Catalyst Pharmaceuticals Stock (NASDAQ: CPRX)

Dernières nouvelles pour Catalyst Pharmaceuticals (NASDAQ:CPRX) Stock

Catalyst Pharmaceuticals

Catalyst Pharmaceuticals Inc is a biopharmaceutical company. It focuses on developing and commercializing, developing therapies for people with rare, debilitating, chronic neuromuscular and neurological diseases. It offers Firdapse, a proprietary form of amifampridine phosphate for the treatment of patients with Lambert-Eaton myasthenic syndrome.

Catalyst Pharmaceuticals, Inc. - Common Stock

Catalyst Pharmaceuticals Inc

HC Wainwright &amp; Co. analyst Andrew Fein maintains Catalyst Pharmaceuticals (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/CPRX#NASDAQ">CPRX</a>) with a Buy and raises the price target from $30 to $35.

News

Price Target

Analyst Ratings

CPRX

HC Wainwright & Co. Maintains Buy on Catalyst Pharmaceuticals, Raises Price Target to $35

B of A Securities analyst Jason Gerberry reiterates Catalyst Pharmaceuticals (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/CPRX#NASDAQ">CPRX</a>) with a Buy and maintains $30 price target.

Reiteration

B of A Securities Reiterates Buy on Catalyst Pharmaceuticals, Maintains $30 Price Target

On Wednesday, Catalyst Pharmaceuticals Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/CPRX#NASDAQ">CPRX</a>) entered into a settlement agreement with Teva Pharmaceuticals Industries Ltd (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/TEVA#NYSE">TEVA</a>).
This Agreement resolves the patent litigation brought by Catalyst and its licensor SERB S.A in response to Teva&#8217;s Abbreviated New Drug Application (ANDA) seeking approval to market a generic version of Firdapse (amifampridine) 10 mg tablets before the <a target="_blank" href="https://www.benzinga.com/pressreleases/25/01/g42881700/catalyst-pharmaceuticals-announces-settlement-of-firdapse-amifampridine-patent-litigation-with-tev" rel="noreferrer noopener">expiration of the applicable patents</a>.
If approved by the FDA, Teva will not market its generic version of Firdapse in the United States before February 25, 2035, unless certain limited circumstances customarily included in these types of agreements occur.
The parties will terminate all ongoing patent litigation between Catalyst/SERB and Teva regarding Firdapse patents pending in the U.S. District Court for the District of New Jersey.
The ongoing Firdapse patent litigation involves two defendants: Hetero, which is being challenged on all of Firdapse&#8217;s Orange Book-listed patents, and Lupin, which is facing a case focused on Catalyst&#8217;s Firdapse patent that expires in 2037.
In the Notice Letter in January 2023, Teva stated that it intended to market a generic version of Firdapse before the expiration of multiple of Catalyst&#8217;s patents listed in the <a target="_blank" href="https://www.benzinga.com/news/23/01/30523209/why-catalyst-pharmaceuticals-shares-are-moving" rel="noreferrer noopener">FDA Orange Book</a>.
In May, the FDA approved its supplemental New Drug Application, increasing the indicated maximum daily dose of Firdapse&#8217;s (amifampridine) for adults and pediatric patients weighing more than 45 kg from 80 mg to 100 mg for Lambert-Eaton myasthenic syndrome (LEMS).
LEMS is a rare autoimmune disorder characterized by muscle weakness and fatigue. Firdapse is a potassium channel blocker indicated for LEMS in adults and pediatric patients six years of age and older and works by increasing the release of acetylcholine, a neurotransmitter, at the neuromuscular junction, which helps improve muscle <a target="_blank" href="https://www.benzinga.com/pressreleases/24/05/g39094213/catalyst-pharmaceuticals-receives-u-s-fda-approval-for-increased-maximum-daily-dose-for-firdapse" rel="noreferrer noopener">function in people with LEMS</a>.
In the third quarter of 2024, Firdapse revenues increased 19.7% year over year to $79.3&nbsp;million. The company expects full-year 2024 net product revenue of <a target="_blank" href="https://www.benzinga.com/pressreleases/24/11/g41787062/catalyst-pharmaceuticals-reports-strong-third-quarter-2024-financial-results-and-provides-corporat" rel="noreferrer noopener">$300 million—$310 million</a>.
Price Action: CPRX stock closed at $19.53 on Wednesday.
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Biotech

Large Cap

Health Care

Legal

General

TEVA

Catalyst Pharmaceuticals Settles Patent Litigation Case With Teva Pharmaceutical

Trading Halt: Halt status updated at 12:55:00 PM ET: Quotation Resumption: News and Resumption Times

