SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
PURSUANT TO SECTION 13 OR 15(d)
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|Item 8.01|| |
On January 10, 2022, the Company issued a press release reporting that the 11th Circuit Court of Appeals has denied Jacobus Pharmaceutical Company Inc.’s petition for rehearing of the 11th Circuit’s prior ruling to overturn the U.S. Food and Drug Administration (FDA) approval of Ruzurgi® for pediatric patients with Lambert-Eaton myasthenic syndrome (LEMS) based on the orphan drug exclusivity of FIRDAPSE®. The Company expects that the mandate to the District Court with instructions to enter summary judgment for the Company will be issued in the near future.
A copy of the Company’s press release is attached as Exhibit 99.1 to this Form 8-K and is incorporated herein by reference.
|Item 9.01|| |
Financial Statements and Exhibits.
|99.1||Press release issued by the Company on January 10, 2022.|
|104||Cover Page Interactive Data File (embedded within the Inline XBRL document)|
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.
Vice President, Treasurer and CFO
Dated: January 10, 2022
Catalyst Pharmaceuticals Announces 11th Circuit Court of Appeals Denial of Jacobus Pharmaceutical Company Inc.s Petition for Rehearing
CORAL GABLES, Fla., January 10, 2022 Catalyst Pharmaceuticals, Inc. (Catalyst) (Nasdaq: CPRX), a commercial-stage, patient-centric biopharmaceutical company focused on in-licensing, developing, and commercializing novel high-quality medicines for patients living with rare diseases, today reported that the 11th Circuit Court of Appeals has denied Jacobus Pharmaceutical Company Inc.s petition for rehearing of the 11th Circuits prior ruling to overturn the U.S. Food and Drug Administration (FDA) approval of Ruzurgi® for pediatric patients with Lambert-Eaton myasthenic syndrome (LEMS) based on the orphan drug exclusivity of FIRDAPSE®. Catalyst expects that the mandate to the District Court with instructions to enter summary judgment for Catalyst will be issued in the near future.
Patrick J. McEnany, Catalysts Chairman and CEO stated: Catalysts priority has always been, and will continue to be, to put patients needs first, and we are well prepared to address their questions and do everything we can to ensure that ALL LEMS patients continue with uninterrupted access to amifampridine for treating their LEMS condition, whether through commercial access or compassionate use access for those who qualify. Our patient-focused Catalyst Pathways® team stands ready to provide information to patients currently being treated with Ruzurgi on how best to transition to FIRDAPSE.
Information for Prescribers and Patients is available at 1-833-422-8259 and www.yourcatalystpathways.com.
About Catalyst Pharmaceuticals
Catalyst Pharmaceuticals is a commercial-stage, patient-centric biopharmaceutical company focused on in-licensing, developing, and commercializing novel high-quality medicines for patients living with rare diseases. With exceptional patient focus, Catalyst is committed to developing a robust pipeline of cutting-edge, first- or best-in-class medicines for other rare diseases. Catalysts New Drug Application for FIRDAPSE® (amifampridine) Tablets 10 mg for the treatment of adults with Lambert-Eaton myasthenic syndrome (LEMS) was approved in 2018 by the U.S. Food & Drug Administration (FDA), and FIRDAPSE is commercially available in the United States as a treatment for adults with LEMS. Further, Canadas national healthcare regulatory agency, Health Canada, has approved the use of FIRDAPSE for the treatment of adult patients in Canada with LEMS.
This press release contains forward-looking statements. Forward-looking statements involve known and unknown risks and uncertainties, which may cause Catalysts actual results in future periods to differ materially from forecasted results. A number of factors, including (i) whether Jacobus will appeal the ruling of the 11th Circuit to the U.S. Supreme Court, (ii) the timing as to when the mandate will issue, and the timing, following the issuance of the mandate, when the District Court will enter summary judgment in favor of Catalyst in its lawsuit against the FDA, and (iii) those factors described in Catalysts Annual Report on Form 10-K for the fiscal year 2020 and Catalysts other filings with the U.S. Securities and Exchange Commission (SEC), could adversely affect Catalyst. Copies of Catalysts filings with the SEC are available from the SEC, may be found on Catalysts 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.
Catalyst Pharmaceuticals, Inc.