Tillkännagivande • Jul 01
Santhera Pharmaceuticals Notes Topline Results from Catalyst Pharmaceuticals Phase 1 Clinical Study of AGAMREE Santhera Pharmaceuticals noted topline results from a two-part Phase 1 clinical study of AGAMREE conducted by its North American licensing partner, Catalyst Pharmaceuticals, Inc. The study suggests that AGAMREE delivers glucocorticoid and anti-inflammatory activity, while avoiding significant immunosuppressive effects, supporting its potential use as a treatment across a broad range of chronic inflammatory rare diseases. The study, conducted in healthy adult volunteers, evaluated equipotency between deflazacort and AGAMREE and assessed the clinical immunosuppressive potential of AGAMREE across ascending doses. In part A, both AGAMREE and deflazacort demonstrated expected on-target glucocorticoid receptor activity and comparable cortisol suppression at clinical doses, with AGAMREE showing less pronounced immunosuppressive biomarker effects, consistent with the currently labelled dosing of AGAMREE in the treatment of Duchenne muscular dystrophy (DMD). Part B demonstrated that clinically relevant immunosuppressive effects were observed only at the highest dose level, above currently approved AGAMREE dosing. No relevant immunosuppressive effects were observed at lower dose levels. Under an exclusive license agreement entered into in 2023, Catalyst holds commercialization rights to AGAMREE in North America for DMD and all potential future indications, while Santhera retains a right of first negotiation for any rights outside North America relating to new indications. Under the terms of the license agreement, Santhera is eligible to receive sales-based milestone payments as well as royalties on net sales across all commercialized indications. AGAMREE is a dissociative corticosteroid approved for the treatment of Duchenne muscular dystrophy (DMD). It binds selectively to the glucocorticoid receptor and triggers anti-inflammatory activity through inhibition of NF-?B-mediated gene transcription, while inducing reduced transactivation of other genes. AGAMREE is not a substrate for 11-ß-hydroxysteroid dehydrogenase (11ß-HSD) enzymes, which are involved in the local amplification of glucocorticoid activity in tissues and have been implicated in corticosteroid-associated toxicity. This pharmacological profile is the basis for its classification as a dissociative corticosteroid, designed to preserve anti-inflammatory efficacy while reducing the systemic effects associated with long-term conventional corticosteroid therapy. In the pivotal Phase 2b VISION-DMD study, AGAMREE met its primary endpoint, demonstrating a statistically significant improvement in Time to Stand (TTSTAND) velocity versus placebo at 24 weeks (p = 0.002). The most commonly reported adverse reactions were cushingoid features, vomiting, weight increase, increased appetite, and irritability; most were mild to moderate in severity. Long-term data from up to eight years of AGAMREE treatment were presented at the Muscular Dystrophy Association Clinical & Scientific Conference in March 2026. In propensity-matched analyses, AGAMREE demonstrated durable efficacy comparable to standard-of-care corticosteroids and a differentiated safety profile: a lower incidence of vertebral fractures versus deflazacort-treated cohorts (8.1% vs 41.9%; p = 0.0082); maintained a normal growth trajectory with a mean height advantage of 12.17 cm versus conventional corticosteroids (p < 0.0001), and a lower incidence of cataracts versus deflazacort (p = 0.015), with no observed cases of glaucoma. This medicinal product is subject to additional monitoring. Healthcare professionals are asked to report any suspected adverse reactions. Tillkännagivande • Jun 30
Catalyst Pharmaceuticals Announces Topline Results From Two-Part Phase 1 Clinical Study Of Vamorolone In Healthy Adult Volunteers Catalyst Pharmaceuticals, Inc. announced topline results from a two-part Phase 1 clinical study of vamorolone in healthy adult volunteers. The study demonstrated balanced corticosteroid activity with expected cortisol suppression and no evidence of significant immunosuppressive activity at clinical doses. These findings suggest that vamorolone delivers glucocorticoid and anti-inflammatory activity, while avoiding significant immunosuppressant effects, supporting its potential use as a treatment across a broad range of chronic inflammatory rare diseases. A two-part (referred to as Parts A and B) Phase 1 study was conducted in healthy adult volunteers. The primary purpose of Part A was to assess equipotency between deflazacort and vamorolone to help address the clinical case in which a patient might experience differential cortisol effects when switching from deflazacort to vamorolone. The primary purpose of Part B was to evaluate ascending doses of vamorolone to assess vamorolone’s clinical immunosuppressive potential in consideration of potential life cycle management indications. The study evaluated cortisol suppression, anti-inflammatory activity, and immunosuppressive effects across clinical and supratherapeutic doses. 