Welcome to our dedicated page for Catalyst Pharmaceuticals news (Ticker: CPRX), a resource for investors and traders seeking the latest updates and insights on Catalyst Pharmaceuticals stock.
Catalyst Pharmaceuticals, Inc. (NASDAQ: CPRX) is a commercial-stage biopharmaceutical company focused on in-licensing, developing, and commercializing medicines for patients living with rare and difficult-to-treat diseases. The CPRX news feed on Stock Titan aggregates company announcements, financial updates, scientific disclosures, and investor conference appearances drawn from Catalyst’s own public communications and regulatory filings.
Readers can find earnings and financial result announcements, where Catalyst reports product revenue contributions from FIRDAPSE, AGAMREE, and FYCOMPA, along with commentary on operating performance and business outlook. These releases often discuss factors such as organic growth in Lambert-Eaton myasthenic syndrome markets, demand in Duchenne muscular dystrophy centers of excellence, and the impact of generic competition on specific products.
The news stream also features corporate and strategic updates, including authorization of share repurchase programs, patent litigation settlements related to FIRDAPSE, and developments in clinical practice guidelines that reference conditions and therapies linked to the company’s portfolio. In addition, Catalyst regularly announces participation in major healthcare and investor conferences, providing insight into how management presents the story behind CPRX to the investment community.
For those following the scientific and patient-focused side of the business, the news includes conference presentations and advocacy initiatives, such as real-world analyses in Duchenne muscular dystrophy, research on Lambert-Eaton myasthenic syndrome, and programs like the Catalyst Advocacy Scholars Summit with academic partners. Investors, analysts, and patients can use this page to monitor how Catalyst’s rare disease strategy, clinical activities, and capital allocation decisions evolve over time. Bookmark this CPRX news page for a centralized view of the company’s key public announcements.
Catalyst Pharmaceuticals (CPRX) reported a 2021 revenue increase of 18% YoY, reaching $141 million. The fourth quarter saw revenues of $38 million, up 24% from 2020. Catalyst anticipates 2022 revenues between $195 million and $205 million, bolstered by orphan drug exclusivity for FIRDAPSE and new patent issuances extending exclusivity to 2034. Cash and investments stand at $191 million with no funded debt. The company is actively pursuing opportunities to diversify its portfolio and will host a conference call on March 17, 2022, for further updates.
Catalyst Pharmaceuticals (CPRX) announced a favorable ruling from the Federal Court of Canada, reversing Health Canada's decision on Ruzurgi (amifampridine) for Lambert-Eaton Myasthenic Syndrome (LEMS). The Court found that Health Canada improperly evaluated data linked to the Innovative Drug status of FIRDAPSE, which protects its data for eight years. Catalyst expressed satisfaction with the ruling, emphasizing its commitment to making Ruzurgi accessible to LEMS patients in Canada.
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Catalyst Pharmaceuticals (CPRX) will release its Q4 and FY 2021 financial results on March 16, 2022, after market close. A conference call and webcast will follow on March 17, 2022, at 8:30 AM ET to discuss these results and provide a corporate update. The company's FIRDAPSE (amifampridine) Tablets, approved for treating adults with Lambert-Eaton myasthenic syndrome, is currently available in the U.S. and Canada. Catalyst emphasizes a commitment to developing innovative medicines for rare diseases.
Catalyst Pharmaceuticals (CPRX) announced three new patents related to its flagship product, FIRDAPSE (amifampridine), set to issue in March 2022. These patents strengthen intellectual property protection for FIRDAPSE, the only approved treatment for Lambert-Eaton myasthenic syndrome (LEMS) in adults in the U.S. The new patents cover treatment for all patient metabolizer types and extend patent exclusivity until 2034. The company aims to submit these patents for inclusion in the FDA Orange Book following issuance.
Catalyst Pharmaceuticals (CPRX) announces participation in Rare Disease Day by ringing the Nasdaq opening bell on February 28, 2022. This event highlights the collaboration between the biopharma industry and patient advocacy groups to raise awareness and develop treatments for rare diseases. Approximately 30 million Americans are affected by rare disorders, yet only 5% of these diseases have approved treatments. Catalyst aims to support patients with Lambert-Eaton myasthenic syndrome (LEMS) through its FDA-approved drug FIRDAPSE.
Catalyst Pharmaceuticals announced the launch of a podcast named LEMS Aware aimed at raising awareness within the Lambert-Eaton Myasthenic Syndrome (LEMS) community. The podcast will feature discussions with patients, physicians, and advocates, focusing on topics unique to LEMS. The inaugural episode is set to release on February 28, 2022, coinciding with Rare Disease Day. This initiative underscores Catalyst's commitment to enhancing education and resources for patients, particularly as only 5% of over 7,000 rare diseases have an FDA-approved treatment.
Catalyst Pharmaceuticals (Nasdaq: CPRX) announced estimated total revenues for 2021 of approximately $141 million, up 18% year-over-year, with Q4 revenues of around $38 million, a 24% increase from 2020. Looking ahead, the company projects 2022 revenues between $195 million and $205 million, a growth of 38%-45%. Catalyst has regained orphan drug exclusivity in the U.S. for Amifampridine (FIRDAPSE) and enters 2022 with a strong cash position of $191 million and no funded debt, poised for potential acquisitions.
Catalyst Pharmaceuticals has achieved a significant legal victory as the District Court granted summary judgment in its lawsuit against the FDA. This ruling confirms that the FDA's approval of Ruzurgi® for treating pediatric patients with LEMS infringes on Catalyst's exclusivity rights for FIRDAPSE®. Consequently, the FDA's prior marketing approval for Ruzurgi® is invalid. Catalyst is prepared to assist patients transitioning from Ruzurgi® to FIRDAPSE®, ensuring uninterrupted treatment. The company remains focused on developing medicines for rare diseases.
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.