Catalyst Pharmaceuticals, Inc. ("Catalyst" or "Company") (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/CPRX#NASDAQ">CPRX</a>), a commercial-stage biopharmaceutical company focused on in-licensing, developing, and commercializing novel medicines for patients living with rare and difficult-to-treat diseases, today announced that the Company and its licensor SERB S.A. ("SERB") have entered into a Settlement Agreement (Agreement) with Teva Pharmaceuticals USA, Inc. and Teva Pharmaceuticals, Inc. (collectively Teva). This Agreement resolves the patent litigation brought by Catalyst and SERB in response to Teva's Abbreviated New Drug Application (ANDA) seeking approval to market a generic version of FIRDAPSE&#xAE; (amifampridine) 10 mg tablets prior to expiration of the applicable patents.
Pursuant to the terms of the Agreement, Teva will not market its generic version of FIRDAPSE in the United States any earlier than February 25, 2035, if approved by the U.S. Food and Drug Administration (FDA), unless certain limited circumstances customarily included in these types of agreements occur. In accordance with the Agreement, the parties will terminate all ongoing patent litigation between Catalyst/SERB and Teva regarding FIRDAPSE patents pending in the U.S. District Court for the District of New Jersey. The pending FIRDAPSE patent litigation against the remaining defendants, Hetero (for all of FIRDAPSE's Orange Book-listed patents) and Lupin (only for Catalyst's FIRDAPSE patent expiring in 2037), is ongoing.
As required by law, the companies will submit the confidential license agreement to the U.S. Federal Trade Commission and the U.S. Department of Justice for review.
 &nbsp;

Contracts

Catalyst Pharmaceuticals Announces Settlement Of FIRDAPSE Patent Litigation With Teva Pharmaceuticals; Teva Will Not Market Its Generic Version Of FIRDAPSE In The U.S. Any Earlier Than February 25, 2035, If Approved By The FDA

Trading Halt: Halted at 12:25:07 p.m. ET - Trading Halt: Halt News Pending

Disclosed on November 21, Patrick J McEnany, Director at Catalyst Pharmaceuticals (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/CPRX#NASDAQ">CPRX</a>), executed a substantial insider sell as per the latest SEC filing.
What Happened: According to a Form 4 filing with the <a href="https://www.sec.gov/Archives/edgar/data/0001369568/000116169724000457//Archives/edgar/data/1369568/000116169724000457/0001161697-24-000457-index.htm">U.S. Securities and Exchange Commission</a> on Thursday, McEnany sold 170,845 shares of Catalyst Pharmaceuticals. The total transaction value is $3,627,258.
Monitoring the market, Catalyst Pharmaceuticals's shares up by 1.23% at $21.38 during Friday's morning.
<h3>Discovering Catalyst Pharmaceuticals: A Closer Look</h3>
Catalyst Pharmaceuticals Inc is a biopharmaceutical company. It focuses on developing and commercializing, developing therapies for people with rare, debilitating, chronic neuromuscular and neurological diseases. It offers Firdapse, a proprietary form of amifampridine phosphate for the treatment of patients with Lambert-Eaton myasthenic syndrome.
<h3>Breaking Down Catalyst Pharmaceuticals's Financial Performance</h3>
Revenue Growth: Over the 3 months period, Catalyst Pharmaceuticals showcased positive performance, achieving a revenue growth rate of 25.33% as of 30 September, 2024. This reflects a substantial increase in the company's top-line earnings. As compared to competitors, the company surpassed expectations with a growth rate higher than the average among peers in the Health Care sector.
Key Profitability Indicators:
<ul>
<li>
Gross Margin: The company excels with a remarkable gross margin of 85.02%, indicating superior cost efficiency and profitability compared to its industry peers.
</li>
<li>
Earnings per Share (EPS): Catalyst Pharmaceuticals's EPS is a standout, portraying a positive bottom-line trend that exceeds the industry average with a current EPS of 0.37.
</li>
</ul>
Debt Management: Catalyst Pharmaceuticals's debt-to-equity ratio is below the industry average. With a ratio of 0.0, the company relies less on debt financing, maintaining a healthier balance between debt and equity, which can be viewed positively by investors.
Navigating Market Valuation:
<ul>
<li>
Price to Earnings (P/E) Ratio: Catalyst Pharmaceuticals's P/E ratio of 17.9 is below the industry average, suggesting the stock may be undervalued.
</li>
<li>
Price to Sales (P/S) Ratio: With a P/S ratio of 5.59 below industry standards, the stock shows potential undervaluation, making it an appealing investment option for those focusing on sales performance.
</li>
<li>
EV/EBITDA Analysis (Enterprise Value to its Earnings Before Interest, Taxes, Depreciation &amp; Amortization): With a lower-than-industry-average EV/EBITDA ratio of 9.84, Catalyst Pharmaceuticals presents a potential value opportunity, as investors are paying less for each unit of EBITDA.
</li>
</ul>
Market Capitalization: With restricted market capitalization, the company is positioned below industry averages. This reflects a smaller scale relative to peers.
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<h3>Why Insider Activity Matters in Finance</h3>
Considering insider transactions is valuable, but it's crucial to evaluate them in conjunction with other investment factors.
In legal terms, an "insider" refers to any officer, director, or beneficial owner of more than ten percent of a company's equity securities registered under Section 12 of the Securities Exchange Act of 1934. This can include executives in the c-suite and large hedge funds. These insiders are required to let the public know of their transactions via a Form 4 filing, which must be filed within two business days of the transaction.
When a company insider makes a new purchase, that is an indication that they expect the stock to rise.
Insider sells, on the other hand, can be made for a variety of reasons, and may not necessarily mean that the seller thinks the stock will go down. 
<h3>Breaking Down the Significance of Transaction Codes</h3>
In the domain of transactions, <a href="https://www.benzinga.com/money/investing-tools">investors</a> frequently turn their focus to those taking place in the open market, as meticulously outlined in Table I of the Form 4 filing. A P in Box 3 indicates a purchase, while S signifies a sale. Transaction code C signals the conversion of an option, and transaction code A denotes a grant, award, or other acquisition of securities from the company.
<a href="https://www.benzinga.com/sec/insider-trades/search/index?company_cik=0001369568">Check Out The Full List Of Catalyst Pharmaceuticals's Insider Trades.</a>
Insider Buying Alert: Profit from C-Suite Moves
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This article was generated by Benzinga's automated content engine and reviewed by an editor.

