CORAL GABLES, Fla., Oct. 09, 2025 (GLOBE NEWSWIRE) -- Catalyst Pharmaceuticals, Inc. ("Catalyst") (Nasdaq: CPRX), a commercial-stage biopharmaceutical company focused on in-licensing, developing and commercializing novel medicines for people living with rare and difficult-to-treat diseases, today announced that data developed by or in conjunction with the company will be presented at several upcoming scientific conferences, details of which are listed below. "At Catalyst, everything begins with patients. Ou ...

Catalyst Pharmaceuticals, Inc. (NASDAQ:CPRX) is one of the best biotech stocks with high potential. HC Wainwright reiterated a Buy rating on Catalyst Pharmaceuticals, Inc. (NASDAQ:CPRX) on September 17 and set a $35 price target. Catalyst Pharmaceuticals, Inc. (CPRX): Among Stocks with Consistent Growth to Buy Now Similarly, in a report released on September 11, Jason Gerberry from Bank of America Securities also reiterated a Buy rating on Catalyst Pharmaceuticals, Inc. (NASDAQ:CPRX) and set a price targ ...

Catalyst Pharmaceuticals, Inc. (CPRX) shares rose 5.38 percent to $20.76 on Wednesday, gaining $1.06, after the company announced that its Board of Directors authorized a new share repurchase program to buy back up to $200 million of outstanding common stock between October 1, 2025, and December 31, 2026. The stock opened at $20.38 and traded between $20.13 and $22.02, compared with a previous close of $19.70 on the Nasdaq. Trading volume reached 2.96 million shares, above the average of 1.47 million. Cata ...

CORAL GABLES, Fla., Oct. 01, 2025 (GLOBE NEWSWIRE) -- Catalyst Pharmaceuticals, Inc. (“Catalyst” or “Company”) (Nasdaq: CPRX), a commercial-stage biopharmaceutical company focused on in-licensing, developing and commercializing novel medicines for people living with rare and difficult-to-treat diseases, today announced that its Board of Directors has authorized a new share repurchase program to repurchase up to $200 million of shares of Catalyst's outstanding common stock between October 1, 2025, and Decemb ...

Group 1 - Zacks Premium offers various tools for investors to enhance their stock market strategies, including daily updates, research reports, and stock screens [1][2] - The Zacks Style Scores are designed to help investors select stocks with the highest potential to outperform the market over the next 30 days, based on value, growth, and momentum characteristics [2][3] Group 2 - Each stock is rated from A to F, with A indicating the highest potential for outperformance, and the Style Scores are categorized into Value, Growth, Momentum, and a combined VGM Score [3][4][6] - The Value Score focuses on identifying undervalued stocks using financial ratios, while the Growth Score assesses a company's financial health and future growth potential [3][4] - The Momentum Score identifies trends in stock prices and earnings estimates, helping investors time their positions effectively [5] Group 3 - The Zacks Rank is a proprietary model that utilizes earnings estimate revisions to guide investors, with 1 (Strong Buy) stocks achieving an average annual return of +23.64% since 1988, significantly outperforming the S&P 500 [7][9] - Investors are encouraged to consider stocks with a Zacks Rank of 1 or 2 and Style Scores of A or B for optimal return potential [9][10] Group 4 - Catalyst Pharmaceuticals, Inc. is highlighted as a stock to watch, currently holding a 3 (Hold) Zacks Rank and a VGM Score of A, with a forward P/E ratio of 8.74 indicating attractive valuation [11] - The company has seen upward revisions in earnings estimates, with the Zacks Consensus Estimate for fiscal 2025 increasing by $0.04 to $2.29 per share, and an average earnings surprise of +24.1% [12]