24 healthy adults were enrolled in a randomized, single-center, crossover study. Single doses of vamorolone (300 mg) and deflazacort (0.9 mg/kg) were evaluated. Both agents demonstrated expected on-target glucocorticoid receptor activity, including cortisol suppression, leukocyte redistribution, and effects on functional immune biomarkers. Similar time to onset was observed for both treatments (approximately 2–4 hours post-dose). Comparable cortisol suppression was observed at clinical doses. Vamorolone demonstrated less pronounced immunosuppressive biomarker effects compared with deflazacort. 36 healthy volunteers received vamorolone at doses of 9, 27, or 40 mg/kg once daily for seven days. Immune biomarkers and cellular markers were evaluated through Day 21. Clinically relevant immunosuppressive effects were observed only at the highest dose level (40 mg/kg/day). No relevant immunosuppressive effects observed at lower dose levels (9 or 27 mg/kg/day). Immunosuppressive effects increased with repeated dosing at 40 mg/kg/day and persisted after treatment cessation. As the 40 mg/kg/day dose is above currently approved vamorolone dosing and higher than doses previously studied in clinical trials, these findings suggest that clinically meaningful immunosuppression with vamorolone is unlikely at clinically relevant doses. The prospect of this favorable profile—glucocorticoid and anti-inflammatory activity without clinically meaningful immunosuppression at clinically relevant doses—has the potential to distinguish vamorolone from conventional corticosteroids. Additionally, this profile may support vamorolone’s potential utility across a broad range of chronically inflammatory rare diseases. 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. 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 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. 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. 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. 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. 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 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. 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 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. New Risk • Jan 09
New minor risk - Share price stability The company's share price has been volatile over the past 3 months. It is more volatile than 75% of German stocks, typically moving 7.3% a week. This is considered a minor risk. Share price volatility indicates the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. It also increases the risk of potential losses in the short term as the stock tends to have larger drops in price more frequently than other stocks. This is currently the only risk that has been identified for the company. 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. Reported Earnings • Nov 07
Third quarter 2024 earnings released: EPS: US$0.37 (vs US$0.29 loss in 3Q 2023) 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 is forecast to grow 13% p.a. on average during the next 3 years, compared to a 22% growth forecast for the Biotechs industry in Europe. 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 57% 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 • Aug 23
Executive VP recently sold €2.7m worth of stock On the 20th of August, Steven Miller sold around 150k shares on-market at roughly €18.33 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 €3.3m. New Risk • Aug 14