Insider Trades

Trading Ideas

Catalyst Pharmaceuticals Insider Trades Send A Signal

Stephens &amp; Co. analyst Sudan Loganathan initiates coverage on Catalyst Pharmaceuticals (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/CPRX#NASDAQ">CPRX</a>) with a Overweight rating and announces Price Target of $35.

Initiation

Stephens & Co. Initiates Coverage On Catalyst Pharmaceuticals with Overweight Rating, Announces Price Target of $35

Patrick J McEnany, Board Member at Catalyst Pharmaceuticals (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/CPRX#NASDAQ">CPRX</a>), reported an insider sell on November 13, according to a new SEC filing. 
What Happened: After conducting a thorough analysis, McEnany sold 492,000 shares of Catalyst Pharmaceuticals. This information was disclosed in a Form 4 filing with the <a href="https://www.sec.gov/Archives/edgar/data/0001369568/000116169724000445//Archives/edgar/data/1369568/000116169724000445/0001161697-24-000445-index.htm">U.S. Securities and Exchange Commission</a> on Wednesday. The total transaction value is $11,510,102.
Tracking the Thursday's morning session, Catalyst Pharmaceuticals shares are trading at $22.76, showing a down of 0.18%.
<h3>About Catalyst Pharmaceuticals</h3>
Catalyst Pharmaceuticals Inc is a biopharmaceutical company. It focuses on developing and commercializing, developing therapies for people with rare, debilitating, chronic neuromuscular and neurological diseases. It offers Firdapse, a proprietary form of amifampridine phosphate for the treatment of patients with Lambert-Eaton myasthenic syndrome.
<h3>Key Indicators: Catalyst Pharmaceuticals's Financial Health</h3>
Revenue Growth: Over the 3 months period, Catalyst Pharmaceuticals showcased positive performance, achieving a revenue growth rate of 25.33% as of 30 September, 2024. This reflects a substantial increase in the company's top-line earnings. As compared to competitors, the company surpassed expectations with a growth rate higher than the average among peers in the Health Care sector.
Evaluating Earnings Performance:
<ul>
<li>
Gross Margin: The company excels with a remarkable gross margin of 85.02%, indicating superior cost efficiency and profitability compared to its industry peers.
</li>
<li>
Earnings per Share (EPS): Catalyst Pharmaceuticals's EPS is a standout, portraying a positive bottom-line trend that exceeds the industry average with a current EPS of 0.37.
</li>
</ul>
Debt Management: Catalyst Pharmaceuticals's debt-to-equity ratio is below the industry average at 0.0, reflecting a lower dependency on debt financing and a more conservative financial approach.
Valuation Metrics: A Closer Look
<ul>
<li>
Price to Earnings (P/E) Ratio: The Price to Earnings ratio of 19.32 is lower than the industry average, indicating potential undervaluation for the stock.
</li>
<li>
Price to Sales (P/S) Ratio: The P/S ratio of 6.03 is lower than the industry average, implying a discounted valuation for Catalyst Pharmaceuticals's stock in relation to sales performance.
</li>
<li>
EV/EBITDA Analysis (Enterprise Value to its Earnings Before Interest, Taxes, Depreciation &amp; Amortization): The company's EV/EBITDA ratio 10.79 is below the industry average, indicating that it may be relatively undervalued compared to peers.
</li>
</ul>
Market Capitalization: Indicating a reduced size compared to industry averages, the company's market capitalization poses unique challenges.
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<h3>Why Insider Activity Matters in Finance</h3>
While insider transactions should not be the sole basis for making investment decisions, they can play a significant role in an investor's decision-making process.
Considering the legal perspective, an "insider" is defined as any officer, director, or beneficial owner holding more than ten percent of a company's equity securities, according to Section 12 of the Securities Exchange Act of 1934. This includes executives in the c-suite and major hedge funds. These insiders are mandated to disclose their transactions through a Form 4 filing, to be submitted within two business days of the transaction.
Pointing towards optimism, a company insider's new purchase signals their positive anticipation for the stock to rise.
Nevertheless, insider sells may not necessarily indicate a bearish view and can be influenced by various factors.
<h3>Understanding Crucial Transaction Codes</h3>
Navigating through the landscape of transactions, <a href="https://www.benzinga.com/money/investing-tools">investors</a> often prioritize those unfolding in the open market, precisely detailed in Table I of the Form 4 filing. A P in Box 3 denotes a purchase, while S signifies a sale. Transaction code C signals the conversion of an option, and transaction code A denotes a grant, award, or other acquisition of securities from the company.
<a href="https://www.benzinga.com/sec/insider-trades/search/index?company_cik=0001369568">Check Out The Full List Of Catalyst Pharmaceuticals's Insider Trades.</a>
Insider Buying Alert: Profit from C-Suite Moves
Benzinga Edge reveals every insider trade in real-time. Don't miss the next big stock move driven by insider confidence. Unlock this ultimate sentiment indicator now. <a href="https://www.benzinga.com/premium/ideas/benzinga-edge-checkout/?t=Be8be9arja3be22in8&amp;utm_source=benzinga-insights">Click here for access</a>.
This article was generated by Benzinga's automated content engine and reviewed by an editor.

