Catalyst Pharmaceuticals Announces Issuance of Mandate by the U.S. Court of Appeals for the 11th Circuit Directing the District Court Judge in Catalyst's Lawsuit Against the FDA to Grant Summary Judgement in Favor of Catalyst

Rhea-AI Summary

Catalyst Pharmaceuticals (Nasdaq: CPRX) announced that the U.S. Court of Appeals for the 11th Circuit has favored the company in its lawsuit against the FDA, which will vacate FDA's approval of Ruzurgi, a competing amifampridine product. CEO Patrick J. McEnany stated the company is committed to ensuring patients' access to amifampridine for Lambert-Eaton myasthenic syndrome (LEMS). FIRDAPSE, Catalyst's approved treatment, remains available in the U.S. and Canada. The announcement notes potential risks related to further legal appeals and outcomes affecting Catalyst's future operations.

Positive

• Court ruling favorable to Catalyst, potentially strengthening FIRDAPSE's market position against Ruzurgi.
• Continued patient access to amifampridine assured, enhancing Catalyst's reputation and patient trust.

Negative

• Legal uncertainties remain if Jacobus appeals the court ruling to the U.S. Supreme Court.
• Future operations may be impacted by the timeline of the District Court's summary judgment process.

CORAL GABLES, Fla., Jan. 28, 2022 (GLOBE NEWSWIRE) -- 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 U.S. Court of Appeals for the 11^th Circuit has issued a mandate directing the District Court that heard Catalyst's claim against the FDA to enter summary judgment in favor of Catalyst in its lawsuit against the FDA, thereby vacating the FDA's approval of Ruzurgi^® (Jacobus Pharmaceutical Company's amifampridine product).

Patrick J. McEnany, Catalyst's Chairman and CEO stated: "Catalyst's 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. Catalyst's 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, Canada's national healthcare regulatory agency, Health Canada, has approved the use of FIRDAPSE^® for the treatment of adult patients in Canada with LEMS.

Forward-Looking Statements
This press release contains forward-looking statements. 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 Jacobus will appeal the ruling of the U.S. Court of Appeals for the 11th Circuit to the U.S. Supreme Court, and whether the Supreme Court will agree to hear the appeal, (ii) now that the mandate has been issued, when the District Court will enter summary judgment in favor of Catalyst in its lawsuit against the FDA, and (iii) those factors described in Catalyst's Annual Report on Form 10-K for the fiscal year 2020 and Catalyst's 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.

FAQ

What did the recent court ruling mean for Catalyst Pharmaceuticals (CPRX)?

The ruling favored Catalyst by vacating the FDA's approval of Ruzurgi, enhancing the competitive position of its product FIRDAPSE.

How is Catalyst Pharmaceuticals supporting patients after the court ruling?

Catalyst is ensuring uninterrupted access to amifampridine and providing support through its Catalyst Pathways program.

What are the potential risks following the court ruling for CPRX investors?

Continued legal challenges are possible if Jacobus appeals, which could delay Catalyst's market operations.

Is FIRDAPSE available in markets outside the U.S.?

Yes, FIRDAPSE is also approved for use in Canada for adult patients with LEMS.