New minor risk - Insider selling There has been significant insider selling in the company's shares over the past 3 months. Total value of shares sold: €294k This is considered a minor risk. There are several reasons why an insider may be selling, including to cover a tax obligation or pay for some other expense. However, we generally consider it a negative if insiders have been selling, especially if they do so below the current price. It implies that they considered a lower price to be reasonable. This is a weak signal, but if there is a pattern of unexplained selling, it can be a sign the insider believes the company's stock is overpriced. Note: We only include open market transactions and private dispositions of directly owned stock by individuals, not by corporations or trusts. Currently, the following risks have been identified for the company: Minor Risks Profit margins are more than 30% lower than last year (16% net profit margin). Shareholders have been diluted in the past year (11% increase in shares outstanding). Significant insider selling over the past 3 months (€294k sold). 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 Tillkännagivande • May 31
Catalyst Pharmaceuticals, Inc. Receives U.S. FDA Approval For Increased Maximum Daily Dose For FIRDAPSE Catalyst Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (“FDA”) has approved its supplemental New Drug Application (“sNDA”) increasing the indicated maximum daily dose of FIRDAPSE® (amifampridine) for adults and pediatric patients weighing more than 45 kg from 80 mg to 100 mg for the treatment of Lambert-Eaton myasthenic syndrome (“LEMS”). The increased maximum daily dose offers healthcare providers and patients greater flexibility in treatment regimens for the management of LEMS. LEMS is a rare autoimmune disorder characterized by muscle weakness and fatigue. FIRDAPSE is a potassium channel blocker indicated for the treatment of LEMS in adults and pediatric patients six years of age and older and works by increasing the release of acetylcholine, a neurotransmitter, at the neuromuscular junction, which helps improve muscle function in people with LEMS. FIRDAPSE is currently the only U.S. approved treatment for LEMS and this approval broadens the approved dosing options for prescribers treating LEMS. Patients in the U.S. can access FIRDAPSE by prescription through their healthcare providers. 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 released: EPS: US$0.20 (vs US$0.28 in 1Q 2023) 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 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 Europe. 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 52% 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 • Mar 29
Insider recently sold €380k worth of stock On the 27th of March, Brian Elsbernd sold around 25k shares on-market at roughly €15.19 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 €960k 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. Valuation Update With 7 Day Price Move • Mar 06
Investor sentiment improves as stock rises 15% After last week's 15% share price gain to €14.84, the stock trades at a forward P/E ratio of 15x. Average trailing P/E is 35x in the Biotechs industry in Europe. Total returns to shareholders of 409% over the past three years. 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. Reported Earnings • Feb 29
Full year 2023 earnings released: EPS: US$0.67 (vs US$0.80 in FY 2022) 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 is forecast to grow 9.1% p.a. on average during the next 3 years, compared to a 13% growth forecast for the Biotechs industry in Germany. 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 63% per year, which means it is tracking significantly ahead of earnings growth. 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 Valuation Update With 7 Day Price Move • Dec 28
Investor sentiment improves as stock rises 17% After last week's 17% share price gain to €15.31, the stock trades at a forward P/E ratio of 16x. Average forward P/E is 26x in the Biotechs industry in Europe. Total returns to shareholders of 464% over the past three years. 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 €528k worth of stock On the 5th of December, Steven Miller sold around 40k shares on-market at roughly €13.19 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. 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 09
Third quarter 2023 earnings released: US$0.29 loss per share (vs US$0.22 profit in 3Q 2022) 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 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 Germany. 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 61% 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. New Risk • Oct 31