Catalyst Pharmaceuticals Board Member Trades $11.51M In Company Stock

Truist Securities analyst Joon Lee maintains Catalyst Pharmaceuticals (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/CPRX#NASDAQ">CPRX</a>) with a Buy and raises the price target from $30 to $36.

Truist Securities Maintains Buy on Catalyst Pharmaceuticals, Raises Price Target to $36

HC Wainwright &amp; Co. analyst Andrew Fein reiterates Catalyst Pharmaceuticals (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/CPRX#NASDAQ">CPRX</a>) with a Buy and maintains $30 price target.

HC Wainwright & Co. Reiterates Buy on Catalyst Pharmaceuticals, Maintains $30 Price Target

<ul>
<li>Expect total revenues for the full year 2024 to be between $475 million and $485 million, which includes the $2.1 million milestone payment received from DyDo that is included in License and other revenue. &nbsp;</li>
<li>Revising full-year 2024 net product revenue guidance for FIRDAPSE to be between $300 million and $310 million;&nbsp;reaffirming FYCOMPA net product revenue guidance to be between $130 million and $135 million; and increasing AGAMREE net product revenue guidance to be between $40 million and $45 million, respectively. &nbsp;</li>
<li>Revising full year research and development ("R&amp;D") expense guidance to less than $15 million due to delays in the timing of certain R&amp;D related initiatives.</li>
</ul>

Guidance

Catalyst Pharmaceuticals Sees FY24 Revenue $475M-$485M Vs $473.67  Est.

Catalyst Pharmaceuticals (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/CPRX#NASDAQ">CPRX</a>) reported quarterly earnings of $0.57 per share which beat the analyst consensus estimate of $0.30 by 90 percent. This is a 16.33 percent increase over earnings of $0.49 per share from the same period last year. The company reported quarterly sales of $126.42 million which beat the analyst consensus estimate of $123.42 million by 2.43 percent. This is a 23.11 percent increase over sales of $102.69 million the same period last year.

Earnings

Earnings Beats

Catalyst Pharmaceuticals Q3 Adj $0.57 Beats $0.30 Estimate, Sales $126.42M Beat $123.42M Estimate

Catalyst Pharmaceuticals (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/CPRX#NASDAQ">CPRX</a>) will release its quarterly earnings report on Wednesday, 2024-11-06. Here's a brief overview for investors ahead of the announcement.
Analysts anticipate Catalyst Pharmaceuticals to report an earnings per share (EPS) of $0.30.
Anticipation surrounds Catalyst Pharmaceuticals's announcement, with investors hoping to hear about both surpassing estimates and receiving positive guidance for the next quarter.
New investors should understand that while earnings performance is important, market reactions are often driven by guidance.
<h3>Earnings History Snapshot</h3>
During the last quarter, the company reported an EPS beat by $0.30, leading to a 12.75% increase in the share price on the subsequent day.
Here's a look at Catalyst Pharmaceuticals's past performance and the resulting price change:

<table>
<thead>
<tr>
<th>Quarter</th>
<th>Q2 2024</th>
<th>Q1 2024</th>
<th>Q4 2023</th>
<th>Q3 2023</th>
</tr>
</thead>
<tbody>
<tr>
<td>EPS Estimate</td>
<td>0.26</td>
<td>0.17</td>
<td>0.26</td>
<td>0.44</td>
</tr>
<tr>
<td>EPS Actual</td>
<td>0.56</td>
<td>0.38</td>
<td>0.53</td>
<td>0.49</td>
</tr>
<tr>
<td>Price Change %</td>
<td>13.0%</td>
<td>6.0%</td>
<td>10.0%</td>
<td>-2.0%</td>
</tr>
</tbody>
</table>

