CATALYST PHARMACEUTICALS (CPRX) Company Report

Santhera Pharmaceuticals announced that the Spanish Interministerial Commission on Prices of Medicines has proposed to include AGAMREE® (vamorolone) in the pharmaceutical coverage of the Spanish National Health System, making it eligible for reimbursement.
The company anticipates making AGAMREE available across various regions in Spain from early in the second quarter of 2026.
AGAMREE is approved by the European Commission for treating Duchenne muscular dystrophy in patients from 4 years of age.
This development follows commercial launches of AGAMREE in Germany, Austria, and the UK, with additional EU countries expected to follow during both the first and second halves of 2026.

19 hours ago

Press Release

Catalyst Pharmaceuticals Reports Record 2025 Revenues and Issues Strong 2026 Guidance

CPRX

Earnings

Guidance Update

Revenue Acceleration/Inflection

Catalyst Pharmaceuticals reported record total revenues of $589 million for the full year 2025, representing a 19.8% increase year-over-year, driven by strong performance from Firdapse and AGAMREE.
The company provided 2026 total revenue guidance of $615 million to $645 million, with Firdapse projected to be $435 million to $450 million and AGAMREE $140 million to $150 million.
For 2025, Firdapse net product revenue reached $358.4 million (up 17.1% year-over-year) and AGAMREE net product revenue was $117.1 million (up 154.3% year-over-year), while Fycompa generated $113.3 million but faces continued revenue erosion due to generic competition.
GAAP net income for 2025 increased by 30.8% to $214.3 million, or $1.68 per diluted share, and the company ended the year with $709.2 million in cash and cash equivalents, an increase of $191.6 million from 2024.
A trial for the remaining legal suit against Hetero USA regarding Firdapse is set to begin on March 23, 2026.

1 day ago

Transcript

Catalyst Pharmaceuticals Reports Record 2025 Revenues and Provides 2026 Guidance

CPRX

Earnings

Guidance Update

Revenue Acceleration/Inflection

Catalyst Pharmaceuticals reported record total revenues of $589 million for the full year 2025, a 19.8% increase year-over-year, exceeding previous guidance, with GAAP net income of $214.3 million or $1.68 per diluted share.
The company issued 2026 total revenue guidance between $615 million and $645 million.
Firdapse revenue grew 17% to $358.4 million in 2025, with 2026 guidance of $435 million to $450 million. AGAMREE revenue surged 154.3% to $117.1 million in 2025, with 2026 guidance of $140 million to $150 million.
Fycompa revenue was $113.3 million in 2025, but 2026 guidance is $40 million to $45 million due to generic competition that began in 2025, leading to discontinued promotion.

1 day ago

Transcript

Catalyst Pharmaceuticals Reports Strong Q4 and Full Year 2025 Results, Issues 2026 Guidance

CPRX

Earnings

Guidance Update

Revenue Acceleration/Inflection

Catalyst Pharmaceuticals reported total revenues of $589.0 million for the full year 2025, an approximate 19.8% increase over 2024, exceeding its previous guidance range of $565 million-$585 million. GAAP net income for 2025 was $214.3 million, or $1.68 per diluted share, representing a 30.8% increase compared to 2024.
Firdapse net product revenue reached $358.4 million in 2025, growing 17.1% year-over-year, driven by continued patient identification and market penetration in both idiopathic and cancer-associated LEMS. AGAMREE delivered $117.1 million in 2025 revenues, marking 154.3% year-over-year growth, attributed to its launch strategy targeting centers of excellence penetration.
For 2026, the company forecasts total revenue between $615 million and $645 million. This includes Firdapse net product revenue guidance of $435 million-$450 million and AGAMREE net product revenue guidance of $140 million-$150 million.
The company ended 2025 with cash and cash equivalents of $709.2 million, an increase of $191.6 million from December 31, 2024, largely driven by cash generated from operating activities. During the fourth quarter of 2025, Catalyst Pharmaceuticals repurchased $25.3 million of common stock.

1 day ago

Transcript

Catalyst Pharmaceuticals Reports Record Q4 and Full Year 2025 Results, Provides Strong 2026 Revenue Guidance

CPRX

Earnings

Guidance Update

Share Buyback

Catalyst Pharmaceuticals reported record full year 2025 total revenues of $589.0 million, a 19.8% year-over-year increase, and Q4 2025 total revenues of $152.6 million, a 7.6% year-over-year increase. GAAP net income for full year 2025 was $214.3 million.
Full year 2025 product revenue growth was significantly driven by FIRDAPSE, which increased 17.1% to $358.4 million, and AGAMREE, which grew 154.3% to $117.1 million.
For full year 2026, the company forecasts total revenues between $615 million and $645 million, with FIRDAPSE revenue expected between $435 million and $450 million and AGAMREE revenue between $140 million and $150 million.
As of December 31, 2025, cash and cash equivalents stood at $709.2 million. In the fourth quarter of 2025, Catalyst announced a $200 million share repurchase program and purchased 1,124,948 shares at an average price of $22.49 per share.
Beginning January 26, 2026, the overall royalty rate paid to upstream licensors for net U.S. sales of FIRDAPSE will be 6%, a significant reduction from the previous maximum rate of 18.5%.

