Axsome Therapeutics 株価情報 (NASDAQ: AXSM)

最新ニュース Axsome Therapeutics (NASDAQ:AXSM) 株価情報

Axsome Therapeutics

Axsome Therapeutics Inc is a clinical-stage biopharmaceutical company. It is engaged in developing novel therapies for the management of the central nervous system, or CNS, disorders for which there are limited treatment options. Its pipeline products include AXS-05, AXS-07, AXS-12, and AXS-14. It manages its business as one operating segment and reporting unit, which is the business of developing and delivering novel therapies for the management of CNS disorders.

Axsome Therapeutics Inc

Needham analyst Ami Fadia reiterates Axsome Therapeutics (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/AXSM#NASDAQ">AXSM</a>) with a Buy and maintains $133 price target.

News

Price Target

Reiteration

Analyst Ratings

AXSM

Needham Reiterates Buy on Axsome Therapeutics, Maintains $133 Price Target

Mizuho analyst Graig Suvannavejh maintains Axsome Therapeutics (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/AXSM#NASDAQ">AXSM</a>) with a Outperform and lowers the price target from $124 to $122.

Mizuho Maintains Outperform on Axsome Therapeutics, Lowers Price Target to $122

On Monday, Axsome Therapeutics, Inc.&nbsp;(NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/AXSM#NASDAQ">AXSM</a>) released data from ACCORD-2, ADVANCE-2, and long-term safety trials AXS-05 (dextromethorphan-bupropion) in <a target="_blank" href="https://www.benzinga.com/pressreleases/24/12/g42719707/axsome-therapeutics-announces-successful-completion-and-results-of-phase-3-clinical-program-of-axs" rel="noreferrer noopener">Alzheimer's disease agitation</a>.
The ACCORD-2 Phase 3 trial achieved the primary endpoint with AXS-05 statistically significantly delaying the time to relapse of agitation, demonstrating a 3.6-fold lower risk of relapse compared to placebo.
AXS-05 also met the key secondary endpoint (relapse prevention, p=0.001). Further, AXS-05 reduced the worsening of overall Alzheimer's disease severity compared to the placebo.
Also Read: <a target="_blank" href="https://www.benzinga.com/general/biotech/24/11/42221091/axsome-therapeutics-axs-12-data-for-sleeping-disorder-boosts-confidence-in-approval-and-market-potential-analyst-says" rel="noreferrer noopener">Axsome Therapeutics' AXS-12 Data For Sleeping Disorder Boosts Confidence In Approval And Market Potential, Analyst Says</a>
The ADVANCE-2 Phase 3 trial did not demonstrate statistical significance for the primary endpoint in delaying the time to relapse of agitation from baseline to Week 5, with reductions of 13.8 and 12.6 points for AXS-05 and placebo, respectively.
However, results for the primary and nearly all secondary endpoints numerically favored AXS-05 over placebo.
AXS-05 was safe and well tolerated in both controlled studies.
The long-term safety and tolerability of AXS-05 were also evaluated in more than 300 subjects treated for at least 6 months and more than 100 treated for at least 12 months.
In the controlled and long-term studies in subjects with Alzheimer's disease, AXS-05 was not associated with an increased risk of falls, cognitive decline, or sedation.
In the clinical program for AXS-05 in Alzheimer's disease agitation, there have been no deaths in subjects receiving AXS-05.
Axsome plans to submit an NDA for AXS-05 in Alzheimer's disease agitation to the FDA in the second half of 2025.
William Blair writes that the data from the trials represent a mixed scenario for investors to digest how regulators will interpret the total pivotal data package for AXS-05 in Alzheimer's disease agitation.
The analyst notes that neuropsychiatry drugs have been approved based on their overall data, even if they faced setbacks in key trials.
Examples include Intra-Cellular Therapies Inc's (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ITCI#NASDAQ">ITCI</a>) Caplyta and Johnson &amp; Johnson's (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/JNJ#NYSE">JNJ</a>) esketamine.
William Blair notes the approval of Otsuka Holdings Co Ltd (OTC:<a class="ticker" href="https://www.benzinga.com/stock/OTSKY#OTC">OTSKY</a>) (OTC:<a class="ticker" href="https://www.benzinga.com/stock/OTSKF#OTC">OTSKF</a>) Rexulti for Alzheimer's-related agitation, despite mixed trial results, is a strong comparison for Axsome's AXS-05.
However, a key difference is that Rexulti's approval relied on placebo-controlled parallel group studies, while Axsome is expected to depend on results from the ADVANCE-1 and ACCORD-1/2 trials to meet the FDA's requirement for two well-controlled studies.
The analyst remains optimistic about AXS-05's approval, highlighting that the FDA's continued designation of AXS-05 as a breakthrough therapy reflects the high unmet need in this area, which could work in Axsome's favor.
Price Action: AXSM stock is up 2.62% to $87.00 premarket at the last check on Tuesday.
Read Next:
<ul>
<li><a href="https://www.benzinga.com/24/12/42729529/social-media-stocks-react-as-trump-targets-censorship-and-delays-tiktok-ban" target="_blank" rel="noreferrer noopener">Trump Administration to Challenge Social Media Censorship, Setting Stage for Conflict with EU Regulations</a></li>
</ul>

Analyst Color

Biotech

Health Care

Trading Ideas

General

ITCI

OTSKF

OTSKY

Axsome Reveals Data From Alzheimer's Studies, Analyst Sees Hope Despite Mixed Trial Results

HC Wainwright &amp; Co. analyst Raghuram Selvaraju reiterates Axsome Therapeutics (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/AXSM#NASDAQ">AXSM</a>) from Buy to Buy.

