# EDGAR Filing Document

**Accession Number:** 0001369568
**File Stem:** 0001193125-25-191273
**Filing Date:** 2025-8
**Character Count:** 10869
**Document Hash:** 7c28761794d01a0dbed78055ad79a886
**Contains OCR:** False
**Source Format:** 

## Filing Content

## Filing Summary
**0001193125-25-191273.hdr.sgml**: 20250828

**ACCESSION NUMBER**: 0001193125-25-191273

**CONFORMED SUBMISSION TYPE**: 8-K/A

**PUBLIC DOCUMENT COUNT**: 11

**CONFORMED PERIOD OF REPORT**: 20250825

**ITEM INFORMATION**: Financial Statements and Exhibits

**FILED AS OF DATE**: 20250828

**DATE AS OF CHANGE**: 20250828

**FILER**: 

**COMPANY DATA:**
- **COMPANY CONFORMED NAME:** CATALYST PHARMACEUTICALS, INC.
- **CENTRAL INDEX KEY:** 0001369568
- **STANDARD INDUSTRIAL CLASSIFICATION:** PHARMACEUTICAL PREPARATIONS [2834]
- **ORGANIZATION NAME:** 03 Life Sciences
- **EIN:** 000000000
- **STATE OF INCORPORATION:** DE
- **FISCAL YEAR END:** 1231

**FILING VALUES:**
- **FORM TYPE:** 8-K/A
- **SEC ACT:** 1934 Act
- **SEC FILE NUMBER:** 001-33057
- **FILM NUMBER:** 251273998

**BUSINESS ADDRESS:**
- **STREET 1:** 355 ALHAMBRA CIRCLE
- **STREET 2:** SUITE 801
- **CITY:** CORAL GABLES
- **STATE:** FL
- **ZIP:** 33134
- **BUSINESS PHONE:** (305) 529-2522

**MAIL ADDRESS:**
- **STREET 1:** 355 ALHAMBRA CIRCLE
- **STREET 2:** SUITE 801
- **CITY:** CORAL GABLES
- **STATE:** FL
- **ZIP:** 33134

**FORMER COMPANY:**
- **FORMER CONFORMED NAME:** CATALYST PHARMACEUTICAL PARTNERS, INC.
- **DATE OF NAME CHANGE:** 20110215

**FORMER COMPANY:**
- **FORMER CONFORMED NAME:** Catalyst Pharmaceutical Partners, Inc.
- **DATE OF NAME CHANGE:** 20060719

?xml version='1.0' encoding='ASCII'? 8-K/A

### UNITED STATES

### SECURITIES AND EXCHANGE COMMISSION

#### Washington, D.C. 20549

### FORM 8-K/A

#### (Amendment No. 1)

#### CURRENT REPORT PURSUANT TO SECTION 13 OR 15(d) OF

#### THE SECURITIES EXCHANGE ACT OF 1934

#### Date of Report (Date of Earliest Event Reported): August 25, 2025

## CATALYST PHARMACEUTICALS, INC.

#### (Exact Name Of Registrant As Specified In Its Charter)

---

| | | |
|:---|:---|:---|
| **Delaware** | **001-33057** | **76-0837053** |
| **(State or other jurisdiction**<br>**of incorporation)** | **(Commission File Number)** | **(I.R.S. Employer**<br>**Identification No.)** |
| **355 Alhambra Circle**<br>**Suite 801**<br>**Coral Gables, Florida**<br>**(Address of principal executive offices)** | **355 Alhambra Circle**<br>**Suite 801**<br>**Coral Gables, Florida**<br>**(Address of principal executive offices)** | **33134**<br>**(Zip Code)** |

---

#### Registrant's telephone number, including area code: (305) 420-3200

#### Not Applicable

#### Former Name or Former address, if changed since last report
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

☐ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR240.14d-2(b)) 

☐ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) 

Securities registered pursuant to Section 12(b) of the Act:

---

| | | |
|:---|:---|:---|
| **Title of Each Class** | **Name of Exchange on Which Registered** | **Ticker Symbol** |
| **Common Stock, par value $0.001<br> per share**<br>| **NASDAQ Capital Market** | **CPRX** |

---

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this Chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging Growth Company ☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

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#### EXPLANATORY NOTE
On August 25, 2025, Catalyst Pharmaceuticals, Inc. (the "Company") filed a Current Report on Form 8-K (the "Original 8-K") with the U.S. Securities and Exchange Commission reporting that the Company had entered into a settlement agreement with Lupin Pharmaceuticals, Inc. and Lupin Ltd. ("Lupin") resolving certain patent litigation brought by the Company and SERB S.A. against Lupin.