New minor risk - Share price stability The company's share price has been volatile over the past 3 months. It is more volatile than 75% of German stocks, typically moving 6.3% a week. This is considered a minor risk. Share price volatility indicates the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. It also increases the risk of potential losses in the short term as the stock tends to have larger drops in price more frequently than other stocks. Currently, the following risks have been identified for the company: Major Risk High level of non-cash earnings (151% accrual ratio). Minor Risks Share price has been volatile over the past 3 months (6.3% average weekly change). Shareholders have been diluted in the past year (3.7% increase in shares outstanding). 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. Tillkännagivande • Oct 24
Catalyst Pharmaceuticals, Inc. to Report Q3, 2023 Results on Nov 08, 2023 Catalyst Pharmaceuticals, Inc. announced that they will report Q3, 2023 results After-Market on Nov 08, 2023 Tillkännagivande • Oct 20
Catalyst Pharmaceuticals, Inc. Announces Chief Executive Officer Changes Catalyst Pharmaceuticals, Inc. announced the appointment of Richard J. Daly as its new Chief Executive Officer effective January 1, 2024. Mr. Daly is a seasoned pharmaceutical executive bringing more than three decades of experience to Catalyst. In order to facilitate an orderly transition, Patrick J. McEnany, Founder, Chairman, and CEO, will retire from the CEO position effective December 31, 2023, and at that time will continue in his role as Chairman of the Board. Mr. Daly has held distinguished positions in multinational corporations and at innovative biotech companies. Prior to his appointment at Catalyst, Mr. Daly served as President of CARsgen Therapeutics Corporation since January 2022. Previously, he served as Chief Operating Officer at Beyond Springs Inc. from 2018 to 2022 and as CEO, President, and Chairman of Neuralstem, Inc., a publicly held biotechnology company specializing in central nervous system therapies based on neuronal stem cell technology from 2016 to 2018. Throughout his career, Mr. Daly has held prominent leadership positions at leading global pharmaceutical companies, including serving as President of AstraZeneca's U.S. diabetes subsidiary, leading all commercial and medical plans and objectives for a $1.2 billion revenue, 3,000-employee division, and the successful launch of an orphan rare disorder drug, Myalept, for the treatment of Lipodystrophy. Earlier, Mr. Daly served at Takeda and TAP Pharmaceuticals, a joint venture established between Takeda and Abbott Laboratories, where he held several senior leadership positions, including the Executive Vice President at Takeda Pharmaceutical North America and the Senior Vice President of Marketing at TAP Pharmaceuticals. Mr. Daly has served on Catalyst's Board of Directors since February 2015 and will continue to serve on the board as the newly appointed CEO. He holds an MBA from the Kellogg School of Management at Northwestern University and a Bachelor of Science in Microbiology from the University of Notre Dame. Tillkännagivande • Oct 14
Catalyst Pharmaceuticals, Inc. Announces FDA Acceptance of the Supplemental New Drug Application for Firapse Catalyst Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration has accepted for review the Company's supplemental New Drug Application ("sNDA") to increase the indicated maximum daily dosage of FIRDAPSE®? (amifampridine) Tablets 10 mg from 80mg to 100mg for the treatment of Lambert-Eaton myasthenic syndrome ("LEMS"). The Agency assigned a Prescription Drug User Fee Act ("PDUFA") action date of June 4, 2024. FIRDAPSE is currently approved in the U.S. for the treatment of LEMS for adults and for children ages six to nine. Lambert-Eaton myastenic syndrome, or LEMS, is a rare autoimmune neuromuscular disorder characterized primarily by muscle weakness of the limbs. Acetylcholine is the neurotransmitter responsible for causing muscles to contract, and the failure to release enough of this neurotransmitter results in muscle weakness in LEMS patients. Additionally, LEMS is often associated with an underlying malignancy, most commonly small-cell lung cancer, and in some individuals, LEMS is the first symptom of such malignancy. Tillkännagivande • Aug 27
Catalyst Pharmaceuticals, Inc. Announces the Resignation of Philip H. Coelho as Independent Member of the Board Catalyst Pharmaceuticals, Inc. announced that Philip H. Coelho, an independent member of the Board, did not stand for re-election at the Annual Meeting held on August 22, 2023. Mr. Coelho had been a member of the Board since October 2002. His decision to retire from the Board was not the result of any disagreement with the Company on any matter relating to the Company’s operations, policies or practices. Tillkännagivande • Aug 17