HC Wainwright & Co. Reiterates Buy on Axsome Therapeuticsto Buy

Whales with a lot of money to spend have taken a noticeably bearish stance on Axsome Therapeutics.
Looking at options history for Axsome Therapeutics (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/AXSM#NASDAQ">AXSM</a>) we detected 14 trades.
If we consider the specifics of each trade, it is accurate to state that 42% of the investors opened trades with bullish expectations and 50% with bearish.
From the overall spotted trades, 9 are puts, for a total amount of $2,365,912 and 5, calls, for a total amount of $327,807.
<h3>Projected Price Targets</h3>
Based on the trading activity, it appears that the significant investors are aiming for a price territory stretching from $75.0 to $110.0 for Axsome Therapeutics over the recent three months. 
<h3>Volume &amp; Open Interest Development</h3>
Looking at the volume and open interest is a powerful move while trading options. This data can help you track the liquidity and interest for Axsome Therapeutics's options for a given strike price. Below, we can observe the evolution of the volume and open interest of calls and puts, respectively, for all of Axsome Therapeutics's whale trades within a strike price range from $75.0 to $110.0 in the last 30 days. 
<h3>Axsome Therapeutics 30-Day Option Volume &amp; Interest Snapshot</h3>
<img src="https://www.benzinga.com/files/images/story/2024/1735578918_0.png" alt="Options Call Chart" />
<h3>Largest Options Trades Observed:</h3>

<table>
<thead>
<tr>
<th>Symbol</th>
<th>PUT/CALL</th>
<th>Trade Type</th>
<th>Sentiment</th>
<th>Exp. Date</th>
<th>Ask</th>
<th>Bid</th>
<th>Price</th>
<th>Strike Price</th>
<th>Total Trade Price</th>
<th>Open Interest</th>
<th>Volume</th>
</tr>
</thead>
<tbody>
<tr>
<td>AXSM</td>
<td>PUT</td>
<td>TRADE</td>
<td>BULLISH</td>
<td>01/17/25</td>
<td>$15.0</td>
<td>$11.7</td>
<td>$12.05</td>
<td>$92.50</td>
<td>$1.6M</td>
<td>1.7K</td>
<td>1.3K</td>
</tr>
<tr>
<td>AXSM</td>
<td>PUT</td>
<td>SWEEP</td>
<td>BEARISH</td>
<td>01/17/25</td>
<td>$6.0</td>
<td>$4.9</td>
<td>$6.0</td>
<td>$80.00</td>
<td>$245.4K</td>
<td>3.0K</td>
<td>1.6K</td>
</tr>
<tr>
<td>AXSM</td>
<td>PUT</td>
<td>SWEEP</td>
<td>BEARISH</td>
<td>01/17/25</td>
<td>$6.4</td>
<td>$6.1</td>
<td>$6.4</td>
<td>$80.00</td>
<td>$190.6K</td>
<td>3.0K</td>
<td>184</td>
</tr>
<tr>
<td>AXSM</td>
<td>CALL</td>
<td>TRADE</td>
<td>BEARISH</td>
<td>01/16/26</td>
<td>$11.5</td>
<td>$9.9</td>
<td>$9.9</td>
<td>$110.00</td>
<td>$122.7K</td>
<td>16</td>
<td>250</td>
</tr>
<tr>
<td>AXSM</td>
<td>CALL</td>
<td>TRADE</td>
<td>BULLISH</td>
<td>01/16/26</td>
<td>$9.9</td>
<td>$7.2</td>
<td>$9.2</td>
<td>$110.00</td>
<td>$115.0K</td>
<td>16</td>
<td>125</td>
</tr>
</tbody>
</table>

<h3>About Axsome Therapeutics</h3>
Axsome Therapeutics Inc is a clinical-stage biopharmaceutical company. It is engaged in developing novel therapies for the management of the central nervous system, or CNS, disorders for which there are limited treatment options. Its pipeline products include AXS-05, AXS-07, AXS-12, and AXS-14. It manages its business as one operating segment and reporting unit, which is the business of developing and delivering novel therapies for the management of CNS disorders.
After a thorough review of the options trading surrounding Axsome Therapeutics, we move to examine the company in more detail. This includes an assessment of its current market status and performance.
<h3>Axsome Therapeutics's Current Market Status</h3>
<ul>
<li>Currently trading with a volume of 2,190,797, the AXSM's price is down by -9.18%, now at $78.75. </li>
<li>RSI readings suggest the stock is currently may be oversold.</li>
<li>Anticipated earnings release is in 50 days.</li>
</ul>
<h3>What The Experts Say On Axsome Therapeutics</h3>
In the last month, 2 experts released ratings on this stock with an average target price of $125.5.
Turn $1000 into $1270 in just 20 days?
20-year pro options trader reveals his one-line chart technique that shows when to buy and sell. Copy his trades, which have had averaged a 27% profit every 20 days. <a href="https://www.benzinga.com/premium/ideas/options-moneyline-2/?t=Moop1arja3be22op14&amp;utm_source=benzinga-insights">Click here for access</a>. 
&#x2A; Reflecting concerns, an analyst from Cantor Fitzgerald lowers its rating to Overweight with a new price target of $121. 
&#x2A; In a cautious move, an analyst from Needham downgraded its rating to Buy, setting a price target of $130. 
Trading options involves greater risks but also offers the potential for higher profits. Savvy traders mitigate these risks through ongoing education, strategic trade adjustments, utilizing various indicators, and staying attuned to market dynamics. Keep up with the latest options trades for Axsome Therapeutics with <a href="https://benzinga.grsm.io/register174">Benzinga Pro</a> for real-time alerts.

