Latest news with #Auvelity
Yahoo
27-05-2025
- Business
- Yahoo
Why Is Teva Stock Trading Higher On Tuesday?
Teva Pharmaceutical Industries Ltd (NYSE:TEVA) and Biolojic Design Ltd announced that Teva initiated IND-enabling studies with BD9, a dual-specific multibody targeting both TSLP (Thymic stromal lymphopoietin) and IL-13. Teva has an exclusive license to develop BD9 for TH2-driven inflammatory diseases such as atopic dermatitis and asthma. By simultaneously blocking two key drivers of TH2-driven inflammation, BD9 can potentially improve outcomes for patients with conditions such as atopic dermatitis and asthma, where current treatments fall initiation of IND-enabling studies marks a critical milestone in translating this scientific innovation into a potential therapeutic option. It will pave the way for clinical trials and ultimately bring hope to underserved patient populations. Under the terms of their agreement, Teva is developing BD9 worldwide. In exchange, Biolojic is eligible to receive milestone payments based on the achievement of certain pre-clinical, clinical, regulatory, and commercial milestones, including the initiation of IND-enabling studies. In May, the U.S. Food and Drug Administration (FDA) approved Teva and Alvotech's (NASDAQ:ALVO) Selarsdi (ustekinumab-aekn) injection as interchangeable with the reference biologic Johnson & Johnson's (NYSE:JNJ) Stelara (ustekinumab). In January, The U.S. Food and Drug Administration (FDA) issued a warning regarding the risk of anaphylaxis, a rare but severe allergic reaction associated with glatiramer acetate, a medication used to treat relapsing forms of multiple sclerosis (MS). Glatiramer acetate, sold under the brand name Copaxone by Teva and as generics like Glatopa, is an injectable medication designed to reduce the frequency of MS relapses. In February, Axsome Therapeutics, Inc. (NASDAQ:AXSM) signed a settlement agreement with Teva Pharmaceuticals. The settlement resolves all patent litigation related to Axsome's Auvelity (dextromethorphan HBr – bupropion HCl) product. Auvelity is approved in the U.S. for major depressive disorder. The litigation resulted from Teva submitting an Abbreviated New Drug Application to the U.S. Food and Drug Administration (FDA) seeking approval to market a generic version of Auvelity in the U.S. before the expiration of applicable Axsome patents. Price Action: TEVA stock is up 6.01% at $17.98 at the last check Tuesday. Read Next:Photo via Shutterstock Up Next: Transform your trading with Benzinga Edge's one-of-a-kind market trade ideas and tools. Click now to access unique insights that can set you ahead in today's competitive market. Get the latest stock analysis from Benzinga? TEVA PHARMACEUTICAL INDUS (TEVA): Free Stock Analysis Report This article Why Is Teva Stock Trading Higher On Tuesday? originally appeared on © 2025 Benzinga does not provide investment advice. All rights reserved. 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
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
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
Yahoo
12-02-2025
- Business
- Yahoo
Why Axsome Therapeutics (AXSM) Is Advancing Today
Axsome Therapeutics (AXSM) is climbing nearly 4% after Swiss bank UBS increased its price target on the shares to $133 from $105. The bank is confident that the company's potential treatment for Alzheimer's Disease Agitation (ADA) will ultimately be approved by the FDA. UBS' Take on AXSM The bank expects the FDA to accept AXSM's filing of its potential ADA treatment, AXS-05, for the agency's approval, and UBS anticipates that the drug will ultimately be approved by the FDA for this indication. The drug hit its primary endpoints in three trials of its effectiveness as an ADA treatment and failed to meaningfully surpass the placebo in one such trial. AXS-05 is already approved as a treatment for major depressive disorder. UBS reports that there are only limited therapies for ADA at this point, and it kept a Buy rating on AXSM. AXSM Settled Patent Litigation The company disclosed yesterday that it had settled patent litigation with Teva (TEVA) related to AXSM's antidepressant drug, Auvelity. Teva was trying to receive authorization from the FDA to market a generic version of the drug before a number of AXSM's patents expire. Under the deal, Teva will not be allowed to market a generic version of the drug until 2038 or 2039. The settlement will be reviewed by the Department of Justice and the Federal Trade Commission. While we acknowledge the potential of AXSM, our conviction lies in the belief that some AI stocks hold greater promise for delivering higher returns, and doing so within a shorter time frame. If you are looking for an AI stock that is more promising than AXSM but that trades at less than 5 times its earnings, check out our report about the cheapest AI stock. READ ALSO 8 Best Wide Moat Stocks to Buy Now and 30 Most Important AI Stocks According to BlackRock Disclosure: None. This article is originally published at Insider Monkey.