Catalyst Pharmaceuticals, Inc. Announces Abstract on Lambert Eaton Myasthenic Syndrome (LEMS) to Be Presented at the Upcoming IASLC 2023 World Conference of Lung Cancer Catalyst Pharmaceuticals, Inc. announced that an abstract assessing the prevalence of Lambert-Eaton myasthenic syndrome ("LEMS") among patients with small cell lung cancer ("SCLC") in the United States, was accepted and will be presented at the IASLC 2023 World Conference of Lung Cancer (#WCLC23) hosted by the International Association for the Study of Lung Cancer, happening September 9-12, 2023 in Singapore. The abstract details the results from a study analyzing real-world data to determine the prevalence of LEMS diagnoses among patients with SCLC in the United States. While published data estimate that 3% of patients with SCLC have a concurrent LEMS diagnosis, this analysis of oncology healthcare claims between 2017-2022 found that 0.16 - 0.24% of patients with SCL C had LEMS claims, indicating a 10-fold underdiagnosis of LEMS in patients with SCLC. The authors hypothesize non-specific LEMS symptoms, such as fatigue and weakness, may have been attributed to SCLC, leading to underdiagnosis. These data imply that the overall population of LEMS is significantly larger than previous estimates. Tillkännagivande • Aug 10
Catalyst Pharmaceuticals, Inc. Provides Revenue Guidance for the Year 2023 Catalyst Pharmaceuticals, Inc. provided revenue guidance for the year 2023. The Company forecasts full-year 2023 total revenues, including FYCOMPA, to be between $380 million and $390 million, representing a 77% to 82% 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 • Aug 10
Second quarter 2023 earnings released: EPS: US$0.35 (vs US$0.21 in 2Q 2022) Second quarter 2023 results: EPS: US$0.35 (up from US$0.21 in 2Q 2022). Revenue: US$99.6m (up 88% from 2Q 2022). Net income: US$37.8m (up 75% from 2Q 2022). Profit margin: 38% (down from 41% in 2Q 2022). The decrease in margin was driven by higher expenses. Revenue is forecast to grow 13% p.a. on average during the next 3 years, compared to a 14% growth forecast for the Biotechs industry in Germany. Over the last 3 years on average, earnings per share has increased by 18% per year but the company’s share price has increased by 67% per year, which means it is tracking significantly ahead of earnings growth. Tillkännagivande • Jul 26
Catalyst Pharmaceuticals, Inc. Announces Resignation of Patrick J. Mcenany as Chief Executive Officer Catalyst Pharmaceuticals, Inc. announced that Patrick J. McEnany, Catalyst’s Co-Founder, Chairman, and Chief Executive Officer has informed the Board of Directors of his intention to retire from his position as CEO by the end of 2023. Tillkännagivande • Jul 25
Catalyst Pharmaceuticals, Inc. to Report Q2, 2023 Results on Aug 09, 2023 Catalyst Pharmaceuticals, Inc. announced that they will report Q2, 2023 results After-Market on Aug 09, 2023 Tillkännagivande • Jul 13
Catalyst Pharmaceuticals, Inc., Annual General Meeting, Aug 22, 2023 Catalyst Pharmaceuticals, Inc., Annual General Meeting, Aug 22, 2023, at 09:00 US 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 company's 2018 Stock Incentive Plan to increase the shares available for issuance by three million shares; to approve, on an advisory basis, the 2022 compensation of company's named executive officers as set forth herein; to ratify Grant Thornton LLP as company's independent registered public accounting firm for the fiscal year ending December 31, 2023; and to transact such other business as may properly come before the meeting. Valuation Update With 7 Day Price Move • Jun 22
Investor sentiment improves as stock rises 15% After last week's 15% share price gain to €12.30, the stock trades at a forward P/E ratio of 11x. Average forward P/E is 28x in the Biotechs industry in Europe. Total returns to shareholders of 188% over the past three years. Tillkännagivande • May 31
