Direktnyheter • 20h
Angelini Pharma Acquisition and FIRDAPSE Settlement Set New Direction for Catalyst Pharmaceuticals Angelini Pharma has agreed to acquire Catalyst Pharmaceuticals, marking Angelini’s planned entry into the U.S. market with a focus on brain health and rare diseases.
As part of the deal, all outstanding patent litigation related to Catalyst’s FIRDAPSE product is being resolved.
The combination aligns Catalyst’s established rare disease portfolio with Angelini’s broader pharmaceutical ambitions.
This acquisition effectively shifts Catalyst’s future trajectory under the umbrella of a larger international pharmaceutical group while removing the overhang of ongoing FIRDAPSE patent disputes.
Investors may wish to pay close attention to closing conditions, expected timing, and any details on treatment of existing shareholders, as well as how post-deal integration could affect the company’s product focus and capital allocation. Reported Earnings • May 12
First quarter 2026 earnings: EPS exceeds analyst expectations First 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. Tillkännagivande • Apr 29
Catalyst Pharmaceuticals, Inc. to Report Q1, 2026 Results on May 11, 2026 Catalyst Pharmaceuticals, Inc. announced that they will report Q1, 2026 results After-Market on May 11, 2026 Tillkännagivande • Apr 28
Angelini Pharma Reportedly Explores A Potential Acquisition of Catalyst Pharmaceuticals Catalyst 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 26
Full year 2025 earnings: EPS and revenues exceed analyst expectations Full 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. Tillkännagivande • Feb 26
Catalyst Pharmaceuticals, Inc. Provides Earnings Guidance for the Full Year 2026 Catalyst 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. Tillkännagivande • Feb 11
Catalyst Pharmaceuticals, Inc. to Report Q4, 2025 Results on Feb 25, 2026 Catalyst 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 18
Lead Independent Director exercised options and sold US$351k worth of stock On 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 28
Executive VP & Chief Commercial Officer notifies of intention to sell stock Jeffrey 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 17
Insider recently sold US$908k worth of stock On 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 14
Insider notifies of intention to sell stock Brian 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. Tillkännagivande • Nov 07
Catalyst Pharmaceuticals, Inc. Raises Revenue Guidance for the Full Year 2025 Catalyst 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 06
Third quarter 2025 earnings: EPS and revenues exceed analyst expectations Third 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. Tillkännagivande • Oct 22
Catalyst Pharmaceuticals, Inc. to Report Q3, 2025 Results on Nov 05, 2025 Catalyst Pharmaceuticals, Inc. announced that they will report Q3, 2025 results After-Market on Nov 05, 2025 Tillkännagivande • Oct 01
Catalyst 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. Recent Insider Transactions Derivative • Aug 27
Executive VP notifies of intention to sell stock Steven 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. Tillkännagivande • Aug 26
Catalyst Pharmaceuticals Announces Settlement of FIRDAPSE® (amifampridine) Patent Litigation with Lupin Pharmaceuticals Catalyst 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 07
Second quarter 2025 earnings: EPS and revenues exceed analyst expectations Second 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. Tillkännagivande • Aug 07
Catalyst Pharmaceuticals, Inc. Reaffirms Earnings Guidance for the Full Year 2025 Catalyst 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 06
High number of new directors Director Dan Curran was the last director to join the board, commencing their role in the last week. Tillkännagivande • Aug 06
Catalyst Pharmaceuticals, Inc. Announces National Comprehensive Cancer Network Clinical Practice Guidelines in Oncology Catalyst 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. Tillkännagivande • Aug 05
Catalyst Pharmaceuticals, Inc. Appoints Daniel Curran to the Board of Directors Catalyst 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. Tillkännagivande • Jul 22
Catalyst Pharmaceuticals, Inc. to Report Q2, 2025 Results on Aug 06, 2025 Catalyst Pharmaceuticals, Inc. announced that they will report Q2, 2025 results After-Market on Aug 06, 2025 Tillkännagivande • Jun 30
Catalyst Pharmaceuticals, Inc.(NasdaqCM:CPRX) dropped from Russell 2000 Dynamic Index Catalyst Pharmaceuticals, Inc.(NasdaqCM:CPRX) dropped from Russell 2000 Dynamic Index Recent Insider Transactions • Jun 11
Co-Founder & Non-Executive Chairman recently sold US$5.2m worth of stock On 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 08
Co-Founder & Non-Executive Chairman notifies of intention to sell stock Patrick 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 05
President recently sold US$1.7m worth of stock On 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. Tillkännagivande • Jun 03
Catalyst Pharmaceuticals, Inc. Announces Executive Changes Catalyst 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 01
President notifies of intention to sell stock Richard 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. Recent Insider Transactions Derivative • May 14
Chief Medical & Regulatory Officer notifies of intention to sell stock Gary 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 10
First quarter 2025 earnings: EPS and revenues exceed analyst expectations First 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. Tillkännagivande • May 08
Catalyst Pharmaceuticals, Inc. Reaffirms Full-Year 2025 Revenue Outlook Catalyst 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. Tillkännagivande • Apr 22
Catalyst Pharmaceuticals, Inc. to Report Q1, 2025 Results on May 07, 2025 Catalyst Pharmaceuticals, Inc. announced that they will report Q1, 2025 results After-Market on May 07, 2025 Tillkännagivande • Apr 14
Catalyst Pharmaceuticals, Inc., Annual General Meeting, May 20, 2025 Catalyst Pharmaceuticals, Inc., Annual General Meeting, May 20, 2025. Location: held via the internet, United States Valuation Update With 7 Day Price Move • Mar 21
Investor 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 06
Executive VP & Chief Commercial Officer recently sold US$696k worth of stock On 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 04
Insider notifies of intention to sell stock Brian 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 27
Full year 2024 earnings: EPS and revenues exceed analyst expectations Full 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. Tillkännagivande • Feb 27
Catalyst Pharmaceuticals, Inc. Provides Revenue Guidance for the Full Year 2025 Catalyst 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. Tillkännagivande • Feb 12
Catalyst Pharmaceuticals, Inc. to Report Q4, 2024 Results on Feb 26, 2025 Catalyst Pharmaceuticals, Inc. announced that they will report Q4, 2024 results After-Market on Feb 26, 2025 Tillkännagivande • Jan 25
Charles B. O’Keeffe Decides to Not Stand for Reelection for Board At the 2025 Annual Meeting of Catalyst Pharmaceuticals, Inc On 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. Tillkännagivande • Jan 21
Catalyst Pharmaceuticals, Inc. Announces Sub- Licensee DyDo Pharma Launches Firapse®? in Japan Catalyst 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. Tillkännagivande • Jan 09
Catalyst Pharmaceuticals and SERB S.A. Announces Settlement of FIRDAPSE® (amifampridine) Patent Litigation with Teva Pharmaceuticals Catalyst 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. Recent Insider Transactions Derivative • Dec 11
Executive VP notifies of intention to sell stock Steven 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 13
Co-Founder & Chairman notifies of intention to sell stock Patrick 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. Reported Earnings • Nov 07
Third quarter 2024 earnings: EPS and revenues exceed analyst expectations Third 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. Tillkännagivande • Nov 07
Catalyst Pharmaceuticals, Inc. Provides Revenue Guidance for the Year 2024 Catalyst 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. Tillkännagivande • Oct 22
Catalyst Pharmaceuticals, Inc. to Report Q3, 2024 Results on Nov 06, 2024 Catalyst Pharmaceuticals, Inc. announced that they will report Q3, 2024 results After-Market on Nov 06, 2024 Recent Insider Transactions Derivative • Aug 30
Independent Director notifies of intention to sell stock David 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 23
Executive VP recently sold US$3.1m worth of stock On 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 22
Executive VP notifies of intention to sell stock Steven 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 14
Investor 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 14
Consensus 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 12
Chief Medical & Regulatory Officer notifies of intention to sell stock Gary 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 11
Price target increased by 8.4% to US$29.57 Up 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 08
Second quarter 2024 earnings: EPS and revenues exceed analyst expectations Second 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. Tillkännagivande • Aug 08
Catalyst Pharmaceuticals, Inc. Revises Revenue Guidance for the Full-Year 2024 Catalyst 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. Tillkännagivande • Jul 22
Catalyst Pharmaceuticals, Inc. to Report Q2, 2024 Results on Aug 07, 2024 Catalyst Pharmaceuticals, Inc. announced that they will report Q2, 2024 results After-Market on Aug 07, 2024 Recent Insider Transactions Derivative • Jun 08
Chief Medical & Regulatory Officer notifies of intention to sell stock Gary 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 15
Consensus 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. Tillkännagivande • May 10
Catalyst Pharmaceuticals, Inc. Reaffirms Revenue Guidance for the Full-Year 2024 Catalyst 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 09
First quarter 2024 earnings: EPS misses analyst expectations First 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. Tillkännagivande • Apr 23
Catalyst Pharmaceuticals, Inc. to Report Q1, 2024 Results on May 08, 2024 Catalyst Pharmaceuticals, Inc. announced that they will report Q1, 2024 results After-Market on May 08, 2024 Tillkännagivande • Apr 11
Catalyst Pharmaceuticals, Inc., Annual General Meeting, May 21, 2024 Catalyst 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 10
Independent Director notifies of intention to sell stock David 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. Recent Insider Transactions • Mar 29
Insider recently sold US$411k worth of stock On 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. Tillkännagivande • Mar 13
Catalyst 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 29
Full year 2023 earnings: EPS and revenues exceed analyst expectations Full 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. Tillkännagivande • Feb 29
Catalyst Pharmaceuticals, Inc. Provides Revenue Guidance for the Year 2024 Catalyst 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. Tillkännagivande • Feb 15
Catalyst Pharmaceuticals, Inc. to Report Q4, 2023 Results on Feb 28, 2024 Catalyst Pharmaceuticals, Inc. announced that they will report Q4, 2023 results After-Market on Feb 28, 2024 Recent Insider Transactions Derivative • Jan 04
Co-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 22
Investor 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 22
Price target increased by 13% to US$26.20 Up 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. Tillkännagivande • Dec 18
Catalyst Pharmaceuticals, Inc. Announces Firapse New Drug Application Submitted in Japan by Partner DyDo Pharma Catalyst 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 08
COO & Chief Scientific Officer recently sold US$570k worth of stock On 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 07
COO & Chief Scientific Officer notifies of intention to sell stock Steven 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. Tillkännagivande • Dec 05
Catalyst Pharmaceuticals, Inc. Appoints Michael W. Kalb as Its Chief Financial Officer, Effective on January 1, 2024 Catalyst 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. Tillkännagivande • Dec 04
Catalyst Pharmaceuticals, Inc. Announces Management Changes, Effective on January 1, 2024 Catalyst 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. Tillkännagivande • Nov 10
Catalyst Pharmaceuticals, Inc. Raises Revenue Guidance for the Full Year 2023 Catalyst 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 10
Third quarter 2023 earnings: Revenues exceed analysts expectations while EPS lags behind Third 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. Tillkännagivande • Nov 04
Catalyst Pharmaceuticals, Inc. Receives Two New U.S. Patent Allowances for FIRDAPSE Catalyst 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. Tillkännagivande • Oct 28
Catalyst Pharmaceuticals, Inc. Reports FDA Approval of AGAMREE® (vamorolone) for Duchenne Muscular Dystrophy Granted to Santhera Pharmaceuticals Catalyst 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. 