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.
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.
Catalyst Pharmaceuticals (Nasdaq: CPRX) announced Health Canada’s approval of Firdapse® (amifampridine) for treating Lambert-Eaton myasthenic syndrome (LEMS), a rare neurodegenerative condition. The approval was granted under Priority Review based on data from two multinational clinical trials. Firdapse® was previously approved in the U.S. and Europe. Catalyst is exploring partnerships for distribution in Canada and aims to expand Firdapse® indications. LEMS is often linked to autoimmune disorders and can be life-threatening.
Catalyst Pharmaceuticals (Nasdaq: CPRX) has transitioned its 2020 Annual Meeting of Stockholders to a virtual-only format due to the COVID-19 pandemic. The meeting is scheduled for August 20, 2020, at 9:00 AM ET. Stockholders can participate in voting and submitting questions via an online platform. Only those registered by June 22, 2020, can attend. The company has provided detailed instructions for both registered and street name stockholders to register for the meeting. Additionally, the Proxy Statement and related information are available on their website.
Catalyst Pharmaceuticals (Nasdaq: CPRX) will release its Q2 2020 financial results after market close on August 10, 2020. An investment-community conference call is scheduled for August 11, 2020, at 8:30 a.m. ET to discuss the results and provide a corporate update. Investors can participate by calling (877) 407-8912 for domestic and (201) 689-8059 for international callers, or stream via the company's website. A webcast replay will be available for 30 days post-call.
Catalyst Pharmaceuticals (CPRX) announced a disappointing recommendation from a Magistrate Judge regarding its lawsuit against the FDA, advising to deny Catalyst's motion for summary judgment. The recommendation, which Catalyst believes is legally flawed, could jeopardize the exclusivity benefits of the Orphan Drug Act. Chairman Patrick J. McEnany stated that if upheld, the decision could discourage investment in orphan drug development. Despite this setback, Catalyst remains committed to protecting its drug Firdapse® from competition.