Charles Duncan

Jason Gerberry

Asim Rana

Benjamin Paluch

Felix Ampomah

Joel Beatty

Joon Lee

Samantha Semenkow

Jennifer Kim

Joseph Catanzaro

Leland Gershell

Pavan Patel

Rohan Mathur

Sudan Loganathan

- **Catalyst Pharmaceuticals, Inc.** (CPRX) announced a new **share repurchase program** authorized by its Board of Directors on October 1, 2025.  **[1369568_0001193125-25-226837_d118298dex991.htm:0]** **[1369568_0001193125-25-226837_d118298d8k.htm:0]** **[1369568_0001193125-25-226837_d118298d8k.htm:1]** 
- The program allows for the repurchase of up to **$200 million** of the company's common stock between **October 1, 2025, and December 31, 2026**.  **[1369568_0001193125-25-226837_d118298dex991.htm:0]** **[1369568_0001193125-25-226837_d118298d8k.htm:1]** 
- The company plans to fund the repurchases using **existing cash on hand**, supported by a strong balance sheet that included **over $650 million in cash and cash equivalents** and no funded debt as of June 30, 2025.  **[1369568_0001193125-25-226837_d118298dex991.htm:0]** **[1369568_0001193125-25-226837_d118298d8k.htm:1]** 
- The timing and amount of repurchases are discretionary, and the program may be suspended or terminated at any time.  **[1369568_0001193125-25-226837_d118298dex991.htm:0]** **[1369568_0001193125-25-226837_d118298d8k.htm:1]**

Catalyst Pharmaceuticals Announces $200 Million Share Repurchase Program

- Catalyst Pharmaceuticals provided **FY 2025 guidance** for Firdapse of **$355 million to $360 million** and for GammaRay of **$100 million to $110 million**.  **[1369568_tx_380801_3]** **[1369568_tx_380801_6]** 
- Firdapse, for Lambert-Eaton myasthenic syndrome (LEMS), has an addressable market of approximately **$1 billion** with potential patent exclusivity until **February 2035**.  **[1369568_tx_380801_4]**  The company is focused on increasing its current **30% penetration** in idiopathic LEMS and **10% penetration** in cancer-associated LEMS through initiatives like NCCN guideline inclusion and frictionless testing.  **[1369568_tx_380801_0]** **[1369568_tx_380801_2]** 
- GammaRay, launched in March for Duchenne's muscular dystrophy (DMD), has an addressable market of **$1.2 billion** and is capturing market share from existing treatments.  **[1369568_tx_380801_0]** **[1369568_tx_380801_5]** **[1369568_tx_380801_6]**  Key upcoming data includes an immunosuppressive dose study (late **2025/early 2026**) and the SUMMIT post-marketing study for label updates (data in **18 months to a couple of years**).  **[1369568_tx_380801_7]** 
- The company's epilepsy product, Fycompa, generated **$70 million** in H1 2025 against **FY 2025 guidance of $90 million to $95 million**, but is experiencing generic erosion with more generic entrants expected in November 2025.  **[1369568_tx_380801_8]** 
- Catalyst Pharma's business development strategy targets immediately accretive products with peak annual sales below **$500 million**, leveraging its efficient SG&A structure.  **[1369568_tx_380801_9]**

Catalyst Pharmaceuticals Discusses FY 2025 Guidance and Product Growth

- Catalyst Pharmaceuticals, Inc. and its licensor SERB S.A. have entered into a **Settlement Agreement** with Lupin Ltd and Lupin Pharmaceuticals, Inc., resolving patent litigation concerning Lupin's Abbreviated New Drug Application (ANDA) for a generic version of FIRDAPSE® (amifampridine) 10 mg tablets.  **[1369568_3f50596821044eec997da75cd4702b72_0]** 
- Under the terms of the Agreement, Lupin will not market its generic version of FIRDAPSE® in the United States any earlier than **February 25, 2035**, unless certain limited circumstances occur.  **[1369568_3f50596821044eec997da75cd4702b72_0]** 
- The parties will terminate all ongoing patent litigation between Catalyst/SERB and Lupin regarding FIRDAPSE® patents.  **[1369568_3f50596821044eec997da75cd4702b72_0]** 
- While this resolves litigation with Lupin, patent litigation against the remaining defendant, **Hetero**, regarding FIRDAPSE®'s Orange Book-listed patents is **ongoing**.  **[1369568_3f50596821044eec997da75cd4702b72_0]**

Catalyst Pharmaceuticals Settles FIRDAPSE® Patent Litigation with Lupin

- **Catalyst Pharmaceuticals** and its licensor **SERB S.A.** have reached a **settlement agreement** with **Lupin Ltd** and **Lupin Pharmaceuticals, Inc.**, resolving patent litigation concerning Lupin's generic version of **FIRDAPSE®** (amifampridine) 10 mg tablets.  **[1369568_56ac8ad90020434090274adc62a19e30_0]** 
- Pursuant to the agreement, **Lupin** will not market its generic **FIRDAPSE** in the United States any earlier than **February 25, 2035**, unless certain limited circumstances occur.  **[1369568_56ac8ad90020434090274adc62a19e30_0]** 
- This settlement terminates all ongoing patent litigation between Catalyst/SERB and Lupin regarding FIRDAPSE patents, though patent litigation against **Hetero** remains ongoing.  **[1369568_56ac8ad90020434090274adc62a19e30_0]**

Catalyst Pharmaceuticals Settles FIRDAPSE Patent Litigation with Lupin

CATALYST PHARMACEUTICALS (CPRX)