Yahoo
11-02-2025
- Business
- Yahoo
Axsome Stock Surges 20% on Auvelity Patent Settlement With Teva
Shares of Axsome Therapeutics AXSM jumped 20.2% on Monday after the company announced that it has entered into a settlement agreement with Teva Pharmaceuticals TEVA related to patents for the psychiatry drug, Auvelity. The settlement agreement resolves the patent litigation brought by Axsome on Teva for submitting an abbreviated new drug application to the FDA, seeking marketing approval for a generic version of Auvelity in the United States before applicable patents expire. Auvelity is approved for the treatment of adults with major depressive disorder ('MDD'). It is the first approved drug in Axsome's portfolio. Auvelity was launched in the United States in 2022. The company is conducting several label expansion studies on Auvelity targeting other central nervous system disorders like Alzheimer's disease ('AD') associated with agitation and smoking cessation. In the past three months, shares of Axsome have surged 27.7% against the industry's 7.8% decline. Image Source: Zacks Investment Research Per the settlement terms, Axsome will grant Teva a license to sell a generic version of Auvelity in the United States, subject to approval and other customary conditions, on or after Sept. 30, 2038. However, if pediatric exclusivity is granted for Auvelity, the launch of Teva's generic version will be delayed until or after March 31, 2039. Axsome and Teva will end all ongoing patent litigation over Auvelity patents in the U.S. District Court in New Jersey. Per AXSM, the settlement agreement resolves all outstanding patent litigation relating to Auvelity. Axsome and Teva are required to submit the settlement agreement for review by the U.S. Federal Trade Commission and the U.S. Department of Justice, as mandated by law. This is a huge win for Axsome. It protects the company's Auvelity sales from generic erosion in the U.S. market for MDD treatment. The drug is the primary top-line driver for AXSM. In the first nine months of 2024, the drug generated sales worth $198.8 million, driven by an increase in unit sales volume which indicates a rise of 145.4% year over year in the United States. Auvelity sales accounted for 75% of the company's net product revenues recognized during the same period. Last month, Axsome reported robust preliminary net-product revenues for Auvelity and narcolepsy drug, Sunosi, for the fourth quarter and full-year 2024. Auvelity sales in the fourth quarter of 2024 are expected to be around $92.6 million, bringing the full-year number to around $291.4 million. Sunosi's net-product revenues are expected to be around $25.7 million and $93.8 million for the fourth quarter and full-year 2024, respectively. Axsome is also currently gearing up to submit a new drug application for AXS-05 in AD agitation to the FDA in the second half of 2025, based on efficacy and safety data from two separate phase III studies, evaluating the candidate for treating agitation associated with the same. Axsome Therapeutics, Inc. price-consensus-chart | Axsome Therapeutics, Inc. Quote Axsome currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks from the sector are BioMarin Pharmaceutical BMRN and Alnylam Pharmaceuticals ALNY, each currently carryinga Zacks Rank #2 (Buy). You can see the complete list of today's Zacks #1 (Strong Buy) Rank stocks here. In the past 30 days, estimates for BioMarin Pharmaceutical's 2024 earnings per share have increased from $3.28 to $3.29. Estimates for 2025 earnings per share have remained constant at $4.01 during the same timeframe. In the past three months, BioMarin Pharmaceutical shares have lost 4%. BMRN's earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 28.7%. In the past 30 days, estimates for Alnylam Pharmaceuticals' 2024 loss per share have remained constant at 39 cents. The estimate for 2025 earnings per share is currently pegged at 41 cents. In the past three months, shares of Alnylam Pharmaceuticals have gained 1.9%. ALNY's earnings beat estimates in three of the trailing four quarters and matched once, delivering an average surprise of 65.67%. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Alnylam Pharmaceuticals, Inc. (ALNY) : Free Stock Analysis Report BioMarin Pharmaceutical Inc. (BMRN) : Free Stock Analysis Report Teva Pharmaceutical Industries Ltd. (TEVA) : Free Stock Analysis Report Axsome Therapeutics, Inc. (AXSM) : Free Stock Analysis Report To read this article on click here. Zacks Investment Research Sign in to access your portfolio
