Latest news with #Sunosi
Yahoo
11-04-2025
- Business
- Yahoo
Seeking Recession-Proof Stocks? RBC Suggests 2 Healthcare Stocks to Buy
President Trump's newly announced tariff policy has done more than just push the stock markets deeper into correction territory — the sudden panic on Wall Street has increased worries about a full-blown recession hitting in the near future. According to USA Today, several big banks are putting the chance of a recession at 40% or higher. Discover outperforming stocks and invest smarter with Top Smart Score Stocks. Filter, analyze, and streamline your search for investment opportunities using Tipranks' Stock Screener. Only time will tell if we dip into recession. For now, worried investors are seeking 'recession-proof' stocks to shore up their portfolios. The biopharma team at RBC has some concrete suggestions on this front. 'With recently-announced tariffs and other macro developments, we have been receiving more questions from investors on how to position for a potential recession, and whether biopharma is in fact a defensive sector,' RBC's biotech team noted. RBC crunched over three decades of data and found that large-cap biotech stocks have consistently held up during economic downturns — with a median downside of just 1% across major negative economic events. Even more encouraging, they believe selective mid-cap biotech names offer real upside potential when the market rebounds. To back up their thesis, RBC followed up with actionable recommendations — pinpointing specific healthcare stocks that could offer both protection and potential. We've used the TipRanks database to look up the broader Wall Street view on two of them. Let's take a closer look. Axsome Therapeutics (AXSM) We'll start with Axsome Therapeutics, a biotech research company that is developing new therapeutic agents for central nervous system (CNS) conditions. Diseases of the CNS are difficult on both patients and caregivers; they frequently resist treatment, and many CNS diseases lack any effective therapies. While this makes research into the field difficult, it also makes for a rich field of research targets. And Axsome has proven adept at hitting those targets. For research-oriented biopharma companies, getting a new drug approved and on the market is akin to the Holy Grail – and Axsome has three of these on the market. The company's first product to receive FDA approval was Sunosi, a prescription medication used in the treatment of excessive daytime sleepiness. In May 2022, Axsome bought the rights to Sunosi from Jazz Pharmaceuticals, after Sunosi had already been approved by the FDA in drug has been found useful in the treatment of narcolepsy and obstructive sleep apnea, and is described as an orally dosed wakefulness-promoting therapeutic agent. Next on the list is Auvelity, which was approved by the FDA in August of 2022 as a treatment for major depressive disorder (MDD) in adults. The drug, which is the first oral NMDA receptor agonist approved as an MDD treatment, is notable as the first depression therapy in 60 years to introduce a new mode of action. Finally, in January, Axsome announced that the FDA had approved Symbravo, a new treatment for migraine headaches. The drug was launched in February as a treatment for migraines, with or without an aura, in adults. Symbravo is a combination tablet, taken once daily. On the financial side, Axsome's three marketable products are its prime revenue generators. It's still too early for quarterly sales numbers on Symbravo – but both Auvelity and Sunosi showed strong revenue growth in 2024, per Axsome's 4Q24 earnings report. Auvelity's full-year revenue came to $291.4 million, up an impressive 124% year-over-year, while Sunosi's $94.3 million in revenue represented sound y/y growth of 26%. Overall, Axsome saw net product revenue of $385.7 million last year, up 88% from 2023. In addition to its stable of marketable products, Axsome has a solid pipeline of drug candidates. Notable among these is the company's Alzheimer's Disease program. Drug candidate AXS-05 is at the late clinical stages, and earlier this month the company announced positive results from the Phase 3 ACCORD-2 trial of AXS-05 in the treatment of agitation due to Alzheimer's. Last month, on March 3, the company announced that it had received from the FDA the formal pre-New Drug Application meeting minutes, an important step on the path to submitting the supplemental NDA. The sNDA submission for AXS-05 is planned for 3Q25. Despite the market losses of recent trading sessions, Axsome's stock has gained 34% over the past 12 months, and is up 15% for the year-to-date while AXSM still boasts a market cap of $4.8 billion. That market cap, along with several other factors, informs RBC's Leonid Timashev's bullish take here. He writes of Axsome, 'We believe AXSM's profile suggests the company should recover well in the event of a recession given their market cap, three commercial products, and a growing revenue base. Further, with their lead drug positioned to treat depression (we note economic decline is often also associated with increased rates of mental health issues in the population), we believe demand should continue to grow in the near-term. We believe Auvelity can deliver $500M in 2025 sales, and regulatory catalysts in 2H25 (AD agitation filing) and 2026 (potential AD agitation approval) can provide an opportunity for shares to inflect.' Timashev goes on to rate AXSM as Outperform (i.e., Buy), with a $190 price target that points toward a one-year upside potential of 95%. (To watch Timashev's track record, click here) There are 18 recent analyst reviews on record for Axsome, and they are unanimously positive for a Strong Buy consensus rating. The stock's $97.55 trading price and $175.87 average target price together imply a gain of 80% in the next 12 months. (See AXSM stock forecast) Alnylam Pharma (ALNY) The second stock we'll look at here is another biotech/biopharma, Alnylam. This company is focused on RNAi therapeutics, that is, RNA interference drugs used in the treatment of genetically-based diseases. Alnylam was a pioneer in the field of RNAi, and has used the approach to develop a new class of medications that treat diseases by silencing the causative genes. RNAi selectively targets and prevents specific proteins, the physical form of gene expression, from being made, effectively stopping disease conditions where they begin. Like Axsome above, Alnylam has several approved drugs on the market. The first of these to reach commercialization was Onpattro, which received its FDA approval in 2018, . This drug was designated as 'first-in-class,' and is used as a treatment for polyneuropathy caused by hereditary transthyretin-mediated amyloidosis (hATTR amyloidosis) in adult patients. Alnylam followed this in 2019, with the approval of Givlaari for the treatment of acute hepatic porphyria, also in adult patients. This condition affects the production of heme, which helps to bind oxygen in the blood. Patients suffer from the buildup of porphyrin molecules, which are a toxic byproduct of heme production. Givlaari targets the delta-aminolevulinate synthase 1 (ALAS1) enzyme, which is involved in producing heme. In 2020, Alnylam received FDA approval of Oxlumo, the first therapy on the market to lower urinary oxalate levels as a treatment for primary hyperoxaluria type 1 (PH1). The drug is a subcutaneous injection, and is available for both adult and pediatric patients. Next, in 2022, the Alnylam drug Amvuttra was approved. This drug is an RNAi therapeutic agent designed for the treatment of the polyneuropathy of hereditary transthyretin-mediated (hATTR) amyloidosis. This condition prevents the proper expression of the transthyretin (TTR) gene, resulting in TTR buildup that causes nerve damage. In addition, Alnylam announced this past March that its supplemental NDA for Amvuttra, in the treatment of cardiomyopathy of wild-type or hereditary transthyretin-mediated amyloidosis (ATTR-CM) in adults, has also received FDA approval. This approval gives Amvuttra an expanded indication, and makes it the only approved drug on the market to treat both ATTR-CM and the polyneuropathy of hereditary transthyretin-mediated amyloidosis (hATTR-PN) in adult patients. The most recent approved drug in Alnylam's lineup is Qfitlia, the approval of which was announced this past March 28. This drug is the first RNAi treatment approved for the treatment of hemophilia A or B. The approved indication of the drug is described as 'routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients 12 years of age and older with hemophilia A or B, with or without factor VIII or IX inhibitors.' Alnylam has been developing and commercializing Qfitlia in partnership with Sanofi. Qfitlia is Alnylam's second partnership project. The company previously developed Leqvio, a treatment for high cholesterol, as a partnership project with Novartis. On the financial side, Alnylam's 4Q24 report showed that the company generated $593.17 million in total revenue during the quarter, for a 35% gain year-over-year – and beat the forecast by $12.55 million. At the bottom line, Alnylam recorded a quarterly net loss in Q4 of 65 cents per share, missing the estimates by 6 cents per share. A biotech with a solid line-up of approved products will always get attention from the analysts, and RBC's Luca Issi has been following Alnylam. Issi is impressed by the approved drugs, the partnership programs, and the recently expanded indication on Amvuttra. He also sees potential in the firm's development pipeline, and writes of the company, 'We believe ALNY's profile suggests the company could both act as a safe haven and recover well in the event of a recession given their market cap ($30 billion), four commercial products (plus two approved partnered products), and a $2.5b revenue stream anticipated to almost double over the next 3 years. Further, with their lead drug recently approved to treat TTR-CM (a relatively large prevalence pool of ~350k patients, but only 20% on treatment today) we believe demand should