<img src="https://www.benzinga.com/files/images/story/2024/1730833333_0.png" alt="eps graph" />
<h3>Stock Performance</h3>
Shares of Catalyst Pharmaceuticals were trading at $21.75 as of November 04. Over the last 52-week period, shares are up 74.24%. Given that these returns are generally positive, long-term shareholders should be satisfied going into this earnings release. 
<h3>Analyst Observations about Catalyst Pharmaceuticals</h3>
For investors, grasping market sentiments and expectations in the industry is vital. This analysis explores the latest insights regarding Catalyst Pharmaceuticals.
Catalyst Pharmaceuticals has received a total of 3 ratings from analysts, with the consensus rating as Buy. With an average one-year price target of $30.33, the consensus suggests a potential 39.45% upside.
<h3>Comparing Ratings with Peers</h3>
The following analysis focuses on the analyst ratings and average 1-year price targets of Geron, Alnylam Pharmaceuticals and Twist Bioscience, three prominent industry players, providing insights into their relative performance expectations and market positioning.
<ul>
<li>The consensus among analysts is an Buy trajectory for Geron, with an average 1-year price target of $6.75, indicating a potential 68.97% downside.</li>
<li>The consensus outlook from analysts is an Outperform trajectory for Alnylam Pharmaceuticals, with an average 1-year price target of $53.5, indicating a potential 145.98% upside.</li>
<li>The consensus outlook from analysts is an Neutral trajectory for Twist Bioscience, with an average 1-year price target of $52.0, indicating a potential 139.08% upside.</li>
</ul>
<h3>Comprehensive Peer Analysis Summary</h3>
The peer analysis summary provides a snapshot of key metrics for Geron, Alnylam Pharmaceuticals and Twist Bioscience, illuminating their respective standings within the industry. These metrics offer valuable insights into their market positions and comparative performance.

<table>
<thead>
<tr>
<th>Company</th>
<th>Consensus</th>
<th>Revenue Growth</th>
<th>Gross Profit</th>
<th>Return on Equity</th>
</tr>
</thead>
<tbody>
<tr>
<td>Catalyst Pharmaceuticals</td>
<td>Buy</td>
<td>23.23%</td>
<td>$107.31M</td>
<td>6.97%</td>
</tr>
<tr>
<td>Geron</td>
<td>Buy</td>
<td>2941.38%</td>
<td>$865K</td>
<td>-20.68%</td>
</tr>
<tr>
<td>Alnylam Pharmaceuticals</td>
<td>Outperform</td>
<td>21.15%</td>
<td>$8.18M</td>
<td>82.89%</td>
</tr>
<tr>
<td>Twist Bioscience</td>
<td>Neutral</td>
<td>27.81%</td>
<td>$35.27M</td>
<td>-16.28%</td>
</tr>
</tbody>
</table>

Key Takeaway:
Catalyst Pharmaceuticals ranks at the top for Gross Profit and Return on Equity among its peers. It is in the middle for Revenue Growth.
<h3>Unveiling the Story Behind Catalyst Pharmaceuticals</h3>
Catalyst Pharmaceuticals Inc is a biopharmaceutical company. It focuses on developing and commercializing, developing therapies for people with rare, debilitating, chronic neuromuscular and neurological diseases. It offers Firdapse, a proprietary form of amifampridine phosphate for the treatment of patients with Lambert-Eaton myasthenic syndrome.
<h3>A Deep Dive into Catalyst Pharmaceuticals's Financials</h3>
Market Capitalization: With restricted market capitalization, the company is positioned below industry averages. This reflects a smaller scale relative to peers.
Revenue Growth: Catalyst Pharmaceuticals's revenue growth over a period of 3 months has been noteworthy. As of 30 June, 2024, the company achieved a revenue growth rate of approximately 23.23%. This indicates a substantial increase in the company's top-line earnings. When compared to others in the Health Care sector, the company faces challenges, achieving a growth rate lower than the average among peers.
Net Margin: Catalyst Pharmaceuticals's net margin falls below industry averages, indicating challenges in achieving strong profitability. With a net margin of 33.24%, the company may face hurdles in effective cost management.
Return on Equity (ROE): Catalyst Pharmaceuticals's ROE surpasses industry standards, highlighting the company's exceptional financial performance. With an impressive 6.97% ROE, the company effectively utilizes shareholder equity capital.
Return on Assets (ROA): Catalyst Pharmaceuticals's ROA excels beyond industry benchmarks, reaching 6.03%. This signifies efficient management of assets and strong financial health.
Debt Management: With a below-average debt-to-equity ratio of 0.01, Catalyst Pharmaceuticals adopts a prudent financial strategy, indicating a balanced approach to debt management.
<a href="https://www.benzinga.com/quote/CPRX/earnings">To track all earnings releases for Catalyst Pharmaceuticals visit their earnings calendar on our site.</a>
This article was generated by Benzinga's automated content engine and reviewed by an editor.