Catalyst Pharmaceuticals Appoints Tamar Thompson to its Board of Directors Catalyst Pharmaceuticals, Inc. announced the appointment of Ms. Tamar Thompson to the company's board of directors (‘Board’), effective on May 25, 2023. Ms. Thompson has more than twenty years of leadership experience in health care, health policy strategy, government affairs, and market access, with a diverse background across multiple healthcare sectors and therapeutic categories, including rare diseases, with a focus on developing strategic and tactical recommendations to ensure optimal reimbursement and market access for rare disease products. Ms. Thompson currently serves as Vice President, Head of Global Corporate Affairs for Alexion Pharmaceutical, AstraZeneca Rare Diseases. Prior to joining Alexion, Ms. Thompson served as Executive Director, State Government Affairs and Federal Policy for Bristol-Myers Squibb Company. Prior to joining Bristol Myers Squibb, she served as a strategic policy advisor and consultant for various governmental affairs firms based in Washington, D.C. Ms. Thompson received a Master of Science in Health Sciences with a concentration in Public Health from Trident University in Cypress, California, and currently serves on the Board of Directors of Avidity Biosciences. Valuation Update With 7 Day Price Move • May 17
Investor sentiment deteriorates as stock falls 28% After last week's 28% share price decline to €11.37, the stock trades at a forward P/E ratio of 10x. Average forward P/E is 32x in the Biotechs industry in Europe. Total returns to shareholders of 177% over the past three years. Reported Earnings • May 11
First quarter 2023 earnings released: EPS: US$0.28 (vs US$0.13 in 1Q 2022) First quarter 2023 results: EPS: US$0.28 (up from US$0.13 in 1Q 2022). Revenue: US$85.4m (up 98% from 1Q 2022). Net income: US$29.6m (up 123% from 1Q 2022). Profit margin: 35% (up from 31% in 1Q 2022). The increase in margin was driven by higher revenue. Revenue is forecast to grow 9.6% p.a. on average during the next 3 years, compared to a 19% growth forecast for the Biotechs industry in Germany. Over the last 3 years on average, earnings per share has increased by 13% per year but the company’s share price has increased by 61% per year, which means it is tracking significantly ahead of earnings growth. Tillkännagivande • May 11
Catalyst Pharmaceuticals, Inc. Provides Revenue Guidance for the Full Year 2023 Catalyst Pharmaceuticals, Inc. provides revenue guidance for the full year 2023. The Company forecasts full-year 2023 total revenues, including FYCOMPA®, to be between $375 Million and $385 Million, representing a 75% - 80% increase in total revenues compared to 2022. Tillkännagivande • May 10
Catalyst Pharmaceuticals, Inc. Advances sNDA Submission Plans to Increase Indicated Maximum Dose for FIRDAPSE®? from 80 Mg Per Day to 100 Mg Per Day Catalyst Pharmaceuticals, Inc. reported that it recently concluded a Type C meeting with the U.S. Food and Drug Administration regarding its plans to file a supplemental New Drug Application (sNDA) to increase the maximum daily dosage of FIRDAPSE® (amifampridine) from 80mg to 100mg for the treatment of Lambert Eaton myasthenic syndrome (LEMS). Based on the feedback received from the meeting, Catalyst believes it now has the information necessary to complete the submission of its sNDA for marketing approval in the U.S. early in the third quarter of 2023. FIRDAPSE® (amifampridine) Tablets 10mg is currently approved in the U.S. for the treatment of LEMS in adults and for children ages six to seventeen with an indicated maximum daily dose of 80 milligrams. Lambert-Eaton myasthenic syndrome, or LEMS, is a rare autoimmune neuromuscular disorder characterized primarily by muscle weakness of the limbs. The disease is caused by an autoimmune reaction where antibodies are formed against voltage-gated calcium channels on nerve endings, which damages the channels. These calcium channels are responsible for the transport of charged calcium atoms that activate the biochemical machinery responsible for releasing acetylcholine. Acetylcholine is the neurotransmitter responsible for causing muscles to contract, and the failure to release enough of this neurotransmitter results in muscle weakness in LEMS patients. Additionally, LEMS is often associated with an underlying malignancy, most commonly small-cell lung cancer (SCLC), and in some individuals, LEMS is the first symptom of such malignancy. Reported Earnings • Mar 17
Full year 2022 earnings released: EPS: US$0.80 (vs US$0.38 in FY 2021) Full year 2022 results: EPS: US$0.80 (up from US$0.38 in FY 2021). Revenue: US$214.2m (up 52% from FY 2021). Net income: US$83.1m (up 110% from FY 2021). Profit margin: 39% (up from 28% in FY 2021). The increase in margin was driven by higher revenue. Revenue is forecast to grow 12% p.a. on average during the next 3 years, compared to a 21% growth forecast for the Biotechs industry in Europe. Over the last 3 years on average, earnings per share has increased by 12% per year but the company’s share price has increased by 72% per year, which means it is tracking significantly ahead of earnings growth. Valuation Update With 7 Day Price Move • Jan 17
