-term functional disability. ALTO-101 is delivered through a proprietary transdermal system developed with MEDRx, designed to reduce the gastrointestinal side effects common to oral PDE4 inhibitors while maintaining central nervous system target engagement. The FDA has granted ALTO-101 Fast Track Designation for this indication.Axsome Therapeutics (NASDAQ: AXSM) in December announced that the FDA has accepted and granted Priority Review to its supplemental New Drug Application for AXS-05, a novel NMDA receptor antagonist and sigma-1 agonist, for the treatment of Alzheimer's disease agitation. The PDUFA target action date is April 30, 2026."Up to 76% of people with Alzheimer's disease experience agitation, representing a significant unmet medical need for patients and their caregivers, and currently there is a dearth of approved treatments," said Herriot Tabuteau, MD, CEO of Axsome Therapeutics. "We look forward to continuing to work with the FDA for the remainder of the review."AXS-05 previously received FDA Breakthrough Therapy designation for Alzheimer's agitation in 2020 and is already approved in the United States as Auvelity for the treatment of major depressive disorder in adults. The supplemental NDA is supported by four randomized, double-blind, controlled Phase 3 trials and a long-term safety study. Approximately 7 million Americans live with Alzheimer's disease, and the company's patent estate for AXS-05 extends through at least 2043.Article Source: https://usanewsgroup.com/2026/02/24/this-fda-breakthrough-depression-drug-just-hit-nature-medicine-wall-street-says-its-worth-22-share/ CONTACT:USA NEWS GROUP
info @acblanke1DISCLAIMER: Nothing in this publication should be considered as personalized financial advice. We are not licensed under securities laws to address your particular financial situation. No communication by our employees to you should be deemed as personalized financial advice. Please consult a licensed financial advisor before making any investment decision. This is a paid advertisement and is neither an offer nor recommendation to buy or sell any security. We hold no investment licenses and are thus neither licensed nor qualified to provide investment advice. The content in this report or email is not provided to any individual with a view toward their individual circumstances. This article is being distributed by USA News Group on behalf of Market IQ Media Group Inc. ("MIQ"). MIQ has been paid a fee for Helus Pharma advertising and digital media from Creative Digital Media Group ("CDMG"). There may be 3rd parties who may have shares of Helus Pharma, and may liquidate their shares which could have a negative effect on the price of the stock. This compensation constitutes a conflict of interest as to our ability to remain objective in our communication regarding the profiled company. Because of this conflict, individuals are strongly encouraged to not use this publication as the basis for any investment decision. The owner/operator of MIQ/BAY does not own any shares of Helus Pharma but reserve the right to buy and sell, and will buy and sell shares of Helus Pharma at any time without any further notice commencing immediately and ongoing. We also expect further compensation as an ongoing digital media effort to increase visibility for the company, no further notice will be given, but let this disclaimer serve as notice that all material, including this article, which is disseminated by MIQ has been approved on behalf of Helus Pharma by CDMG; this is a paid advertisement, we currently own shares of Helus Pharma and will buy and sell shares of the company in the open market, or through private placements, and/or other investment vehicles. While all information is believed to be reliable, it is not guaranteed by us to be accurate. Individuals should assume that all information contained in our newsletter is not trustworthy unless verified by their own independent research. Also, because events and circumstances frequently do not occur as expected, there will likely be differences between the any predictions and actual results. Always consult a licensed investment professional before making any investment decision. Be extremely careful, investing in securities carries a high degree of risk; you may likely lose some or all of the investment.SOURCES:https://www.statnews.com/2026/02/17/compass-pathways-comp360-psilocybin-severe-depression-trial-results/https://www.federalregister.gov/documents/2026/01/05/2025-24277/established-aggregate-production-quotas-for-schedule-i-and-ii-controlled-substances-and-assessmenthttps://www.who.int/news/item/02-09-2025-over-a-billion-people-living-with-mental-health-conditions-services-require-urgent-scale-upLogo - https://mma.prnewswire.com/media/2838876/5826124/USA_News_Group_Logo.jpg
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Original: Psychedelic Medicine Advances: Here Are Five Companies Targeting CNS Disorders
iHub News
5月前