Options

Markets

Smart Money Is Betting Big In AXSM Options

8 analysts have expressed a variety of opinions on Axsome Therapeutics (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/AXSM#NASDAQ">AXSM</a>) over the past quarter, offering a diverse set of opinions from bullish to bearish.
In the table below, you'll find a summary of their recent ratings, revealing the shifting sentiments over the past 30 days and comparing them to the previous months.
<table>
<thead>
<tr>
<th></th>
<th align="right">Bullish</th>
<th align="right">Somewhat Bullish</th>
<th align="right">Indifferent</th>
<th align="right">Somewhat Bearish</th>
<th align="right">Bearish</th>
</tr>
</thead>
<tbody>
<tr>
<td>Total Ratings</td>
<td align="right">5</td>
<td align="right">3</td>
<td align="right">0</td>
<td align="right">0</td>
<td align="right">0</td>
</tr>
<tr>
<td>Last 30D</td>
<td align="right">1</td>
<td align="right">0</td>
<td align="right">0</td>
<td align="right">0</td>
<td align="right">0</td>
</tr>
<tr>
<td>1M Ago</td>
<td align="right">0</td>
<td align="right">1</td>
<td align="right">0</td>
<td align="right">0</td>
<td align="right">0</td>
</tr>
<tr>
<td>2M Ago</td>
<td align="right">4</td>
<td align="right">1</td>
<td align="right">0</td>
<td align="right">0</td>
<td align="right">0</td>
</tr>
<tr>
<td>3M Ago</td>
<td align="right">0</td>
<td align="right">1</td>
<td align="right">0</td>
<td align="right">0</td>
<td align="right">0</td>
</tr>
</tbody>
</table>
Providing deeper insights, analysts have established 12-month price targets, indicating an average target of $139.75, along with a high estimate of $180.00 and a low estimate of $116.00. This current average has increased by 0.45% from the previous average price target of $139.12. 
<img src="https://www.benzinga.com/files/images/story/2024/1735567218_0.png" alt="price target chart" />
<h2>Deciphering Analyst Ratings: An In-Depth Analysis</h2>
In examining recent analyst actions, we gain insights into how financial experts perceive Axsome Therapeutics. The following summary outlines key analysts, their recent evaluations, and adjustments to ratings and price targets.
<table>
<thead>
<tr>
<th>Analyst</th>
<th>Analyst Firm</th>
<th>Action Taken</th>
<th>Rating</th>
<th>Current Price Target</th>
<th>Prior Price Target</th>
</tr>
</thead>
<tbody>
<tr>
<td>Ami Fadia</td>
<td>Needham</td>
<td>Maintains</td>
<td>Buy</td>
<td>$130.00</td>
<td>$130.00</td>
</tr>
<tr>
<td>Charles Duncan</td>
<td>Cantor Fitzgerald</td>
<td>Maintains</td>
<td>Overweight</td>
<td>$121.00</td>
<td>$121.00</td>
</tr>
<tr>
<td>Raghuram Selvaraju</td>
<td>HC Wainwright &amp; Co.</td>
<td>Maintains</td>
<td>Buy</td>
<td>$180.00</td>
<td>$180.00</td>
</tr>
<tr>
<td>Raghuram Selvaraju</td>
<td>HC Wainwright &amp; Co.</td>
<td>Maintains</td>
<td>Buy</td>
<td>$180.00</td>
<td>$180.00</td>
</tr>
<tr>
<td>Joel Beatty</td>
<td>Baird</td>
<td>Raises</td>
<td>Outperform</td>
<td>$116.00</td>
<td>$112.00</td>
</tr>
<tr>
<td>Ami Fadia</td>
<td>Needham</td>
<td>Maintains</td>
<td>Buy</td>
<td>$130.00</td>
<td>$130.00</td>
</tr>
<tr>
<td>Ami Fadia</td>
<td>Needham</td>
<td>Maintains</td>
<td>Buy</td>
<td>$130.00</td>
<td>$130.00</td>
</tr>
<tr>
<td>Leonid Timashev</td>
<td>RBC Capital</td>
<td>Raises</td>
<td>Outperform</td>
<td>$131.00</td>
<td>$130.00</td>
</tr>
</tbody>
</table>
<h3>Key Insights:</h3>
<ul>
<li>Action Taken: In response to dynamic market conditions and company performance, analysts update their recommendations. Whether they 'Maintain', 'Raise', or 'Lower' their stance, it signifies their reaction to recent developments related to Axsome Therapeutics. This insight gives a snapshot of analysts' perspectives on the current state of the company.</li>
<li>Rating: Analysts unravel qualitative evaluations for stocks, ranging from 'Outperform' to 'Underperform'. These ratings offer insights into expectations for the relative performance of Axsome Therapeutics compared to the broader market.</li>
<li>Price Targets: Analysts set price targets as an estimate of a stock's future value. Comparing the current and prior price targets provides insight into how analysts' expectations have changed over time. This information can be valuable for investors seeking to understand consensus views on the stock's potential future performance.</li>
</ul>
Understanding these analyst evaluations alongside key financial indicators can offer valuable insights into Axsome Therapeutics's market standing. Stay informed and make well-considered decisions with our Ratings Table.
<a href="https://www.benzinga.com/quote/AXSM/analyst-ratings?utm_source=Benzinga Insights">Stay up to date on Axsome Therapeutics analyst ratings.</a>
<h2>Discovering Axsome Therapeutics: A Closer Look</h2>
Axsome Therapeutics Inc is a clinical-stage biopharmaceutical company. It is engaged in developing novel therapies for the management of the central nervous system, or CNS, disorders for which there are limited treatment options. Its pipeline products include AXS-05, AXS-07, AXS-12, and AXS-14. It manages its business as one operating segment and reporting unit, which is the business of developing and delivering novel therapies for the management of CNS disorders.
<h3>Financial Milestones: Axsome Therapeutics's Journey</h3>
Market Capitalization Analysis: Reflecting a smaller scale, the company's market capitalization is positioned below industry averages. This could be attributed to factors such as growth expectations or operational capacity.
Positive Revenue Trend: Examining Axsome Therapeutics's financials over 3 months reveals a positive narrative. The company achieved a noteworthy revenue growth rate of 81.27% as of 30 September, 2024, showcasing a substantial increase in top-line earnings. In comparison to its industry peers, the company stands out with a growth rate higher than the average among peers in the Health Care sector.
Net Margin: Axsome Therapeutics's net margin falls below industry averages, indicating challenges in achieving strong profitability. With a net margin of -61.67%, the company may face hurdles in effective cost management.
Return on Equity (ROE): Axsome Therapeutics's ROE is below industry averages, indicating potential challenges in efficiently utilizing equity capital. With an ROE of -66.0%, the company may face hurdles in achieving optimal financial returns.
Return on Assets (ROA): Axsome Therapeutics's ROA is below industry standards, pointing towards difficulties in efficiently utilizing assets. With an ROA of -11.64%, the company may encounter challenges in delivering satisfactory returns from its assets.
Debt Management: Axsome Therapeutics's debt-to-equity ratio is notably higher than the industry average. With a ratio of 2.07, the company relies more heavily on borrowed funds, indicating a higher level of financial risk.
<h2>The Basics of Analyst Ratings</h2>
Ratings come from analysts, or specialists within banking and financial systems that report for specific stocks or defined sectors (typically once per quarter for each stock). Analysts usually derive their information from company conference calls and meetings, financial statements, and conversations with important insiders to reach their decisions.
Beyond their standard evaluations, some analysts contribute predictions for metrics like growth estimates, earnings, and revenue, furnishing investors with additional guidance. Users of analyst ratings should be mindful that this specialized advice is shaped by human perspectives and may be subject to variability.
Which Stocks Are Analysts Recommending Now?
Benzinga Edge gives you instant access to all major analyst upgrades, downgrades, and price targets. Sort by accuracy, upside potential, and more. <a href="https://www.benzinga.com/premium/ideas/benzinga-edge-checkout/?t=be8be9arja3be22bz21&amp;utm_source=benzinga-insights">Click here to stay ahead of the market</a>.
This article was generated by Benzinga's automated content engine and reviewed by an editor.