2 days ago

8-K

Catalyst Pharmaceuticals Highlights Strong Financial Position and Growth Prospects at J.P. Morgan Healthcare Conference

CPRX

Guidance Update

M&A

New Projects/Investments

Catalyst Pharmaceuticals (CPRX) is a profitable commercial-stage biopharmaceutical company focused on rare diseases, reporting more than $700 million in cash and no funded debt as of January 12, 2026, with the ability to spend over $1 billion in acquisitions.
The company anticipates achieving the upper end of its 2025 guidance for overall performance, with Firdapse (LEMS treatment) performing within its range and Agamree (DMD treatment) at or slightly exceeding the upper end of its guidance.
Firdapse continues to demonstrate 15%-20% growth per quarter and has an addressable market exceeding $1 billion. The company has settled patent litigation for Firdapse with Teva and Lupin, with a trial against the last remaining defendant, Hetero, scheduled for late March 2026.
Agamree, launched in March 2024 for Duchenne muscular dystrophy, achieved 224% growth through September 30, 2025, and targets an addressable market of $1 billion.
Catalyst Pharmaceuticals is actively pursuing immediately or nearly immediately accretive acquisitions in rare diseases, targeting opportunities with peak sales of up to $500 million, and evaluated 135 business development opportunities in 2025.

Jan 12, 2026, 11:45 PM

Transcript

Catalyst Pharma Provides Business Update at JPMorgan Healthcare Conference

CPRX

Guidance Update

Legal Proceedings

M&A

Catalyst Pharma maintains strong financial flexibility with $700 million in cash and no funded debt, generating approximately $60 million to the bottom line every quarter. The company anticipates achieving the upper end of its 2025 guidance.
FIRDAPSE, the sole evidence-based treatment for LEMS, continues to grow at 15%-20% per quarter within an addressable market exceeding $1 billion. The company has settled patent litigation for FIRDAPSE with Teva and Lupin, securing IP until February 2035, with one remaining defendant, Hetero, scheduled for trial in late March.
AGAMREE, a novel corticosteroid for Duchenne muscular dystrophy, has achieved 90% penetration in the top 100 centers of excellence and an 85% conversion rate from other products. Catalyst Pharma is advancing the SUMMIT study to further differentiate AGAMREE and evaluate its long-term safety benefits.
The company is actively pursuing an acquisition strategy for immediately or nearly immediately accretive rare disease products with peak sales up to $500 million, leveraging its strong balance sheet to expand its portfolio and capabilities.

Jan 12, 2026, 11:45 PM

Transcript

Catalyst Pharmaceuticals Updates on Strong Financial Position, Product Growth, and Acquisition Strategy

CPRX

Guidance Update

M&A

Legal Proceedings

Catalyst Pharmaceuticals, a profitable rare disease biopharmaceutical company, holds over $700 million in cash with no funded debt, supporting its capacity for over $1 billion in acquisitions. The company updated its 2025 guidance to the upper end and has achieved a 37% CAGR since commercialization.
Key products, Firdapse (for LEMS) and Agamree (for Duchenne muscular dystrophy), are driving growth, with Firdapse showing 15%-20% quarterly growth and Agamree experiencing 224% growth through September 30, 2025. Both products target addressable markets of $1 billion or more.
The company is actively seeking immediately or nearly immediately accretive acquisitions in rare diseases, focusing on products with peak sales up to $500 million and expanding its scope to include products past proof of concept in development. Catalyst evaluated 135 business development opportunities in 2025.
Catalyst has successfully settled patent litigation for Firdapse with Teva and Lupin, with Hetero remaining as the last litigant for a trial scheduled in late March 2026. The company is also advancing the SUMMIT study for Agamree to further differentiate the product.

Jan 12, 2026, 11:45 PM

Transcript

Catalyst Pharmaceuticals Updates 2025 Revenue Guidance and Highlights Strategic Growth

CPRX

Guidance Update

Revenue Acceleration/Inflection

M&A

Catalyst Pharmaceuticals, Inc. reported record Q3 2025 and Year-to-Date 2025 Net Product Revenues, with 17.4% year-over-year growth for Q3 2025 and 25.6% growth for the nine months ended September 30, 2025.
The company increased its 2025 Full Year Total Revenue Guidance to between $565 million and $585 million, driven by strong performance from FIRDAPSE and AGAMREE.
Catalyst Pharmaceuticals maintains a strong financial profile with over $700 million in cash and cash equivalents and no funded debt as of December 31, 2025, providing over $1 billion in capacity for future transactions.
Strategic achievements include the settlement of FIRDAPSE patent litigation with Teva and Lupin (allowing generic entry in February 2035), the launch of FIRDAPSE in Japan, and AGAMREE's NDS approval by Health Canada.
The company is actively pursuing an acquisition strategy with financial flexibility to deploy over $1 billion towards rare disease products and clinical-stage opportunities.

Jan 12, 2026, 1:03 PM

8-K

Catalyst Pharmaceuticals Updates 2025 Revenue Guidance and Highlights Strategic Achievements

CPRX

Guidance Update

M&A

Share Buyback

Catalyst Pharmaceuticals increased its 2025 full-year total revenue guidance to between $565 million and $585 million, with specific guidance for FIRDAPSE ($355M - $360M), AGAMREE ($105M - $115M), and FYCOMPA ($100M - $110M).
The company maintains a strong financial position with over $700 million in cash and cash equivalents and no funded debt as of December 31, 2025, providing over $1 billion capacity for future transactions.
Key product developments in 2025 include updated NCCN guidelines for FIRDAPSE in LEMS, settlement of patent litigation for FIRDAPSE with licenses beginning in February 2035, and sustained demand for AGAMREE in Duchenne muscular dystrophy (DMD).
Catalyst Pharmaceuticals also repurchased over 1 million shares through December 31, 2025, under its current share repurchase program.