View Future GrowthCatalyst Pharmaceuticals 過去の業績過去 基準チェック /46Catalyst Pharmaceuticalsは、平均年間32.6%の収益成長を遂げていますが、 Biotechs業界の収益は、年間 成長しています。収益は、平均年間31.9% 32.4%収益成長率で 成長しています。 Catalyst Pharmaceuticalsの自己資本利益率は21.9%であり、純利益率は37.1%です。主要情報32.59%収益成長率28.26%EPS成長率Biotechs 業界の成長17.04%収益成長率32.42%株主資本利益率21.85%ネット・マージン37.08%前回の決算情報31 Mar 2026最近の業績更新Reported Earnings • May 12First quarter 2026 earnings: EPS exceeds analyst expectationsFirst quarter 2026 results: EPS: US$0.52 (up from US$0.47 in 1Q 2025). Revenue: US$149.4m (up 5.6% from 1Q 2025). Net income: US$63.7m (up 12% from 1Q 2025). Profit margin: 43% (up from 40% in 1Q 2025). The increase in margin was driven by higher revenue. Revenue was in line with analyst estimates. Earnings per share (EPS) surpassed analyst estimates by 9.6%. Revenue is forecast to grow 8.7% p.a. on average during the next 3 years, compared to a 22% growth forecast for the Biotechs industry in the US. Over the last 3 years on average, earnings per share has increased by 35% per year whereas the company’s share price has increased by 36% per year.お知らせ • Apr 29Catalyst Pharmaceuticals, Inc. to Report Q1, 2026 Results on May 11, 2026Catalyst Pharmaceuticals, Inc. announced that they will report Q1, 2026 results After-Market on May 11, 2026Reported Earnings • Feb 26Full year 2025 earnings: EPS and revenues exceed analyst expectationsFull year 2025 results: EPS: US$1.75 (up from US$1.38 in FY 2024). Revenue: US$589.0m (up 20% from FY 2024). Net income: US$214.3m (up 31% from FY 2024). Profit margin: 36% (up from 33% in FY 2024). The increase in margin was driven by higher revenue. Revenue exceeded analyst estimates by 1.7%. Earnings per share (EPS) also surpassed analyst estimates by 4.1%. Revenue is forecast to grow 7.6% p.a. on average during the next 3 years, compared to a 20% growth forecast for the Biotechs industry in the US. Over the last 3 years on average, earnings per share has increased by 34% per year but the company’s share price has only increased by 18% per year, which means it is significantly lagging earnings growth.お知らせ • Feb 11Catalyst Pharmaceuticals, Inc. to Report Q4, 2025 Results on Feb 25, 2026Catalyst Pharmaceuticals, Inc. announced that they will report Q4, 2025 results at 4:00 PM, US Eastern Standard Time on Feb 25, 2026Reported Earnings • Nov 06Third quarter 2025 earnings: EPS and revenues exceed analyst expectationsThird quarter 2025 results: EPS: US$0.43 (up from US$0.37 in 3Q 2024). Revenue: US$148.4m (up 15% from 3Q 2024). Net income: US$52.8m (up 20% from 3Q 2024). Profit margin: 36% (up from 34% in 3Q 2024). The increase in margin was driven by higher revenue. Revenue exceeded analyst estimates by 8.5%. Earnings per share (EPS) also surpassed analyst estimates by 27%. Revenue is forecast to grow 8.6% p.a. on average during the next 3 years, compared to a 21% growth forecast for the Biotechs industry in the US. Over the last 3 years on average, earnings per share has increased by 34% per year but the company’s share price has only increased by 11% per year, which means it is significantly lagging earnings growth.お知らせ • Oct 22Catalyst Pharmaceuticals, Inc. to Report Q3, 2025 Results on Nov 05, 2025Catalyst Pharmaceuticals, Inc. announced that they will report Q3, 2025 results After-Market on Nov 05, 2025すべての更新を表示Recent updatesライブニュース • May 15Angelini Pharma to Acquire Catalyst Pharmaceuticals in US$4.1b All-Cash Deal With 21% PremiumAngelini Pharma agreed to acquire Catalyst Pharmaceuticals in an all-cash deal valued at about $4.1 billion, or $31.50 per share, representing a 21% to 28% premium to recent trading levels. The transaction has unanimous board approval from both companies and is targeted to close in Q3 2026, subject to stockholder and regulatory approvals. Catalyst reported Q1 2026 revenue that was 6% higher year over year, driven by sales of FIRDAPSE and AGAMREE, and reached a settlement with Hetero that defers generic FIRDAPSE competition in the U.S. until 2035 under licensing agreements. The agreed acquisition price and premium effectively shift the near-term focus from standalone valuation debates to deal completion risk, regulatory review, and timing. Investors may want to pay close attention to any updates on regulatory approvals, stockholder voting, and potential closing conditions that could affect the path and timeline to the proposed cash payout.Seeking Alpha • May 13Catalyst Pharmaceuticals: Angelini Deal Caps A Potentially Better StorySummary Catalyst Pharmaceuticals' (CPRX) rare-disease platform now looks better than when I last covered it. Firdapse and Agamree are the main value drivers. CPRX’s Q1 2026 generated $149.3 million in net product revenue. Firdapse and Agamree grew 28.2% together despite Fycompa’s decline. Angelini’s $31.50 per share cash offers a reasonable exit value for CPRX shareholders. But the stock is now basically an M&A play. I can understand why Angelini wants the platform. But there’s now little upside left for new investors willing to bet on the M&A deal closing. Thus, I feel CPRX remains a “Hold” at this point, since Angelini’s cash offer already captures most of the near-term risk-reward. Read the full article on Seeking AlphaReported Earnings • May 12First quarter 2026 earnings: EPS exceeds analyst expectationsFirst quarter 2026 results: EPS: US$0.52 (up from US$0.47 in 1Q 2025). Revenue: US$149.4m (up 5.6% from 1Q 2025). Net income: US$63.7m (up 12% from 1Q 2025). Profit margin: 43% (up from 40% in 1Q 2025). The increase in margin was driven by higher revenue. Revenue was in line with analyst estimates. Earnings per share (EPS) surpassed analyst estimates by 9.6%. Revenue is forecast to grow 8.7% p.a. on average during the next 3 years, compared to a 22% growth forecast for the Biotechs industry in the US. Over the last 3 years on average, earnings per share has increased by 35% per year whereas the company’s share price has increased by 36% per year.お知らせ • May 09+ 1 more updateCatalyst Pharmaceuticals Announces Settlement of FIRDAPSE Patent Litigation With Hetero Labs LtdCatalyst Pharmaceuticals Inc. announced that the Company and its licensor SERB S.A. have entered into a Settlement Agreement with Hetero Labs Ltd., Hetero USA, Grace Consulting Services Inc., and Annora Pharma Private Limited. This Agreement resolves the patent litigation brought by Catalyst and SERB in response to Hetero’s Abbreviated New Drug Application seeking approval to market a generic version of FIRDAPSE (amifampridine) 10 mg tablets prior to expiration of the applicable patents. Pursuant to the terms of the Agreement, Hetero will not market its generic version of FIRDAPSE in the United States any earlier than a specified date in January 2035, if approved by the U.S. Food and Drug Administration, 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 Hetero regarding FIRDAPSE patents pending in the U.S. District Court for the District of New Jersey prior to the scheduled trial commencement on May 18, 2026. Catalyst previously settled similar litigation regarding ANDA applications for FIRDAPSE with Lupin Pharmaceuticals, Teva Pharmaceuticals, and Inventia Healthcare Limited. This settlement resolves all pending patent litigation relating to FIRDAPSE. As required by law, the companies will submit the confidential settlement agreement to the U.S. Federal Trade Commission and the U.S. Department of Justice for review.お知らせ • Apr 29Catalyst Pharmaceuticals, Inc. to Report Q1, 2026 Results on May 11, 2026Catalyst Pharmaceuticals, Inc. announced that they will report Q1, 2026 results After-Market on May 11, 2026お知らせ • Apr 28Angelini Pharma Reportedly Explores A Potential Acquisition of Catalyst PharmaceuticalsCatalyst Pharmaceuticals, Inc. (NasdaqCM:CPRX) surged nearly 20% on April 27, 2026, after a report that Italy-based Angelini Pharma S.p.a. is exploring a potential acquisition of the company. The sharp move reflects renewed investor enthusiasm around merger-and-acquisition activity in the biotech sector, where mid-cap specialty drugmakers like Catalyst often become attractive targets for larger or privately held pharmaceutical groups seeking growth. According to a Bloomberg report citing sources familiar with the matter, Angelini Pharma is working with financial advisers as it evaluates a possible bid for Catalyst, which currently carries a market capitalization of $3.3 billion. While the discussions are said to be in early stages, the mere possibility of a deal was enough to trigger a strong rally in Catalyst’s shares, underscoring how sensitive biotech valuations are to takeover speculation. Angelini Pharma, part of the privately held Angelini Industries group, has been increasingly vocal about its ambitions to expand beyond its core European markets. In a statement, a company representative emphasized that evaluating growth opportunities—including acquisitions—is a central component of its long-term strategy. However, the company stopped short of confirming any specific interest in Catalyst, noting that there is no guarantee ongoing evaluations will lead to a transaction. Still, several uncertainties remain. Angelini is reportedly reviewing multiple acquisition targets, meaning Catalyst is not the only option on the table. Additionally, valuation considerations, regulatory hurdles, and strategic fit will all play critical roles in determining whether talks progress.Reported Earnings • Feb 26Full year 2025 earnings: EPS and revenues exceed analyst expectationsFull year 2025 results: EPS: US$1.75 (up from US$1.38 in FY 2024). Revenue: US$589.0m (up 20% from FY 2024). Net income: US$214.3m (up 31% from FY 2024). Profit margin: 36% (up from 33% in FY 2024). The increase in margin was driven by higher revenue. Revenue exceeded analyst estimates by 1.7%. Earnings per share (EPS) also surpassed analyst estimates by 4.1%. Revenue is forecast to grow 7.6% p.a. on average during the next 3 years, compared to a 20% growth forecast for the Biotechs industry in the US. Over the last 3 years on average, earnings per share has increased by 34% per year but the company’s share price has only increased by 18% per year, which means it is significantly lagging earnings growth.お知らせ • Feb 26Catalyst Pharmaceuticals, Inc. Provides Earnings Guidance for the Full Year 2026Catalyst Pharmaceuticals, Inc. provided earnings guidance for the full year 2026. For the year, the company expects total revenues to be between $615 million and $645 million, reflecting continued robust growth in product revenue.お知らせ • Feb 11Catalyst Pharmaceuticals, Inc. to Report Q4, 2025 Results on Feb 25, 2026Catalyst Pharmaceuticals, Inc. announced that they will report Q4, 2025 results at 4:00 PM, US Eastern Standard Time on Feb 25, 2026Recent Insider Transactions Derivative • Dec 18Lead Independent Director exercised options and sold US$351k worth of stockOn the 12th of December, Molly Harper exercised 20k options at a strike price of around US$5.78 and sold these shares for an average price of US$23.32 per share. This trade did not impact their existing holding. Since December 2024, Molly's direct individual holding has increased from 2.75k shares to 9.11k. Company insiders have collectively sold US$24m more than they bought, via options and on-market transactions in the last 12 months.Recent Insider Transactions Derivative • Nov 28Executive VP & Chief Commercial Officer notifies of intention to sell stockJeffrey Del Carmen intends to sell 11k shares in the next 90 days after lodging an Intent To Sell Form on the 26th of November. If the sale is conducted around the recent share price of US$23.33, it would amount to US$256k. Since December 2024, Jeffrey's direct individual holding has decreased from 22.88k shares to 3.96k. Company insiders have collectively sold US$23m more than they bought, via options and on-market transactions in the last 12 months.Recent Insider Transactions • Nov 17Insider recently sold US$908k worth of stockOn the 12th of November, Brian Elsbernd sold around 40k shares on-market at roughly US$22.70 per share. This transaction amounted to 15% of their direct individual holding at the time of the trade. This was the largest sale by an insider in the last 3 months. Insiders have been net sellers, collectively disposing of US$8.7m more than they bought in the last 12 months.Recent Insider Transactions Derivative • Nov 14Insider notifies of intention to sell stockBrian Elsbernd intends to sell 40k shares in the next 90 days after lodging an Intent To Sell Form on the 12th of November. If the sale is conducted around the recent share price of US$22.70, it would amount to US$908k. Since December 2024, Brian's direct individual holding has increased from 181.25k shares to 271.04k. Company insiders have collectively sold US$26m more than they bought, via options and on-market transactions in the last 12 months.お知らせ • Nov 07Catalyst Pharmaceuticals, Inc. Raises Revenue Guidance for the Full Year 2025Catalyst Pharmaceuticals, Inc. raised revenue guidance for the full year 2025. For the period, Company expects total revenue to between $565 million and $585 million.Reported Earnings • Nov 06Third quarter 2025 earnings: EPS and revenues exceed analyst expectationsThird quarter 2025 results: EPS: US$0.43 (up from US$0.37 in 3Q 2024). Revenue: US$148.4m (up 15% from 3Q 2024). Net income: US$52.8m (up 20% from 3Q 2024). Profit margin: 36% (up from 34% in 3Q 2024). The increase in margin was driven by higher revenue. Revenue exceeded analyst estimates by 8.5%. Earnings per share (EPS) also surpassed analyst estimates by 27%. Revenue is forecast to grow 8.6% p.a. on average during the next 3 years, compared to a 21% growth forecast for the Biotechs industry in the US. Over the last 3 years on average, earnings per share has increased by 34% per year but the company’s share price has only increased by 11% per year, which means it is significantly lagging earnings growth.お知らせ • Oct 22Catalyst Pharmaceuticals, Inc. to Report Q3, 2025 Results on Nov 05, 2025Catalyst Pharmaceuticals, Inc. announced that they will report Q3, 2025 results After-Market on Nov 05, 2025お知らせ • Oct 01Catalyst Pharmaceuticals, Inc. (NasdaqCM:CPRX) announces an Equity Buyback for $200 million worth of its shares.Catalyst Pharmaceuticals, Inc. (NasdaqCM:CPRX) announces a share repurchase program. Under the program, the company will repurchase up to $200 million worth of its common stock. The company plans to use existing cash on hand to fund the share repurchase program. The program is valid till December 31, 2026.分析記事 • Sep 26Does Catalyst Pharmaceuticals (NASDAQ:CPRX) Deserve A Spot On Your Watchlist?Investors are often guided by the idea of discovering 'the next big thing', even if that means buying 'story stocks...Recent Insider Transactions Derivative • Aug 27Executive VP notifies of intention to sell stockSteven Miller intends to sell 115k shares in the next 90 days after lodging an Intent To Sell Form on the 26th of August. If the sale is conducted around the recent share price of US$20.28, it would amount to US$2.3m. Since December 2024, Steven's direct individual holding has increased from 936.00k shares to 949.66k. Company insiders have collectively sold US$34m more than they bought, via options and on-market transactions in the last 12 months.お知らせ • Aug 26Catalyst Pharmaceuticals Announces Settlement of FIRDAPSE® (amifampridine) Patent Litigation with Lupin PharmaceuticalsCatalyst Pharmaceuticals, Inc. announced that the Company and its licensor SERB S.A. (“SERB”) have entered into a Settlement Agreement (“Agreement”) with Lupin Ltd. and Lupin Pharmaceuticals, Inc. (collectively, “Lupin”). This Agreement resolves the patent litigation brought by Catalyst and SERB in response to Lupin’s Abbreviated New Drug Application (“ANDA”) seeking approval to market a generic version of FIRDAPSE (amifampridine) 10 mg tablets prior to expiration of the applicable patents. Pursuant to the terms of the Agreement, Lupin 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, 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 Lupin regarding FIRDAPSE patents pending in the U.S. District Court for the District of New Jersey. Catalyst previously settled similar litigation regarding ANDA applications for FIRDAPSE with Teva Pharmaceuticals and Inventia Life Science Pty Ltd. The pending FIRDAPSE patent litigation against the remaining defendant, Hetero, regarding FIRDAPSE’s Orange Book-listed patents is ongoing. As required by law, the companies will submit the confidential settlement agreement to the U.S. Federal Trade Commission and the U.S. Department of Justice for review.Reported Earnings • Aug 07Second quarter 2025 earnings: EPS and revenues exceed analyst expectationsSecond quarter 2025 results: EPS: US$0.43 (up from US$0.34 in 2Q 2024). Revenue: US$146.6m (up 19% from 2Q 2024). Net income: US$52.1m (up 28% from 2Q 2024). Profit margin: 36% (up from 33% in 2Q 2024). The increase in margin was driven by higher revenue. Revenue exceeded analyst estimates by 4.4%. Earnings per share (EPS) also surpassed analyst estimates by 4.6%. Revenue is forecast to grow 9.9% p.a. on average during the next 3 years, compared to a 18% growth forecast for the Biotechs industry in the US. Over the last 3 years on average, earnings per share has increased by 33% per year but the company’s share price has only increased by 14% per year, which means it is significantly lagging earnings growth.お知らせ • Aug 07Catalyst Pharmaceuticals, Inc. Reaffirms Earnings Guidance for the Full Year 2025Catalyst Pharmaceuticals, Inc. reaffirmed earnings guidance for the full year 2025. For the full year, the company expects total revenue of $545 million to $565 million.Board Change • Aug 06High number of new directorsDirector Dan Curran was the last director to join the board, commencing their role in the last week.お知らせ • Aug 06Catalyst Pharmaceuticals, Inc. Announces National Comprehensive Cancer Network Clinical Practice Guidelines in OncologyCatalyst Pharmaceuticals, Inc. announced the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology (NCCN Guidelines) for Small Cell Lung Cancer (SCLC) now include new additions involving Lambert Eaton myasthenic syndrome (LEMS), amifampridine (FIRDAPSE), and the tests for PQ- and N-type voltage-gated calcium channel (VGCC) antibodies. The updated NCCN Clinical Practice Guidelines in Oncologists for SCLC relating to LEMS now include symptom specificity--characterized by proximal muscle weakness and autonomic dysfunction. Under "Signs and Symptoms of Small Cell Lung Cancer" (SCL-A 2 of 2), the guidelines recommend diagnosis through a neurological evaluation, ideally in consultation with a neurologist, which may include testing for PQ- and N -type voltage-gated calcium channels (VGCC) antibodies. Additionally, under "Prin principles of Supportive Care" (SCL-D), the guidelines recommend that amifampridine should be considered as a treatment in consultation with neurology. Approximately 50% of LEMS cases are associated with an underlying malignancy, most commonly SCLC.ature suggests that LEMS is observed in 3% of SCLC patients. Based on an internal healthcare database analysis of SCLC claims, potentially 90% of LEMS patients with SCLC went undiagnosed. These undiagnosed LEMS patients may suffer from LEMS symptoms while undergoing treatment for SCLC.お知らせ • Aug 05Catalyst Pharmaceuticals, Inc. Appoints Daniel Curran to the Board of DirectorsCatalyst Pharmaceuticals, Inc. announced the appointment of Daniel Curran, MD, to its Board of Directors. Dr. Curran is a distinguished pharmaceutical executive with over 25 years of experience spanning strategy, business development, project leadership, and development. Since March 2024, he has served as Managing Partner of Mountainfield Venture Partners, a company-creation firm. He also currently serves as Chief Executive Officer of Timberlyne Therapeutics. From 2008 to 2023, Dr. Curran held roles of increasing responsibility at Takeda Pharmaceutical Company, serving as Senior Vice President and Head of the Rare Genetics and Hematology Therapeutic Area Unit from January 2019 through December 2023. Prior to his tenure at Takeda, Dr. Curran served as Vice President of Corporate Development at Millennium Pharmaceuticals, Inc., from 1999 to 2008. Earlier in his career, he held a business development role in the product planning and acquisition group at DuPont Merck Pharmaceuticals. Dr. Curran previously served on the board of directors of Tome Biosciences and currently serves on the Board of Directors of Xilio Therapeutics, Inc. Dr. Curran received an M.D. from the University of Pennsylvania School of Medicine, an M.B.A. from The Wharton School of the University of Pennsylvania, and a B.S. in chemistry from King's College.お知らせ • Jul 22Catalyst Pharmaceuticals, Inc. to Report Q2, 2025 Results on Aug 06, 2025Catalyst Pharmaceuticals, Inc. announced that they will report Q2, 2025 results After-Market on Aug 06, 2025お知らせ • Jun 30Catalyst Pharmaceuticals, Inc.(NasdaqCM:CPRX) dropped from Russell 2000 Dynamic IndexCatalyst Pharmaceuticals, Inc.(NasdaqCM:CPRX) dropped from Russell 2000 Dynamic IndexRecent Insider Transactions • Jun 11Co-Founder & Non-Executive Chairman recently sold US$5.2m worth of stockOn the 9th of June, Patrick McEnany sold around 200k shares on-market at roughly US$26.09 per share. This transaction amounted to 4.5% of their direct individual holding at the time of the trade. This was the largest sale by an insider in the last 3 months. This was Patrick's only on-market trade for the last 12 months.Recent Insider Transactions Derivative • Jun 08Co-Founder & Non-Executive Chairman notifies of intention to sell stockPatrick McEnany intends to sell 200k shares in the next 90 days after lodging an Intent To Sell Form on the 6th of June. If the sale is conducted around the recent share price of US$25.88, it would amount to US$5.2m. Since September 2024, Patrick's direct individual holding has increased from 4.48m shares to 5.99m. Company insiders have collectively sold US$34m more than they bought, via options and on-market transactions in the last 12 months.Recent Insider Transactions • Jun 05President recently sold US$1.7m worth of stockOn the 30th of May, Richard John Daly sold around 70k shares on-market at roughly US$24.86 per share. This transaction amounted to 26% of their direct individual holding at the time of the trade. This was the largest sale by an insider in the last 3 months. This was Richard John's only on-market trade for the last 12 months.お知らせ • Jun 03Catalyst Pharmaceuticals, Inc. Announces Executive ChangesCatalyst Pharmaceuticals, Inc. announced the appointment of William (Will) T. Andrews, MD, FACP as Chief Medical Officer. Dr. Andrews will report directly to the Company’s President and Chief Executive Officer, Richard J. Daly, and will serve as a member of the Company’s executive leadership team. He succeeds Dr. Gary Ingenito, who is retiring after a successful career and will support the transition in a consulting capacity. Dr. Andrews brings 24 years of global biopharmaceutical experience across clinical development, medical affairs, corporate strategy and transactions, medical and commercial strategy and business development to Catalyst. Dr. Andrews has worked with both drugs and biologics across multiple therapeutic areas and through all phases of development. His primary area of expertise is in rare diseases, having spent 18 years in this space. Since 2023, Dr. Andrews was the President, CEO and co-founder of Lighthouse Bio, a biopharmaceutical start-up focused on rare disease asset acquisition with the goal of new company formation. Prior to Lighthouse Bio, he was the principal and founder of Aletheia Lifesciences. Before founding Aletheia, Dr. Andrews served as a Chief Medical Officer for Flexion Therapeutics, Akcea Therapeutics and Acer Therapeutics, as well as serving in roles of increasing responsibility at various other biopharmaceutical organizations. Dr. Andrews began his career in clinical practice with Harvard Vanguard Medical Associates and Brigham and Women’s Hospital. He also served as Clinical Faculty of Internal Medicine, Harvard Medical School, and Attending Physician in Internal Medicine, Brigham and Women’s Hospital. He received his Bachelor of Arts degree in biology from Harvard University and his Medical Degree from Yale University School of Medicine.Recent Insider Transactions Derivative • Jun 01President notifies of intention to sell stockRichard John Daly intends to sell 70k shares in the next 90 days after lodging an Intent To Sell Form on the 30th of May. If the sale is conducted around the recent share price of US$24.86, it would amount to US$1.7m. For the year to December 2018, Richard John's total compensation was 10% salary and 90% other compensation. This indicates that these sales could comprise a meaningful part of their income for the year. Since June 2024, Richard John's direct individual holding has increased from 234.82k shares to 269.76k. Company insiders have collectively sold US$34m more than they bought, via options and on-market transactions in the last 12 months.分析記事 • May 30Catalyst Pharmaceuticals, Inc.'s (NASDAQ:CPRX) Earnings Are Not Doing Enough For Some InvestorsWhen close to half the companies in the United States have price-to-earnings ratios (or "P/E's") above 18x, you may...Recent Insider Transactions Derivative • May 14Chief Medical & Regulatory Officer notifies of intention to sell stockGary Ingenito intends to sell 200k shares in the next 90 days after lodging an Intent To Sell Form on the 13th of May. If the sale is conducted around the recent share price of US$23.98, it would amount to US$4.8m. Since June 2024, Gary's direct individual holding has increased from 51.39k shares to 68.87k. Company insiders have collectively sold US$29m more than they bought, via options and on-market transactions in the last 12 months.Reported Earnings • May 10First quarter 2025 earnings: EPS and revenues exceed analyst expectationsFirst quarter 2025 results: EPS: US$0.47 (up from US$0.20 in 1Q 2024). Revenue: US$141.4m (up 44% from 1Q 2024). Net income: US$56.7m (up 144% from 1Q 2024). Profit margin: 40% (up from 24% in 1Q 2024). The increase in margin was driven by higher revenue. Revenue exceeded analyst estimates by 7.8%. Earnings per share (EPS) also surpassed analyst estimates by 32%. Revenue is forecast to grow 10% p.a. on average during the next 3 years, compared to a 17% growth forecast for the Biotechs industry in the US. Over the last 3 years on average, earnings per share has increased by 31% per year but the company’s share price has increased by 50% per year, which means it is tracking significantly ahead of earnings growth.お知らせ • May 08Catalyst Pharmaceuticals, Inc. Reaffirms Full-Year 2025 Revenue OutlookCatalyst Pharmaceuticals, Inc. reaffirmed full-year 2025 revenue outlook. For the period, the total revenues, net for 2025 is expected to range between $545 million and $565 million.お知らせ • Apr 22Catalyst Pharmaceuticals, Inc. to Report Q1, 2025 Results on May 07, 2025Catalyst Pharmaceuticals, Inc. announced that they will report Q1, 2025 results After-Market on May 07, 2025お知らせ • Apr 14Catalyst Pharmaceuticals, Inc., Annual General Meeting, May 20, 2025Catalyst Pharmaceuticals, Inc., Annual General Meeting, May 20, 2025. Location: held via the internet, United StatesValuation Update With 7 Day Price Move • Mar 21Investor sentiment improves as stock rises 15%After last week's 15% share price gain to US$24.23, the stock trades at a forward P/E ratio of 17x. Average trailing P/E is 20x in the Biotechs industry in the US. Total returns to shareholders of 203% over the past three years.Recent Insider Transactions • Mar 06Executive VP & Chief Commercial Officer recently sold US$696k worth of stockOn the 3rd of March, Jeffrey Del Carmen sold around 30k shares on-market at roughly US$22.89 per share. This transaction amounted to 100% of their direct individual holding at the time of the trade. This was the largest sale by an insider in the last 3 months. Insiders have been net sellers, collectively disposing of US$4.5m more than they bought in the last 12 months.Recent Insider Transactions Derivative • Mar 04Insider notifies of intention to sell stockBrian Elsbernd intends to sell 63k shares in the next 90 days after lodging an Intent To Sell Form on the 3rd of March. If the sale is conducted around the recent share price of US$22.97, it would amount to US$1.4m. Since March 2024, Brian's direct individual holding has increased from 124.43k shares to 188.56k. Company insiders have collectively sold US$23m more than they bought, via options and on-market transactions in the last 12 months.Reported Earnings • Feb 27Full year 2024 earnings: EPS and revenues exceed analyst expectationsFull year 2024 results: EPS: US$1.38 (up from US$0.67 in FY 2023). Revenue: US$491.7m (up 24% from FY 2023). Net income: US$163.9m (up 130% from FY 2023). Profit margin: 33% (up from 18% in FY 2023). Revenue exceeded analyst estimates by 1.6%. Earnings per share (EPS) also surpassed analyst estimates by 7.0%. Revenue is forecast to grow 11% p.a. on average during the next 3 years, compared to a 20% growth forecast for the Biotechs industry in the US. Over the last 3 years on average, earnings per share has increased by 27% per year but the company’s share price has increased by 40% per year, which means it is tracking significantly ahead of earnings growth.お知らせ • Feb 27Catalyst Pharmaceuticals, Inc. Provides Revenue Guidance for the Full Year 2025Catalyst Pharmaceuticals, Inc. provided revenue guidance for the full year 2025. For full year 2025, the Company expects total revenues to be between $545 million and $565 million, reflecting continued growth in product revenue, net from FIRDAPSE and AGAMREE.分析記事 • Feb 21Cautious Investors Not Rewarding Catalyst Pharmaceuticals, Inc.'s (NASDAQ:CPRX) Performance CompletelyThere wouldn't be many who think Catalyst Pharmaceuticals, Inc.'s ( NASDAQ:CPRX ) price-to-earnings (or "P/E") ratio of...お知らせ • Feb 12Catalyst Pharmaceuticals, Inc. to Report Q4, 2024 Results on Feb 26, 2025Catalyst Pharmaceuticals, Inc. announced that they will report Q4, 2024 results After-Market on Feb 26, 2025お知らせ • Jan 25Charles B. O’Keeffe Decides to Not Stand for Reelection for Board At the 2025 Annual Meeting of Catalyst Pharmaceuticals, IncOn January 17, 2025, Charles B. O’Keeffe, an independent member of the Board of Directors (“Board”) of Catalyst Pharmaceuticals, Inc. (the “Company”), advised the Company of his decision to not stand for reelection at the 2025 annual meeting of the Company’s stockholders. Mr. O’Keeffe will continue to serve as a member of the Board until the 2025 annual meeting, when his current term will expire. Mr. O’Keeffe, age 85, has been a member of the Board since December 2004 and currently serves as the Board’s Lead Independent Director.お知らせ • Jan 21Catalyst Pharmaceuticals, Inc. Announces Sub- Licensee DyDo Pharma Launches Firapse®? in JapanCatalyst Pharmaceuticals, Inc. reported that its sub-licensee in Japan, DyDo Pharma, Inc., ("DyDo") has launched FIRDAPSE®? (amifampridine) Tablets 10 mg in Japan for the indication of improving muscle weakness in patients living with Lambert-Eaton myasthenic syndrome ("LEMS").FIRDAPSE (amifampridine), is the only U.S. FDA approved, evidence-based therapy 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. 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.FIRDAPSE®? (AMifampridine) tablets 10 mg is an oral, nonspecific, voltage-dependent, potassium (K+) channel blocker that causes depolarization of the presynaptic membrane and slows or inhibits repolarization. This action results in the opening of slow voltage-dependent calcium (Ca2+) channels, allowing for a subsequent influx of Ca2+. In turn, it induces the exocytosis of synaptic vesicles containing acetylcholine (ACh) to release more ACh into the synaptic cleft, enhancing neuromuscular transmission and providing for improved muscle function. Amifampridine phosphate was granted orphan drug designation by the Ministry of Health, Labor, and Welfare in Japan, and FIRDAPSE has previously been approved for use in the U.S. in adults and pediatric patients six months of age and older and in Europe and Canada for the treatment of adults with LEMS.お知らせ • Jan 09Catalyst Pharmaceuticals and SERB S.A. Announces Settlement of FIRDAPSE® (amifampridine) Patent Litigation with Teva PharmaceuticalsCatalyst Pharmaceuticals, Inc. announced that the Company and its licensor SERB S.A. 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 (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.