Latest news with #AXSM
Yahoo
12-05-2025
- Business
- Yahoo
Prediction: These 2 Stocks Will Outperform the Market in the Next Five Years
Vertex Pharmaceuticals is diversifying its already strong lineup of medicines. Axsome Therapeutics has multiple clinical and regulatory catalysts on the way. 10 stocks we like better than Vertex Pharmaceuticals › Regardless of how stocks are performing right now, history tells us that the market tends to generate solid returns over long periods. Investors can do even better than the average market performance by buying shares of companies likely to beat broader equities. Two excellent candidates are Vertex Pharmaceuticals (NASDAQ: VRTX) and Axsome Therapeutics (NASDAQ: AXSM). Here's what makes these stocks solid candidates to outperform the market in the next half-decade. Vertex Pharmaceuticals has made significant clinical progress recently. Over the past six months, it has earned approval for two new medicines. The first is Alyftrek, a next-gen medicine for cystic fibrosis (CF), the area Vertex has dominated for over a decade. The second is Journavx, an oral, non-opioid pain inhibitor -- the first of its kind. These new approvals help strengthen and diversify Vertex's product lineup. The company still has room to grow in its core CF area; only about 75% of CF patients in its core geographies and 33% in other regions are currently benefiting from its medicines. Meanwhile, Journavx fills an unmet need: Opioid-based pain therapies can have significant adverse side effects. Vertex estimates a market of 80 million patients in acute pain. According to some projections, the medicine could generate $2.9 billion in revenue by 2030. Revenue and earnings should continue growing at a good clip in the next five years, even before we account for Casgevy, a gene-editing medicine that earned approval in late 2023 and early 2024 for a pair of rare blood diseases. Administering gene-editing therapies is a complex and lengthy process, so Casgevy isn't yet contributing much to the top line. However, it boasts blockbuster potential and will eventually be a meaningful growth driver for the company. Lastly, Vertex has an attractive pipeline. It's running clinical trials for brand-new products that could be breakthroughs. One is inaxaplin, a potential medicine for APOL1-mediated kidney disease. There are no drugs that address the underlying causes of this disease; Vertex aims to launch the first. And that's just the tip of the innovation iceberg with this biotech. Its shares recently fell post-earnings due to several issues that hardly change its long-term prospects. Vertex Pharmaceuticals' solid business and more diversified lineup will allow it to bounce back, and still provide superior returns through 2030 and beyond. Axsome Therapeutics' top line is growing fast. Revenue in the first quarter was $121.5 million, 62% higher than the year-ago period. The company owes much of this performance to Auvelity, a medication for major depressive disorder (MDD) approved in 2022. The drug's sales should continue increasing at a good clip, but there's more for investors to look forward to. Auvelity, also known as AXS-05, recently completed a clinical trial in treating agitation associated with Alzheimer's disease (AD). Axsome plans a regulatory submission in the third quarter. There are more than 4 million patients in the U.S. who suffer from AD agitation, but there's only one approved therapy. An approval here would significantly expand Auvelity's addressable market, and jolt its already impressive sales growth. In January, Axsome earned approval for Symbravo, a migraine therapy that will be another growth driver for the company. And the biotech has several more brand-new approvals or label expansions on the way. Solriamfetol, a medicine it markets as Sunosi in treating narcolepsy, recently produced positive results in phase 3 studies for MDD and ADHD (attention-deficit/hyperactivity disorder). Another candidate, AXS-14, completed phase 3 studies last year and could soon reach the desk of regulators for approval in treating fibromyalgia. Axsome Therapeutics' lineup will look much stronger within a few years. In the meantime, the biotech will continue to grow its revenue at a good clip. The stock has crushed the market so far this year. It may or may not maintain its momentum in the next few weeks, but it looks likely to perform well through the end of the decade. Before you buy stock in Vertex Pharmaceuticals, consider this: The Motley Fool Stock Advisor analyst team just identified what they believe are the for investors to buy now… and Vertex Pharmaceuticals wasn't one of them. The 10 stocks that made the cut could produce monster returns in the coming years. Consider when Netflix made this list on December 17, 2004... if you invested $1,000 at the time of our recommendation, you'd have $614,911!* Or when Nvidia made this list on April 15, 2005... if you invested $1,000 at the time of our recommendation, you'd have $714,958!* Now, it's worth noting Stock Advisor's total average return is 907% — a market-crushing outperformance compared to 163% for the S&P 500. Don't miss out on the latest top 10 list, available when you join . See the 10 stocks » *Stock Advisor returns as of May 5, 2025 Prosper Junior Bakiny has positions in Vertex Pharmaceuticals. The Motley Fool has positions in and recommends Axsome Therapeutics and Vertex Pharmaceuticals. The Motley Fool has a disclosure policy. Prediction: These 2 Stocks Will Outperform the Market in the Next Five Years was originally published by The Motley Fool Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