Expert Outlook: Axsome Therapeutics Through The Eyes Of 8 Analysts

Needham analyst Ami Fadia reiterates Axsome Therapeutics (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/AXSM#NASDAQ">AXSM</a>) with a Buy and maintains $130 price target.

Needham Reiterates Buy on Axsome Therapeutics, Maintains $130 Price Target

U.S. stock futures were lower this morning, with the Dow futures falling more than 50 points on Monday.
Shares of Axsome Therapeutics, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/AXSM#NASDAQ">AXSM</a>) fell sharply in today's pre-market trading after the announced completion and results of Phase 3 clinical program of AXS-05 in Alzheimer&#8217;s Disease Agitation.
Axsome Therapeutics shares fell 8.9% to $79.00 in the pre-market trading session.
Here are some other stocks moving lower in pre-market trading.
<ul>
<li>Intchains Group Limited (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ICG#NASDAQ">ICG</a>) fell 10.3% to $8.37 in pre-market trading after jumping 53% on Friday.</li>
<li>MRC Global Inc. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/MRC#NYSE">MRC</a>) shares dipped 9.7% to $11.41 in pre-market trading. MRC Global will release its fourth quarter results after the closing bell on Feb. 11, 2025.</li>
<li>Peakstone Realty Trust (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/PKST#NYSE">PKST</a>) fell 7.8% to $10.21 in pre-market trading.</li>
<li>CARGO Therapeutics, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/CRGX#NASDAQ">CRGX</a>) shares declined 7.4% to $13.10 in pre-market trading following a 5% decline on Friday.</li>
<li>Arqit Quantum Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ARQQ#NASDAQ">ARQQ</a>) fell 7.4% to $39.53 in pre-market trading.</li>
<li>SEALSQ Corp (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/LAES#NASDAQ">LAES</a>) dipped 6.7% to $8.47 in pre-market trading after gaining around 4% on Friday.</li>
<li>Pediatrix Medical Group, Inc. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/MD#NYSE">MD</a>) shares slipped 6.5% to $12.61 in pre-market trading after declining around 1.8% on Thursday.</li>
<li>MasterCraft Boat Holdings, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/MCFT#NASDAQ">MCFT</a>) declined 3.1% to $18.14 in pre-market trading.</li>
<li>Tesla, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/TSLA#NASDAQ">TSLA</a>) shares fell 1.5% to $425.19 in pre-market trading following a 5% decline on Friday. Tesla said on Saturday that the company will reduce benefits as part of its referral program in North America starting next year.</li>
</ul>
Now Read This: 
<ul>
<li><a href="https://www.benzinga.com/24/12/42700627/how-to-earn-500-a-month-from-rpm-international-stock-ahead-of-q2-earnings">How To Earn $500 A Month From RPM International Stock Ahead Of Q2 Earnings</a></li>
</ul>

Pre-Market Outlook

Movers

ARQQ

CRGX

IMKTA

LAES

MCFT

PKST

TSLA

Axsome Therapeutics, Tesla And Other Big Stocks Moving Lower In Monday's Pre-Market Session