Financial Data and Key Metrics Changes - Catalyst Pharmaceuticals reported second-quarter sales of FIRDAPSE at approximately $85 million, indicating a strong performance in the market [2] - The company has set its full-year 2025 guidance for FIRDAPSE sales between $355 million and $360 million, with a market potential estimated at $1.2 billion [18] Business Line Data and Key Metrics Changes - FIRDAPSE, the company's leading product, has shown consistent growth, particularly in the idiopathic segment of Lambert-Eaton Myasthenic Syndrome (LEMS), with a growth rate of about 15% each quarter for 15 consecutive quarters [2][4] - The oncology segment, which currently represents about 20% of the patient population, is expected to become a significant growth driver as the company enhances its focus on this area [18] Market Data and Key Metrics Changes - The U.S. prevalence of LEMS is estimated at around 3,600 patients, split approximately 50/50 between idiopathic and cancer-associated cases [5][6] - The company anticipates that the market for cancer-associated LEMS could expand by another 50%, primarily driven by small cell lung cancer patients [5][8] Company Strategy and Development Direction - The company operates as a buy-and-build organization, focusing on acquiring de-risked assets in orphan and rare diseases, while minimizing research and development costs [1] - Catalyst Pharmaceuticals aims to leverage partnerships with oncology practices and enhance physician education to drive the adoption of FIRDAPSE [10][11] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the growth potential in the oncology segment, particularly following updates to the NCCN guidelines that include FIRDAPSE [9][11] - The company believes it can achieve a diagnosis threshold of over 50% for LEMS patients, which would significantly enhance market penetration [14] Other Important Information - The company has settled some intellectual property disputes related to FIRDAPSE, ensuring market exclusivity until February 2035 [38] - Catalyst Pharmaceuticals has a strong balance sheet with $652 million in cash and no debt, positioning it well for future opportunities [44] Q&A Session Summary Question: Can you provide an overview of FIRDAPSE's market potential? - The market for LEMS is estimated at $1.2 billion, with the company focusing on increasing its share in both idiopathic and cancer-associated segments [14][18] Question: What is the strategy for AGAMREE in the DMD market? - AGAMREE is positioned as a foundational therapy for Duchenne Muscular Dystrophy, with a focus on its superior safety profile compared to other corticosteroids [20][31] Question: How does the company plan to drive growth for AGAMREE? - The company is engaging with centers of excellence and conducting studies to demonstrate AGAMREE's advantages, aiming to increase its market share significantly [22][31] Question: What is the current status of the intellectual property for FIRDAPSE? - The company has settled with several litigants, ensuring market exclusivity until February 2035, with ongoing litigation against one remaining party [38] Question: How does the company evaluate new asset opportunities? - The company focuses on differentiated products that are immediately accretive, emphasizing the importance of social compatibility with potential partners [40][43]

Summary of Catalyst Pharmaceuticals FY Conference Call Company Overview - Catalyst Pharmaceuticals operates in the Central Nervous System (CNS) space, focusing on therapies for rare diseases, particularly Lambert-Eaton Myasthenic Syndrome (LEMS) and Duchenne Muscular Dystrophy (DMD) [3][4] Key Product Insights FIRDAPSE - FIRDAPSE is a successful therapy for LEMS, with over six years on the market and a strong performance record, achieving 15 consecutive quarters of 15% or more growth until impacted by a cyberattack [5] - In the first half of 2025, FIRDAPSE sales grew by 17% compared to the first half of 2024, with a current addressable market of approximately $1.2 billion [5] - The company has split its brand team to focus on idiopathic and oncology-related markets, aiming to sustain growth [6] - The NCCN guidelines inclusion is expected to enhance market penetration, with a focus on integrating these guidelines into care pathways of major oncology practices [8][10] AGAMREE - AGAMREE is a differentiated steroid for DMD, with a significant unmet medical need as only 7% of diagnosed patients are currently on steroids despite 95% having used them at some point [23] - The product has penetrated 93% of the 100 centers of excellence in the U.S., with a dedicated sales force to enhance growth [24][25] - The company is addressing competition from gene therapies and has a strong share of voice in the steroid market [26] - AGAMREE's side effect profile is reported to be superior, with benefits in bone health and reduced anxiety compared to other steroids [32] Market Dynamics - The company is actively identifying patients through AI and machine learning, focusing on misdiagnosed cases of myasthenia gravis to drive growth in the idiopathic market [11][12] - The average physician sees very few LEMS patients, making patient prospecting essential [13] - There are approximately 900 LEMS patients diagnosed annually with small cell lung cancer, presenting a significant opportunity for the company [14] Intellectual Property and Litigation - Catalyst Pharmaceuticals has settled three out of four lawsuits related to its intellectual property, with ongoing litigation against Hetero [18] - The settlements extend the product's market exclusivity, potentially allowing for an additional 10 years of growth [19] Business Development Strategy - The company is focused on acquiring differentiated, profitable products and emphasizes the importance of cultural fit in partnerships [38][39] - Current market conditions are seen as favorable for finding new assets, with 80-90% of opportunities being inbound due to the company's success [39] Future Outlook - Catalyst Pharmaceuticals aims to explore opportunities within the CNS space, particularly in movement disorders, while keeping peak year sales under $500 million to avoid competition with larger players [40] - The company is therapeutic agnostic, believing its existing infrastructure can support various therapeutic areas [41] Conclusion - Catalyst Pharmaceuticals expresses optimism about future growth opportunities and appreciates the support from stakeholders [42]

