Catalyst Pharmaceuticals Inc Stock Price, News & Analysis

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.

Catalyst Pharmaceuticals (Nasdaq: CPRX) announced the appointment of Molly Harper to its Board of Directors. Harper brings over 20 years of experience in life sciences, specializing in rare disease drug development and commercialization. Currently, she serves as Executive Vice President of Operations at Relmada Therapeutics and has held senior positions at Akcea Therapeutics and Sanofi Genzyme. The Board's chairman expressed confidence in her ability to strengthen the company's growth strategy as Catalyst focuses on expanding its portfolio of medicines for rare diseases.

Catalyst Pharmaceuticals, Inc. (Nasdaq: CPRX) announced that Health Canada has re-issued a Notice of Compliance for Ruzurgi^® (amifampridine), allowing it to be marketed for Lambert-Eaton Myasthenic Syndrome (LEMS) patients. This decision follows a prior court ruling that quashed the original NOC. CEO Patrick McEnany expressed disappointment over the decision, which affects their market opportunity in Canada. Catalyst and KYE Pharmaceuticals are considering legal action to challenge this ruling, as it does not honor the data protection rights they hold under Canadian law.

Catalyst Pharmaceuticals (Nasdaq: CPRX) has entered an exclusive license and supply agreement with DyDo Pharma for the development and commercialization of Firdapse^® (amifampridine) in Japan, targeting Lambert-Eaton myasthenic syndrome (LEMS). DyDo Pharma will fund all related activities and hold exclusive commercialization rights in Japan, while Catalyst will oversee supply and provide support for regulatory approval. