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 Q3 2024 financial results with total revenues of $128.7 million, up 25.3% year-over-year. The company's performance was driven by FIRDAPSE net product revenues of $79.3 million (+19.7% YoY), AGAMREE revenues of $15.0 million, and FYCOMPA revenues of $32.1 million. Q3 GAAP net income reached $43.9 million ($0.35 per diluted share), while non-GAAP net income was $71.1 million ($0.57 per diluted share). The company updated its 2024 full-year total revenue guidance to between $475-485 million, with cash and cash equivalents at $442.3 million as of September 30, 2024.
Catalyst Pharmaceuticals (Nasdaq: CPRX) has announced that it will release its third quarter 2024 financial results after the market close on Wednesday, November 6, 2024. The company's management team will host a conference call and webcast on Thursday, November 7, 2024, at 8:30 AM ET to discuss the financial results and provide a business update.
Interested parties can access the conference call via the following dial-in numbers:
- US/Canada: 800-715-9871
- International: 646-307-1963
Catalyst Pharmaceuticals, a commercial-stage biopharmaceutical company focused on rare diseases, has donated $100,000 to the American Red Cross for Hurricane Helene relief efforts. The donation aims to support communities impacted by the widespread devastation caused by the hurricane. Richard J. Daly, President and CEO of Catalyst, expressed the company's commitment to helping those affected during this crisis.
Anne McKeough, Chief Development Officer at the American Red Cross, thanked Catalyst for their generous contribution. The Red Cross has mobilized over 1,400 disaster responders across the Carolinas, Tennessee, Georgia, and Florida to provide shelter, meals, and comfort to families facing destruction. Catalyst's donation will help sustain these vital efforts and bring hope to those in need.
Catalyst Pharmaceuticals (Nasdaq: CPRX) announced its participation in the BofA Securities CNS Therapeutics Virtual Conference 2024. The event is scheduled for Monday, October 7, 2024, with Catalyst's presentation set for 9:50 am ET.
Richard J. Daly, President and CEO of Catalyst, along with other management team members, will represent the company. Catalyst is a commercial-stage biopharmaceutical firm focusing on in-licensing, developing, and commercializing novel medicines for rare and difficult-to-treat diseases.
A webcast of the presentation will be available on Catalyst's website under the Investors section, with a replay accessible for at least 30 days following the event.
Catalyst Pharmaceuticals announced that its sub-licensee in Japan, DyDo Pharma, has received approval from the Ministry of Health, Labor and Welfare of Japan to commercialize FIRDAPSE® (amifampridine) Tablets 10 mg for treating Lambert-Eaton Myasthenic Syndrome (LEMS) in Japan. This approval marks a significant advancement in LEMS treatment, addressing unmet needs of patients in Japan.
FIRDAPSE is the only FDA-approved treatment for LEMS in the United States, indicated for adults and pediatric patients six years and older. LEMS is a rare autoimmune disorder characterized by muscle weakness and fatigue, with about 50% of LEMS patients having underlying cancer. This approval aligns with Catalyst's commitment to expanding its rare disease product portfolio globally.
Catalyst Pharmaceuticals (Nasdaq: CPRX), a commercial-stage biopharmaceutical company, has announced its participation in three upcoming investor conferences in September 2024. The company's management team, including CEO Richard J. Daly, will be presenting at:
- 2024 Wells Fargo Healthcare Conference on September 5 at 2:15 PM ET
- H.C. Wainwright 26th Annual Global Investment Conference on September 9 (virtual) at 7:00 AM ET
- 2024 Cantor Global Healthcare Conference on September 18 at 2:30 PM ET
Webcasts of these presentations will be available on the company's website under the Investors section, with replays accessible for at least 30 days.
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.
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