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 financial results for Q3 2021, achieving $35.9 million in FIRDAPSE revenue, a 23.1% increase year-over-year. The company plans to expand U.S. approval of FIRDAPSE to include pediatric LEMS patients. Catalyst's cash position stands at $174.8 million, bolstering its long-term growth strategy. The company also received favorable court support for orphan drug exclusivity and made strategic decisions for sustainable growth. However, GAAP net income for Q3 2021 was $10.3 million, down from $43.3 million in Q3 2020, due to a significant prior year tax asset.
Catalyst Pharmaceuticals (CPRX) announced it will release its Q3 2021 financial results after market close on November 9, 2021. Following this, a conference call and webcast are scheduled for November 10, 2021, at 8:30 AM EST to discuss the results and provide a corporate update. The call can be accessed via US/Canada dial-in at (877) 407-8912 or international at (201) 689-8059. Catalyst focuses on developing medicines for rare diseases, notably FIRDAPSE, approved in the US and Canada for LEMS treatment.
Catalyst Pharmaceuticals, Inc. (Nasdaq: CPRX) announced a favorable ruling from the 11th Circuit Court of Appeals regarding the FDA approval of Ruzurgi® for pediatric LEMS patients, which conflicted with Catalyst's Orphan Drug exclusivity for Firdapse® (amifampridine). The court remanded the case to enforce Catalyst's exclusivity rights. Catalyst aims to ensure uninterrupted access to Firdapse® for patients, including transitioning from Ruzurgi®. The company emphasizes the importance of Orphan Drug incentives in developing treatments for rare diseases, especially given the 6,500 rare diseases without approved therapies.
Catalyst Pharmaceuticals, Inc. (Nasdaq: CPRX) announced that its CEO Patrick J. McEnany and CSO/COO Steven Miller, Ph.D., will participate in the Oppenheimer Fall Healthcare Life Sciences & MedTech Summit on September 21, 2021, at 9:05 AM EDT. The event will feature a presentation and virtual one-on-one meetings. The webcast will be available on the company's website, with a replay accessible for 14 days. Catalyst focuses on developing high-quality medicines for rare diseases, including Firdapse® for LEMS. Firdapse® is also being evaluated for MuSK-MG and has received Orphan Drug Designation.
Catalyst Pharmaceuticals, Inc. (Nasdaq: CPRX), a biopharmaceutical company focused on rare diseases, announced participation in two investor conferences. The H.C. Wainwright 23rd Annual Global Investment Conference is set for September 13-15, 2021, featuring a pre-recorded presentation available on-demand starting September 13 at 7:00 AM EDT. The 2021 Cantor Virtual Global Healthcare Conference will take place September 27-30, with a presentation on September 28 at 1:20 PM EDT. More details are accessible on their website.
Catalyst Pharmaceuticals (Nasdaq: CPRX) announced the appointment of Mary Coleman as Vice President, Head of Investor Relations, a newly created position reporting to the CEO. Coleman's 20 years of experience in investor relations within the biotech sector positions her to enhance Catalyst's investor relations program. Her role will support the company's growth strategy and strengthen its reputation in the investment community. Catalyst is committed to developing innovative medicines for rare diseases, with its flagship product, Firdapse®, already approved in the U.S. and Canada.
Catalyst Pharmaceuticals (CPRX) reported a Q2 2021 total net revenue of $36.4 million, up 23% year-over-year, driven by Firdapse® product sales of $33.6 million. The GAAP net income was $12.2 million, or $0.12 per share, an improvement from $9.8 million in Q2 2020. Catalyst holds $155.3 million in cash with no funded debt. The company aims to enhance its operational portfolio and commercialization efforts, evidenced by recent leadership expansions and partnerships, including an exclusive agreement with DyDo Pharma for Firdapse® in Japan.
Catalyst Pharmaceuticals (Nasdaq: CPRX) will release its second quarter 2021 financial results on August 9, 2021, after market close. An investment-community conference call is scheduled for August 10, 2021, at 8:30 a.m. ET to discuss these results and provide a corporate update. Investors can participate either by phone or by listening online through the company’s website.
With a focus on rare diseases, Catalyst continues its commitment to developing high-quality medicines, including Firdapse®, which is already approved for LEMS treatment in the U.S. and Canada.
Catalyst Pharmaceuticals (CPRX) announced a new patent for Firdapse® (amifampridine) Tablets, U.S. Patent No. 11,060,128, enhancing its intellectual property protection. This patent addresses innovative dosing methods for slow metabolizers of amifampridine, particularly in treating Lambert-Eaton myasthenic syndrome (LEMS). Catalyst is pursuing additional patents, optimistic about their approval. The company aims to support the neuromuscular community and is investigating Firdapse® for other rare diseases, alongside ongoing clinical trials for myasthenia gravis.
Catalyst Pharmaceuticals (Nasdaq: CPRX) has appointed Dr. Preethi Sundaram as the Chief Product Development Officer. Dr. Sundaram brings over 20 years of experience in product development, having held various leadership roles at Sanofi and other companies. In this newly created position, she will oversee Catalyst's product pipeline, focusing on therapies for rare diseases. The company aims to enhance its R&D strategy and expedite the development of innovative treatment options. Catalyst's FDA-approved drug Firdapse® is already on the market for LEMS, with ongoing clinical trials for MuSK-MG.
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