Axsome Therapeutics, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/AXSM#NASDAQ">AXSM</a>), a biopharmaceutical company developing and delivering novel therapies for the management of central nervous system (CNS) disorders, today announced the successful completion of its Phase 3 clinical program evaluating AXS-05 (dextromethorphan-bupropion), a novel, oral, investigational NMDA receptor antagonist, sigma-1 agonist, and aminoketone CYP2D6 inhibitor, in Alzheimer's disease agitation, and results of the ACCORD-2, ADVANCE-2, and long-term safety trials in this indication.
The ACCORD-2 Phase 3 trial achieved the primary endpoint with AXS-05 statistically significantly delaying the time to relapse of agitation, assessed by the Cohen-Mansfield Agitation Inventory (CMAI) total score, in patients with Alzheimer's disease compared to placebo (hazard ratio for time to relapse of 0.276, p=0.001), demonstrating a 3.6-fold lower risk of relapse compared to placebo. AXS-05 also met the key secondary endpoint (relapse prevention, p=0.001). Further, AXS-05 reduced worsening for overall Alzheimer's disease severity compared to placebo, as assessed by the Clinical Global Impression of Severity (CGI-S) for Alzheimer's disease (p&lt;0.001).
The ADVANCE-2 Phase 3 trial did not demonstrate statistical significance for the primary endpoint, change in the CMAI total score from baseline to Week 5 (CMAI reductions of 13.8 and 12.6 points for AXS-05 and placebo, respectively). However, results for the primary and nearly all secondary endpoints numerically favored AXS-05 over placebo.
AXS-05 was safe and well tolerated in both controlled studies. The long-term safety and tolerability of AXS-05 was also evaluated in more than 300 subjects treated for at least 6 months and more than 100 subjects treated for at least 12 months. In the controlled and long-term studies in subjects with Alzheimer's disease, AXS-05 was not associated with increased risk of falls, cognitive decline, or sedation. In the clinical program for AXS-05 in Alzheimer's disease agitation, there have been no deaths in subjects receiving AXS-05.
AXS-05 has now demonstrated statistically significant efficacy compared to placebo in three completed pivotal Phase 3 trials (ADVANCE-1, ACCORD-1 and ACCORD-2), with supportive efficacy and controlled safety results in a fourth trial (ADVANCE-2). Axsome plans to submit an NDA for AXS-05 in Alzheimer's disease agitation to the FDA in the second half of 2025, based on the efficacy and safety data from the above controlled and long-term studies. AXS-05 has been granted Breakthrough Therapy designation for the treatment of Alzheimer's disease agitation.

Government

Regulations

Axsome Completes Phase 3 Trials for AXS-05 in Alzheimer's Agitation, Plans FDA Submission for Alzheimer's Agitation Drug in 2025

Cantor Fitzgerald analyst Charles Duncan reiterates Axsome Therapeutics (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/AXSM#NASDAQ">AXSM</a>) with a Overweight and maintains $121 price target.

Cantor Fitzgerald Reiterates Overweight on Axsome Therapeutics, Maintains $121 Price Target

On Tuesday, Axsome Therapeutics Inc (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/AXSM#NASDAQ">AXSM</a>) said AXS-12 statistically significantly reduced the frequency of cataplexy attacks compared to placebo (p=0.017, primary endpoint) in <a target="_blank" href="https://www.benzinga.com/pressreleases/24/11/g42185380/axsome-therapeutics-announces-axs-12-achieves-primary-endpoint-in-encore-long-term-phase-3-trial-i" rel="noreferrer noopener">Phase 3 ENCORE trial</a>.
AXS-12 was also well tolerated with long-term dosing, and its safety profile was consistent with that observed in previously completed trials.
The primary endpoint was achieved with patients randomized to switch to placebo experiencing a mean increase of 10.29 cataplexy attacks per week compared to a mean increase of 1.32 attacks per week for patients randomized to continue AXS-12 treatment at 3 weeks (p=0.017).
Also Read: <a target="_blank" href="https://www.benzinga.com/analyst-ratings/analyst-color/24/07/39891953/axsome-therapeutics-cns-portfolio-poised-for-major-growth-analyst-predicts-strong-f" rel="noreferrer noopener">Axsome Therapeutics&#8217; CNS Portfolio Poised for Major Growth &#8211; Analyst Predicts Strong Future</a>
AXS-12 resulted in statistically significant benefit in cognition compared to placebo.
A higher number of patients who switched to placebo experienced worsening on the NSAQ Ability to Concentrate item compared to those continuing on AXS-12 (52.6% versus 14.3%) at 3 weeks (p=0.011).
A statistically significant improvement in narcolepsy overall was observed compared to placebo.
More patients randomized to switch to placebo reported worsening of their narcolepsy compared to those continuing on AXS-12 (52.6% versus 16.7%) at 3 weeks (p=0.024).
During the long-term open-label treatment portion of the trial, patients experienced substantial and sustained improvement of cataplexy with AXS-12 treatment.
Patients experienced a 71% reduction from baseline in mean weekly cataplexy attacks at 1 month with AXS-12 treatment, which was sustained with long-term treatment, resulting in a 77% reduction at 6 months.
Long-term open-label treatment with AXS-12 resulted in substantial improvements in excessive daytime sleepiness. Mean scores were reduced by 5.6 points at 1 month, with this improvement maintained with long-term treatment, resulting in a mean reduction of 7.3 points at 6 months.
William Blair views the safety profile of AXS-12 as a key differentiator from Jazz Pharmaceuticals plc&#8217;s (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/JAZZ#NASDAQ">JAZZ</a>) Xyrem. The analyst reiterates the Outperform rating on Axsome.
&#8220;Ultimately, we believe AXS-12 is both an approvable and effective therapy, with the data released today building on both the efficacy and long-term safety of the product,&#8221; the analyst writes.
William Blair conservatively models $440 million in peak AXS-12 sales, relative to growing Wakix sales of $582 million in 2023, and says the asset is undervalued with investor focus on data for AXS-05 in Alzheimer's disease agitation expected before year-end.
Price Action: AXSM stock is up 2.5% at $99.46 at last check Wednesday.
Read Next:
<ul>
<li><a href="https://www.benzinga.com/24/11/42216863/nvidia-intel-suppliers-rethink-mexico-operations-amid-trumps-tariff-threat" target="_blank" rel="noreferrer noopener">Nvidia, Intel Suppliers Rethink Mexico Operations Amid Trump&#8217;s Tariff Threat</a></li>
</ul>
Image via Pixabay.

