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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

 

FORM 8-K

 

 

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 26, 2020

 

 

CATALYST PHARMACEUTICALS, INC.

(Exact Name Of Registrant As Specified In Its Charter)

 

 

 

Delaware   001-33057   76-0837053

(State or other jurisdiction

of incorporation)

 

(Commission

File Number)

 

(I.R.S. Employer

Identification No.)

355 Alhambra Circle

Suite 1250

Coral Gables, Florida

  33134
(Address of principal executive offices)   (Zip Code)

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

Not Applicable

Former Name or Former address, if changed since last report

 

 

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 per share   NASDAQ Capital Market   CPRX

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))

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.  ☐

 

 

 


Item 8.01

Other Events

On August 26, 2020, the Company issued a press release announcing the filing of a proceeding in Canadian Federal Court challenging Health Canada’s issuance of a Notice of Compliance (NOC) on August 10, 2020 for Medunik’s New Drug Submission (NDS) for the drug Ruzurgi® (amifampridine) for the treatment of Lambert-Eaton Myasthenic Syndrome despite the fact that Catalyst’s Firdapse® (amifampridine phosphate) was issued an NOC on July 31, 2020 and was granted data protection as an “innovative drug” as it was the first amifampridine product to be approved in Canada.

The proceeding seeks judicial review of Health Canada’s decision to issue an NOC for Ruzurgi® as incorrect and unreasonable. Data protection, per Health Canada regulations, is supposed to prevent Health Canada from issuing an NOC to a drug that directly or indirectly references an innovative drug’s data, for eight years from the date of the innovative drug’s approval. The Ruzurgi® Product Monograph clearly references pivotal nonclinical carcinogenicity and reproductive toxicity data for amifampridine phosphate developed by Catalyst. As such, the Catalyst data was relied upon to establish the nonclinical safety profile of Ruzurgi® needed to meet the standards of the Canadian Food and Drugs Act. Data protection had, however, been granted to Firdapse® at the time that the NOC was issued for Ruzurgi®. Contrary to the regulations, Health Canada approved Ruzurgi® even though its drug submission included carcinogenicity and reproductive toxicity data with Firdapse®. Firdapse®’s status as an innovative drug should have prevented the marketing authorization of Ruzurgi®.

A copy of the press release is attached hereto as Exhibit 99.1 and is incorporated herein by reference.

 

Item 9.01

Financial Statements and Exhibits.

 

  (d)

Exhibits

 

99.1    Press release issued by the Company on August 26, 2020.
104    Cover Page Interactive Data File (embedded within the Inline XBRL document)

 

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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.
By:  

            /s/ Alicia Grande

          Alicia Grande
          Vice President, Treasurer and CFO

Dated: August 26, 2020

 

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