San Francisco Chronicle
05-05-2025
- Business
- San Francisco Chronicle
Axsome: Q1 Earnings Snapshot
NEW YORK (AP) — NEW YORK (AP) — Axsome Therapeutics Inc. (AXSM) on Monday reported a loss of $59.4 million in its first quarter. The New York-based company said it had a loss of $1.22 per share. Losses, adjusted for non-recurring costs, came to 80 cents per share. The results exceeded Wall Street expectations. The average estimate of 10 analysts surveyed by Zacks Investment Research was for a loss of $1.26 per share. The biopharmaceutical company posted revenue of $121.5 million in the period, which also topped Street forecasts. Eight analysts surveyed by Zacks expected $119.5 million. Axsome shares have risen 33% since the beginning of the year. The stock has increased 50% in the last 12 months. _____
Associated Press
08-04-2025
- Business
- Associated Press
ALERT: Grabar Law Office Investigates Claims on Behalf of Shareholders of Axsome Therapeutics, Inc. (NASDAQ: AXSM); BioVie Inc. (NASDAQ: BIVI); Maison Solutions Inc. (NASDAQ: MSS); and Virtu Financial Inc. (NASDAQ: VIRT), as Securities Fraud Class Actions Survive Motions to Dismiss
PHILADELPHIA, April 08, 2025 (GLOBE NEWSWIRE) -- Axsome Therapeutics Inc. (NASDAQ: AXSM) Class Action Survives Motion to Dismiss: Grabar Law Office is investigating claims on behalf of shareholders of Axsome Therapeutics, Inc. (NASDAQ: AXSM) as an underlying securities fraud class action has survived a motion to dismiss the complaint. The investigation concerns whether certain officers and directors breached the fiduciary duties they owed to the company. If you are a current Axsome (NASDAQ: AXSM) shareholder who purchased Axsome shares on prior to May 10, 2021 and still hold shares today, you may be able to seek corporate reforms, the return of money back to the company, and a court approved incentive award at no cost to you whatsoever. Please visit contact Joshua Grabar at [email protected], or call us at 267-507-6085 WHY?: An underlying securities fraud class action complaint alleges that Axsome Therapeutics (NASDAQ: AXSM), via certain of its officers, made false and/or misleading statements, as well as failed to disclose material adverse facts about the Company's business, operations, and prospects. Specifically, the Complaint alleges Defendants made false and/or misleading statements and/or failed to disclose that: (i) Axsome's chemistry, manufacturing, and control ('CMC') practices were deficient with respect to AXS-07 and its manufacturing process; (ii) as a result, Axsome was unlikely to submit the AXS-07 NDA on its initially represented timeline; (iii) the foregoing CMC issues remained unresolved at the time that the FDA reviewed the AXS-07 NDA; (iv) accordingly, the FDA was unlikely to approve the AXS-07 NDA; (v) as a result of all the foregoing, Axsome had overstated AXS-07's regulatory and commercial prospects; and (vi) as a result, the Company's public statements were materially false and misleading at all relevant times. On March 31, 2025, the Court issued an Order denying Axsome's Motion to Dismiss. In doing so the court determined that the operative complaint sufficiently pleads material misrepresentations or omissions regarding two categories of statements: (1) Defendants' statements that the manufacturing facility and suppliers for AXS-07 were not experiencing problems and (2) Defendants' statements about AXS-07's NDA. $AXSM #Axsome WHAT YOU CAN DO NOW: If you purchased Axsome Therapeutics (NASDAQ: AXSM) prior to May 10, 2021 and still hold shares today, you are encouraged to visit contact Joshua Grabar at [email protected], or call 267-507-6085. You may be able to seek corporate reforms, the return of funds back to the company, and a court approved incentive award at no cost to you whatsoever. BioVie Inc. (NASDAQ: BIVI) Class Action Survives Motion to Dismiss: Grabar Law Office is investigating claims on behalf of shareholders of BioVie Inc. (NASDAQ: BIVI) as an underlying securities fraud class action has survived a motion to dismiss the complaint. The investigation concerns whether certain officers and directors breached the fiduciary duties they owed to the company. If you are a current BioVie (NASDAQ: BIVI) shareholder who purchased BioVie shares on prior to December 7, 2022 and still hold shares today, you may be able to seek corporate reforms, the return of money back to the company, and a court approved incentive award at no cost to you whatsoever. Please visit contact Joshua Grabar at [email protected] or call us at 267-507-6085. Why? On August 5, 2021, BioVie announced in a Form 8-K filed with the SEC the enrollment of the first patient in its Phase 3 study of NE3107 in Alzheimer's Disease. An underlying securities fraud class action complaint has survived a motion to dismiss. According to that complaint, BioVie Inc. (NASDAQ: BIVI), through certain of its officers, made