分析記事 • Dec 19We Ran A Stock Scan For Earnings Growth And Catalyst Pharmaceuticals (NASDAQ:CPRX) Passed With EaseFor beginners, it can seem like a good idea (and an exciting prospect) to buy a company that tells a good story to...Recent Insider Transactions Derivative • Dec 11Executive VP notifies of intention to sell stockSteven Miller intends to sell 50k shares in the next 90 days after lodging an Intent To Sell Form on the 10th of December. If the sale is conducted around the recent share price of US$21.93, it would amount to US$1.1m. Since December 2023, Steven's direct individual holding has decreased from 811.46k shares to 675.12k. Company insiders have collectively sold US$24m more than they bought, via options and on-market transactions in the last 12 months.Recent Insider Transactions Derivative • Nov 13Co-Founder & Chairman notifies of intention to sell stockPatrick McEnany intends to sell 230k shares in the next 90 days after lodging an Intent To Sell Form on the 11th of November. If the sale is conducted around the recent share price of US$23.55, it would amount to US$5.4m. Since December 2023, Patrick's direct individual holding has increased from 4.14m shares to 4.48m. Company insiders have collectively sold US$9.8m more than they bought, via options and on-market transactions in the last 12 months.分析記事 • Nov 13We Think Catalyst Pharmaceuticals' (NASDAQ:CPRX) Profit Is Only A Baseline For What They Can AchieveCatalyst Pharmaceuticals, Inc. ( NASDAQ:CPRX ) recently posted some strong earnings, and the market responded...Reported Earnings • Nov 07Third quarter 2024 earnings: EPS and revenues exceed analyst expectationsThird quarter 2024 results: EPS: US$0.37 (up from US$0.29 loss in 3Q 2023). Revenue: US$128.7m (up 25% from 3Q 2023). Net income: US$43.9m (up US$74.6m from 3Q 2023). Profit margin: 34% (up from net loss in 3Q 2023). The move to profitability was primarily driven by lower expenses. Revenue exceeded analyst estimates by 4.3%. Earnings per share (EPS) also surpassed analyst estimates by 15%. Revenue is forecast to grow 13% p.a. on average during the next 3 years, compared to a 21% growth forecast for the Biotechs industry in the US. Over the last 3 years on average, earnings per share has increased by 24% per year but the company’s share price has increased by 47% per year, which means it is tracking significantly ahead of earnings growth.分析記事 • Nov 07Market Participants Recognise Catalyst Pharmaceuticals, Inc.'s (NASDAQ:CPRX) EarningsCatalyst Pharmaceuticals, Inc.'s ( NASDAQ:CPRX ) price-to-earnings (or "P/E") ratio of 39.6x might make it look like a...お知らせ • Nov 07Catalyst Pharmaceuticals, Inc. Provides Revenue Guidance for the Year 2024Catalyst Pharmaceuticals, Inc. provided revenue guidance for the year 2024. For the period, the company expects total revenues 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. Revising full-year 2024 net product revenue guidance for FIRDAPSE to be between $300 million and $310 million; 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.お知らせ • Oct 22Catalyst Pharmaceuticals, Inc. to Report Q3, 2024 Results on Nov 06, 2024Catalyst Pharmaceuticals, Inc. announced that they will report Q3, 2024 results After-Market on Nov 06, 2024新しいナラティブ • Sep 10Successful Product Expansions And Global Partnerships Fuel Revenue Surge And Profit Growth Diversification and expansion strategies, including new product launches and international partnerships, contribute to financial stability and potential global revenue growth.Recent Insider Transactions Derivative • Aug 30Independent Director notifies of intention to sell stockDavid Tierney intends to sell 15k shares in the next 90 days after lodging an Intent To Sell Form on the 21st of August. If the sale is conducted around the recent share price of US$20.10, it would amount to US$301k. Since December 2023, David's direct individual holding has increased from 334.87k shares to 348.87k. Company insiders have collectively sold US$9.8m more than they bought, via options and on-market transactions in the last 12 months.Recent Insider Transactions • Aug 23Executive VP recently sold US$3.1m worth of stockOn the 20th of August, Steven Miller sold around 150k shares on-market at roughly US$20.35 per share. This transaction amounted to 18% of their direct individual holding at the time of the trade. This was the largest sale by an insider in the last 3 months. Steven has been a net seller over the last 12 months, reducing personal holdings by US$3.6m.Recent Insider Transactions Derivative • Aug 22Executive VP notifies of intention to sell stockSteven Miller intends to sell 150k shares in the next 90 days after lodging an Intent To Sell Form on the 20th of August. If the sale is conducted around the recent share price of US$20.37, it would amount to US$3.1m. Since December 2023, Steven's direct individual holding has increased from 811.46k shares to 825.12k. Company insiders have collectively sold US$6.5m more than they bought, via options and on-market transactions in the last 12 months.Valuation Update With 7 Day Price Move • Aug 14Investor sentiment improves as stock rises 19%After last week's 19% share price gain to US$19.24, the stock trades at a forward P/E ratio of 15x. Average trailing P/E is 23x in the Biotechs industry in the US. Total returns to shareholders of 239% over the past three years.Major Estimate Revision • Aug 14Consensus EPS estimates increase by 16%The consensus outlook for earnings per share (EPS) in fiscal year 2024 has improved. 2024 revenue forecast increased from US$462.5m to US$473.7m. EPS estimate increased from US$0.95 to US$1.10 per share. Net income forecast to grow 129% next year vs 12% decline forecast for Biotechs industry in the US. Consensus price target up from US$27.29 to US$30.14. Share price rose 21% to US$19.59 over the past week.Recent Insider Transactions Derivative • Aug 12Chief Medical & Regulatory Officer notifies of intention to sell stockGary Ingenito intends to sell 100k shares in the next 90 days after lodging an Intent To Sell Form on the 9th of August. If the sale is conducted around the recent share price of US$18.03, it would amount to US$1.8m. Since December 2023, Gary's direct individual holding has increased from 43.83k shares to 51.39k. Company insiders have collectively sold US$4.5m more than they bought, via options and on-market transactions in the last 12 months.Price Target Changed • Aug 11Price target increased by 8.4% to US$29.57Up from US$27.29, the current price target is an average from 7 analysts. New target price is 60% above last closing price of US$18.48. Stock is up 24% over the past year. The company is forecast to post earnings per share of US$1.08 for next year compared to US$0.67 last year.Reported Earnings • Aug 08Second quarter 2024 earnings: EPS and revenues exceed analyst expectationsSecond quarter 2024 results: EPS: US$0.34. Revenue: US$122.7m (up 23% from 2Q 2023). Net income: US$40.8m (up 8.0% from 2Q 2023). Profit margin: 33% (down from 38% in 2Q 2023). The decrease in margin was driven by higher expenses. Revenue exceeded analyst estimates by 9.7%. Earnings per share (EPS) also surpassed analyst estimates by 45%. Revenue is forecast to grow 12% p.a. on average during the next 3 years, compared to a 18% growth forecast for the Biotechs industry in the US.お知らせ • Aug 08Catalyst Pharmaceuticals, Inc. Revises Revenue Guidance for the Full-Year 2024Catalyst Pharmaceuticals, Inc. revised revenue guidance for the full-year ending December 31, 2024. For the year, the company expects that total revenue will be in the upper half of their previously reported total revenue guidance of between $455 million and $475 million.分析記事 • Jul 24Earnings Tell The Story For Catalyst Pharmaceuticals, Inc. (NASDAQ:CPRX)Catalyst Pharmaceuticals, Inc.'s ( NASDAQ:CPRX ) price-to-earnings (or "P/E") ratio of 31.9x might make it look like a...お知らせ • Jul 22Catalyst Pharmaceuticals, Inc. to Report Q2, 2024 Results on Aug 07, 2024Catalyst Pharmaceuticals, Inc. announced that they will report Q2, 2024 results After-Market on Aug 07, 2024Seeking Alpha • Jul 06Catalyst Pharmaceuticals: New Products In Proving PhaseSummary Catalyst's product portfolio has grown through acquisitions to three. Two of these, FYCOMPA and AGAMREE, are relatively new, with AGAMREE having reported but a single partial quarter revenue. Catalyst remains on the outlook for additional business development opportunities. Read the full article on Seeking AlphaRecent Insider Transactions Derivative • Jun 08Chief Medical & Regulatory Officer notifies of intention to sell stockGary Ingenito intends to sell 80k shares in the next 90 days after lodging an Intent To Sell Form on the 5th of June. If the sale is conducted around the recent share price of US$16.16, it would amount to US$1.3m. Since September 2023, Gary's direct individual holding has increased from 38.37k shares to 57.31k. Company insiders have collectively sold US$3.3m more than they bought, via options and on-market transactions in the last 12 months.Major Estimate Revision • May 15Consensus EPS estimates fall by 17%The consensus outlook for fiscal year 2024 has been updated. 2024 EPS estimate fell from US$1.13 to US$0.942 per share. Revenue forecast steady at US$461.5m. Net income forecast to grow 97% next year vs 9.7% decline forecast for Biotechs industry in the US. Consensus price target up from US$26.71 to US$27.29. Share price rose 8.9% to US$16.49 over the past week.お知らせ • May 10Catalyst Pharmaceuticals, Inc. Reaffirms Revenue Guidance for the Full-Year 2024Catalyst Pharmaceuticals, Inc. reaffirmed revenue guidance for the full-year 2024. For the year, the company expected total revenue in the range of $455 million and $475 million.Reported Earnings • May 09First quarter 2024 earnings: EPS misses analyst expectationsFirst quarter 2024 results: EPS: US$0.20 (down from US$0.28 in 1Q 2023). Revenue: US$98.5m (up 15% from 1Q 2023). Net income: US$23.3m (down 21% from 1Q 2023). Profit margin: 24% (down from 35% in 1Q 2023). The decrease in margin was driven by higher expenses. Revenue was in line with analyst estimates. Earnings per share (EPS) missed analyst estimates by 10%. Revenue is forecast to grow 13% p.a. on average during the next 3 years, compared to a 18% growth forecast for the Biotechs industry in the US. Over the last 3 years on average, earnings per share has increased by 11% per year but the company’s share price has increased by 46% per year, which means it is tracking significantly ahead of earnings growth.お知らせ • Apr 23Catalyst Pharmaceuticals, Inc. to Report Q1, 2024 Results on May 08, 2024Catalyst Pharmaceuticals, Inc. announced that they will report Q1, 2024 results After-Market on May 08, 2024お知らせ • Apr 11Catalyst Pharmaceuticals, Inc., Annual General Meeting, May 21, 2024Catalyst Pharmaceuticals, Inc., Annual General Meeting, May 21, 2024, at 09:00 Eastern Standard Time. Agenda: To elect seven directors to serve a term of one year or until their successors are duly elected and qualified, or until their earlier death, resignation, or removal; to approve an amendment to 2018 Stock Incentive Plan to increase the shares available for issuance under the plan by 3,000,000 shares; to approve, on an advisory basis, the 2023 compensation of named executive officers, as set forth herein; to ratify Grant Thornton LLP as independent registered public accounting firm for the fiscal year ending December 31, 2024; and to consider other business issues.Recent Insider Transactions Derivative • Apr 10Independent Director notifies of intention to sell stockDavid Tierney intends to sell 25k shares in the next 90 days after lodging an Intent To Sell Form on the 8th of April. If the sale is conducted around the recent share price of US$15.67, it would amount to US$392k. Since June 2023, David's direct individual holding has increased from 333.54k shares to 348.87k. Company insiders have collectively sold US$2.8m more than they bought, via options and on-market transactions in the last 12 months.Seeking Alpha • Apr 06Catalyst Pharmaceuticals: Revenue Growth Lagging Expense Growth (Rating Downgrade)Summary Catalyst Pharmaceuticals' stock has performed well, up approximately 20% since my previous article's tepid "Buy" rating. Its stock price is no longer depressed, and its guidance for 2024 is unremarkable, leading to a downgrading to a "Hold". Acquisition of commercial rights to FYCOMPA has provided it with a second revenue stream, but the deal's financial viability remains uncertain. Read the full article on Seeking AlphaRecent Insider Transactions • Mar 29Insider recently sold US$411k worth of stockOn the 27th of March, Brian Elsbernd sold around 25k shares on-market at roughly US$16.44 per share. This transaction amounted to 17% of their direct individual holding at the time of the trade. This was the largest sale by an insider in the last 3 months. Insiders have been net sellers, collectively disposing of US$1.0m more than they bought in the last 12 months.お知らせ • Mar 13Catalyst Pharmaceuticals Announces Agamree® Now Commercially Available in the U.S. for the Treatment of Duchenne Muscular Dystrophy (Dmd)Catalyst Pharmaceuticals, Inc. announced the U.S. commercial launch of AGAMREE® (vamorolone) oral suspension 40 mg/mL for the treatment of Duchenne Muscular Dystrophy ("DMD") in patients aged two years and older. Following the U.S. Food and Drug Administration ("FDA") approval on October 26, 2023, AGAMREE is now available by prescription and dispensed throughout the United States through a specialty pharmacy network. Catalyst Pathways® Patient Assistance Program for AGAMREE® is a comprehensive patient support program that includes a dedicated, personalized support team that assists families throughout the AGAMREE treatment journey for eligible patients. Duchenne Muscular Dystrophy, DMD, the most common form of muscular dystrophy, is a rare and life-threatening neuromuscular disorder characterized by progressive muscle dysfunction, ultimately leading to loss of ambulation, respiratory failure, and fatality. Current standard treatment for DMD involves corticosteroids, which often come with significant side effects. It is estimated that between 11,000 and 13,000 patients in the U.S. are affected by DMD, with approximately 70% of patients currently receiving a corticosteroid treatment. Steroids are expected to remain the backbone of therapy for DMD patients and dosed concomitantly with other therapies. The FDA's approval of AGAMREE® was based on the data from the pivotal Phase 2b VISION-DMD study as supplemented with safety information collected from three open-label studies, including extension studies. In these trials, AGAMREE was administered at doses ranging from 2 to 6 mg/kg/day, extending for up to 48 months. Compared with current standard-of-care corticosteroids, this novel corticosteroid treatment exhibited comparable efficacy, with data suggesting a reduction in adverse events, notably related to bone health, growth trajectory, and improved behavior.Reported Earnings • Feb 29Full year 2023 earnings: EPS and revenues exceed analyst expectationsFull year 2023 results: EPS: US$0.67 (down from US$0.80 in FY 2022). Revenue: US$398.2m (up 86% from FY 2022). Net income: US$71.4m (down 14% from FY 2022). Profit margin: 18% (down from 39% in FY 2022). The decrease in margin was driven by higher expenses. Revenue exceeded analyst estimates by 1.2%. Earnings per share (EPS) also surpassed analyst estimates by 6.3%. Revenue is forecast to grow 9.2% p.a. on average during the next 3 years, compared to a 18% growth forecast for the Biotechs industry in the US. Over the last 3 years on average, earnings per share has increased by 11% per year but the company’s share price has increased by 66% per year, which means it is tracking significantly ahead of earnings growth.お知らせ • Feb 29Catalyst Pharmaceuticals, Inc. Provides Revenue Guidance for the Year 2024Catalyst Pharmaceuticals, Inc. provided revenue guidance for the year 2024. For the period, the Company expects total revenues in 2024 within the range of $455 million and $475 million, reflecting net product revenue of approximately $295 million to $310 million for FIRDAPSE, AGAMREE net product revenue of approximately $25 million to $30 million, and FYCOMPA net product revenue of approximately $130 million to $135 million. Product revenue for FYCOMPA in 2024 will be affected by differences in variable consideration (gross-to-net) compared to 2023, when revenues were booked under Eisai’s cost arrangements with distributors and government authorities. Starting on January 1, 2024, all such costs are tied to arrangements between the Company and those distributors and government agencies, which costs are likely to be higher than Eisai’s costs, thereby increasing the gross-to-net deductions for FYCOMPA and correspondingly decreasing FYCOMPA net product revenue.お知らせ • Feb 15Catalyst Pharmaceuticals, Inc. to Report Q4, 2023 Results on Feb 28, 2024Catalyst Pharmaceuticals, Inc. announced that they will report Q4, 2023 results After-Market on Feb 28, 2024分析記事 • Jan 29Earnings Tell The Story For Catalyst Pharmaceuticals, Inc. (NASDAQ:CPRX)Catalyst Pharmaceuticals, Inc.'s ( NASDAQ:CPRX ) price-to-earnings (or "P/E") ratio of 27.1x might make it look like a...Seeking Alpha • Jan 17Catalyst Pharmaceuticals: Until The TEVA ANDA Is Resolved, There Is A RiskSummary Catalyst Pharmaceuticals, Inc. has one approved product and another about to be launched, but its market cap is low at $1.7bn. The company is facing a major patent challenge and has high expenses with no major data catalysts or pipeline molecules. Until the patent issue is resolved, Catalyst Pharmaceuticals stock remains risky. Read the full article on Seeking Alphaお知らせ • Jan 05+ 1 more updateCatalyst Pharmaceuticals, Inc. has completed a Follow-on Equity Offering in the amount of $150 million.Catalyst Pharmaceuticals, Inc. has completed a Follow-on Equity Offering in the amount of $150 million. Security Name: Common Stock Security Type: Common Stock Securities Offered: 10,000,000 Price\Range: $15Recent Insider Transactions Derivative • Jan 04Co-Founder exercised options to buy US$4.3m worth of stock.On the 2nd of January, Patrick McEnany exercised options to buy 250k shares at a strike price of around US$1.13, costing a total of US$283k. This transaction amounted to 6.0% of their direct individual holding at the time of the trade. Since March 2023, Patrick's direct individual holding has increased from 3.95m shares to 4.14m. Company insiders have collectively sold US$6.6m more than they bought, via options and on-market transactions in the last 12 months.Valuation Update With 7 Day Price Move • Dec 22Investor sentiment improves as stock rises 15%After last week's 15% share price gain to US$16.58, the stock trades at a forward P/E ratio of 16x. Average forward P/E is 18x in the Biotechs industry in the US. Total returns to shareholders of 385% over the past three years.Price Target Changed • Dec 22Price target increased by 13% to US$26.20Up from US$23.10, the current price target is an average from 5 analysts. New target price is 58% above last closing price of US$16.58. Stock is down 13% over the past year. The company is forecast to post earnings per share of US$0.55 for next year compared to US$0.80 last year.お知らせ • Dec 18Catalyst Pharmaceuticals, Inc. Announces Firapse New Drug Application Submitted in Japan by Partner DyDo PharmaCatalyst Pharmaceuticals, Inc. announced that its collaboration partner, DyDo Pharma, Inc. reported that it has submitted a New Drug Application ("NDA") to Japan's Pharmaceuticals and Medical Devices Agency ("PMDA") seeking marketing approval for FIRDAPSE®? (amifampridine) Tablets 10 mg (generic name: amifampridine phosphate), for the treatment of Lambert Eaton myasthenic syndrome ("LEMS") in Japan. The submission is based on preliminary favorable analysis results of interim data after six months into the safety phase of the registration study to evaluate the efficacy and safety of FIRDAPSE for the treatment of LEMS. The review period is expected to be approximately a minimum of nine months from the submission date. In June 2021, Catalyst entered into a license agreement with DyDo for the development and commercialization of FIRDAPSE in Japan. Under the terms of the agreement, Catalyst is eligible to receive a regulatory milestone payment from DyDo upon submission of the NDA to the PMDA. Under the Company's license agreement with SERB S.A., upon acceptance of the NDA submission to the PMDA in Japan, Catalyst's territorial rights to develop and market the product will automatically extend to other key markets in Asia, Central, and South America. The Company is currently initiating plans to seek opportunities to expand the product's global footprint through strategic partnerships, with a current focus on the Asia Pacific and Latin American regions.Recent Insider Transactions • Dec 08COO & Chief Scientific Officer recently sold US$570k worth of stockOn the 5th of December, Steven Miller sold around 40k shares on-market at roughly US$14.24 per share. This transaction amounted to 5.8% of their direct individual holding at the time of the trade. This was the largest sale by an insider in the last 3 months. This was Steven's only on-market trade for the last 12 months.Recent Insider Transactions Derivative • Dec 07COO & Chief Scientific Officer notifies of intention to sell stockSteven Miller intends to sell 40k shares in the next 90 days after lodging an Intent To Sell Form on the 5th of December. If the sale is conducted around the recent share price of US$14.24, it would amount to US$570k. Since March 2023, Steven's direct individual holding has increased from 587.46k shares to 687.46k. Company insiders have collectively sold US$4.0m more than they bought, via options and on-market transactions in the last 12 months.お知らせ • Dec 05Catalyst Pharmaceuticals, Inc. Appoints Michael W. Kalb as Its Chief Financial Officer, Effective on January 1, 2024Catalyst Pharmaceuticals, Inc. announced the appointment of Michael W. Kalb as its Chief Financial Officer, effective on January 1, 2024. Mr. Kalb will report directly to the Company’s Chief Executive Officer and will serve as a member of the Company's executive leadership team. Mr. Kalb's distinguished career in finance spans over three decades in the pharmaceutical and financial services sector. He succeeds Ms. Alicia Grande, who will retire from the Company at the end of this year. Mr. Kalb brings extensive financial expertise to Catalyst, backed by his distinguished career in senior financial leadership roles. Before joining the Company, Mr. Kalb served as Chief Financial Officer at Impel Pharmaceuticals, Inc., and previously served as Executive Vice President and Chief Financial Officer of CinCor Pharma, Inc. Further, Mr. Kalb served as Senior Vice President and Chief Financial Officer of Amarin Corporation plc, where he contributed to its significant revenue growth, increased market capitalization, and successfully led multiple financing rounds of varying sizes and structures. Before his tenure at Amarin, Mr. Kalb served in several financial senior management positions at Taro Pharmaceutical Industries Ltd., including as Group Vice President and Chief Financial Officer, and as a Director in the Accounting and Financial Consulting Group of Huron Consulting Group Inc. His experience also includes over ten years of public accounting experience, principally at Ernst and Young. Mr. Kalb holds a B.S. in Accounting from the State University of New York at Albany, School of Business. Mr. Kalb is a certified public accountant.お知らせ • Dec 04Catalyst Pharmaceuticals, Inc. Announces Management Changes, Effective on January 1, 2024Catalyst Pharmaceuticals, Inc. announced the appointment of Michael W. Kalb as its Executive Vice President, effective on January 1, 2024. Mr. Kalb will report directly to the Company’s Chief Executive Officer and will serve as a member of the Company's executive leadership team. Mr. Kalb's distinguished career in finance spans over three decades in the pharmaceutical and financial services sector. He succeeds Ms. Alicia Grande, who will retire from the Company at the end of this year. Mr. Kalb brings extensive financial expertise to Catalyst, backed by his distinguished career in senior financial leadership roles. Before joining the Company, Mr. Kalb served as Chief Financial Officer at Impel Pharmaceuticals, Inc., and previously served as Executive Vice President and Chief Financial Officer of CinCor Pharma, Inc. Further, Mr. Kalb served as Senior Vice President and Chief Financial Officer of Amarin Corporation plc, where he contributed to its significant revenue growth, increased market capitalization, and successfully led multiple financing rounds of varying sizes and structures. Before his tenure at Amarin, Mr. Kalb served in several financial senior management positions at Taro Pharmaceutical Industries Ltd., including as Group Vice President and Chief Financial Officer, and as a Director in the Accounting and Financial Consulting Group of Huron Consulting Group Inc. His experience also includes over ten years of public accounting experience, principally at Ernst and Young. Mr. Kalb holds a B.S. in Accounting from the State University of New York at Albany, School of Business. Mr. Kalb is a certified public accountant. Additionally, company announced that effective on January 1, 2024, Dr. Steven Miller will be promoted to Executive Vice President, Chief Operating and Scientific Officer and Jeffrey Del Carmen will be promoted to Executive Vice President, Chief Commercial Officer.お知らせ • Nov 10Catalyst Pharmaceuticals, Inc. Raises Revenue Guidance for the Full Year 2023Catalyst Pharmaceuticals, Inc. raised revenue guidance for the full year 2023. For the year, the company expects total revenues, including FYCOMPA, to be between $390 million and $395 million, representing an 82% to 84% increase in total revenues compared to 2022. Key guidance assumptions in this forecast reflect a continued recovery in macroeconomic and healthcare activity throughout 2023 related to the current COVID-19 environment.Reported Earnings • Nov 10Third quarter 2023 earnings: Revenues exceed analysts expectations while EPS lags behindThird quarter 2023 results: US$0.29 loss per share (down from US$0.22 profit in 3Q 2022). Revenue: US$102.7m (up 79% from 3Q 2022). Net loss: US$30.8m (down 235% from profit in 3Q 2022). Revenue exceeded analyst estimates by 2.3%. Earnings per share (EPS) missed analyst estimates by 53%. Revenue is forecast to grow 12% p.a. on average during the next 3 years, compared to a 15% growth forecast for the Biotechs industry in the US. Over the last 3 years on average, earnings per share has increased by 10% per year but the company’s share price has increased by 54% per year, which means it is tracking significantly ahead of earnings growth.お知らせ • Nov 04Catalyst Pharmaceuticals, Inc. Receives Two New U.S. Patent Allowances for FIRDAPSECatalyst Pharmaceuticals, Inc. announced that the Company has received notification by the United States Patent and Trademark Office (USPTO) that two additional patents covering FIRDAPSE® (amifampridine) Tablets 10 mg, were allowed and will be granted within the next two months. These new patents are for claims associated with the unique and novel, previously unknown, bioavailability of FIRDAPSE under fasting and fed conditions of dosing. FIRDAPSE is the only approved treatment available in the U.S. for Lambert-Eaton myasthenic syndrome.お知らせ • Oct 28Catalyst Pharmaceuticals, Inc. Reports FDA Approval of AGAMREE® (vamorolone) for Duchenne Muscular Dystrophy Granted to Santhera PharmaceuticalsCatalyst Pharmaceuticals, Inc. reported that Santhera Pharmaceuticals ("Santhera") has obtained U.S. Food and Drug Administration ("FDA") approval for AGAMREE® (vamorolone) oral suspension 40 mg/mL for use in treating Duchenne Muscular Dystrophy ("DMD") in patients aged two years and older. AGAMREE offers a novel corticosteroid treatment option for DMD, addressing a significant unmet medical need. In July 2023, Catalyst secured the exclusive North American license and commercial rights for AGAMREE from Santhera for DMD and other potential indications, bolstering its neuroscience commercial portfolio with a highly synergistic neuromuscular asset. As part of that transaction, Santhera will promptly transfer the approved New Drug Application for AGAMREE to Catalyst. FDA’s approval of AGAMREE® was based on the data from the pivotal Phase 2b VISION-DMD study as supplemented with safety information collected from three open-label studies, including extension studies. In these trials, AGAMREE was administered at doses ranging from 2 to 6 mg/kg/day, extending for a period of up to 48 months. Compared with current standard-of-care corticosteroids, this novel corticosteroid treatment exhibited comparable efficacy, with data suggesting a reduction in adverse events, notably related to bone health, growth trajectory, and behavior. Upon the transfer of AGAMREE's NDA into its neuromuscular franchise, Catalyst will harness its product portfolio synergies by leveraging its well-established expertise and proven commercial capabilities. The Company plans to launch the product in First Quarter 2024, spearheaded by its seasoned and experienced U.S. commercial and medical affairs neuromuscular teams. AGAMREE was granted Orphan Drug and Rare Pediatric Disease designations status for DMD in the U.S. and will be eligible for seven years of orphan drug exclusivity upon approval date and has issued pending patents that could provide protection until 2040. In Europe, it has received Promising Innovative Medicine (PIM) status from the UK MHRA for DMD.収支内訳Catalyst Pharmaceuticals の稼ぎ方とお金の使い方。LTMベースの直近の報告された収益に基づく。収益と収入の歴史NasdaqCM:CPRX 収益、費用、利益 ( )USD Millions日付収益収益G+A経費研究開発費31 Mar 26597221196031 Dec 25589214194030 Sep 25578218185030 Jun 25558209183031 Mar 25535197178031 Dec 24492164178030 Sep 24460143176030 Jun 2443468163031 Mar 2441165151031 Dec 2339871134030 Sep 2334862106030 Jun 2330311686031 Mar 232569970031 Dec 222148357030 Sep 221926756030 Jun 221705455031 Mar 221544553031 Dec 211413950030 Sep 211344250030 Jun 211277548031 Mar 211207247031 Dec 201197544030 Sep 201187142030 Jun 201204240031 Mar 201194339031 Dec 191023237030 Sep 1973932030 Jun 1942-1228031 Mar 1913-2922031 Dec 181-3416030 Sep 180-2511030 Jun 180-219031 Mar 180-198031 Dec 170-187030 Sep 170-176030 Jun 170-176031 Mar 170-186-431 Dec 160-187030 Sep 160-209430 Jun 160-209731 Mar 160-2091331 Dec 150-209030 Sep 150-18810質の高い収益: CPRXは 高品質の収益 を持っています。利益率の向上: CPRXの現在の純利益率 (37.1%)は、昨年(36.9%)よりも高くなっています。フリー・キャッシュフローと収益の比較過去の収益成長分析収益動向: CPRXの収益は過去 5 年間で年間32.6%増加しました。成長の加速: CPRXの過去 1 年間の収益成長率 ( 12.1% ) は、5 年間の平均 ( 年間32.6%を下回っています。収益対業界: CPRXの過去 1 年間の収益成長率 ( 12.1% ) Biotechs業界43%を上回りませんでした。株主資本利益率高いROE: CPRXの 自己資本利益率 ( 21.9% ) は 高い とみなされます。総資産利益率使用総資本利益率過去の好業績企業の発掘7D1Y7D1Y7D1YPharmaceuticals-biotech 、過去の業績が好調な企業。View Financial Health企業分析と財務データの現状データ最終更新日（UTC時間）企業分析2026/05/17 20:29終値2026/05/15 00:00収益2026/03/31年間収益2025/12/31データソース企業分析に使用したデータはS&P Global Market Intelligence LLC のものです。本レポートを作成するための分析モデルでは、以下のデータを使用しています。データは正規化されているため、ソースが利用可能になるまでに時間がかかる場合があります。パッケージデータタイムフレーム米国ソース例会社財務10年損益計算書キャッシュ・フロー計算書貸借対照表SECフォーム10-KSECフォーム10-Qアナリストのコンセンサス予想+プラス3年予想財務アナリストの目標株価アナリストリサーチレポートBlue Matrix市場価格30年株価配当、分割、措置ICEマーケットデータSECフォームS-1所有権10年トップ株主インサイダー取引SECフォーム4SECフォーム13Dマネジメント10年リーダーシップ・チーム取締役会SECフォーム10-KSECフォームDEF 14A主な進展10年会社からのお知らせSECフォーム8-K* 米国証券を対象とした例であり、非米国証券については、同等の規制書式および情報源を使用。特に断りのない限り、すべての財務データは1年ごとの期間に基づいていますが、四半期ごとに更新されます。これは、TTM（Trailing Twelve Month）またはLTM（Last Twelve Month）データとして知られています。詳細はこちら。分析モデルとスノーフレーク本レポートを生成するために使用した分析モデルの詳細は当社のGithubページでご覧いただけます。また、レポートの使用方法に関するガイドやYoutubeのチュートリアルも掲載しています。シンプリー・ウォールストリート分析モデルを設計・構築した世界トップクラスのチームについてご紹介します。業界およびセクターの指標私たちの業界とセクションの指標は、Simply Wall Stによって6時間ごとに計算されます。アナリスト筋Catalyst Pharmaceuticals, Inc. 7 これらのアナリストのうち、弊社レポートのインプットとして使用した売上高または利益の予想を提出したのは、 。アナリストの投稿は一日中更新されます。17 アナリスト機関null nullBairdLuke HerrmannBairdJoel BeattyBaird14 その他のアナリストを表示
Reported Earnings • May 12First quarter 2026 earnings: EPS exceeds analyst expectationsFirst quarter 2026 results: EPS: US$0.52 (up from US$0.47 in 1Q 2025). Revenue: US$149.4m (up 5.6% from 1Q 2025). Net income: US$63.7m (up 12% from 1Q 2025). Profit margin: 43% (up from 40% in 1Q 2025). The increase in margin was driven by higher revenue. Revenue was in line with analyst estimates. Earnings per share (EPS) surpassed analyst estimates by 9.6%. Revenue is forecast to grow 8.7% p.a. on average during the next 3 years, compared to a 22% growth forecast for the Biotechs industry in the US. Over the last 3 years on average, earnings per share has increased by 35% per year whereas the company’s share price has increased by 36% per year.