Summary of Catalyst Pharmaceuticals (CPRX) 2025 Conference Call Company Overview - Catalyst Pharmaceuticals operates under a buy-and-build business model, focusing on orphan and rare diseases, particularly in the CNS (Central Nervous System) sector. This model aims to reduce risk for shareholders and stakeholders by leveraging valuable assets and established infrastructure for patient support and commercial operations [4][5] Key Products and Market Focus - The company has three main assets: - **FIRDAPSE**: For Lambert-Eaton Myasthenic Syndrome (LEMS) with an estimated patient population of 2,500 to 3,000 in the U.S. - **AGAMREE**: A novel corticosteroid for Duchenne muscular dystrophy (DMD) with a patient population of 11,000 to 13,000, launched last year. - **FYCOMPA**: An epilepsy drug recently lost exclusivity, with guidance for 2025 set at $90 to $95 million [6][15][29] Performance Highlights - FIRDAPSE is performing well, with initiatives to improve patient titration and support from specialty pharmacies. The average physician sees one LEMS patient in their career, indicating a need for enhanced education and support [10][11] - AGAMREE is gaining traction, with 45% of patients coming from Influenza treatments and 45% from prednisone, indicating a broad market engagement [46][47] - FYCOMPA's performance is under scrutiny due to the introduction of generics, with expectations of a softer second half of the year [15][16] Growth Potential - FIRDAPSE has a total addressable market estimated at $1.2 billion, with current penetration at 30% for idiopathic LEMS and less than 10% for cancer-associated LEMS. The company sees significant growth opportunities in oncology due to recent guideline changes and testing accessibility [19][34] - AGAMREE's market share is expected to grow as it captures patients transitioning from other steroid treatments, with a focus on pediatric applications [68] Intellectual Property (IP) Status - Catalyst has settled with three out of four generic filers for FIRDAPSE, extending the entry date for generics to February 2035. The remaining litigant is under ongoing discussions [23][24] Business Development Strategy - The company is actively seeking differentiated products under $500 million, focusing on orphan drugs with potential for multiple indications. There is a particular interest in pediatric opportunities and oncology [66][68] Key Value Drivers - Enrollment in the Summit study, which aims to evaluate safety signals for AGAMREE, is crucial for future growth. The prevalence of testing for LEMS is also a significant indirect measure of the company's success [69] Conclusion - Catalyst Pharmaceuticals is positioned for growth in the orphan drug market, with a strong focus on patient support and education. The company is optimistic about its product pipeline and market opportunities, particularly in oncology and pediatric applications, while navigating challenges posed by generics in the epilepsy market [4][68]

Financial Data and Key Metrics Changes - The company reported a first-half performance of $70 million against a guidance of $90 million to $95 million for the year [75][76] - The maximum dose for Firdapse was increased from 80 mg to 100 mg, which is expected to drive patient dosing closer to the new maximum [28][29] - The company anticipates a significant dollar share loss due to the entry of additional generics in the market [80][81] Business Line Data and Key Metrics Changes - Firdapse has a market penetration of approximately 30% in the idiopathic LEMS segment, with an addressable market of about $600 million [9][17] - The cancer-associated LEMS segment has a penetration of only about 10%, with a similar addressable market size [17] - GammaRay for Duchenne's muscular dystrophy has been well received, with 45% of patients coming from prednisone, 45% from Emflaza, and 10% being naive [46] Market Data and Key Metrics Changes - The company is focused on the U.S. market, with a specific emphasis on identifying misdiagnosed patients in the LEMS space [3][4] - The addressable market for both idiopathic and cancer-associated LEMS is estimated at $600 million each, with significant growth potential [17][31] - The company has established partnerships for frictionless testing to improve patient diagnosis and treatment pathways [13][19] Company Strategy and Development Direction - The company aims to grow through acquisitions and lifecycle management of existing products, focusing on commercial execution rather than R&D [2][5] - There is a strong emphasis on building credibility with patient advocacy groups and utilizing non-traditional marketing strategies [86][88] - The company is looking for business development opportunities that are therapeutically agnostic and immediately accretive [91][92] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the growth potential in both idiopathic and cancer-associated LEMS, particularly with recent NCCN guideline updates [19][20] - The company is preparing for potential challenges in the gene therapy market, which may create opportunities for GammaRay [57][61] - Management is focused on achieving full enrollment in the SUMMIT study and advancing the cancer LEMS initiative [93][95] Other Important Information - The company has settled with two of the three first filers in patent litigation, potentially extending exclusivity until February 2035 [32] - The company is actively working on life cycle management strategies for GammaRay to enhance its market position [47][58] Q&A Session Summary Question: Can you talk about the assumptions going into the 2025 guidance for Firdapse? - The guidance of $355 million to $360 million is based on increased dosing and a dedicated sales force focused on both Firdapse and GammaRay [28][29][30] Question: What is the status of the NCCN guidelines and frictionless testing? - The NCCN guidelines were updated favorably in July, and the frictionless testing contract was finalized around May-June [19][20] Question: How does the company plan to address the discontinuation rate for Firdapse? - The primary reason for discontinuation is patient mortality, but the company is implementing a titration schedule to improve patient retention [21][22][23] Question: What is the strategy for GammaRay in a competitive market? - The company is positioning GammaRay slightly below branded Emflaza to avoid market blockage and is targeting a broad patient base [41][42][46] Question: How does the company view future SG&A investments? - The company is cautious about overwhelming healthcare providers with sales representatives and is focusing on non-traditional outreach methods [84][86][89]