Axsome Shares Slip Despite Fourth-Quarter Earnings Beat and Strong Revenue GrowthFebruary 23, 2026 11:11 AM
IH Market News
Axsome Therapeutics Inc. (NASDAQ:AXSM) reported fourth-quarter results that topped analyst forecasts, although the company’s shares fell 2.03% in premarket trading following the announcement.The biopharmaceutical company posted a quarterly loss of $0.56 per share, outperforming the consensus expectation for a loss of $0.73 per share.Revenue for the quarter came in at $196.0 million, exceeding analyst estimates of $189.81 million and marking a 65% increase from $118.8 million recorded in the same period a year earlier.For the full year 2025, Axsome generated total net product revenue of $638.5 million, representing a 66% year-over-year increase compared with $385.7 million in 2024.Sales of the company’s lead product AUVELITY reached $155.1 million in the fourth quarter, rising 68% year over year. SUNOSI contributed $36.7 million in revenue, up 40%, while newly launched SYMBRAVO recorded $4.1 million in quarterly sales.“Our fourth quarter and full year 2025 results demonstrate strong commercial momentum across our marketed products, and advancement and expansion of our innovative CNS pipeline,” said Herriot Tabuteau, MD, Chief Executive Officer.On the regulatory front, the U.S. Food and Drug Administration granted Priority Review status to the company’s supplemental new drug application for AXS-05 as a treatment for Alzheimer’s disease agitation, with a target action date of April 30, 2026.Axsome also said it plans to submit a new drug application for AXS-12 for narcolepsy later this quarter.For the full year, the company reported a net loss of $183.2 million, or $3.68 per share, narrowing from a loss of $287.2 million, or $5.99 per share, in 2024. Cash and cash equivalents totaled $322.9 million as of December 31, 2025, which management believes will support operations until the company reaches cash-flow positivity.Axsome Therapeutics stock price
Original: Axsome Shares Slip Despite Fourth-Quarter Earnings Beat and Strong Revenue Growth
georgejjl
8月前
Two Monster Stocks in the Making
2. Axsome Therapeutics
Axsome Therapeutics has made tremendous clinical and regulatory progress in the past five years. That has paid off for the biotech, as it now generates strong, growing sales. Revenue in the third quarter was $171 million, a 63% year-over-year increase. Axsome owes that performance primarily to Auvelity, a depression medicine. Here's why there is plenty of upside left for the biotech.
First, Auvelity has only been on the market since 2022. It has plenty more years of growing sales before it hits a patent cliff. Axsome Therapeutics expects it to achieve blockbuster status in treating depression alone.
More in Business
Second, the medicine could earn some label expansions. Axsome is now awaiting approval for Auvelity in Alzheimer's disease (AD) agitation. This indication could be another meaningful growth driver, given the significant need for new treatment options in AD. The company estimates that Auvelity could reach peak sales of $1.5 billion to $3 billion in AD agitation.
Third, Axsome has other approved products, plus some that could soon earn approval; these should help it improve its financial results. The company received the green light for Symbravo, a migraine treatment, earlier this year. It's inching closer to submitting a regulatory application for AXS-12 in narcolepsy. And it's running or recently completed late-stage clinical trials for other medicines, including AXS-14 in fibromyalgia, and solriamfetol (approved under the brand name Sunosi) in ADHD.
And there's much more. Axsome Therapeutics' lineup is driving solid sales, and its late-stage pipeline is deep, with several new approvals and label expansions expected in the next five years. The company could deliver strong returns along the way.
https://www.yahoo.com/finance/news/2-monster-stocks-making-094500181.html
Good luck and GOD bless,
Axsome Therapeutics has made tremendous clinical and regulatory progress in the past five years. That has paid off for the biotech, as it now generates strong, growing sales. Revenue in the third quarter was $171 million, a 63% year-over-year increase. Axsome owes that performance primarily to Auvelity, a depression medicine. Here's why there is plenty of upside left for the biotech.
First, Auvelity has only been on the market since 2022. It has plenty more years of growing sales before it hits a patent cliff. Axsome Therapeutics expects it to achieve blockbuster status in treating depression alone.
More in Business
Second, the medicine could earn some label expansions. Axsome is now awaiting approval for Auvelity in Alzheimer's disease (AD) agitation. This indication could be another meaningful growth driver, given the significant need for new treatment options in AD. The company estimates that Auvelity could reach peak sales of $1.5 billion to $3 billion in AD agitation.