お知らせ • Apr 29Catalyst Pharmaceuticals, Inc. to Report Q1, 2026 Results on May 11, 2026Catalyst Pharmaceuticals, Inc. announced that they will report Q1, 2026 results After-Market on May 11, 2026
Reported Earnings • Feb 26Full year 2025 earnings: EPS and revenues exceed analyst expectationsFull year 2025 results: EPS: US$1.75 (up from US$1.38 in FY 2024). Revenue: US$589.0m (up 20% from FY 2024). Net income: US$214.3m (up 31% from FY 2024). Profit margin: 36% (up from 33% in FY 2024). The increase in margin was driven by higher revenue. Revenue exceeded analyst estimates by 1.7%. Earnings per share (EPS) also surpassed analyst estimates by 4.1%. Revenue is forecast to grow 7.6% p.a. on average during the next 3 years, compared to a 20% growth forecast for the Biotechs industry in the US. Over the last 3 years on average, earnings per share has increased by 34% per year but the company’s share price has only increased by 18% per year, which means it is significantly lagging earnings growth.
お知らせ • Feb 11Catalyst Pharmaceuticals, Inc. to Report Q4, 2025 Results on Feb 25, 2026Catalyst Pharmaceuticals, Inc. announced that they will report Q4, 2025 results at 4:00 PM, US Eastern Standard Time on Feb 25, 2026
Reported Earnings • Nov 06Third quarter 2025 earnings: EPS and revenues exceed analyst expectationsThird quarter 2025 results: EPS: US$0.43 (up from US$0.37 in 3Q 2024). Revenue: US$148.4m (up 15% from 3Q 2024). Net income: US$52.8m (up 20% from 3Q 2024). Profit margin: 36% (up from 34% in 3Q 2024). The increase in margin was driven by higher revenue. Revenue exceeded analyst estimates by 8.5%. Earnings per share (EPS) also surpassed analyst estimates by 27%. Revenue is forecast to grow 8.6% p.a. on average during the next 3 years, compared to a 21% growth forecast for the Biotechs industry in the US. Over the last 3 years on average, earnings per share has increased by 34% per year but the company’s share price has only increased by 11% per year, which means it is significantly lagging earnings growth.
お知らせ • Oct 22Catalyst Pharmaceuticals, Inc. to Report Q3, 2025 Results on Nov 05, 2025Catalyst Pharmaceuticals, Inc. announced that they will report Q3, 2025 results After-Market on Nov 05, 2025
ライブニュース • May 15Angelini Pharma to Acquire Catalyst Pharmaceuticals in US$4.1b All-Cash Deal With 21% PremiumAngelini Pharma agreed to acquire Catalyst Pharmaceuticals in an all-cash deal valued at about $4.1 billion, or $31.50 per share, representing a 21% to 28% premium to recent trading levels. The transaction has unanimous board approval from both companies and is targeted to close in Q3 2026, subject to stockholder and regulatory approvals. Catalyst reported Q1 2026 revenue that was 6% higher year over year, driven by sales of FIRDAPSE and AGAMREE, and reached a settlement with Hetero that defers generic FIRDAPSE competition in the U.S. until 2035 under licensing agreements. The agreed acquisition price and premium effectively shift the near-term focus from standalone valuation debates to deal completion risk, regulatory review, and timing. Investors may want to pay close attention to any updates on regulatory approvals, stockholder voting, and potential closing conditions that could affect the path and timeline to the proposed cash payout.
Seeking Alpha • May 13Catalyst Pharmaceuticals: Angelini Deal Caps A Potentially Better StorySummary Catalyst Pharmaceuticals' (CPRX) rare-disease platform now looks better than when I last covered it. Firdapse and Agamree are the main value drivers. CPRX’s Q1 2026 generated $149.3 million in net product revenue. Firdapse and Agamree grew 28.2% together despite Fycompa’s decline. Angelini’s $31.50 per share cash offers a reasonable exit value for CPRX shareholders. But the stock is now basically an M&A play. I can understand why Angelini wants the platform. But there’s now little upside left for new investors willing to bet on the M&A deal closing. Thus, I feel CPRX remains a “Hold” at this point, since Angelini’s cash offer already captures most of the near-term risk-reward. Read the full article on Seeking Alpha
Reported Earnings • May 12First quarter 2026 earnings: EPS exceeds analyst expectationsFirst quarter 2026 results: EPS: US$0.52 (up from US$0.47 in 1Q 2025). Revenue: US$149.4m (up 5.6% from 1Q 2025). Net income: US$63.7m (up 12% from 1Q 2025). Profit margin: 43% (up from 40% in 1Q 2025). The increase in margin was driven by higher revenue. Revenue was in line with analyst estimates. Earnings per share (EPS) surpassed analyst estimates by 9.6%. Revenue is forecast to grow 8.7% p.a. on average during the next 3 years, compared to a 22% growth forecast for the Biotechs industry in the US. Over the last 3 years on average, earnings per share has increased by 35% per year whereas the company’s share price has increased by 36% per year.
お知らせ • May 09+ 1 more updateCatalyst Pharmaceuticals Announces Settlement of FIRDAPSE Patent Litigation With Hetero Labs LtdCatalyst Pharmaceuticals Inc. announced that the Company and its licensor SERB S.A. have entered into a Settlement Agreement with Hetero Labs Ltd., Hetero USA, Grace Consulting Services Inc., and Annora Pharma Private Limited. This Agreement resolves the patent litigation brought by Catalyst and SERB in response to Hetero’s Abbreviated New Drug Application seeking approval to market a generic version of FIRDAPSE (amifampridine) 10 mg tablets prior to expiration of the applicable patents. Pursuant to the terms of the Agreement, Hetero will not market its generic version of FIRDAPSE in the United States any earlier than a specified date in January 2035, if approved by the U.S. Food and Drug Administration, 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 Hetero regarding FIRDAPSE patents pending in the U.S. District Court for the District of New Jersey prior to the scheduled trial commencement on May 18, 2026. Catalyst previously settled similar litigation regarding ANDA applications for FIRDAPSE with Lupin Pharmaceuticals, Teva Pharmaceuticals, and Inventia Healthcare Limited. This settlement resolves all pending patent litigation relating to FIRDAPSE. As required by law, the companies will submit the confidential settlement agreement to the U.S. Federal Trade Commission and the U.S. Department of Justice for review.
お知らせ • Apr 29Catalyst Pharmaceuticals, Inc. to Report Q1, 2026 Results on May 11, 2026Catalyst Pharmaceuticals, Inc. announced that they will report Q1, 2026 results After-Market on May 11, 2026
お知らせ • Apr 28Angelini Pharma Reportedly Explores A Potential Acquisition of Catalyst PharmaceuticalsCatalyst Pharmaceuticals, Inc. (NasdaqCM:CPRX) surged nearly 20% on April 27, 2026, after a report that Italy-based Angelini Pharma S.p.a. is exploring a potential acquisition of the company. The sharp move reflects renewed investor enthusiasm around merger-and-acquisition activity in the biotech sector, where mid-cap specialty drugmakers like Catalyst often become attractive targets for larger or privately held pharmaceutical groups seeking growth. According to a Bloomberg report citing sources familiar with the matter, Angelini Pharma is working with financial advisers as it evaluates a possible bid for Catalyst, which currently carries a market capitalization of $3.3 billion. While the discussions are said to be in early stages, the mere possibility of a deal was enough to trigger a strong rally in Catalyst’s shares, underscoring how sensitive biotech valuations are to takeover speculation. Angelini Pharma, part of the privately held Angelini Industries group, has been increasingly vocal about its ambitions to expand beyond its core European markets. In a statement, a company representative emphasized that evaluating growth opportunities—including acquisitions—is a central component of its long-term strategy. However, the company stopped short of confirming any specific interest in Catalyst, noting that there is no guarantee ongoing evaluations will lead to a transaction. Still, several uncertainties remain. Angelini is reportedly reviewing multiple acquisition targets, meaning Catalyst is not the only option on the table. Additionally, valuation considerations, regulatory hurdles, and strategic fit will all play critical roles in determining whether talks progress.
Reported Earnings • Feb 26Full year 2025 earnings: EPS and revenues exceed analyst expectationsFull year 2025 results: EPS: US$1.75 (up from US$1.38 in FY 2024). Revenue: US$589.0m (up 20% from FY 2024). Net income: US$214.3m (up 31% from FY 2024). Profit margin: 36% (up from 33% in FY 2024). The increase in margin was driven by higher revenue. Revenue exceeded analyst estimates by 1.7%. Earnings per share (EPS) also surpassed analyst estimates by 4.1%. Revenue is forecast to grow 7.6% p.a. on average during the next 3 years, compared to a 20% growth forecast for the Biotechs industry in the US. Over the last 3 years on average, earnings per share has increased by 34% per year but the company’s share price has only increased by 18% per year, which means it is significantly lagging earnings growth.
お知らせ • Feb 26Catalyst Pharmaceuticals, Inc. Provides Earnings Guidance for the Full Year 2026Catalyst Pharmaceuticals, Inc. provided earnings guidance for the full year 2026. For the year, the company expects total revenues to be between $615 million and $645 million, reflecting continued robust growth in product revenue.
お知らせ • Feb 11Catalyst Pharmaceuticals, Inc. to Report Q4, 2025 Results on Feb 25, 2026Catalyst Pharmaceuticals, Inc. announced that they will report Q4, 2025 results at 4:00 PM, US Eastern Standard Time on Feb 25, 2026
Recent Insider Transactions Derivative • Dec 18Lead Independent Director exercised options and sold US$351k worth of stockOn the 12th of December, Molly Harper exercised 20k options at a strike price of around US$5.78 and sold these shares for an average price of US$23.32 per share. This trade did not impact their existing holding. Since December 2024, Molly's direct individual holding has increased from 2.75k shares to 9.11k. Company insiders have collectively sold US$24m more than they bought, via options and on-market transactions in the last 12 months.
Recent Insider Transactions Derivative • Nov 28Executive VP & Chief Commercial Officer notifies of intention to sell stockJeffrey Del Carmen intends to sell 11k shares in the next 90 days after lodging an Intent To Sell Form on the 26th of November. If the sale is conducted around the recent share price of US$23.33, it would amount to US$256k. Since December 2024, Jeffrey's direct individual holding has decreased from 22.88k shares to 3.96k. Company insiders have collectively sold US$23m more than they bought, via options and on-market transactions in the last 12 months.
Recent Insider Transactions • Nov 17Insider recently sold US$908k worth of stockOn the 12th of November, Brian Elsbernd sold around 40k shares on-market at roughly US$22.70 per share. This transaction amounted to 15% of their direct individual holding at the time of the trade. This was the largest sale by an insider in the last 3 months. Insiders have been net sellers, collectively disposing of US$8.7m more than they bought in the last 12 months.
Recent Insider Transactions Derivative • Nov 14Insider notifies of intention to sell stockBrian Elsbernd intends to sell 40k shares in the next 90 days after lodging an Intent To Sell Form on the 12th of November. If the sale is conducted around the recent share price of US$22.70, it would amount to US$908k. Since December 2024, Brian's direct individual holding has increased from 181.25k shares to 271.04k. Company insiders have collectively sold US$26m more than they bought, via options and on-market transactions in the last 12 months.
お知らせ • Nov 07Catalyst Pharmaceuticals, Inc. Raises Revenue Guidance for the Full Year 2025Catalyst Pharmaceuticals, Inc. raised revenue guidance for the full year 2025. For the period, Company expects total revenue to between $565 million and $585 million.
Reported Earnings • Nov 06Third quarter 2025 earnings: EPS and revenues exceed analyst expectationsThird quarter 2025 results: EPS: US$0.43 (up from US$0.37 in 3Q 2024). Revenue: US$148.4m (up 15% from 3Q 2024). Net income: US$52.8m (up 20% from 3Q 2024). Profit margin: 36% (up from 34% in 3Q 2024). The increase in margin was driven by higher revenue. Revenue exceeded analyst estimates by 8.5%. Earnings per share (EPS) also surpassed analyst estimates by 27%. Revenue is forecast to grow 8.6% p.a. on average during the next 3 years, compared to a 21% growth forecast for the Biotechs industry in the US. Over the last 3 years on average, earnings per share has increased by 34% per year but the company’s share price has only increased by 11% per year, which means it is significantly lagging earnings growth.