A Peek at Catalyst Pharmaceuticals's Future Earnings

Avadel Pharmaceuticals plc (NASDAQ:AVDL) announced that the FDA has approved its supplemental new drug application (sNDA) seeking label expansion of Lumryz.
The drug is now approved in the United States for the treatment of cataplexy or excessive daytime sleepiness (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/eds#NASDAQ">EDS</a>) in patients aged seven years and older with narcolepsy.
The company&#39;s shares rose 5.1% on the news.&nbsp;
The stock fell 1.4% year to date compared with the <a href="https://www.zacks.com/stocks/industry-rank/industry/medical-biomedical-and-genetics-105">industry</a>&#39;s 0.7% decline.
<img alt="Zacks Investment Research" src="https://staticx-tuner.zacks.com/images/articles/charts/97/81744.jpg?v=1324361988" style="height:245px; width:624px" /> 
Image Source: Zacks Investment Research
<h3>Label Expansion Of AVDL&#39;s Lumryz</h3>
Lumryz is a once-at-bedtime formulation extended-release sodium oxybate. It was first approved by the FDA on May 1, 2023, for the treatment of cataplexy or EDS in adult patients with narcolepsy.
Along with the approval, the FDA also granted seven years of orphan drug exclusivity to Lumryz for the treatment of cataplexy or EDS in adults with narcolepsy due to a finding of clinical superiority of Lumryz relative to currently available oxybate treatments.
Narcolepsy is a chronic neurological condition, wherein the brain&#39;s ability to regulate the sleep-wake cycle is impaired.
The latest FDA approval expands the drug&#39;s indication for younger narcolepsy patients.&nbsp; The drug was also granted orphan drug exclusivity in pediatric narcolepsy patients aged seven years and older through Oct. 16, 2031.
Pediatric patients (seven years and older) living with narcolepsy will now have the same opportunity that adult patients with narcolepsy have &mdash; to choose a once-nightly treatment option that does not disrupt sleep for a middle-of-the-night dose.
<h3>Lumryz Uptake Boosts AVDL</h3>
Avadel generated $41.5 million of net product revenues from the sales of Lumryz in the second quarter of 2024.
As of June 30, there were more than 1,900 patients on Lumryz compared to more than 1,400 as of March 31.
Pediatric patients currently represent approximately 5% of all oxybate-treated narcolepsy patients. Hence, the label expansion of the drug for this population should boost sales.
In addition, a phase III double-blind, placebo-controlled, randomized withdrawal, multicenter study is evaluating the efficacy and safety of Lumryz in idiopathic hypersomnia (IH).&nbsp; Enrollment is open to patients who are currently being treated with a twice-nightly oxybate and those not taking oxybates. The study, which is expected to enroll approximately 150 adults diagnosed with IH, includes an open-label extension portion.
<h3>AVDL&#39;s Rank &amp; Other Stocks To Consider</h3>
Avadel carries a Zacks Rank #3 (Hold) at present.&nbsp; Some other top-ranked stocks in the drug/biotech sector are Catalyst Pharmaceuticals CPRX, ANI Pharmaceuticals ANIP and
<a href="https://www.zacks.com/stock/news/2353213/avadel-obtains-fda-nod-for-label-expansion-of-narcolepsy-drug-lumryz?cid=CS-BENZ-FT-analyst_blog|company_news_medical_sector-2353213">To read this article on Zacks.com click here.</a>

Small Cap

ALNY

ANIP

Avadel Obtains FDA Nod for Label Expansion Of Narcolepsy Drug Lumryz

Catalyst Pharmaceuticals, Inc.&nbsp;("Catalyst" or "Company") (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/CPRX#NASDAQ">CPRX</a>), a commercial-stage biopharmaceutical company focused on in-licensing, developing, and commercializing novel medicines for patients living with rare diseases, today announced that its sub-licensee in Japan, DyDo Pharma, Inc., ("DyDo") has reported that the Ministry of Health, Labor and Welfare of Japan has approved DyDo's New Drug Application ("NDA") to commercialize FIRDAPSE&#xAE; (amifampridine) Tablets 10 mg for treatment of patients with Lambert-Eaton Myasthenic Syndrome ("LEMS") in Japan. This approval marks a pivotal advancement in the treatment of LEMS, a rare autoimmune disorder that can severely impact quality of life and represents a significant step forward in addressing the unmet needs of patients affected by LEMS in Japan.
"We are pleased that our partner, DyDo, has secured regulatory approval for FIRDAPSE in Japan. This represents a meaningful milestone, bringing renewed hope to patients and further affirming FIRDAPSE's proven effectiveness in the treatment of LEMS," said Richard J. Daly, Catalyst's President and Chief Executive Officer. "This achievement underscores our unwavering commitment to advancing patient care. We appreciate the collaborative efforts of our partner in securing this approval, and we remain focused on expanding our innovative rare disease product portfolio beyond the U.S. to make a meaningful impact on patients' lives worldwide."
FIRDAPSE (amifampridine) is a leading therapy indicated in the United States for the treatment of LEMS in adults and pediatric patients six years of age and older. LEMS is a rare autoimmune disorder characterized by muscle weakness and fatigue. About 50% of people with LEMS have underlying cancer, as LEMS is observed in approximately 3% of small-cell lung cancer patients. FIRDAPSE is the only U.S. FDA-approved, evidence-based treatment for LEMS. As a cornerstone of Catalyst's commitment to serving those with rare diseases, FIRDAPSE is supported in the U.S. by a comprehensive patient support program to help ensure accessibility and assistance for eligible U.S. patients.