Since the Company disseminated its press release reporting on the settlement with Lupin, the Company has become aware that the Original 8-K and the press release that was an exhibit to the Original 8-K (the "Original Press Release") inadvertently misidentified one of the parties that had previously settled patent litigation with the Company and SERB S.A. relating to the Company's FIRDAPSE<sup>®</sup> patents. The party that previously settled its litigation with the Company and SERB S.A. relating to the Company's FIRDAPSE<sup>®</sup> patents is Inventia Healthcare Limited and not Inventia Life Science Pty Ltd.

On August 26, 2025, the Company reissued the Original Press Release to update the identity of the party that previously settled the litigation with the Company and SERB S.A. relating to the Company's FIRDAPSE<sup>®</sup> patents. Other than a change to correct the identity of the previous settling party, no other changes were made to the Original Press Release that was disseminated on August 25, 2025.

The updated press release that was disseminated on August 26, 2025 is attached to this Form 8-K/A as Exhibit 99.1 and is incorporated herein by reference.

---

| | |
|:---|:---|
| **Item 9.01** | **Financial Statements and Exhibits.**  |

---

---

| | |
|:---|:---|
| (d) | <u>Exhibits</u> |
| 99.1 | [Press release issued by the Company on August 26, 2025.](d40349dex991.htm) |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document) |

---

------

#### SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.

---

| | |
|:---|:---|
| **Catalyst Pharmaceuticals, Inc.** | **Catalyst Pharmaceuticals, Inc.** |
| By: | /s/ Michael W. Kalb |
|  | Michael W. Kalb |
|  | Executive Vice President and Chief Financial Officer |

---

Dated: August 28, 2025

## Exhibit 99.1

**Exhibit 99.1** 

**<u>UPDATED:</u> Catalyst Pharmaceuticals Announces Settlement of FIRDAPSE<sup>®</sup>** 

**(amifampridine) Patent Litigation with Lupin Pharmaceuticals** 

***As Part of the Settlement, Lupin Receives a License to Market Generic FIRDAPSE Beginning in February 2035***

**CORAL GABLES, Fla., August 26, 2025**- Catalyst Pharmaceuticals, Inc. ("Catalyst" or "Company") (Nasdaq: CPRX), a commercial-stage biopharmaceutical company focused on in-licensing, developing, and commercializing novel medicines for patients living with rare and difficult-to-treat diseases, today 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<sup>®</sup> (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 Healthcare Limited. 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.

**About Catalyst Pharmaceuticals** 

Catalyst Pharmaceuticals, Inc. (Nasdaq: CPRX), is a biopharmaceutical company committed to improving the lives of patients with rare diseases. With a proven track record of bringing life-changing treatments to the market, we focus on in-licensing, commercializing, and developing innovative therapies. Guided by our deep commitment to patient care, we prioritize accessibility, ensuring patients receive the care they need through a comprehensive suite of support services designed to provide seamless access and ongoing assistance. Catalyst maintains a well-established U.S. presence, which remains the cornerstone of our commercial strategy, while continuously evaluating strategic opportunities to expand our global footprint. Catalyst, headquartered in Coral Gables, Fla., was recognized on the Forbes 2025 list as one of America's Most Successful Mid-Cap Companies and on the 2024 Deloitte Technology Fast 500<sup>™</sup> list as one of North America's Fastest-Growing Companies.

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For more information, please visit Catalyst's website at <u>www.catalystpharma.com</u>.

**Forward-Looking Statements** 

This press release contains forward-looking statements, as that term is defined in the Private Securities Litigation Reform Act of 1995. Forward-looking statements involve known and unknown risks and uncertainties, which may cause Catalyst's actual results in future periods to differ materially from forecasted results. A number of factors, including (i) whether the ongoing litigation matters referenced above between Catalyst/SERB and Hetero with respect to FIRDAPSE<sup>®</sup>'s Orange Book listed patents will allow a generic version of FIRDAPSE to be marketed in the U.S. prior to February 25, 2035, and (ii) those factors described in Catalyst's Annual Report on Form 10-K for the fiscal year 2024, its Quarterly Report on Form 10-Q for the fiscal quarter ending June 30, 2025, and its other filings with the U.S. Securities and Exchange Commission ("SEC"), could adversely affect Catalyst. Copies of Catalyst's filings with the SEC are available from the SEC, may be found on Catalyst's website, or may be obtained upon request from Catalyst. Catalyst does not undertake any obligation to update the information contained herein, which speaks only as of this date.

Source: Catalyst Pharmaceuticals, Inc.

**Investor Contact** 

Mary Coleman, Catalyst Pharmaceuticals, Inc.

(305) 420-3200

<u>IR@catalystpharma.com</u> 

**Media Contact** 

David Schull, Russo Partners

(858) 717-2310

<u>david.schull@russopartnersllc.com</u>