Equities

JAZZ

Axsome Therapeutics' AXS-12 Data For Sleeping Disorder Boosts Confidence In Approval And Market Potential, Analyst Says

HC Wainwright &amp; Co. analyst Raghuram Selvaraju reiterates Axsome Therapeutics (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/AXSM#NASDAQ">AXSM</a>) with a Buy and maintains $180 price target.

HC Wainwright & Co. Reiterates Buy on Axsome Therapeutics, Maintains $180 Price Target

<ul>
<li>AXS-12 statistically significantly reduced the frequency of cataplexy attacks compared to placebo (p=0.017, primary endpoint)</li>
<li>Statistically significant improvement in cognition compared to placebo (p=0.011, NSAQ)</li>
<li>Statistically significant improvement in narcolepsy overall compared to placebo (p=0.024, PGI-C)</li>
<li>Cataplexy response (≥50% improvement) achieved by 72% of patients at 1 month and 82% at 6 months</li>
<li>Improvement in excessive daytime sleepiness (EDS), assessed by the CGI-C, achieved by 84% of patients at 1 month and 78% at 6 months</li>
<li>Improvement in narcolepsy overall, assessed by the CGI-C, achieved by 90% of patients at 1 month and 90% at 6 months</li>
<li>Well-tolerated with long-term safety profile consistent with previously completed trials and no new safety signals detected</li>
<li>NEW YORK, Nov. 26, 2024 (GLOBE NEWSWIRE) -- Axsome The</li>
</ul>

Axsome Therapeutics Reveals AXS-12 Meets Primary Endpoint In ENCORE Long-Term Phase 3 Trial In Narcolepsy

Baird analyst Joel Beatty maintains Axsome Therapeutics (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/AXSM#NASDAQ">AXSM</a>) with a Outperform and raises the price target from $112 to $116.