Government

Regulations

Catalyst Pharma's FIRDAPSE Approved in Japan for Rare Autoimmune Disorder Lambert-Eaton Myasthenic Syndrome ("LEMS")

As of Aug 14, 2024, three stocks in the health care sector could be flashing a real warning to investors who value momentum as a key criteria in their trading decisions.
The RSI is a momentum indicator, which compares a stock&#8217;s strength on days when prices go up to its strength on days when prices go down. When compared to a stock&#8217;s price action, it can give traders a better sense of how a stock may perform in the short term. An asset is typically considered overbought when the <a href="https://www.benzinga.com/topic/rsi">RSI is above 70</a>, according to <a href="https://pro.benzinga.com/">Benzinga Pro</a>. 
Here's the latest list of major overbought players in this sector.
<h3 class="wp-block-heading">Cardinal Health Inc (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/CAH#NYSE">CAH</a>)</h3>
<ul>
<li>On Aug. 14, Cardinal Health posted better-than-expected quarterly results. &#8220;Fiscal 2024 marked a year of strong operational execution and record financial results, delivered in tandem with key strategic progress in the portfolio,&#8221; said Jason Hollar, CEO of Cardinal Health. The company's stock gained around 9% over the past month and has a <a href="https://www.benzinga.com/quote/CAH">52-week high of $116.04</a>.</li>
<li>RSI Value: 72.55&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;</li>
<li>CAH Price Action: Shares of Cardinal Health gained 1.9% to close at $102.58 on Tuesday.</li>
</ul>
<h3 class="wp-block-heading">Catalyst Pharmaceuticals Inc (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/CPRX#NASDAQ">CPRX</a>)</h3>
<ul>
<li>On Aug. 7, Catalyst Pharmaceuticals reported better-than-expected second-quarter financial results. &#8220;Since the onset of this year, we have advanced with continued momentum, propelled by the strong performance of our established product portfolio and the successful U.S. commercial launch of AGAMREE. Our accomplishments have significantly strengthened our financial position, aligning with our revenue guidance for the year, and we believe that we are on track to achieve the upper end of our previously provided total revenue forecast,&#8221; stated Richard J. Daly, President and CEO of Catalyst. The company's stock gained around 19% over the past five days and <a href="https://www.benzinga.com/quote/CPRX">has a 52-week high</a> of $19.86.</li>
<li>RSI Value: 73.73</li>
<li>CPRX Price Action: Shares of Catalyst Pharmaceuticals gained 1.5% to close at $19.59 on Tuesday.</li>
</ul>
<h3 class="wp-block-heading">Verona Pharma PLC &#8211; ADR (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/VRNA#NASDAQ">VRNA</a>)</h3>
<ul>
<li>On Aug. 8, Verona Pharma posted a narrower-than-expected quarterly loss. &#8220;We are very pleased today to announce that Ohtuvayre (ensifentrine) is now available in the US for the maintenance treatment of chronic obstructive pulmonary disease (&#8220;COPD&#8221;) in adults,&#8221; said David Zaccardelli, Pharm. D., President and Chief Executive Officer. The company's stock gained around 26% over the past five days and has a <a href="https://www.benzinga.com/quote/VRNA">52-week high</a> of $28.26.</li>
<li>RSI Value: 71.22</li>
<li>VRNA Price Action: Shares of Verona Pharma gained 8.3% to close at $26.73 on Tuesday.</li>
</ul>
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5 analysts have expressed a variety of opinions on Catalyst Pharmaceuticals (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/CPRX#NASDAQ">CPRX</a>) over the past quarter, offering a diverse set of opinions from bullish to bearish.
Summarizing their recent assessments, the table below illustrates the evolving sentiments in the past 30 days and compares them to the preceding months.
<table>
<thead>
<tr>
<th></th>
<th style="text-align: right;">Bullish</th>
<th style="text-align: right;">Somewhat Bullish</th>
<th style="text-align: right;">Indifferent</th>
<th style="text-align: right;">Somewhat Bearish</th>
<th style="text-align: right;">Bearish</th>
</tr>
</thead>
<tbody>
<tr>
<td>Total Ratings</td>
<td style="text-align: right;">4</td>
<td style="text-align: right;">1</td>
<td style="text-align: right;">0</td>
<td style="text-align: right;">0</td>
<td style="text-align: right;">0</td>
</tr>
<tr>
<td>Last 30D</td>
<td style="text-align: right;">1</td>
<td style="text-align: right;">0</td>
<td style="text-align: right;">0</td>
<td style="text-align: right;">0</td>
<td style="text-align: right;">0</td>
</tr>
<tr>
<td>1M Ago</td>
<td style="text-align: right;">2</td>
<td style="text-align: right;">0</td>
<td style="text-align: right;">0</td>
<td style="text-align: right;">0</td>
<td style="text-align: right;">0</td>
</tr>
<tr>
<td>2M Ago</td>
<td style="text-align: right;">0</td>
<td style="text-align: right;">0</td>
<td style="text-align: right;">0</td>
<td style="text-align: right;">0</td>
<td style="text-align: right;">0</td>
</tr>
<tr>
<td>3M Ago</td>
<td style="text-align: right;">1</td>
<td style="text-align: right;">1</td>
<td style="text-align: right;">0</td>
<td style="text-align: right;">0</td>
<td style="text-align: right;">0</td>
</tr>
</tbody>
</table>