continue to grow in the near-term. We believe the TTR franchise can deliver $1.7b in 2025 sales, and the rest of the pipeline (AGT readout 2H25, next-gen TTR phase III start, initiation of obesity studies) can provide an opportunity for shares to inflect.' For Issi, this adds up to an Outperform (i.e., Buy) rating, which he supports with a $330 price target, implying an upside of 47% on the one-year horizon. (To watch Issi's track record, click here) Overall, this stock gets a Strong Buy consensus rating, based on 22 recent reviews that include 18 to Buy and 4 to Hold. The shares are priced at $224.32 and their $323.33 average target price suggests that the stock has a one-year upside potential of 44%. (See ALNY stock forecast) To find good ideas for stocks trading at attractive valuations, visit TipRanks' Best Stocks to Buy, a tool that unites all of TipRanks' equity insights. Disclaimer: The opinions expressed in this article are solely those of the featured analysts. The content is intended to be used for informational purposes only. It is very important to do your own analysis before making any investment. Disclaimer & DisclosureReport an Issue Sign in to access your portfolio
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@
Reuters
01-04-2025
- Health
- Reuters
Axsome to narrow focus of depression drug trial after limited success in initial run
April 1 (Reuters) - Axsome Therapeutics (AXSM.O), opens new tab said on Tuesday it will narrow the focus of a late-stage study of its depression drug after an initial run of the trial showed improvement only in a small subgroup of patients. The drug, solriamfetol, did not show statistically significant improvement in the overall group of patients. Keep up with the latest medical breakthroughs and healthcare trends with the Reuters Health Rounds newsletter. Sign up here. However, it helped reduce symptoms in some patients with major depressive disorder who also suffered from excessive daytime sleepiness (EDS), a common symptom of MDD. "The study missing in the overall MDD population limits the market opportunity significantly, and is disappointing given the company's expertise in the space," RBC Capital Markets analyst Leonid Timashev said in a client note. Axsome said it plans to start a larger late-stage study of the drug in MDD patients with EDS this year. The initial late-stage study that served as a proof of concept for the larger trial had enrolled 346 participants with MDD, of which 51 patients had severe EDS, the company said. The drug was well-tolerated in the study with no new safety concerns, Axsome said. Each year, around 21 million adults in the U.S. are affected by MDD, according to the company. Solriamfetol has already been approved in the U.S. to improve wakefulness in adults with excessive sleepiness from sleep disorders, narcolepsy and sleep apnea, and is sold under the brand Sunosi.
Yahoo
05-03-2025
- Business
- Yahoo
Axsome Therapeutics Settles Sunosi® (solriamfetol) Patent Litigation with Hikma Pharmaceuticals USA
NEW YORK, March 05, 2025 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ: AXSM) (Axsome), a biopharmaceutical company leading a new era in the treatment of central nervous system (CNS) disorders, today announced that it has entered into a settlement agreement with Hikma Pharmaceuticals USA, Inc. (Hikma) resolving patent litigation related to Axsome's product Sunosi® (solriamfetol). The litigation, which is pending in the United States District Court for the District of New Jersey, resulted from submission by Hikma of an Abbreviated New Drug Application to the U.S. Food and Drug Administration seeking approval to market a generic equivalent of Sunosi in the United States. Under the terms of the settlement agreement, Axsome will grant Hikma a license to sell its generic version of Sunosi beginning on or after September 1, 2040, if pediatric exclusivity is granted for Sunosi, or on or after March 1, 2040, if no pediatric exclusivity is granted, subject to FDA approval and conditions and exceptions customary for agreements of this type. As required by law, Axsome and Hikma will submit the settlement agreement to the U.S. Federal Trade Commission and the U.S. Department of Justice for review. Similar patent litigation brought by Axsome against other parties related to Sunosi remains pending in the U.S. District Court for the District of New Jersey. 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 the Company's website at 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 Company's ability to successfully resolve any intellectual property litigation, and even if such disputes are settled, whether the applicable federal agencies will approve of such settlements; 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 circumstance. Investors:Mark JacobsonChief Operating Officer(212) 332-3243mjacobson@ Media:Darren OplandDirector, Corporate Communications(929) 837-1065dopland@ in to access your portfolio
Yahoo
16-02-2025
- Business
- Yahoo
This Stock Is Already Up by 55% in 2025: Is It Too Late to Buy?
