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 reports developments as a commercial-stage biopharmaceutical company focused on in-licensing, developing, and commercializing medicines for rare and difficult-to-treat diseases. Its recurring updates center on the commercial performance of FIRDAPSE® (amifampridine), AGAMREE® (vamorolone), and FYCOMPA® (perampanel), along with financial results, revenue guidance, conference presentations, and business updates.
Company news also covers product-specific medical and legal developments, including vamorolone research in Duchenne muscular dystrophy and patent litigation settlements involving FIRDAPSE. Additional announcements address patient advocacy initiatives, support services, and strategic portfolio activity tied to Catalyst’s U.S.-based rare-disease commercial model.
Catalyst Pharmaceuticals (CPRX) reported Q3 2020 net revenues of $29.2 million, a slight decrease from $30.9 million in Q3 2019. The company ended the quarter with $127.1 million in cash and investments. Net income surged to $43.3 million ($0.42 per share), bolstered by a $31.3 million tax benefit. A U.S. patent for Firdapse® was issued, expiring in April 2034, and the drug was approved in Canada. Research and development costs decreased to $3.7 million. Catalyst plans to expand Firdapse® commercialization and continue clinical trials for additional indications.
Catalyst Pharmaceuticals (CPRX) will announce its third-quarter 2020 financial results on November 9, 2020, after market close. An investment-community conference call is scheduled for November 10, 2020, at 8:30 a.m. ET to discuss these results and provide a corporate update. The call can be accessed via phone or streamed online through the company's investor webpage. Catalyst focuses on innovative therapies for rare neuromuscular diseases, including Firdapse®, which is approved in the U.S. and Canada for Lambert-Eaton myasthenic syndrome, and is under evaluation for other conditions.
On October 19, 2020, Catalyst Pharmaceuticals (Nasdaq: CPRX) filed lawsuits against Jacobus Pharmaceuticals and PantherRx Rare for infringing U.S. Patent No. 10,793,893, which relates to treatments using amifampridine, specifically targeting their Ruzurgi® product. Catalyst seeks damages and injunctive relief to halt Ruzurgi®'s marketing, asserting the necessity to protect its intellectual property and the investment made in neuromuscular drug development. The FDA-approved Firdapse® product is central to Catalyst's business model, with ongoing evaluations for other conditions.
Catalyst Pharmaceuticals (Nasdaq: CPRX) announced the issuance of U.S. Patent No. 10,793,893 for Firdapse® (amifampridine), expiring April 7, 2034. This patent is expected to create barriers against generic competition, extending the exclusivity period by nine years beyond current orphan drug protections. The patent specifically addresses methods of administering the drug to slow metabolizers. Catalyst plans to submit the patent for listing in the FDA's Orange Book. Currently, Firdapse is approved for treating Lambert-Eaton myasthenic syndrome and is being evaluated for other conditions.
On September 29, 2020, Catalyst Pharmaceuticals (CPRX) announced that a federal judge ruled in favor of the FDA, dismissing Catalyst's case involving the approval of Ruzurgi® for pediatric LEMS patients. The judge found the Orphan Drug Act's language ambiguous and upheld the FDA's interpretation. Catalyst plans to appeal this decision to the Eleventh Circuit Court. Despite the ruling, Catalyst emphasized that it will continue its marketing for Firdapse® and protect its exclusivity under the Orphan Drug Act, as it represents 99% of the LEMS patient community.
Catalyst Pharmaceuticals (Nasdaq: CPRX) reported on Sept. 29, 2020, that a federal judge has dismissed its case against the FDA regarding the approval of Ruzurgi® for pediatric LEMS treatment. The judge found the statutory language ambiguous and sided with the FDA's interpretation. Catalyst plans to appeal this decision to the Eleventh Circuit Court. Despite this setback, the approval for Ruzurgi® remains intact, and the company's ongoing market efforts for Firdapse®, which serves 99% of the LEMS patient community, will not be affected.
Catalyst Pharmaceuticals (Nasdaq: CPRX) has filed a legal proceeding in Canadian Federal Court against Health Canada concerning its recent approval of Ruzurgi® (amifampridine) for Lambert-Eaton Myasthenic Syndrome (LEMS). Catalyst argues that Health Canada wrongly issued a Notice of Compliance (NOC) for Ruzurgi® despite granting data protection to its own product, Firdapse® (amifampridine phosphate), just 10 days prior. The company claims that Ruzurgi® improperly referenced Catalyst's data in its drug submission, infringing on the regulations meant to protect innovative drugs for eight years.
Catalyst Pharmaceuticals (Nasdaq: CPRX) has entered into an exclusive licensing agreement with KYE Pharmaceuticals to commercialize Firdapse® in Canada, aimed at treating Lambert-Eaton myasthenic syndrome (LEMS) in adults. Under this agreement, Catalyst will supply Firdapse® while KYE handles promotion, sales, and distribution. The partnership aims to enhance patient access to this therapy in Canada, where Firdapse® has recently received approval from Health Canada. CEO Patrick J. McEnany expressed optimism about the collaboration's potential impact on patients suffering from rare diseases.
Catalyst Pharmaceuticals (Nasdaq: CPRX) has received a Notice of Allowance for U.S. Patent Application Serial Number 14/128,672 from the USPTO. This patent covers methods for treating patients with certain mutations using 3,4-Diaminopyridine (3,4-DAP). The expected patent issuance will protect Catalyst's Firdapse® franchise until at least June 29, 2032, with potential extensions. The company plans to list this patent in the FDA's "Orange Book," blocking generic competition unless challenged. This development supports Catalyst's ongoing research and product expansion in neuromuscular disease therapies.
Catalyst Pharmaceuticals (Nasdaq: CPRX) reported second quarter 2020 net revenues of $29.6 million, up from $28.8 million in Q2 2019. Net income was $9.8 million or $0.09 per share. The company received Health Canada marketing authorization for Firdapse® for LEMS treatment. However, the Phase 3 trial for anti-MuSK-MG did not achieve statistical significance for primary or secondary endpoints. Catalyst ended the quarter with $115.1 million in cash and no debt, while continuing various clinical development programs and expansion efforts in Canada and Japan.