Baird Maintains Outperform on Axsome Therapeutics, Raises Price Target to $116

10 analysts have shared their evaluations of Axsome Therapeutics (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/AXSM#NASDAQ">AXSM</a>) during the recent three months, expressing a mix of bullish and bearish perspectives.
The table below provides a snapshot of their recent ratings, showcasing how sentiments have evolved over the past 30 days and comparing them to the preceding months.
<table>
<thead>
<tr>
<th></th>
<th align="right">Bullish</th>
<th align="right">Somewhat Bullish</th>
<th align="right">Indifferent</th>
<th align="right">Somewhat Bearish</th>
<th align="right">Bearish</th>
</tr>
</thead>
<tbody>
<tr>
<td>Total Ratings</td>
<td align="right">4</td>
<td align="right">6</td>
<td align="right">0</td>
<td align="right">0</td>
<td align="right">0</td>
</tr>
<tr>
<td>Last 30D</td>
<td align="right">1</td>
<td align="right">0</td>
<td align="right">0</td>
<td align="right">0</td>
<td align="right">0</td>
</tr>
<tr>
<td>1M Ago</td>
<td align="right">0</td>
<td align="right">0</td>
<td align="right">0</td>
<td align="right">0</td>
<td align="right">0</td>
</tr>
<tr>
<td>2M Ago</td>
<td align="right">0</td>
<td align="right">3</td>
<td align="right">0</td>
<td align="right">0</td>
<td align="right">0</td>
</tr>
<tr>
<td>3M Ago</td>
<td align="right">3</td>
<td align="right">3</td>
<td align="right">0</td>
<td align="right">0</td>
<td align="right">0</td>
</tr>
</tbody>
</table>
In the assessment of 12-month price targets, analysts unveil insights for Axsome Therapeutics, presenting an average target of $131.9, a high estimate of $180.00, and a low estimate of $107.00. This upward trend is evident, with the current average reflecting a 0.77% increase from the previous average price target of $130.89.
<img src="https://www.benzinga.com/files/images/story/2024/1731430809_0.png" alt="price target chart" />
<h2>Analyzing Analyst Ratings: A Detailed Breakdown</h2>
An in-depth analysis of recent analyst actions unveils how financial experts perceive Axsome Therapeutics. The following summary outlines key analysts, their recent evaluations, and adjustments to ratings and price targets.
<table>
<thead>
<tr>
<th>Analyst</th>
<th>Analyst Firm</th>
<th>Action Taken</th>
<th>Rating</th>
<th>Current Price Target</th>
<th>Prior Price Target</th>
</tr>
</thead>
<tbody>
<tr>
<td>Ami Fadia</td>
<td>Needham</td>
<td>Maintains</td>
<td>Buy</td>
<td>$130.00</td>
<td>$130.00</td>
</tr>
<tr>
<td>Leonid Timashev</td>
<td>RBC Capital</td>
<td>Raises</td>
<td>Outperform</td>
<td>$131.00</td>
<td>$130.00</td>
</tr>
<tr>
<td>Charles Duncan</td>
<td>Cantor Fitzgerald</td>
<td>Maintains</td>
<td>Overweight</td>
<td>$107.00</td>
<td>$107.00</td>
</tr>
<tr>
<td>Charles Duncan</td>
<td>Cantor Fitzgerald</td>
<td>Maintains</td>
<td>Overweight</td>
<td>$107.00</td>
<td>$107.00</td>
</tr>
<tr>
<td>Charles Duncan</td>
<td>Cantor Fitzgerald</td>
<td>Maintains</td>
<td>Overweight</td>
<td>$107.00</td>
<td>$107.00</td>
</tr>
<tr>
<td>Charles Duncan</td>
<td>Cantor Fitzgerald</td>
<td>Maintains</td>
<td>Overweight</td>
<td>$107.00</td>
<td>$107.00</td>
</tr>
<tr>
<td>Raghuram Selvaraju</td>
<td>HC Wainwright &amp; Co.</td>
<td>Maintains</td>
<td>Buy</td>
<td>$180.00</td>
<td>$180.00</td>
</tr>
<tr>
<td>Ami Fadia</td>
<td>Needham</td>
<td>Maintains</td>
<td>Buy</td>
<td>$130.00</td>
<td>$130.00</td>
</tr>
<tr>
<td>Cerena Chen</td>
<td>Wells Fargo</td>
<td>Announces</td>
<td>Overweight</td>
<td>$140.00</td>
<td>-</td>
</tr>
<tr>
<td>Raghuram Selvaraju</td>
<td>HC Wainwright &amp; Co.</td>
<td>Maintains</td>
<td>Buy</td>
<td>$180.00</td>
<td>$180.00</td>
</tr>
</tbody>
</table>
<h3>Key Insights:</h3>
<ul>
<li>Action Taken: Analysts adapt their recommendations to changing market conditions and company performance. Whether they 'Maintain', 'Raise' or 'Lower' their stance, it reflects their response to recent developments related to Axsome Therapeutics. This information provides a snapshot of how analysts perceive the current state of the company.</li>
<li>Rating: Analysts unravel qualitative evaluations for stocks, ranging from 'Outperform' to 'Underperform'. These ratings offer insights into expectations for the relative performance of Axsome Therapeutics compared to the broader market.</li>
<li>Price Targets: Analysts provide insights into price targets, offering estimates for the future value of Axsome Therapeutics's stock. This comparison reveals trends in analysts' expectations over time.</li>
</ul>
To gain a panoramic view of Axsome Therapeutics's market performance, explore these analyst evaluations alongside essential financial indicators. Stay informed and make judicious decisions using our Ratings Table.
<a href="https://www.benzinga.com/quote/AXSM/analyst-ratings?utm_source=Benzinga Insights">Stay up to date on Axsome Therapeutics analyst ratings.</a>
<h2>Discovering Axsome Therapeutics: A Closer Look</h2>
Axsome Therapeutics Inc is a clinical-stage biopharmaceutical company. It is engaged in developing novel therapies for the management of the central nervous system, or CNS, disorders for which there are limited treatment options. Its pipeline products include AXS-05, AXS-07, AXS-12, and AXS-14. It manages its business as one operating segment and reporting unit, which is the business of developing and delivering novel therapies for the management of CNS disorders.
<h3>Financial Insights: Axsome Therapeutics</h3>
Market Capitalization Analysis: The company's market capitalization is below the industry average, suggesting that it is relatively smaller compared to peers. This could be due to various factors, including perceived growth potential or operational scale.
Revenue Growth: Over the 3 months period, Axsome Therapeutics showcased positive performance, achieving a revenue growth rate of 86.65% as of 30 June, 2024. This reflects a substantial increase in the company's top-line earnings. In comparison to its industry peers, the company stands out with a growth rate higher than the average among peers in the Health Care sector.
Net Margin: The company's net margin is below industry benchmarks, signaling potential difficulties in achieving strong profitability. With a net margin of -91.03%, the company may need to address challenges in effective cost control.
Return on Equity (ROE): Axsome Therapeutics's ROE lags behind industry averages, suggesting challenges in maximizing returns on equity capital. With an ROE of -64.28%, the company may face hurdles in achieving optimal financial performance.
Return on Assets (ROA): Axsome Therapeutics's ROA lags behind industry averages, suggesting challenges in maximizing returns from its assets. With an ROA of -14.51%, the company may face hurdles in achieving optimal financial performance.
Debt Management: With a high debt-to-equity ratio of 1.86, Axsome Therapeutics faces challenges in effectively managing its debt levels, indicating potential financial strain.
<h2>Understanding the Relevance of Analyst Ratings</h2>
Analysts are specialists within banking and financial systems that typically report for specific stocks or within defined sectors. These people research company financial statements, sit in conference calls and meetings, and speak with relevant insiders to determine what are known as analyst ratings for stocks. Typically, analysts will rate each stock once a quarter. 
Analysts may supplement their ratings with predictions for metrics like growth estimates, earnings, and revenue, offering investors a more comprehensive outlook. However, investors should be mindful that analysts, like any human, can have subjective perspectives influencing their forecasts.
Which Stocks Are Analysts Recommending Now?
Benzinga Edge gives you instant access to all major analyst upgrades, downgrades, and price targets. Sort by accuracy, upside potential, and more. <a href="https://www.benzinga.com/premium/ideas/benzinga-edge-checkout/?t=be8be9arja3be22bz21&amp;utm_source=benzinga-insights">Click here to stay ahead of the market</a>.
This article was generated by Benzinga's automated content engine and reviewed by an editor.

