Latest news with #AXSM
Yahoo
06-07-2025
- Business
- Yahoo
Morgan Stanley Assumes Coverage of Axsome Therapeutics (AXSM) with an Overweight Rating
Axsome Therapeutics, Inc. (NASDAQ:AXSM) is one of the 13 Best Pharma Stocks to Buy According to Wall Street Analysts. On July 3, Morgan Stanley analyst Sean Laaman assumed coverage of Axsome Therapeutics, Inc. (NASDAQ:AXSM) with an Overweight rating and a $190 price target. The firm stated that the base case for the rating is the expected on-time supplemental New Drug application Submission for AXS-05 in Alzheimer's Disease Agitation. According to the analyst, it has a high probability of regulatory success and may lead to a potential $900 million in sales by 2030. A pharmacist preparing a prescription for a rapidly absorbed multi-mechanistic medicine. He further stated that the continued launch progress of Auvelity in major depressive disorder is another positive factor for Axsome Therapeutics, Inc. (NASDAQ:AXSM). The analyst told investors in a research note that this growth trajectory is anticipated to continue, supported by market penetration strategies and an expanded sales force. Axsome Therapeutics, Inc. (NASDAQ:AXSM) is a commercial-stage biopharmaceutical company that develops and delivers therapies for central nervous system conditions with limited treatment options. Its two commercial products and development programs include Auvelity and Sunosi. Auvelity treats major depressive disorder (MDD), and Sunosi is an oral medication for the treatment of excessive daytime sleepiness in patients with narcolepsy or obstructive sleep apnea. While we acknowledge the potential of AXSM as an investment, we believe certain AI stocks offer greater upside potential and carry less downside risk. If you're looking for an extremely undervalued AI stock that also stands to benefit significantly from Trump-era tariffs and the onshoring trend, see our free report on the best short-term AI stock. READ NEXT: The Best and Worst Dow Stocks for the Next 12 Months and 10 Unstoppable Stocks That Could Double Your Money. Disclosure: None.
Yahoo
05-07-2025
- Business
- Yahoo
Piper Sandler Reaffirms Price Target on Axsome (AXSM) Despite AXS-14 FDA Hurdle
Axsome Therapeutics Inc. (NASDAQ:AXSM) ranks among the 30 stocks expected to beat the market by 20 percentage points this year. Piper Sandler analysts maintained their $148 price target for Axsome Therapeutics Inc. (NASDAQ:AXSM) and reaffirmed their Overweight rating on June 10. This decision comes after the company revealed that the FDA had sent it a Refuse to File (RTF) notice regarding its New Drug Application (NDA) for AXS-14, an oral norepinephrine reuptake inhibitor used to treat fibromyalgia. Although Piper Sandler analysts acknowledged the setback, they stressed that Axsome's shares are not significantly impacted by this incident. Given the lack of new agent approvals in the fibromyalgia sector over the past ten years, the analysts pointed out that the FDA's requested additional study would be useful, and claim that Axsome Therapeutics Inc. (NASDAQ:AXSM) can support the new study with its current commercial infrastructure. Axsome Therapeutics Inc. (NASDAQ:AXSM) is a clinical stage biopharmaceutical company that contributes to the creation of novel therapies for disorders of the central nervous system. While we acknowledge the potential of AXSM as an investment, we believe certain AI stocks offer greater upside potential and carry less downside risk. If you're looking for an extremely undervalued AI stock that also stands to benefit significantly from Trump-era tariffs and the onshoring trend, see our free report on the best short-term AI stock. Read More: and Disclosure: None.
Yahoo
12-06-2025
- Business
- Yahoo
Axsome's AXS-14 Gets Regulatory Setback with RTF, says Morgan Stanley
Axsome Therapeutics, Inc. (NASDAQ:AXSM) is one of the 13 Biotech Stocks with Huge Upside Potential. The FDA's Division of Anesthesiology, Addiction Medicine, and Pain Medicine has issued a Refusal to File letter for Axsome Therapeutics, Inc. (NASDAQ:AXSM) AXS-14 new drug application. A pharmacist preparing a prescription for a rapidly absorbed multi-mechanistic medicine. The submission was deemed incomplete by the agency due to the use of an 8-week primary endpoint in one of the two supporting trials and a flexible-dose schedule. Vikram Purohit, an analyst at Morgan Stanley, stated that Axsome Therapeutics, Inc. (NASDAQ:AXSM) intends to start a fresh 12-week primary endpoint trial with a fixed dose in Q4. The stock is still rated as overweight by Morgan Stanley, which has set a price target of $190. AXS-14's regulatory setback is viewed as a temporary setback. The regulatory development of AXS-05 for Alzheimer's disease agitation and the commercial success of Auvelity in major depressive disorder are seen by Morgan Stanley as Axsome Therapeutics, Inc. (NASDAQ:AXSM)'s primary 2025 value drivers. The company is nevertheless optimistic about Axsome Therapeutics, Inc. (NASDAQ:AXSM)'s overall pipeline momentum and prospects for near-term revenue growth despite the AXS-14 filing struggle. Axsome Therapeutics, Inc. (NASDAQ:AXSM) is a biopharmaceutical business in the clinical stage. It is involved in the development of new treatments for conditions of the central nervous system or CNS, for which there are few available options. The business is among the stocks with the biggest upside. While we acknowledge the potential of AXSM as an investment, we believe certain AI stocks offer greater upside potential and carry less downside risk. If you're looking for an extremely undervalued AI stock that also stands to benefit significantly from Trump-era tariffs and the onshoring trend, see our free report on the best short-term AI stock. READ NEXT: 10 High-Growth EV Stocks to Invest In and 13 Best Car Stocks to Buy in 2025. Disclosure. None. Sign in to access your portfolio
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. _____
