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 reported strong Q2 2024 financial results, with total revenues of $122.7 million, a 23.2% year-over-year increase. Key highlights include:
- FIRDAPSE net product revenues of $77.4 million (19.2% YoY growth)
- AGAMREE net product revenues of $8.7 million (first full quarter)
- FYCOMPA net product revenues of $36.5 million (5.7% YoY increase)
The company reported GAAP net income of $40.8 million ($0.33 per diluted share) and non-GAAP net income of $69.6 million ($0.56 per diluted share). Catalyst reaffirmed its 2024 total revenue guidance of $455-$475 million, expecting results in the upper range.
Catalyst Pharmaceuticals has entered into an exclusive License, Supply, and Commercialization Agreement with Kye Pharmaceuticals for AGAMREE® (vamorolone) in Canada. This agreement grants Kye the exclusive Canadian commercial rights for AGAMREE, a novel corticosteroid for treating Duchenne Muscular Dystrophy (DMD). Catalyst will supply the product, while Kye will be responsible for obtaining regulatory approval from Health Canada and commercialization within Canada.
Key points:
- Kye already markets Catalyst's FIRDAPSE® in Canada
- Regulatory application submission to Health Canada anticipated by early 2025
- Catalyst will receive an upfront payment, potential milestones, and sales royalties
- This partnership expands AGAMREE's footprint in North America
Catalyst Pharmaceuticals (Nasdaq: CPRX), a commercial-stage biopharmaceutical company focusing on rare and difficult-to-treat diseases, has announced its plans to release second quarter 2024 financial results on August 7, 2024, after market close. The company will host a conference call and webcast on August 8, 2024, at 8:30 AM ET to discuss the financial results and provide a business update.
Investors can access the call via US/Canada dial-in number (877) 407-8912 or international dial-in number (201) 689-8059. The webcast will be available under the Investors section on Catalyst's website, with a replay accessible for at least 30 days following the event.
Catalyst Pharmaceuticals has received FDA approval to increase the maximum daily dose of FIRDAPSE® from 80 mg to 100 mg for treating Lambert-Eaton myasthenic syndrome (LEMS) in patients over 45 kg. This adjustment provides more flexibility in treatment options for both adult and pediatric patients. FIRDAPSE, a potassium channel blocker, is the only FDA-approved treatment for LEMS, a rare autoimmune disorder that causes muscle weakness and fatigue. Catalyst's CEO Richard J. Daly highlighted the significance of this approval in enhancing patient outcomes. The Catalyst Pathways® Patient Assistance Program offers additional support for those seeking treatment information.
Catalyst Pharmaceuticals announced its participation in the Jefferies Global Healthcare Conference 2024, scheduled for June 5, 2024, in New York. CEO Richard J. Daly and other management members will represent the company at the event. The presentation will be available via webcast on the Catalyst Pharmaceuticals website and archived for 14 days. Catalyst focuses on in-licensing, developing, and commercializing novel treatments for rare and difficult-to-treat diseases. This event represents an opportunity for Catalyst to showcase its progress and future plans to investors and industry stakeholders.
Catalyst Pharmaceuticals reported solid first-quarter 2024 financial results, achieving total revenues of $98.5 million, a 15.4% YoY increase. Highlights include the successful launch of AGAMREE®, robust revenue momentum for FIRDAPSE®, and reaffirmed full-year 2024 total revenue guidance of $455-475 million.
Catalyst Pharmaceuticals, Inc. will participate in the BofA Securities Health Care Conference 2024. Richard J. Daly, President and CEO, will lead the team at the event in Las Vegas, Nevada. The presentation will take place on May 14, 2024, at 5:00 pm PT. Investors can access the webcast on the company's website with a replay available for at least 14 days.
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