Analysts have recently evaluated Catalyst Pharmaceuticals and provided 12-month price targets. The average target is $29.2, accompanied by a high estimate of $31.00 and a low estimate of $26.00. Witnessing a positive shift, the current average has risen by 9.77% from the previous average price target of $26.60.
<img src="https://www.benzinga.com/files/images/story/2024/1723467649_0.png" alt="price target chart" />
<h2>Decoding Analyst Ratings: A Detailed Look</h2>
The standing of Catalyst Pharmaceuticals among financial experts is revealed through an in-depth exploration of recent analyst actions. The summary below 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>Andrew Fein</td>
<td>HC Wainwright &amp; Co.</td>
<td>Raises</td>
<td>Buy</td>
<td>$30.00</td>
<td>$26.00</td>
</tr>
<tr>
<td>Samantha Semenkow</td>
<td>Citigroup</td>
<td>Raises</td>
<td>Buy</td>
<td>$31.00</td>
<td>$27.00</td>
</tr>
<tr>
<td>Joon Lee</td>
<td>Truist Securities</td>
<td>Raises</td>
<td>Buy</td>
<td>$30.00</td>
<td>$25.00</td>
</tr>
<tr>
<td>Leland Gershell</td>
<td>Oppenheimer</td>
<td>Maintains</td>
<td>Outperform</td>
<td>$29.00</td>
<td>$29.00</td>
</tr>
<tr>
<td>Andrew Fein</td>
<td>HC Wainwright &amp; Co.</td>
<td>Maintains</td>
<td>Buy</td>
<td>$26.00</td>
<td>$26.00</td>
</tr>
</tbody>
</table>
<h3>Key Insights:</h3>
<ul>
<li>Action Taken: Analysts frequently update their recommendations based on evolving market conditions and company performance. Whether they 'Maintain', 'Raise' or 'Lower' their stance, it reflects their reaction to recent developments related to Catalyst Pharmaceuticals. This information provides a snapshot of how analysts perceive the current state of the company.</li>
<li>Rating: Delving into assessments, analysts assign qualitative values, from 'Outperform' to 'Underperform'. These ratings communicate expectations for the relative performance of Catalyst Pharmaceuticals compared to the broader market.</li>
<li>Price Targets: Delving into movements, analysts provide estimates for the future value of Catalyst Pharmaceuticals's stock. This analysis reveals shifts in analysts' expectations over time.</li>
</ul>
Analyzing these analyst evaluations alongside relevant financial metrics can provide a comprehensive view of Catalyst Pharmaceuticals's market position. Stay informed and make data-driven decisions with the assistance of our Ratings Table.
<a href="https://www.benzinga.com/quote/CPRX/analyst-ratings?utm_source=Benzinga Insights">Stay up to date on Catalyst Pharmaceuticals analyst ratings.</a>
<h2>Get to Know Catalyst Pharmaceuticals Better</h2>
Catalyst Pharmaceuticals Inc is a biopharmaceutical company. It focuses on developing and commercializing, developing therapies for people with rare, debilitating, chronic neuromuscular and neurological diseases. It offers Firdapse, a proprietary form of amifampridine phosphate for the treatment of patients with Lambert-Eaton myasthenic syndrome.
<h3>Catalyst Pharmaceuticals's Economic Impact: An Analysis</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, Catalyst Pharmaceuticals showcased positive performance, achieving a revenue growth rate of 23.23% 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 trails behind with a growth rate lower than the average among peers in the Health Care sector.
Net Margin: Catalyst Pharmaceuticals's net margin excels beyond industry benchmarks, reaching 33.24%. This signifies efficient cost management and strong financial health.
Return on Equity (ROE): Catalyst Pharmaceuticals's ROE excels beyond industry benchmarks, reaching 6.97%. This signifies robust financial management and efficient use of shareholder equity capital.
Return on Assets (ROA): Catalyst Pharmaceuticals's ROA surpasses industry standards, highlighting the company's exceptional financial performance. With an impressive 6.03% ROA, the company effectively utilizes its assets for optimal returns.
Debt Management: Catalyst Pharmaceuticals's debt-to-equity ratio is below industry norms, indicating a sound financial structure with a ratio of 0.01.
<h2>What Are Analyst Ratings?</h2>
Analyst ratings serve as essential indicators of stock performance, provided by experts in banking and financial systems. These specialists diligently analyze company financial statements, participate in conference calls, and engage with insiders to generate quarterly ratings for individual stocks.
In addition to their assessments, some analysts extend their insights by offering predictions for key metrics such as earnings, revenue, and growth estimates. This supplementary information provides further guidance for traders. It is crucial to recognize that, despite their specialization, analysts are human and can only provide forecasts based on their beliefs.
This article was generated by Benzinga's automated content engine and reviewed by an editor.

The Latest Analyst Ratings For Catalyst Pharmaceuticals

HC Wainwright &amp; Co. analyst Andrew Fein maintains Catalyst Pharmaceuticals (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/CPRX#NASDAQ">CPRX</a>) with a Buy and raises the price target from $26 to $30.

HC Wainwright & Co. Maintains Buy on Catalyst Pharmaceuticals, Raises Price Target to $30

Citigroup analyst Samantha Semenkow maintains Catalyst Pharmaceuticals (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/CPRX#NASDAQ">CPRX</a>) with a Buy and raises the price target from $27 to $31.

Citigroup Maintains Buy on Catalyst Pharmaceuticals, Raises Price Target to $31

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