Welcome to our dedicated page for Catalyst Pharmaceutical news (Ticker: CPRX), a resource for investors and traders seeking the latest updates and insights on Catalyst Pharmaceutical stock.
Catalyst Pharmaceuticals Inc. (CPRX) is a pioneering biopharmaceutical company dedicated to developing and commercializing innovative therapies for rare and debilitating diseases. The company's primary focus lies in addressing chronic neuromuscular and neurological conditions that severely impact patients' lives. Among its core areas are Lambert-Eaton myasthenic syndrome (LEMS), congenital myasthenic syndromes (CMS), infantile spasms, and Tourette's disorder.
Firdapse®, Catalyst's lead candidate, is a proprietary form of amifampridine phosphate designed for the treatment of patients with LEMS. This drug has successfully completed a global, multi-center, double-blinded randomized pivotal Phase 3 trial, yielding positive top-line data. Following these promising results, Catalyst submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA), seeking approval for the treatment of both LEMS and CMS. Notably, Firdapse® has received breakthrough therapy designation and orphan drug designation from the FDA for these conditions. Additionally, Firdapse® stands as the first and only European-approved drug for symptomatic treatment in adults with LEMS.
Catalyst Pharmaceuticals is also advancing CPP-115, a promising candidate for the treatment of infantile spasms, epilepsy, and other neurological conditions. This initiative underscores the company's commitment to addressing unmet medical needs within the realm of rare diseases.
The company boasts a solid financial foundation, enabling sustained investment in research and development, as well as strategic partnerships to enhance its product pipeline. Catalyst's innovative approach and dedication to improving patients' lives make it a significant player in the biopharmaceutical industry.
Latest News:
- Santhera's study reports the results of the 48-week treatment with Vamorolone in patients with Duchenne Muscular Dystrophy (DMD), supporting the long-term efficacy and safety profile of Vamorolone. (Reference: Neurology 2024;102:e208112)
- Financial highlights and recent business updates, including the 2024 outlook and details about an upcoming conference call and webcast on February 29, 2024.
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.
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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