Investor sentiment improved over the past week After last week's 16% share price gain to €20.62, the stock trades at a forward P/E ratio of 17x. Average forward P/E is 28x in the Biotechs industry in Europe. Total returns to shareholders of 457% over the past three years. Valuation Update With 7 Day Price Move • Dec 23
Investor sentiment improved over the past week After last week's 22% share price gain to €18.09, the stock trades at a forward P/E ratio of 19x. Average forward P/E is 27x in the Biotechs industry in Europe. Total returns to shareholders of 435% over the past three years. Recent Insider Transactions • Nov 16
Independent Director recently sold €321k worth of stock On the 11th of November, Donald Denkhaus sold around 20k shares on-market at roughly €16.07 per share. This transaction amounted to 6.7% of their direct individual holding at the time of the trade. In the last 3 months, there was an even bigger sale from another insider worth €16m. Insiders have been net sellers, collectively disposing of €23m more than they bought in the last 12 months. Reported Earnings • Nov 11
Third quarter 2022 earnings released: EPS: US$0.22 (vs US$0.10 in 3Q 2021) Third quarter 2022 results: EPS: US$0.22 (up from US$0.10 in 3Q 2021). Revenue: US$57.2m (up 59% from 3Q 2021). Net income: US$22.7m (up 120% from 3Q 2021). Profit margin: 40% (up from 29% in 3Q 2021). The increase in margin was driven by higher revenue. Revenue is forecast to grow 9.8% p.a. on average during the next 3 years, compared to a 21% growth forecast for the Biotechs industry in Germany. Over the last 3 years on average, earnings per share has increased by 19% per year but the company’s share price has increased by 52% per year, which means it is tracking significantly ahead of earnings growth. Tillkännagivande • Nov 10
Catalyst Pharmaceuticals, Inc. Provides Earnings Guidance for the Year 2022 Catalyst Pharmaceuticals, Inc. provided earnings guidance for the year 2022. The company has increased its forecast for the full year 2022 total revenues to be in the range of between $205 million and $210 million, representing a 46% - 49% increase in total revenues compared to 2021. Tillkännagivande • Oct 26
Catalyst Pharmaceuticals, Inc. to Report Q3, 2022 Results on Nov 09, 2022 Catalyst Pharmaceuticals, Inc. announced that they will report Q3, 2022 results at 4:00 PM, US Eastern Standard Time on Nov 09, 2022 Tillkännagivande • Sep 30
Catalyst Pharmaceuticals Announces FDA Approval of Supplemental New Drug Application for Firdapse(R) Expanding Patient Population to Include Pediatric Patients Catalyst Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration ("FDA") has approved the supplemental New Drug Application ("sNDA") to expand the indicated age range for FIRDAPSE(R) (amifampridine) Tablets 10 mg to include pediatric patients, six years of age and older for the treatment of Lambert-Eaton myasthenic syndrome (" LEMS"). FIRDAPSE is currently approved in the U.S. and Canada for the treatment of LEMS in adult patients. As part of Catalyst's efforts to help ensure those patients who can benefit from FIRDAPSE are able to obtain access, Catalyst offers a comprehensive patient access support program and patient assistance for qualifying LEMS patients through its Catalyst Pathways(R) program. Recent Insider Transactions • Sep 27
Chief Accounting Officer recently sold €734k worth of stock On the 23rd of September, Alicia Grande sold around 60k shares on-market at roughly €12.24 per share. This transaction amounted to 22% of their direct individual holding at the time of the trade. In the last 3 months, there was an even bigger sale from another insider worth €16m. Alicia has been a net seller over the last 12 months, reducing personal holdings by €3.7m. Recent Insider Transactions • Sep 16
Co-Founder recently sold €16m worth of stock On the 14th of September, Patrick McEnany sold around 1m shares on-market at roughly €15.41 per share. This transaction amounted to 21% 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. Valuation Update With 7 Day Price Move • Sep 14
Investor sentiment improved over the past week After last week's 23% share price gain to €17.06, the stock trades at a forward P/E ratio of 20x. Average forward P/E is 20x in the Biotechs industry in Europe. Total returns to shareholders of 190% over the past three years. Recent Insider Transactions • Aug 31