materially false and/or misleading statements and failed to disclose material adverse facts about the Company's business, operations, and prospects. Specifically, the Complaint alleges that Defendants misled investors by failing to disclose that (1) BioVie was not conducting proper oversight of its Phase 3 clinical trial; (2) that the COVID-19 pandemic significantly and negatively impacted the Company's ability to adequately conduct proper oversight of the Phase 3 clinical trial; (3) that due to lack of proper oversight and reliance on contract research organizations, the data from Defendants' Phase 3 clinical trial faced a greater risk of being unreliable and that the majority of patients would have to be excluded from the clinical trial; (4) that, as a result of the significant exclusions from the trial results, the Phase 3 clinical trial would fail to meet its primary endpoints; and (5) statements about BioVie's business, operations, prospects, and compliance with current good clinical practices were materially false and/or misleading and/or lacked a reasonable basis at all relevant times. On March 27, 2025, the Court issued an Order denying Defendants' Motion to Dismiss. In so doing, the Court noted that 'that a compelling inference that Individual Defendants acted with minimum deliberate recklessness is at least as strong as an opposing inference of good faith.' WHAT YOU CAN DO NOW: If you purchased BioVie (NASDAQ: BIVI) prior to December 7, 2022 and still hold shares today, you are encouraged to visit contact Joshua Grabar at [email protected], or call 267-507-6085. You may be able to seek corporate reforms, the return of funds back to the company, and a court approved incentive award at no cost to you whatsoever. #BioVie $BIVI Maison Solutions Inc. (NASDAQ: MSS) Class Action Survives Motion to Dismiss: Grabar Law Office is investigating claims on behalf of shareholders of Maison Solutions Inc. (NASDAQ: MSS) as an underlying securities fraud class action has survived a motion to dismiss the complaint. The investigation concerns whether certain officers and directors breached the fiduciary duties they owed to the company. If you are a current Maison Solutions Inc. (NASDAQ: MSS) shareholder who purchased Maison shares on or near its October 5, 2023 IPO and still hold shares today, you may be able to seek corporate reforms, the return of money back to the company, and a court approved incentive award at no cost to you whatsoever. Please visit contact Joshua Grabar at [email protected] or call us at 267-507-6085 WHY? On October 5, 2023, the Maison Solutions filed its prospectus on Form 424B4 with the SEC, which forms part of the Registration Statement. In the IPO, the Company sold 2,500,000 shares of Class A common stock at a price of $4.00 per share. The Company received net proceeds of approximately $10 million from the Offering. On December 15, 2023, at approximately 2:30 p.m. Eastern Standard Time, Hindenburg Research published a report about Maison, alleging a number of 'red flags' concerning potentially illegal activities. An underlying securities fraud class action complaint alleges that in the Registration Statement and throughout the Class Period (October 5, 2023 through December 15, 2023), Maison, through certain of its officers, made materially false and/or misleading statements, including failing to disclose to investors: (1) that the Company's vendor XHJC Holdings Inc., is a related party; (2) that the Company's CEO and related entities were alleged to have used supermarkets as a front to defraud the EB-5 visa program; and (3) that, as a result of the foregoing, Defendants' positive statements about the Company's business, operations, and prospects were materially misleading and/or lacked a reasonable basis. On March 31, 2025, material portions of the underlying complaint survived a motion to dismiss. WHAT YOU CAN DO NOW: If you purchased Maison Solutions Inc. (NASDAQ: MSS) on or near its October 5, 2023 IPO and still hold shares today, you are encouraged to visit contact Joshua Grabar at [email protected], or call 267-507-6085. You may be able to seek corporate reforms, the return of funds back to the company, and a court approved incentive award at no cost to you whatsoever. $MSS #MaisonSolutions Virtu Financial Inc. (NASDAQ: VIRT) Class Action Survives Motion to Dismiss: A federal securities fraud class action alleging that Virtu Financial Inc. (NASDAQ: VIRT), and certain of its officers failed to disclose to investors that it had improper safeguards in place and was not monitoring which of its employees were accessing the primary database containing sensitive trader information, has survived a motion to dismiss. Virtu shareholders who have continuously held Virtu shares since prior to November 7, 2018, can seek corporate reforms, the return of funds back to the company, and a court approved incentive award at no cost to them whatsoever. Learn more or join by clicking contact Joshua H. Grabar at [email protected], or call 267-507-6085. WHAT IS HAPPENING: Grabar Law Office is investigating claims on behalf of long-term Virtu (NASDAQ: VIRT) shareholders. The investigation concerns whether certain officers of the company have breached their fiduciary duties owed to the