お知らせ • Oct 22Catalyst Pharmaceuticals, Inc. to Report Q3, 2025 Results on Nov 05, 2025Catalyst Pharmaceuticals, Inc. announced that they will report Q3, 2025 results After-Market on Nov 05, 2025
お知らせ • Oct 01Catalyst Pharmaceuticals, Inc. (NasdaqCM:CPRX) announces an Equity Buyback for $200 million worth of its shares.Catalyst Pharmaceuticals, Inc. (NasdaqCM:CPRX) announces a share repurchase program. Under the program, the company will repurchase up to $200 million worth of its common stock. The company plans to use existing cash on hand to fund the share repurchase program. The program is valid till December 31, 2026.
分析記事 • Sep 26Does Catalyst Pharmaceuticals (NASDAQ:CPRX) Deserve A Spot On Your Watchlist?Investors are often guided by the idea of discovering 'the next big thing', even if that means buying 'story stocks...
Recent Insider Transactions Derivative • Aug 27Executive VP notifies of intention to sell stockSteven Miller intends to sell 115k shares in the next 90 days after lodging an Intent To Sell Form on the 26th of August. If the sale is conducted around the recent share price of US$20.28, it would amount to US$2.3m. Since December 2024, Steven's direct individual holding has increased from 936.00k shares to 949.66k. Company insiders have collectively sold US$34m more than they bought, via options and on-market transactions in the last 12 months.
お知らせ • Aug 26Catalyst Pharmaceuticals Announces Settlement of FIRDAPSE® (amifampridine) Patent Litigation with Lupin PharmaceuticalsCatalyst Pharmaceuticals, Inc. announced that the Company and its licensor SERB S.A. (“SERB”) have entered into a Settlement Agreement (“Agreement”) with Lupin Ltd. and Lupin Pharmaceuticals, Inc. (collectively, “Lupin”). This Agreement resolves the patent litigation brought by Catalyst and SERB in response to Lupin’s Abbreviated New Drug Application (“ANDA”) seeking approval to market a generic version of FIRDAPSE (amifampridine) 10 mg tablets prior to expiration of the applicable patents. Pursuant to the terms of the Agreement, Lupin 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, 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 Lupin regarding FIRDAPSE patents pending in the U.S. District Court for the District of New Jersey. Catalyst previously settled similar litigation regarding ANDA applications for FIRDAPSE with Teva Pharmaceuticals and Inventia Life Science Pty Ltd. The pending FIRDAPSE patent litigation against the remaining defendant, Hetero, regarding FIRDAPSE’s Orange Book-listed patents is ongoing. As required by law, the companies will submit the confidential settlement agreement to the U.S. Federal Trade Commission and the U.S. Department of Justice for review.
Reported Earnings • Aug 07Second quarter 2025 earnings: EPS and revenues exceed analyst expectationsSecond quarter 2025 results: EPS: US$0.43 (up from US$0.34 in 2Q 2024). Revenue: US$146.6m (up 19% from 2Q 2024). Net income: US$52.1m (up 28% from 2Q 2024). Profit margin: 36% (up from 33% in 2Q 2024). The increase in margin was driven by higher revenue. Revenue exceeded analyst estimates by 4.4%. Earnings per share (EPS) also surpassed analyst estimates by 4.6%. Revenue is forecast to grow 9.9% p.a. on average during the next 3 years, compared to a 18% growth forecast for the Biotechs industry in the US. Over the last 3 years on average, earnings per share has increased by 33% per year but the company’s share price has only increased by 14% per year, which means it is significantly lagging earnings growth.
お知らせ • Aug 07Catalyst Pharmaceuticals, Inc. Reaffirms Earnings Guidance for the Full Year 2025Catalyst Pharmaceuticals, Inc. reaffirmed earnings guidance for the full year 2025. For the full year, the company expects total revenue of $545 million to $565 million.
Board Change • Aug 06High number of new directorsDirector Dan Curran was the last director to join the board, commencing their role in the last week.
お知らせ • Aug 06Catalyst Pharmaceuticals, Inc. Announces National Comprehensive Cancer Network Clinical Practice Guidelines in OncologyCatalyst Pharmaceuticals, Inc. announced the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology (NCCN Guidelines) for Small Cell Lung Cancer (SCLC) now include new additions involving Lambert Eaton myasthenic syndrome (LEMS), amifampridine (FIRDAPSE), and the tests for PQ- and N-type voltage-gated calcium channel (VGCC) antibodies. The updated NCCN Clinical Practice Guidelines in Oncologists for SCLC relating to LEMS now include symptom specificity--characterized by proximal muscle weakness and autonomic dysfunction. Under "Signs and Symptoms of Small Cell Lung Cancer" (SCL-A 2 of 2), the guidelines recommend diagnosis through a neurological evaluation, ideally in consultation with a neurologist, which may include testing for PQ- and N -type voltage-gated calcium channels (VGCC) antibodies. Additionally, under "Prin principles of Supportive Care" (SCL-D), the guidelines recommend that amifampridine should be considered as a treatment in consultation with neurology. Approximately 50% of LEMS cases are associated with an underlying malignancy, most commonly SCLC.ature suggests that LEMS is observed in 3% of SCLC patients. Based on an internal healthcare database analysis of SCLC claims, potentially 90% of LEMS patients with SCLC went undiagnosed. These undiagnosed LEMS patients may suffer from LEMS symptoms while undergoing treatment for SCLC.
お知らせ • Aug 05Catalyst Pharmaceuticals, Inc. Appoints Daniel Curran to the Board of DirectorsCatalyst Pharmaceuticals, Inc. announced the appointment of Daniel Curran, MD, to its Board of Directors. Dr. Curran is a distinguished pharmaceutical executive with over 25 years of experience spanning strategy, business development, project leadership, and development. Since March 2024, he has served as Managing Partner of Mountainfield Venture Partners, a company-creation firm. He also currently serves as Chief Executive Officer of Timberlyne Therapeutics. From 2008 to 2023, Dr. Curran held roles of increasing responsibility at Takeda Pharmaceutical Company, serving as Senior Vice President and Head of the Rare Genetics and Hematology Therapeutic Area Unit from January 2019 through December 2023. Prior to his tenure at Takeda, Dr. Curran served as Vice President of Corporate Development at Millennium Pharmaceuticals, Inc., from 1999 to 2008. Earlier in his career, he held a business development role in the product planning and acquisition group at DuPont Merck Pharmaceuticals. Dr. Curran previously served on the board of directors of Tome Biosciences and currently serves on the Board of Directors of Xilio Therapeutics, Inc. Dr. Curran received an M.D. from the University of Pennsylvania School of Medicine, an M.B.A. from The Wharton School of the University of Pennsylvania, and a B.S. in chemistry from King's College.
お知らせ • Jul 22Catalyst Pharmaceuticals, Inc. to Report Q2, 2025 Results on Aug 06, 2025Catalyst Pharmaceuticals, Inc. announced that they will report Q2, 2025 results After-Market on Aug 06, 2025
お知らせ • Jun 30Catalyst Pharmaceuticals, Inc.(NasdaqCM:CPRX) dropped from Russell 2000 Dynamic IndexCatalyst Pharmaceuticals, Inc.(NasdaqCM:CPRX) dropped from Russell 2000 Dynamic Index
Recent Insider Transactions • Jun 11Co-Founder & Non-Executive Chairman recently sold US$5.2m worth of stockOn the 9th of June, Patrick McEnany sold around 200k shares on-market at roughly US$26.09 per share. This transaction amounted to 4.5% of their direct individual holding at the time of the trade. This was the largest sale by an insider in the last 3 months. This was Patrick's only on-market trade for the last 12 months.
Recent Insider Transactions Derivative • Jun 08Co-Founder & Non-Executive Chairman notifies of intention to sell stockPatrick McEnany intends to sell 200k shares in the next 90 days after lodging an Intent To Sell Form on the 6th of June. If the sale is conducted around the recent share price of US$25.88, it would amount to US$5.2m. Since September 2024, Patrick's direct individual holding has increased from 4.48m shares to 5.99m. Company insiders have collectively sold US$34m more than they bought, via options and on-market transactions in the last 12 months.
Recent Insider Transactions • Jun 05President recently sold US$1.7m worth of stockOn the 30th of May, Richard John Daly sold around 70k shares on-market at roughly US$24.86 per share. This transaction amounted to 26% of their direct individual holding at the time of the trade. This was the largest sale by an insider in the last 3 months. This was Richard John's only on-market trade for the last 12 months.
お知らせ • Jun 03Catalyst Pharmaceuticals, Inc. Announces Executive ChangesCatalyst Pharmaceuticals, Inc. announced the appointment of William (Will) T. Andrews, MD, FACP as Chief Medical Officer. Dr. Andrews will report directly to the Company’s President and Chief Executive Officer, Richard J. Daly, and will serve as a member of the Company’s executive leadership team. He succeeds Dr. Gary Ingenito, who is retiring after a successful career and will support the transition in a consulting capacity. Dr. Andrews brings 24 years of global biopharmaceutical experience across clinical development, medical affairs, corporate strategy and transactions, medical and commercial strategy and business development to Catalyst. Dr. Andrews has worked with both drugs and biologics across multiple therapeutic areas and through all phases of development. His primary area of expertise is in rare diseases, having spent 18 years in this space. Since 2023, Dr. Andrews was the President, CEO and co-founder of Lighthouse Bio, a biopharmaceutical start-up focused on rare disease asset acquisition with the goal of new company formation. Prior to Lighthouse Bio, he was the principal and founder of Aletheia Lifesciences. Before founding Aletheia, Dr. Andrews served as a Chief Medical Officer for Flexion Therapeutics, Akcea Therapeutics and Acer Therapeutics, as well as serving in roles of increasing responsibility at various other biopharmaceutical organizations. Dr. Andrews began his career in clinical practice with Harvard Vanguard Medical Associates and Brigham and Women’s Hospital. He also served as Clinical Faculty of Internal Medicine, Harvard Medical School, and Attending Physician in Internal Medicine, Brigham and Women’s Hospital. He received his Bachelor of Arts degree in biology from Harvard University and his Medical Degree from Yale University School of Medicine.
Recent Insider Transactions Derivative • Jun 01President notifies of intention to sell stockRichard John Daly intends to sell 70k shares in the next 90 days after lodging an Intent To Sell Form on the 30th of May. If the sale is conducted around the recent share price of US$24.86, it would amount to US$1.7m. For the year to December 2018, Richard John's total compensation was 10% salary and 90% other compensation. This indicates that these sales could comprise a meaningful part of their income for the year. Since June 2024, Richard John's direct individual holding has increased from 234.82k shares to 269.76k. Company insiders have collectively sold US$34m more than they bought, via options and on-market transactions in the last 12 months.
分析記事 • May 30Catalyst Pharmaceuticals, Inc.'s (NASDAQ:CPRX) Earnings Are Not Doing Enough For Some InvestorsWhen close to half the companies in the United States have price-to-earnings ratios (or "P/E's") above 18x, you may...
Recent Insider Transactions Derivative • May 14Chief Medical & Regulatory Officer notifies of intention to sell stockGary Ingenito intends to sell 200k shares in the next 90 days after lodging an Intent To Sell Form on the 13th of May. If the sale is conducted around the recent share price of US$23.98, it would amount to US$4.8m. Since June 2024, Gary's direct individual holding has increased from 51.39k shares to 68.87k. Company insiders have collectively sold US$29m more than they bought, via options and on-market transactions in the last 12 months.
Reported Earnings • May 10First quarter 2025 earnings: EPS and revenues exceed analyst expectationsFirst quarter 2025 results: EPS: US$0.47 (up from US$0.20 in 1Q 2024). Revenue: US$141.4m (up 44% from 1Q 2024). Net income: US$56.7m (up 144% from 1Q 2024). Profit margin: 40% (up from 24% in 1Q 2024). The increase in margin was driven by higher revenue. Revenue exceeded analyst estimates by 7.8%. Earnings per share (EPS) also surpassed analyst estimates by 32%. Revenue is forecast to grow 10% p.a. on average during the next 3 years, compared to a 17% growth forecast for the Biotechs industry in the US. Over the last 3 years on average, earnings per share has increased by 31% per year but the company’s share price has increased by 50% per year, which means it is tracking significantly ahead of earnings growth.
お知らせ • May 08Catalyst Pharmaceuticals, Inc. Reaffirms Full-Year 2025 Revenue OutlookCatalyst Pharmaceuticals, Inc. reaffirmed full-year 2025 revenue outlook. For the period, the total revenues, net for 2025 is expected to range between $545 million and $565 million.
お知らせ • Apr 22Catalyst Pharmaceuticals, Inc. to Report Q1, 2025 Results on May 07, 2025Catalyst Pharmaceuticals, Inc. announced that they will report Q1, 2025 results After-Market on May 07, 2025
お知らせ • Apr 14Catalyst Pharmaceuticals, Inc., Annual General Meeting, May 20, 2025Catalyst Pharmaceuticals, Inc., Annual General Meeting, May 20, 2025. Location: held via the internet, United States
Valuation Update With 7 Day Price Move • Mar 21Investor sentiment improves as stock rises 15%After last week's 15% share price gain to US$24.23, the stock trades at a forward P/E ratio of 17x. Average trailing P/E is 20x in the Biotechs industry in the US. Total returns to shareholders of 203% over the past three years.
Recent Insider Transactions • Mar 06Executive VP & Chief Commercial Officer recently sold US$696k worth of stockOn the 3rd of March, Jeffrey Del Carmen sold around 30k shares on-market at roughly US$22.89 per share. This transaction amounted to 100% of their direct individual holding at the time of the trade. This was the largest sale by an insider in the last 3 months. Insiders have been net sellers, collectively disposing of US$4.5m more than they bought in the last 12 months.
Recent Insider Transactions Derivative • Mar 04Insider notifies of intention to sell stockBrian Elsbernd intends to sell 63k shares in the next 90 days after lodging an Intent To Sell Form on the 3rd of March. If the sale is conducted around the recent share price of US$22.97, it would amount to US$1.4m. Since March 2024, Brian's direct individual holding has increased from 124.43k shares to 188.56k. Company insiders have collectively sold US$23m more than they bought, via options and on-market transactions in the last 12 months.
Reported Earnings • Feb 27Full year 2024 earnings: EPS and revenues exceed analyst expectationsFull year 2024 results: EPS: US$1.38 (up from US$0.67 in FY 2023). Revenue: US$491.7m (up 24% from FY 2023). Net income: US$163.9m (up 130% from FY 2023). Profit margin: 33% (up from 18% in FY 2023). Revenue exceeded analyst estimates by 1.6%. Earnings per share (EPS) also surpassed analyst estimates by 7.0%. Revenue is forecast to grow 11% p.a. on average during the next 3 years, compared to a 20% growth forecast for the Biotechs industry in the US. Over the last 3 years on average, earnings per share has increased by 27% per year but the company’s share price has increased by 40% per year, which means it is tracking significantly ahead of earnings growth.
お知らせ • Feb 27Catalyst Pharmaceuticals, Inc. Provides Revenue Guidance for the Full Year 2025Catalyst Pharmaceuticals, Inc. provided revenue guidance for the full year 2025. For full year 2025, the Company expects total revenues to be between $545 million and $565 million, reflecting continued growth in product revenue, net from FIRDAPSE and AGAMREE.
