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 biopharmaceutical leader focused on rare neuromuscular and neurological disorders, including its FDA-approved therapy for Lambert-Eaton Myasthenic Syndrome (LEMS). This page provides official updates and analysis of Catalyst's developments in drug commercialization, regulatory milestones, and clinical research.
Investors and healthcare professionals can monitor critical updates including FDA decisions, clinical trial progress, and strategic partnerships. All content is sourced from verified filings, press releases, and reputable financial analysis to ensure accuracy.
Key focus areas include developments around Firdapse® commercialization, pipeline advancements for CPP-115, and regulatory strategies for orphan drug designations. The curated news collection enables efficient tracking of Catalyst's position in the competitive rare disease therapeutics market.
Bookmark this page for consolidated access to Catalyst's latest business and scientific developments. Check regularly for updates impacting the company's growth trajectory in a sector where regulatory approvals directly influence market performance.
Catalyst Pharmaceuticals (CPRX) reported record revenue of $43.1 million for Q1 2022, marking a 42.7% year-over-year increase. This growth is attributed to increased patient conversions to FIRDAPSE® after Ruzurgi® was removed from the U.S. market. The company affirmed its full-year revenue guidance of $195 million to $205 million, expecting a 38% to 45% revenue growth from 2021. Catalyst's cash position stands at $198 million with no debt. It continues to enhance its patent portfolio and expand treatment options for rare diseases.
Catalyst Pharmaceuticals (Nasdaq: CPRX) announced it will release its first-quarter 2022 financial results on May 10, 2022, after market close. A conference call and webcast will be hosted the next morning, May 11, 2022, at 8:30 AM ET, to discuss financial results and provide corporate updates. Catalyst focuses on developing medicines for patients with rare diseases, with its FIRDAPSE® medication approved for Lambert-Eaton myasthenic syndrome. Further details and a replay of the webcast will be available on the company's website.
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.
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.
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