Third, Axsome has other approved products, plus some that could soon earn approval; these should help it improve its financial results. The company received the green light for Symbravo, a migraine treatment, earlier this year. It's inching closer to submitting a regulatory application for AXS-12 in narcolepsy. And it's running or recently completed late-stage clinical trials for other medicines, including AXS-14 in fibromyalgia, and solriamfetol (approved under the brand name Sunosi) in ADHD.
And there's much more. Axsome Therapeutics' lineup is driving solid sales, and its late-stage pipeline is deep, with several new approvals and label expansions expected in the next five years. The company could deliver strong returns along the way.
https://www.yahoo.com/finance/news/2-monster-stocks-making-094500181.html
Good luck and GOD bless,
someconcerns
8月前
Axsome Therapeutics Reports Third Quarter 2025 Financial Results and Provides Business Update
GlobeNewswire - 42 minutes ago Investment News
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Total 3Q 2025 net product revenue of $171.0 million, representing 63% year-over-year growth
AUVELITY® 3Q 2025 net product sales of $136.1 million, representing 69% year-over-year growth
SUNOSI® 3Q 2025 net product revenue of $32.8 million, representing 35% year-over-year growth
SYMBRAVO® 3Q 2025 net product sales of $2.1 million
sNDA for AXS-05 in Alzheimer’s disease agitation submitted to the FDA
Company to host conference call today at 8:00 AM Eastern
NEW YORK, Nov. 03, 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 financial results for the third quarter of 2025 and provided a general business update.
“Axsome posted strong revenue growth in the third quarter driven by contributions from all three of our marketed products,” said Herriot Tabuteau, MD, Chief Executive Officer of Axsome Therapeutics ( AXSM ). “Our broad development pipeline continues to advance, and we recently submitted our supplemental NDA for AXS-05 for the treatment of Alzheimer’s disease agitation, a serious condition affecting millions of patients in the U.S., and a critical unmet medical need. With robust commercial performance and pipeline execution, Axsome is well positioned to continue delivering substantial and sustained growth and transformative new medicines for patients living with serious CNS disorders.”
Financial Highlights
Total net product revenue was $171.0 million for the third quarter of 2025, representing 63% year-over-year growth, and 14% sequential growth compared to the second quarter of 2025. Total net product revenue for the third quarter of 2024 was $104.8 million.
AUVELITY net product sales were $136.1 million for the third quarter of 2025, representing 69% year-over-year growth, and 14% sequential growth compared to the second quarter of 2025. AUVELITY net product sales for the third quarter of 2024 were $80.4 million.
SUNOSI net product revenue was $32.8 million for the third quarter of 2025, representing 35% year-over-year growth, and 9% sequential growth compared to the second quarter of 2025. SUNOSI net product revenue for the third quarter of 2025 consisted of $31.6 million in net product sales and $1.2 million in royalty revenue associated with SUNOSI sales in out-licensed territories. SUNOSI net product revenue for the third quarter of 2024 was $24.4 million, which consisted of $23.4 million in net product sales and $1.0 million in royalty revenue.
SYMBRAVO net product sales were $2.1 million for the third quarter of 2025, the first full quarter of commercialization following its launch in June 2025.
Total cost of revenue was $11.9 million for the third quarter of 2025. Total cost of revenue for the comparable period in 2024 was $8.4 million.
Research and development (R&D) expenses were $40.2 million for the third quarter of 2025, compared to $45.4 million for the comparable period in 2024. The decrease was primarily related to the completion of trials for solriamfetol in ADHD and MDD, which was partially offset by higher costs related to AXS-07.
Selling, general, and administrative (SG&A) expenses were $150.2 million for the third quarter of 2025, compared to $95.6 million for the comparable period in 2024. The increase was primarily related to commercialization activities for AUVELITY, including the sales force expansion and direct-to-consumer advertising campaign, and the commercial launch of SYMBRAVO.
Net loss for the third quarter of 2025 was $47.2 million, or $(0.94) per share, compared to a net loss of $64.6 million, or $(1.34) per share, for the comparable period in 2024. The net loss in the third quarter of 2025 includes $23.1 million of stock-based compensation expense and a $13.2 million non-cash charge for contingent consideration.
Cash and cash equivalents totaled $325.3 million at September 30, 2025, compared to $315.4 million at December 31, 2024.
Shares of common stock outstanding were 50,307,834 at September 30, 2025.
Financial Guidance
Axsome believes that its current cash is sufficient to fund anticipated operations into cash flow positivity, based on the current operating plan.
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