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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
11-02-2025
- Business
- Yahoo
Axsome Therapeutics Resolves Generic Patent Litigation With Teva Over Depression Drug, Analyst Maintains Axsome As 'Top Pick For 2025'
On Monday, Axsome Therapeutics, Inc. (NASDAQ:AXSM) signed a settlement agreement with Teva Pharmaceuticals Inc (NYSE:TEVA). 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. Also Read: Under the terms of the settlement agreement, Axsome will grant Teva a license to sell its generic version of Auvelity beginning on or after March 31, 2039, if pediatric exclusivity is granted for Auvelity, or on or after September 30, 2038, if no pediatric exclusivity is granted. The parties will terminate all ongoing litigation between Axsome and Teva regarding Auvelity patents pending in the U.S. District Court for the District of New Jersey. In January, Axsome Therapeutics reported preliminary Auvelity net product sales are expected to be approximately $92.6 million and $291.4 million for the fourth quarter and full year of 2024, respectively. Recently, the FDA approved Axsome Therapeutics' Symbravo (meloxicam and rizatriptan) for the acute treatment of migraine with or without aura in adults. 'Axsome is our top pick for 2025,' William Blair writes. Analyst Myles Minter reiterates the Outperform rating based on favorable litigation settlement and clarity on Auvelity's generic launch timing. 'We also remain impressed with the Auvelity launch, which showed 15% growth in revenue over the prior quarter and is annualizing about $370 million after two years of launch,' William Blair adds. Axsome now has three commercial products with the approval of Symbravo for migraines. While investors are mainly watching Auvelity's rollout for depression and its potential use in Alzheimer's-related agitation, analyst Minter writes Symbravo's potential in treating acute migraines is being overlooked. William Blair also views Axsome as a takeout candidate with Johnson & Johnson buying Intra-Cellular Therapies Inc. for $14.6 billion. Needham analyst Ami Fadia reiterates Axsome Therapeutics with a Buy and maintains a $133 price target. Price Action: AXSM stock is up 24.6% at $131.77 at last check Monday. Read Next:Photo: Courtesy of Ulf Wittrock via Shutterstock. Date Firm Action From To Mar 2022 SVB Leerink Maintains Outperform Nov 2021 SVB Leerink Maintains Outperform Aug 2021 HC Wainwright & Co. Maintains Buy View More Analyst Ratings for AXSM View the Latest Analyst Ratings UNLOCKED: 5 NEW TRADES EVERY WEEK. Click now to get top trade ideas daily, plus unlimited access to cutting-edge tools and strategies to gain an edge in the markets. Get the latest stock analysis from Benzinga? AXSOME THERAPEUTICS (AXSM): Free Stock Analysis Report This article Axsome Therapeutics Resolves Generic Patent Litigation With Teva Over Depression Drug, Analyst Maintains Axsome As 'Top Pick For 2025' originally appeared on © 2025 Benzinga does not provide investment advice. All rights reserved.