A Closer Look at 10 Analyst Recommendations For Axsome Therapeutics

WIIM

Axsome Therapeutics shares are trading higher after the company reported better-than-expected Q3 financial results and provided updates regarding the cash on its balance sheet. Also, Needham reiterated a Buy rating on the stock.

Guidance

Axsome Says Current Cash Is Sufficient To Fund Anticipated Operations Into Cash Flow Positivity, Based On Current Operating Plan

Wells Fargo says that while the ADVANCE-2 miss makes the regulatory path less certain, the totality of the data supports approval for Axsome Therap...

Axsome data support Alzheimer's agitation approval, says Wells Fargo

H.C. Wainwright analyst Ram Selvaraju has reiterated their bullish stance on AXSM stock, giving a Buy rating yesterday. Ram Selvaraju has given his...

Buy Rating for Axsome Therapeutics: Promising AXS-05 Efficacy in Alzheimer's Agitation

H.C. Wainwright says Axsome Therapeutics (AXSM)' AXS-05 pivotal Alzheimer's-associated agitation program yielded "mixed data," although these may y...

Axsome data 'mixed' but sufficient for approval, says H.C. Wainwright

In a report released today, Graig Suvannavejh from Mizuho Securities maintained a Buy rating on Axsome Therapeutics (AXSM – Research Report), with ...

Axsome Therapeutics (AXSM) Gets a Buy from Mizuho Securities

Cantor Fitzgerald raised the firm's price target on Axsome Therapeutics (AXSM) to $124 from $121 and keeps an Overweight rating on the shares after...

Axsome Therapeutics price target raised to $124 from $121 at Cantor Fitzgerald

Truist analyst Joon Lee keeps a Buy rating and $150 price target on Axsome Therapeutics (AXSM) while noting that the firm is an "aggressive buyer" ...

Truist says 'aggressive' buying Axsome Therapeutics after AXS-05 ADA data

Axsome Therapeutics Remains A Buy Despite AXS-05's Mixed Results

Mizuho lowered the firm's price target on Axsome Therapeutics (AXSM) to $122 from $124 and keeps an Outperform rating on the shares after the compa...

Axsome Therapeutics price target lowered to $122 from $124 at Mizuho

Wondering which stocks are trending today? TipRanks has calculated which stocks have received the greatest number of new ratings from analysts and ...

Top 3 Trending Stocks, According to Analysts – 1/2/2025

In a report released yesterday, Myles Minter from William Blair reiterated a Buy rating on Axsome Therapeutics (AXSM – Research Report). The compan...

William Blair Reaffirms Their Buy Rating on Axsome Therapeutics (AXSM)

FTAI

SGMO

Screenshot 2024-07-10 at 9.08.28 PM

TNXP

A Redux Of The Lyrica-Cymbalta Fibromyalgia War Of The 2010s May Look More Like David Vs. Goliath

Screenshot 2024-02-24 at 12.03.42 AM

ABBV

New Drug Study Shows Improving Sleep Quality Can Relieve Fibromyalgia Pain

Legal

Press Releases

Axsome Therapeutics Reaches Agreement to Dismiss Sunosi® (Solriamfetol) Patent Litigation with Sandoz Inc.

Axsome Therapeutics to Participate in Investor Conferences in September

Axsome Therapeutics Announces FDA Acceptance of NDA Resubmission for AXS-07 for the Acute Treatment of Migraine

Axsome Therapeutics Presents Data from Multiple Programs at Sleep Europe 2024

Axsome Therapeutics to Report Third Quarter 2024 Financial Results on November 12

Axsome Therapeutics Presents Data from Multiple Programs Spanning Its Innovative Neuroscience Portfolio at Psych Congress 2024

Axsome Therapeutics Presents Data from Its Leading Neuroscience Pipeline at NEI Congress 2024

Earnings

Axsome Therapeutics Reports Third Quarter 2024 Financial Results and Provides Business Update

Axsome Therapeutics Announces AXS-12 Achieves Primary Endpoint in ENCORE Long-Term Phase 3 Trial in Narcolepsy

Axsome Therapeutics Announces Successful Completion and Results of Phase 3 Clinical Program of AXS-05 in Alzheimer's Disease Agitation

Amneal Pharmaceuticals, Inc. - Class A Common Stock

Amneal Pharmaceuticals

AstraZeneca PLC - American Depositary Shares

AstraZeneca

Bristol-Myers Squibb Company Common Stock

Bristol-Myers Squibb

Corcept Therapeutics Incorporated - Common Stock

Corcept Therapeutics

Elanco Animal Health Incorporated Common Stock

Elanco Animal Health

GSK plc American Depositary Shares (Each representing two Ordinary Shares)

HUTCHMED (China) Limited - American Depositary Shares

HUTCHMED (China)

Intra-Cellular Therapies Inc. - Common Stock

Intra-Cellular Therapies

Jazz Pharmaceuticals plc - Ordinary Shares

Jazz Pharmaceuticals

Johnson & Johnson

Eli Lilly

Merck & Co

Novo Nordisk

Novartis

Organon

Prestige Consumer Healthcare Inc. Common Stock

Prestige Consumer

Pfizer

Dr. Reddy's Laboratories Ltd Common Stock

Dr Reddy's Laboratories

Royalty Pharma plc - Class A Ordinary Shares

Royalty Pharma

Sanofi

Takeda Pharmaceutical Company Limited American Depositary Shares (each representing 1/2 of a share of Common Stock)

Comments

Axsome Therapeutics

ニュース

最新ニュース Axsome Therapeutics (NASDAQ:AXSM) 株価情報

こんな人も見ています

ニュース

パートナーシップ

ベンジンガ・グローバル