分析記事 • Feb 21Cautious Investors Not Rewarding Catalyst Pharmaceuticals, Inc.'s (NASDAQ:CPRX) Performance CompletelyThere wouldn't be many who think Catalyst Pharmaceuticals, Inc.'s ( NASDAQ:CPRX ) price-to-earnings (or "P/E") ratio of...
お知らせ • Feb 12Catalyst Pharmaceuticals, Inc. to Report Q4, 2024 Results on Feb 26, 2025Catalyst Pharmaceuticals, Inc. announced that they will report Q4, 2024 results After-Market on Feb 26, 2025
お知らせ • Jan 25Charles B. O’Keeffe Decides to Not Stand for Reelection for Board At the 2025 Annual Meeting of Catalyst Pharmaceuticals, IncOn January 17, 2025, Charles B. O’Keeffe, an independent member of the Board of Directors (“Board”) of Catalyst Pharmaceuticals, Inc. (the “Company”), advised the Company of his decision to not stand for reelection at the 2025 annual meeting of the Company’s stockholders. Mr. O’Keeffe will continue to serve as a member of the Board until the 2025 annual meeting, when his current term will expire. Mr. O’Keeffe, age 85, has been a member of the Board since December 2004 and currently serves as the Board’s Lead Independent Director.
お知らせ • Jan 21Catalyst Pharmaceuticals, Inc. Announces Sub- Licensee DyDo Pharma Launches Firapse®? in JapanCatalyst Pharmaceuticals, Inc. reported that its sub-licensee in Japan, DyDo Pharma, Inc., ("DyDo") has launched FIRDAPSE®? (amifampridine) Tablets 10 mg in Japan for the indication of improving muscle weakness in patients living with Lambert-Eaton myasthenic syndrome ("LEMS").FIRDAPSE (amifampridine), is the only U.S. FDA approved, evidence-based therapy 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. 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.FIRDAPSE®? (AMifampridine) tablets 10 mg is an oral, nonspecific, voltage-dependent, potassium (K+) channel blocker that causes depolarization of the presynaptic membrane and slows or inhibits repolarization. This action results in the opening of slow voltage-dependent calcium (Ca2+) channels, allowing for a subsequent influx of Ca2+. In turn, it induces the exocytosis of synaptic vesicles containing acetylcholine (ACh) to release more ACh into the synaptic cleft, enhancing neuromuscular transmission and providing for improved muscle function. Amifampridine phosphate was granted orphan drug designation by the Ministry of Health, Labor, and Welfare in Japan, and FIRDAPSE has previously been approved for use in the U.S. in adults and pediatric patients six months of age and older and in Europe and Canada for the treatment of adults with LEMS.
お知らせ • Jan 09Catalyst Pharmaceuticals and SERB S.A. Announces Settlement of FIRDAPSE® (amifampridine) Patent Litigation with Teva PharmaceuticalsCatalyst Pharmaceuticals, Inc. announced that the Company and its licensor SERB S.A. 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 (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.
分析記事 • Dec 19We Ran A Stock Scan For Earnings Growth And Catalyst Pharmaceuticals (NASDAQ:CPRX) Passed With EaseFor beginners, it can seem like a good idea (and an exciting prospect) to buy a company that tells a good story to...
Recent Insider Transactions Derivative • Dec 11Executive VP notifies of intention to sell stockSteven Miller intends to sell 50k shares in the next 90 days after lodging an Intent To Sell Form on the 10th of December. If the sale is conducted around the recent share price of US$21.93, it would amount to US$1.1m. Since December 2023, Steven's direct individual holding has decreased from 811.46k shares to 675.12k. Company insiders have collectively sold US$24m more than they bought, via options and on-market transactions in the last 12 months.
Recent Insider Transactions Derivative • Nov 13Co-Founder & Chairman notifies of intention to sell stockPatrick McEnany intends to sell 230k shares in the next 90 days after lodging an Intent To Sell Form on the 11th of November. If the sale is conducted around the recent share price of US$23.55, it would amount to US$5.4m. Since December 2023, Patrick's direct individual holding has increased from 4.14m shares to 4.48m. Company insiders have collectively sold US$9.8m more than they bought, via options and on-market transactions in the last 12 months.
分析記事 • Nov 13We Think Catalyst Pharmaceuticals' (NASDAQ:CPRX) Profit Is Only A Baseline For What They Can AchieveCatalyst Pharmaceuticals, Inc. ( NASDAQ:CPRX ) recently posted some strong earnings, and the market responded...
Reported Earnings • Nov 07Third quarter 2024 earnings: EPS and revenues exceed analyst expectationsThird quarter 2024 results: EPS: US$0.37 (up from US$0.29 loss in 3Q 2023). Revenue: US$128.7m (up 25% from 3Q 2023). Net income: US$43.9m (up US$74.6m from 3Q 2023). Profit margin: 34% (up from net loss in 3Q 2023). The move to profitability was primarily driven by lower expenses. Revenue exceeded analyst estimates by 4.3%. Earnings per share (EPS) also surpassed analyst estimates by 15%. Revenue is forecast to grow 13% p.a. on average during the next 3 years, compared to a 21% growth forecast for the Biotechs industry in the US. Over the last 3 years on average, earnings per share has increased by 24% per year but the company’s share price has increased by 47% per year, which means it is tracking significantly ahead of earnings growth.
分析記事 • Nov 07Market Participants Recognise Catalyst Pharmaceuticals, Inc.'s (NASDAQ:CPRX) EarningsCatalyst Pharmaceuticals, Inc.'s ( NASDAQ:CPRX ) price-to-earnings (or "P/E") ratio of 39.6x might make it look like a...
お知らせ • Nov 07Catalyst Pharmaceuticals, Inc. Provides Revenue Guidance for the Year 2024Catalyst Pharmaceuticals, Inc. provided revenue guidance for the year 2024. For the period, the company expects total revenues 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. Revising full-year 2024 net product revenue guidance for FIRDAPSE to be between $300 million and $310 million; 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.
お知らせ • Oct 22Catalyst Pharmaceuticals, Inc. to Report Q3, 2024 Results on Nov 06, 2024Catalyst Pharmaceuticals, Inc. announced that they will report Q3, 2024 results After-Market on Nov 06, 2024
新しいナラティブ • Sep 10Successful Product Expansions And Global Partnerships Fuel Revenue Surge And Profit Growth Diversification and expansion strategies, including new product launches and international partnerships, contribute to financial stability and potential global revenue growth.
Recent Insider Transactions Derivative • Aug 30Independent Director notifies of intention to sell stockDavid Tierney intends to sell 15k shares in the next 90 days after lodging an Intent To Sell Form on the 21st of August. If the sale is conducted around the recent share price of US$20.10, it would amount to US$301k. Since December 2023, David's direct individual holding has increased from 334.87k shares to 348.87k. Company insiders have collectively sold US$9.8m more than they bought, via options and on-market transactions in the last 12 months.
Recent Insider Transactions • Aug 23Executive VP recently sold US$3.1m worth of stockOn the 20th of August, Steven Miller sold around 150k shares on-market at roughly US$20.35 per share. This transaction amounted to 18% of their direct individual holding at the time of the trade. This was the largest sale by an insider in the last 3 months. Steven has been a net seller over the last 12 months, reducing personal holdings by US$3.6m.
Recent Insider Transactions Derivative • Aug 22Executive VP notifies of intention to sell stockSteven Miller intends to sell 150k shares in the next 90 days after lodging an Intent To Sell Form on the 20th of August. If the sale is conducted around the recent share price of US$20.37, it would amount to US$3.1m. Since December 2023, Steven's direct individual holding has increased from 811.46k shares to 825.12k. Company insiders have collectively sold US$6.5m more than they bought, via options and on-market transactions in the last 12 months.
Valuation Update With 7 Day Price Move • Aug 14Investor sentiment improves as stock rises 19%After last week's 19% share price gain to US$19.24, the stock trades at a forward P/E ratio of 15x. Average trailing P/E is 23x in the Biotechs industry in the US. Total returns to shareholders of 239% over the past three years.
Major Estimate Revision • Aug 14Consensus EPS estimates increase by 16%The consensus outlook for earnings per share (EPS) in fiscal year 2024 has improved. 2024 revenue forecast increased from US$462.5m to US$473.7m. EPS estimate increased from US$0.95 to US$1.10 per share. Net income forecast to grow 129% next year vs 12% decline forecast for Biotechs industry in the US. Consensus price target up from US$27.29 to US$30.14. Share price rose 21% to US$19.59 over the past week.
Recent Insider Transactions Derivative • Aug 12Chief Medical & Regulatory Officer notifies of intention to sell stockGary Ingenito intends to sell 100k shares in the next 90 days after lodging an Intent To Sell Form on the 9th of August. If the sale is conducted around the recent share price of US$18.03, it would amount to US$1.8m. Since December 2023, Gary's direct individual holding has increased from 43.83k shares to 51.39k. Company insiders have collectively sold US$4.5m more than they bought, via options and on-market transactions in the last 12 months.
Price Target Changed • Aug 11Price target increased by 8.4% to US$29.57Up from US$27.29, the current price target is an average from 7 analysts. New target price is 60% above last closing price of US$18.48. Stock is up 24% over the past year. The company is forecast to post earnings per share of US$1.08 for next year compared to US$0.67 last year.
Reported Earnings • Aug 08Second quarter 2024 earnings: EPS and revenues exceed analyst expectationsSecond quarter 2024 results: EPS: US$0.34. Revenue: US$122.7m (up 23% from 2Q 2023). Net income: US$40.8m (up 8.0% from 2Q 2023). Profit margin: 33% (down from 38% in 2Q 2023). The decrease in margin was driven by higher expenses. Revenue exceeded analyst estimates by 9.7%. Earnings per share (EPS) also surpassed analyst estimates by 45%. Revenue is forecast to grow 12% p.a. on average during the next 3 years, compared to a 18% growth forecast for the Biotechs industry in the US.
お知らせ • Aug 08Catalyst Pharmaceuticals, Inc. Revises Revenue Guidance for the Full-Year 2024Catalyst Pharmaceuticals, Inc. revised revenue guidance for the full-year ending December 31, 2024. For the year, the company expects that total revenue will be in the upper half of their previously reported total revenue guidance of between $455 million and $475 million.
分析記事 • Jul 24Earnings Tell The Story For Catalyst Pharmaceuticals, Inc. (NASDAQ:CPRX)Catalyst Pharmaceuticals, Inc.'s ( NASDAQ:CPRX ) price-to-earnings (or "P/E") ratio of 31.9x might make it look like a...
お知らせ • Jul 22Catalyst Pharmaceuticals, Inc. to Report Q2, 2024 Results on Aug 07, 2024Catalyst Pharmaceuticals, Inc. announced that they will report Q2, 2024 results After-Market on Aug 07, 2024
Seeking Alpha • Jul 06Catalyst Pharmaceuticals: New Products In Proving PhaseSummary Catalyst's product portfolio has grown through acquisitions to three. Two of these, FYCOMPA and AGAMREE, are relatively new, with AGAMREE having reported but a single partial quarter revenue. Catalyst remains on the outlook for additional business development opportunities. Read the full article on Seeking Alpha
Recent Insider Transactions Derivative • Jun 08Chief Medical & Regulatory Officer notifies of intention to sell stockGary Ingenito intends to sell 80k shares in the next 90 days after lodging an Intent To Sell Form on the 5th of June. If the sale is conducted around the recent share price of US$16.16, it would amount to US$1.3m. Since September 2023, Gary's direct individual holding has increased from 38.37k shares to 57.31k. Company insiders have collectively sold US$3.3m more than they bought, via options and on-market transactions in the last 12 months.
Major Estimate Revision • May 15Consensus EPS estimates fall by 17%The consensus outlook for fiscal year 2024 has been updated. 2024 EPS estimate fell from US$1.13 to US$0.942 per share. Revenue forecast steady at US$461.5m. Net income forecast to grow 97% next year vs 9.7% decline forecast for Biotechs industry in the US. Consensus price target up from US$26.71 to US$27.29. Share price rose 8.9% to US$16.49 over the past week.
お知らせ • May 10Catalyst Pharmaceuticals, Inc. Reaffirms Revenue Guidance for the Full-Year 2024Catalyst Pharmaceuticals, Inc. reaffirmed revenue guidance for the full-year 2024. For the year, the company expected total revenue in the range of $455 million and $475 million.
Reported Earnings • May 09First quarter 2024 earnings: EPS misses analyst expectationsFirst quarter 2024 results: EPS: US$0.20 (down from US$0.28 in 1Q 2023). Revenue: US$98.5m (up 15% from 1Q 2023). Net income: US$23.3m (down 21% from 1Q 2023). Profit margin: 24% (down from 35% in 1Q 2023). The decrease in margin was driven by higher expenses. Revenue was in line with analyst estimates. Earnings per share (EPS) missed analyst estimates by 10%. Revenue is forecast to grow 13% p.a. on average during the next 3 years, compared to a 18% growth forecast for the Biotechs industry in the US. Over the last 3 years on average, earnings per share has increased by 11% per year but the company’s share price has increased by 46% per year, which means it is tracking significantly ahead of earnings growth.
お知らせ • Apr 23Catalyst Pharmaceuticals, Inc. to Report Q1, 2024 Results on May 08, 2024Catalyst Pharmaceuticals, Inc. announced that they will report Q1, 2024 results After-Market on May 08, 2024
お知らせ • Apr 11Catalyst Pharmaceuticals, Inc., Annual General Meeting, May 21, 2024Catalyst Pharmaceuticals, Inc., Annual General Meeting, May 21, 2024, at 09:00 Eastern Standard Time. Agenda: To elect seven directors to serve a term of one year or until their successors are duly elected and qualified, or until their earlier death, resignation, or removal; to approve an amendment to 2018 Stock Incentive Plan to increase the shares available for issuance under the plan by 3,000,000 shares; to approve, on an advisory basis, the 2023 compensation of named executive officers, as set forth herein; to ratify Grant Thornton LLP as independent registered public accounting firm for the fiscal year ending December 31, 2024; and to consider other business issues.
Recent Insider Transactions Derivative • Apr 10Independent Director notifies of intention to sell stockDavid Tierney intends to sell 25k shares in the next 90 days after lodging an Intent To Sell Form on the 8th of April. If the sale is conducted around the recent share price of US$15.67, it would amount to US$392k. Since June 2023, David's direct individual holding has increased from 333.54k shares to 348.87k. Company insiders have collectively sold US$2.8m more than they bought, via options and on-market transactions in the last 12 months.
Seeking Alpha • Apr 06Catalyst Pharmaceuticals: Revenue Growth Lagging Expense Growth (Rating Downgrade)Summary Catalyst Pharmaceuticals' stock has performed well, up approximately 20% since my previous article's tepid "Buy" rating. Its stock price is no longer depressed, and its guidance for 2024 is unremarkable, leading to a downgrading to a "Hold". Acquisition of commercial rights to FYCOMPA has provided it with a second revenue stream, but the deal's financial viability remains uncertain. Read the full article on Seeking Alpha
Recent Insider Transactions • Mar 29Insider recently sold US$411k worth of stockOn the 27th of March, Brian Elsbernd sold around 25k shares on-market at roughly US$16.44 per share. This transaction amounted to 17% of their direct individual holding at the time of the trade. This was the largest sale by an insider in the last 3 months. Insiders have been net sellers, collectively disposing of US$1.0m more than they bought in the last 12 months.