Financial Data and Key Metrics Changes - The company reported a guidance for Firdapse revenue in 2025 of $355 million to $360 million, with year-to-date trends tracking positively against these assumptions [28] - The addressable market for Firdapse is estimated at over $1 billion, with confidence in reaching this target due to recent increases in maximum dosage from 80 mg to 100 mg [30][31] - The company anticipates a revenue of $100 million to $110 million for GammaRay in 2025, with an addressable market of $1.2 billion [52] Business Line Data and Key Metrics Changes - Firdapse has a market penetration of approximately 30% in the idiopathic LEMS segment, with an addressable market of about 1,700 to 2,000 patients [9] - The cancer-associated LEMS segment has a market penetration of only about 10%, with an addressable market of $600 million [18] - GammaRay has been successful in capturing market share, with 45% of patients coming from prednisone, 45% from Emflaza, and 10% being naive patients [45] Market Data and Key Metrics Changes - The company has established a partnership with Quest Diagnostics for frictionless testing, which is expected to enhance patient diagnosis and treatment pathways [14] - The NCCN guidelines have been updated favorably for LEMS patients, which is anticipated to improve market access and treatment adherence [20] Company Strategy and Development Direction - The company is focused on a "buy and build" strategy, seeking opportunities in the market while managing commercial and regulatory risks [3] - There is a strong emphasis on lifecycle management of existing products and potential acquisitions to drive growth [5] - The company aims to maintain a strong balance sheet while exploring business development opportunities in CNS and other therapeutic areas [90] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the growth potential in both idiopathic and cancer-associated LEMS markets, particularly with improved diagnostic capabilities [21] - The company is preparing for potential challenges in the market, including competition from generics and the need for effective patient education [56] - Management highlighted the importance of building credibility with patient advocacy groups and adapting to the evolving landscape of gene therapy [87] Other Important Information - The company has a dedicated sales force for both Firdapse and GammaRay, which is expected to enhance market penetration and patient engagement [83] - There is an upcoming Markman hearing related to patent litigation, which could influence the company's market position and exclusivity [36] Q&A Session Summary Question: What are the assumptions behind the 2025 guidance for Firdapse? - The guidance is based on an increase in maximum dosage and a reassigned sales force dedicated to Firdapse, which is expected to drive patient uptake [28][29] Question: How does the company plan to address the discontinuation rate of Firdapse? - Management noted that the primary reason for discontinuation is patient mortality, but they are implementing a titration schedule to improve patient retention [22][23] Question: What is the strategy for GammaRay in a competitive market? - The company plans to position GammaRay slightly below the branded Emflaza to ensure market access and capitalize on existing patient dissatisfaction with current therapies [41][42] Question: How does the company view the impact of generics on Fycompa? - Management acknowledged that while prescription volumes may remain stable, dollar share is expected to decline as generics enter the market [78][79] Question: What are the key achievements the company aims for in the next year? - The company aims to achieve full enrollment in the SUMMIT study and advance its cancer LEMS initiative [93]