Chief Accounting Officer recently sold €970k worth of stock On the 29th of August, Alicia Grande sold around 68k shares on-market at roughly €14.25 per share. This transaction amounted to 14% 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 Alicia's only on-market trade for the last 12 months. Recent Insider Transactions • Aug 24
Chief Commercial Officer recently sold €198k worth of stock On the 19th of August, Jeffrey Del Carmen sold around 14k shares on-market at roughly €13.99 per share. This was the largest sale by an insider in the last 3 months. This was the only on-market transaction from insiders over the last 12 months. Valuation Update With 7 Day Price Move • Aug 16
Investor sentiment improved over the past week After last week's 28% share price gain to €13.59, the stock trades at a forward P/E ratio of 18x. Average forward P/E is 22x in the Biotechs industry in Europe. Total returns to shareholders of 154% over the past three years. Reported Earnings • Aug 11
Second quarter 2022 earnings released: EPS: US$0.21 (vs US$0.12 in 2Q 2021) Second quarter 2022 results: EPS: US$0.21 (up from US$0.12 in 2Q 2021). Revenue: US$53.1m (up 46% from 2Q 2021). Net income: US$21.6m (up 78% from 2Q 2021). Profit margin: 41% (up from 34% in 2Q 2021). The increase in margin was driven by higher revenue. Over the next year, revenue is forecast to grow 29%, compared to a 15% growth forecast for the industry in Germany. Over the last 3 years on average, earnings per share has increased by 31% per year whereas the company’s share price has increased by 32% per year. Tillkännagivande • Aug 11
Catalyst Pharmaceuticals, Inc. Provides Earnings Guidance for the Year 2022 Catalyst Pharmaceuticals, Inc. provided earnings guidance for the year 2022. For the year, total revenues will be in the range of between $195 million and $205 million, representing a 38% - 45% increase in total revenues compared to 2021. Tillkännagivande • Aug 06
Catalyst Pharmaceuticals, Inc., Annual General Meeting, Sep 19, 2022 Catalyst Pharmaceuticals, Inc., Annual General Meeting, Sep 19, 2022, at 09:00 US 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, on an advisory basis, the 2021 compensation of company's named executive officers; to ratify Grant Thornton LLP as company's independent registered public accounting firm for the fiscal year ending December 31, 2022; and to transact such other business as may properly come before the meeting. Tillkännagivande • Jul 28
Catalyst Pharmaceuticals, Inc. to Report Q2, 2022 Results on Aug 09, 2022 Catalyst Pharmaceuticals, Inc. announced that they will report Q2, 2022 results After-Market on Aug 09, 2022 Valuation Update With 7 Day Price Move • Jul 19
Investor sentiment improved over the past week After last week's 15% share price gain to €8.45, the stock trades at a forward P/E ratio of 12x. Average forward P/E is 30x in the Biotechs industry in Europe. Total returns to shareholders of 112% over the past three years. Tillkännagivande • May 12
Catalyst Pharmaceuticals, Inc. Provides Revenue Guidance for the Year 2022 Catalyst Pharmaceuticals, Inc. continued to forecast full year 2022 total revenues to be in the range of between $195 million and $205 million, representing a 38% - 45% increase in total revenues as compared to 2021. Reported Earnings • May 11
First quarter 2022 earnings released: EPS: US$0.13 (vs US$0.074 in 1Q 2021) First quarter 2022 results: EPS: US$0.13 (up from US$0.074 in 1Q 2021). Revenue: US$43.1m (up 43% from 1Q 2021). Net income: US$13.2m (up 73% from 1Q 2021). Profit margin: 31% (up from 25% in 1Q 2021). The increase in margin was driven by higher revenue. Over the next year, revenue is forecast to grow 35%, compared to a 37% growth forecast for the industry in Germany. Over the last 3 years on average, earnings per share has increased by 51% per year but the company’s share price has only increased by 31% per year, which means it is significantly lagging earnings growth. Tillkännagivande • Apr 26
Catalyst Pharmaceuticals, Inc. to Report Q1, 2022 Results on May 10, 2022 Catalyst Pharmaceuticals, Inc. announced that they will report Q1, 2022 results After-Market on May 10, 2022 Tillkännagivande • Mar 06
Catalyst Pharmaceuticals, Inc. to Report Q4, 2021 Results on Mar 16, 2022 Catalyst Pharmaceuticals, Inc. announced that they will report Q4, 2021 results After-Market on Mar 16, 2022