お知らせ • Mar 13Catalyst Pharmaceuticals Announces Agamree® Now Commercially Available in the U.S. for the Treatment of Duchenne Muscular Dystrophy (Dmd)Catalyst Pharmaceuticals, Inc. announced the U.S. commercial launch of AGAMREE® (vamorolone) oral suspension 40 mg/mL for the treatment of Duchenne Muscular Dystrophy ("DMD") in patients aged two years and older. Following the U.S. Food and Drug Administration ("FDA") approval on October 26, 2023, AGAMREE is now available by prescription and dispensed throughout the United States through a specialty pharmacy network. Catalyst Pathways® Patient Assistance Program for AGAMREE® is a comprehensive patient support program that includes a dedicated, personalized support team that assists families throughout the AGAMREE treatment journey for eligible patients. Duchenne Muscular Dystrophy, DMD, the most common form of muscular dystrophy, is a rare and life-threatening neuromuscular disorder characterized by progressive muscle dysfunction, ultimately leading to loss of ambulation, respiratory failure, and fatality. Current standard treatment for DMD involves corticosteroids, which often come with significant side effects. It is estimated that between 11,000 and 13,000 patients in the U.S. are affected by DMD, with approximately 70% of patients currently receiving a corticosteroid treatment. Steroids are expected to remain the backbone of therapy for DMD patients and dosed concomitantly with other therapies. The FDA's approval of AGAMREE® was based on the data from the pivotal Phase 2b VISION-DMD study as supplemented with safety information collected from three open-label studies, including extension studies. In these trials, AGAMREE was administered at doses ranging from 2 to 6 mg/kg/day, extending for up to 48 months. Compared with current standard-of-care corticosteroids, this novel corticosteroid treatment exhibited comparable efficacy, with data suggesting a reduction in adverse events, notably related to bone health, growth trajectory, and improved behavior.
Reported Earnings • Feb 29Full year 2023 earnings: EPS and revenues exceed analyst expectationsFull year 2023 results: EPS: US$0.67 (down from US$0.80 in FY 2022). Revenue: US$398.2m (up 86% from FY 2022). Net income: US$71.4m (down 14% from FY 2022). Profit margin: 18% (down from 39% in FY 2022). The decrease in margin was driven by higher expenses. Revenue exceeded analyst estimates by 1.2%. Earnings per share (EPS) also surpassed analyst estimates by 6.3%. Revenue is forecast to grow 9.2% p.a. on average during the next 3 years, compared to a 18% growth forecast for the Biotechs industry in the US. Over the last 3 years on average, earnings per share has increased by 11% per year but the company’s share price has increased by 66% per year, which means it is tracking significantly ahead of earnings growth.
お知らせ • Feb 29Catalyst Pharmaceuticals, Inc. Provides Revenue Guidance for the Year 2024Catalyst Pharmaceuticals, Inc. provided revenue guidance for the year 2024. For the period, the Company expects total revenues in 2024 within the range of $455 million and $475 million, reflecting net product revenue of approximately $295 million to $310 million for FIRDAPSE, AGAMREE net product revenue of approximately $25 million to $30 million, and FYCOMPA net product revenue of approximately $130 million to $135 million. Product revenue for FYCOMPA in 2024 will be affected by differences in variable consideration (gross-to-net) compared to 2023, when revenues were booked under Eisai’s cost arrangements with distributors and government authorities. Starting on January 1, 2024, all such costs are tied to arrangements between the Company and those distributors and government agencies, which costs are likely to be higher than Eisai’s costs, thereby increasing the gross-to-net deductions for FYCOMPA and correspondingly decreasing FYCOMPA net product revenue.
お知らせ • Feb 15Catalyst Pharmaceuticals, Inc. to Report Q4, 2023 Results on Feb 28, 2024Catalyst Pharmaceuticals, Inc. announced that they will report Q4, 2023 results After-Market on Feb 28, 2024
分析記事 • Jan 29Earnings Tell The Story For Catalyst Pharmaceuticals, Inc. (NASDAQ:CPRX)Catalyst Pharmaceuticals, Inc.'s ( NASDAQ:CPRX ) price-to-earnings (or "P/E") ratio of 27.1x might make it look like a...
Seeking Alpha • Jan 17Catalyst Pharmaceuticals: Until The TEVA ANDA Is Resolved, There Is A RiskSummary Catalyst Pharmaceuticals, Inc. has one approved product and another about to be launched, but its market cap is low at $1.7bn. The company is facing a major patent challenge and has high expenses with no major data catalysts or pipeline molecules. Until the patent issue is resolved, Catalyst Pharmaceuticals stock remains risky. Read the full article on Seeking Alpha
お知らせ • Jan 05+ 1 more updateCatalyst Pharmaceuticals, Inc. has completed a Follow-on Equity Offering in the amount of $150 million.Catalyst Pharmaceuticals, Inc. has completed a Follow-on Equity Offering in the amount of $150 million. Security Name: Common Stock Security Type: Common Stock Securities Offered: 10,000,000 Price\Range: $15
Recent Insider Transactions Derivative • Jan 04Co-Founder exercised options to buy US$4.3m worth of stock.On the 2nd of January, Patrick McEnany exercised options to buy 250k shares at a strike price of around US$1.13, costing a total of US$283k. This transaction amounted to 6.0% of their direct individual holding at the time of the trade. Since March 2023, Patrick's direct individual holding has increased from 3.95m shares to 4.14m. Company insiders have collectively sold US$6.6m more than they bought, via options and on-market transactions in the last 12 months.
Valuation Update With 7 Day Price Move • Dec 22Investor sentiment improves as stock rises 15%After last week's 15% share price gain to US$16.58, the stock trades at a forward P/E ratio of 16x. Average forward P/E is 18x in the Biotechs industry in the US. Total returns to shareholders of 385% over the past three years.
Price Target Changed • Dec 22Price target increased by 13% to US$26.20Up from US$23.10, the current price target is an average from 5 analysts. New target price is 58% above last closing price of US$16.58. Stock is down 13% over the past year. The company is forecast to post earnings per share of US$0.55 for next year compared to US$0.80 last year.
お知らせ • Dec 18Catalyst Pharmaceuticals, Inc. Announces Firapse New Drug Application Submitted in Japan by Partner DyDo PharmaCatalyst Pharmaceuticals, Inc. announced that its collaboration partner, DyDo Pharma, Inc. reported that it has submitted a New Drug Application ("NDA") to Japan's Pharmaceuticals and Medical Devices Agency ("PMDA") seeking marketing approval for FIRDAPSE®? (amifampridine) Tablets 10 mg (generic name: amifampridine phosphate), for the treatment of Lambert Eaton myasthenic syndrome ("LEMS") in Japan. The submission is based on preliminary favorable analysis results of interim data after six months into the safety phase of the registration study to evaluate the efficacy and safety of FIRDAPSE for the treatment of LEMS. The review period is expected to be approximately a minimum of nine months from the submission date. In June 2021, Catalyst entered into a license agreement with DyDo for the development and commercialization of FIRDAPSE in Japan. Under the terms of the agreement, Catalyst is eligible to receive a regulatory milestone payment from DyDo upon submission of the NDA to the PMDA. Under the Company's license agreement with SERB S.A., upon acceptance of the NDA submission to the PMDA in Japan, Catalyst's territorial rights to develop and market the product will automatically extend to other key markets in Asia, Central, and South America. The Company is currently initiating plans to seek opportunities to expand the product's global footprint through strategic partnerships, with a current focus on the Asia Pacific and Latin American regions.
Recent Insider Transactions • Dec 08COO & Chief Scientific Officer recently sold US$570k worth of stockOn the 5th of December, Steven Miller sold around 40k shares on-market at roughly US$14.24 per share. This transaction amounted to 5.8% of their direct individual holding at the time of the trade. This was the largest sale by an insider in the last 3 months. This was Steven's only on-market trade for the last 12 months.
Recent Insider Transactions Derivative • Dec 07COO & Chief Scientific Officer notifies of intention to sell stockSteven Miller intends to sell 40k shares in the next 90 days after lodging an Intent To Sell Form on the 5th of December. If the sale is conducted around the recent share price of US$14.24, it would amount to US$570k. Since March 2023, Steven's direct individual holding has increased from 587.46k shares to 687.46k. Company insiders have collectively sold US$4.0m more than they bought, via options and on-market transactions in the last 12 months.
お知らせ • Dec 05Catalyst Pharmaceuticals, Inc. Appoints Michael W. Kalb as Its Chief Financial Officer, Effective on January 1, 2024Catalyst Pharmaceuticals, Inc. announced the appointment of Michael W. Kalb as its Chief Financial Officer, effective on January 1, 2024. Mr. Kalb will report directly to the Company’s Chief Executive Officer and will serve as a member of the Company's executive leadership team. Mr. Kalb's distinguished career in finance spans over three decades in the pharmaceutical and financial services sector. He succeeds Ms. Alicia Grande, who will retire from the Company at the end of this year. Mr. Kalb brings extensive financial expertise to Catalyst, backed by his distinguished career in senior financial leadership roles. Before joining the Company, Mr. Kalb served as Chief Financial Officer at Impel Pharmaceuticals, Inc., and previously served as Executive Vice President and Chief Financial Officer of CinCor Pharma, Inc. Further, Mr. Kalb served as Senior Vice President and Chief Financial Officer of Amarin Corporation plc, where he contributed to its significant revenue growth, increased market capitalization, and successfully led multiple financing rounds of varying sizes and structures. Before his tenure at Amarin, Mr. Kalb served in several financial senior management positions at Taro Pharmaceutical Industries Ltd., including as Group Vice President and Chief Financial Officer, and as a Director in the Accounting and Financial Consulting Group of Huron Consulting Group Inc. His experience also includes over ten years of public accounting experience, principally at Ernst and Young. Mr. Kalb holds a B.S. in Accounting from the State University of New York at Albany, School of Business. Mr. Kalb is a certified public accountant.
お知らせ • Dec 04Catalyst Pharmaceuticals, Inc. Announces Management Changes, Effective on January 1, 2024Catalyst Pharmaceuticals, Inc. announced the appointment of Michael W. Kalb as its Executive Vice President, effective on January 1, 2024. Mr. Kalb will report directly to the Company’s Chief Executive Officer and will serve as a member of the Company's executive leadership team. Mr. Kalb's distinguished career in finance spans over three decades in the pharmaceutical and financial services sector. He succeeds Ms. Alicia Grande, who will retire from the Company at the end of this year. Mr. Kalb brings extensive financial expertise to Catalyst, backed by his distinguished career in senior financial leadership roles. Before joining the Company, Mr. Kalb served as Chief Financial Officer at Impel Pharmaceuticals, Inc., and previously served as Executive Vice President and Chief Financial Officer of CinCor Pharma, Inc. Further, Mr. Kalb served as Senior Vice President and Chief Financial Officer of Amarin Corporation plc, where he contributed to its significant revenue growth, increased market capitalization, and successfully led multiple financing rounds of varying sizes and structures. Before his tenure at Amarin, Mr. Kalb served in several financial senior management positions at Taro Pharmaceutical Industries Ltd., including as Group Vice President and Chief Financial Officer, and as a Director in the Accounting and Financial Consulting Group of Huron Consulting Group Inc. His experience also includes over ten years of public accounting experience, principally at Ernst and Young. Mr. Kalb holds a B.S. in Accounting from the State University of New York at Albany, School of Business. Mr. Kalb is a certified public accountant. Additionally, company announced that effective on January 1, 2024, Dr. Steven Miller will be promoted to Executive Vice President, Chief Operating and Scientific Officer and Jeffrey Del Carmen will be promoted to Executive Vice President, Chief Commercial Officer.
お知らせ • Nov 10Catalyst Pharmaceuticals, Inc. Raises Revenue Guidance for the Full Year 2023Catalyst Pharmaceuticals, Inc. raised revenue guidance for the full year 2023. For the year, the company expects total revenues, including FYCOMPA, to be between $390 million and $395 million, representing an 82% to 84% increase in total revenues compared to 2022. Key guidance assumptions in this forecast reflect a continued recovery in macroeconomic and healthcare activity throughout 2023 related to the current COVID-19 environment.
Reported Earnings • Nov 10Third quarter 2023 earnings: Revenues exceed analysts expectations while EPS lags behindThird quarter 2023 results: US$0.29 loss per share (down from US$0.22 profit in 3Q 2022). Revenue: US$102.7m (up 79% from 3Q 2022). Net loss: US$30.8m (down 235% from profit in 3Q 2022). Revenue exceeded analyst estimates by 2.3%. Earnings per share (EPS) missed analyst estimates by 53%. Revenue is forecast to grow 12% p.a. on average during the next 3 years, compared to a 15% growth forecast for the Biotechs industry in the US. Over the last 3 years on average, earnings per share has increased by 10% per year but the company’s share price has increased by 54% per year, which means it is tracking significantly ahead of earnings growth.
お知らせ • Nov 04Catalyst Pharmaceuticals, Inc. Receives Two New U.S. Patent Allowances for FIRDAPSECatalyst Pharmaceuticals, Inc. announced that the Company has received notification by the United States Patent and Trademark Office (USPTO) that two additional patents covering FIRDAPSE® (amifampridine) Tablets 10 mg, were allowed and will be granted within the next two months. These new patents are for claims associated with the unique and novel, previously unknown, bioavailability of FIRDAPSE under fasting and fed conditions of dosing. FIRDAPSE is the only approved treatment available in the U.S. for Lambert-Eaton myasthenic syndrome.
お知らせ • Oct 28Catalyst Pharmaceuticals, Inc. Reports FDA Approval of AGAMREE® (vamorolone) for Duchenne Muscular Dystrophy Granted to Santhera PharmaceuticalsCatalyst Pharmaceuticals, Inc. reported that Santhera Pharmaceuticals ("Santhera") has obtained U.S. Food and Drug Administration ("FDA") approval for AGAMREE® (vamorolone) oral suspension 40 mg/mL for use in treating Duchenne Muscular Dystrophy ("DMD") in patients aged two years and older. AGAMREE offers a novel corticosteroid treatment option for DMD, addressing a significant unmet medical need. In July 2023, Catalyst secured the exclusive North American license and commercial rights for AGAMREE from Santhera for DMD and other potential indications, bolstering its neuroscience commercial portfolio with a highly synergistic neuromuscular asset. As part of that transaction, Santhera will promptly transfer the approved New Drug Application for AGAMREE to Catalyst. FDA’s approval of AGAMREE® was based on the data from the pivotal Phase 2b VISION-DMD study as supplemented with safety information collected from three open-label studies, including extension studies. In these trials, AGAMREE was administered at doses ranging from 2 to 6 mg/kg/day, extending for a period of up to 48 months. Compared with current standard-of-care corticosteroids, this novel corticosteroid treatment exhibited comparable efficacy, with data suggesting a reduction in adverse events, notably related to bone health, growth trajectory, and behavior. Upon the transfer of AGAMREE's NDA into its neuromuscular franchise, Catalyst will harness its product portfolio synergies by leveraging its well-established expertise and proven commercial capabilities. The Company plans to launch the product in First Quarter 2024, spearheaded by its seasoned and experienced U.S. commercial and medical affairs neuromuscular teams. AGAMREE was granted Orphan Drug and Rare Pediatric Disease designations status for DMD in the U.S. and will be eligible for seven years of orphan drug exclusivity upon approval date and has issued pending patents that could provide protection until 2040. In Europe, it has received Promising Innovative Medicine (PIM) status from the UK MHRA for DMD.