company. This investigation comes as a shareholder securities fraud class action has survived a motion to dismiss. WHY: A securities fraud class action complaint alleges that Virtu Financial, via certain of its officers and directors, made false and/or misleading statements and/or failed to disclose that: (i) the Company maintained deficient policies and procedures with respect to its information access barriers; (ii) accordingly, Virtu had overstated the Company's operational and technological efficacy as well as its capacity to block the exchange of confidential information between departments or individuals within the Company; (iii) the foregoing deficiencies increased the likelihood that the Company would be subject to enhanced regulatory scrutiny; and (iv) as a result, Defendants' public statements were materially false and/or misleading at all relevant times. On March 17, 2025, a federal Court determined that key allegations were sufficiently pled to survive defendants' motion to dismiss. According to the Court's Order, 'essentially anyone at Virtu, including its proprietary traders' could directly access this material non-public information from at least January 2018 through April 2019, and to do so, Virtu traders only needed to use a 'widely known and frequently shared username and password.' 'The court concludes that plaintiff's 'inference of scienter,' [inference that defendants knew their statements or omissions were false or misleading or acted with reckless disregard for the truth] supported by circumstantial evidence of defendants' reckless failure to inform its investors about the FS Database issue, is 'cogent and at least as compelling as' defendants' opposing inference that they identified the FS Database issue, rectified it, and self-reported it to the SEC, while continuously updating the market on the fact of and substance of the resultant SEC investigation.' WHAT YOU SHOULD DO NOW: If you are a current Virtu shareholder who has held Virtu stock since on or before November 7, 2018, you can seek corporate reforms, the return of funds spent defending litigation back to the company, and a court approved incentive award, at no cost to you. Contact: Joshua H. Grabar, Esq. Grabar Law Office One Liberty Place 1650 Market Street, Suite 3600 Philadelphia, PA 19103 Tel: 267-507-6085
Yahoo
08-04-2025
- Business
- Yahoo
Axsome Therapeutics to Report First Quarter 2025 Financial Results on May 5
NEW YORK, April 08, 2025 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company leading a new era in the treatment of central nervous system (CNS) disorders, today announced it will report its financial results for the first quarter of 2025 on Monday, May 5, 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. To participate in the live conference call, please dial (877) 405-1239 (toll-free domestic) or +1 (201) 389-0851 (international). A live webcast of the conference call can be accessed on the 'Webcasts & Presentations' page of the 'Investors' section of the Company's website at A replay of the conference call will be available on the Company's website for approximately 30 days following the live event. About Axsome Therapeutics Axsome Therapeutics is a biopharmaceutical company leading a new era in the treatment of central nervous system (CNS) conditions. We deliver scientific breakthroughs by identifying critical gaps in care and develop differentiated products with a focus on novel mechanisms of action that enable meaningful advancements in patient outcomes. Our industry-leading neuroscience portfolio includes FDA-approved treatments for major depressive disorder, excessive daytime sleepiness associated with narcolepsy and obstructive sleep apnea, and migraine, and multiple late-stage development programs addressing a broad range of serious neurological and psychiatric conditions that impact over 150 million people in the United States. Together, we are on a mission to solve some of the brain's biggest problems so patients and their loved ones can flourish. For more information, please visit us at and follow us on LinkedIn and X. Forward Looking Statements Certain matters discussed in this press release are 'forward-looking statements'. The Company may, in some cases, use terms such as 'predicts,' 'believes,' 'potential,' 'continue,' 'estimates,' 'anticipates,' 'expects,' 'plans,' 'intends,' 'may,' 'could,' 'might,' 'will,' 'should' or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. In particular, the Company's statements regarding trends and potential future results are examples of such forward-looking statements. The forward-looking statements include risks and uncertainties, including, but not limited to, the commercial success of the Company's Sunosi®, Auvelity®, and Symbravo® products and the success of the Company's efforts to obtain any additional indication(s) with respect to solriamfetol and/or AXS-05; the Company's ability to maintain and expand payer coverage; the success, timing and cost of the Company's ongoing clinical trials and anticipated clinical trials for the Company's current product candidates, including statements regarding the timing of initiation, pace of enrollment and completion of the trials (including the Company's ability to fully fund the