It's only mid-February, but as of this writing biotech company Axsome Therapeutics (NASDAQ: AXSM) is up by 55% year to date. Substantial stock-market gains over short periods aren't that rare in the industry. For those who missed Axsome's rally this year, the question is whether the company can perform well over the long run. If that's the case, its shares might still be worth investing in even after their rise. Let's find out whether there's more upside ahead for Axsome Therapeutics. Let's start with a development that recently sent Axsome's stock soaring by about 25% in one day. The company settled a patent lawsuit related to Auvelity, a medicine for major depressive disorder (MDD), with generic drugmaker Teva Pharmaceutical Industries. Auvelity was first approved in 2022; it's one of only three medicines Axsome has on the market. If Teva had launched a generic version of Auvelity, that would have been a significant headwind for Axsome and completely altered its prospects. Fortunately, Teva's settlement with Axsome now means the former won't be able to launch a generic version of Auvelity until 2038 at the earliest. Axsome will grant Teva a license to launch an Auvelity generic at that point, but it's still 13 or more years away. That's excellent news for Axsome Therapeutics and its shareholders. Besides Auvelity, Axsome's lineup features a treatment for narcolepsy, Sunosi, and the newly approved therapy for migraine, Symbravo. Sunosi and Auvelity are driving strong revenue growth. While Axsome has yet to release its fourth-quarter and full-year 2024 financial results, it gave investors a sneak peek. It expects product revenue of $385.2 million for 2024, compared to total revenue of $270.6 million reported last year. So Axsome's 2024 top line should grow by at least 42% compared to 2023. The addition of Symbravo will make an impact on financial results this year. Moreover, the company should make clinical and regulatory progress. It plans to submit Auvelity to the U.S. Food and Drug Administration (FDA) as a potential treatment for Alzheimer's disease (AD) agitation in the second half of the year. In December, Axsome released data from two phase 3 clinical trials from its lead medicine in this indication; Auvelity hit its primary endpoint in the first study but missed it in the second. However, considering there's a high unmet need in AD -- and very few treatments for the disease have been approved in the past two decades -- there's still an excellent chance the FDA will give the go-ahead. Also in December, Axsome reported that an investigational medicine called AXS-12 aced a phase 3 study in treating narcolepsy. The FDA granted AXS-12 its orphan drug designation, which helps expedite the development of promising medications for orphan diseases (life-threatening conditions that affect fewer than 200,000 people in the U.S.). So the company will move forward with AXS-12, too. Elsewhere, Axsome expects late-stage clinical trial results for Sunosi in MDD and attention-deficit/hyperactivity disorder (ADHD) in the first quarter of 2025. It's also working on the submission of a regulatory application for AXS-14 in fibromyalgia. Axsome could launch at least one product and earn a key indication for another (Auvelity) in the next 18 months. In the next three years, it could have two other brand-new medicines in its portfolio on top of that. These drugs will drive solid top-line growth well into the 2030s. In my view, Axsome Therapeutics has yet to peak. The biotech company could deliver solid returns in the next five years and beyond, so it's not too late to invest in the stock. Ever feel like you missed the boat in buying the most successful stocks? Then you'll want to hear this. On rare occasions, our expert team of analysts issues a 'Double Down' stock recommendation for companies that they think are about to pop. If you're worried you've already missed your chance to invest, now is the best time to buy before it's too late. And the numbers speak for themselves: Nvidia: if you invested $1,000 when we doubled down in 2009, you'd have $360,040!* Apple: if you invested $1,000 when we doubled down in 2008, you'd have $46,374!* Netflix: if you invested $1,000 when we doubled down in 2004, you'd have $570,894!* Right now, we're issuing 'Double Down' alerts for three incredible companies, and there may not be another chance like this anytime soon.*Stock Advisor returns as of February 3, 2025 Prosper Junior Bakiny 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. This Stock Is Already Up by 55% in 2025: Is It Too Late to Buy? was originally published by The Motley Fool Sign in to access your portfolio