Company's disclosed clinical trials, which assumes no material changes to the Company's currently projected revenues or expenses), futility analyses and receipt of interim results, which are not necessarily indicative of the final results of the Company's ongoing clinical trials, and/or data readouts, and the number or type of studies or nature of results necessary to support the filing of a new drug application ('NDA') for any of the Company's current product candidates; the Company's ability to fund additional clinical trials to continue the advancement of the Company's product candidates; the timing of and the Company's ability to obtain and maintain U.S. Food and Drug Administration ('FDA') or other regulatory authority approval of, or other action with respect to, the Company's product candidates, including statements regarding the timing of any NDA submission; the Company's ability to successfully defend its intellectual property or obtain the necessary licenses at a cost acceptable to the Company, if at all; the successful implementation of the Company's research and development programs and collaborations; the success of the Company's license agreements; the acceptance by the market of the Company's products and product candidates, if approved; the Company's anticipated capital requirements, including the amount of capital required for the commercialization of Sunosi, Auvelity, and Symbravo and for the Company's commercial launch of its other product candidates, if approved, and the potential impact on the Company's anticipated cash runway; the Company's ability to convert sales to recognized revenue and maintain a favorable gross to net sales; unforeseen circumstances or other disruptions to normal business operations arising from or related to domestic political climate, geo-political conflicts or a global pandemic and other factors, including general economic conditions and regulatory developments, not within the Company's control. The factors discussed herein could cause actual results and developments to be materially different from those expressed in or implied by such statements. The forward-looking statements are made only as of the date of this press release and the Company undertakes no obligation to publicly update such forward-looking statements to reflect subsequent events or circumstances. Investors:Mark JacobsonChief Operating Officer(212) 332-3243mjacobson@ Media:Darren OplandDirector, Corporate Communications(929) 837-1065dopland@
Yahoo
01-04-2025
- Business
- Yahoo
Why Shares of Axsome Therapeutics Slumped Today
Shares of biopharmaceutical company Axsome Therapeutics (NASDAQ: AXSM) had declined 6% at 11 a.m. ET today. The slump comes after the company announced the results of a phase 3 trial of solriamfetol (brand name Sunosi) in major depressive disorder (MDD). The trial was somewhat complicated, so bear with me. It was a six-week proof-of-concept phase 3 trial for MDD "with and without severe excess daytime sleepiness (EDS)." The primary aim of the trial was to demonstrate significant improvement in the overall population (consisting of 51 patients with severe EDS and 295 without severe EDS) using solriamfetol. The degree of severity of EDS was assessed with the Epworth Sleepiness Scale (ESS), and the trial used the Montgomery-Asberg Depression Rating Scale (MADRS). The details: The trial did not demonstrate a statistical improvement in the overall population when comparing patients on solriamfetol to those on a placebo. In the MDD patients with severe EDS, the use of solriamfetol "resulted in clinically meaningful and numerically greater improvements compared to placebo on multiple efficacy measures including MADRS total score" according to the press release. The second point encouraged the pharmaceutical company's management enough to prompt a phase 3 trial in MDD patients with EDS in 2025. It's mixed news. The proof-of-concept trial did not meet its primary aim, and that's enough to take the stock lower. Still, there's data to indicate a positive response in severe EDS cases. If those results are replicated in the forthcoming phase 3 trial, Axsome can claim success, but if solriamfetol is approved only for use in severe EDS, it will mean fewer sales than if the drug is approved for the total population of EDS patients. Before you buy stock in Axsome Therapeutics, consider this: The Motley Fool Stock Advisor analyst team just identified what they believe are the for investors to buy now… and Axsome Therapeutics wasn't one of them. The 10 stocks that made the cut could produce monster returns in the coming years. Consider when Nvidia made this list on April 15, 2005... if you invested $1,000 at the time of our recommendation, you'd have $664,271!* Now, it's worth noting Stock Advisor's total average return is 812% — a market-crushing outperformance compared to 163% for the S&P 500. Don't miss out on the latest top 10 list, available when you join . See the 10 stocks » *Stock Advisor returns as of April 1, 2025 Lee Samaha has no position in any of the stocks mentioned. The Motley Fool has positions in and recommends Axsome Therapeutics. The Motley Fool has a disclosure policy. Why Shares of Axsome Therapeutics Slumped Today was originally published by The Motley Fool
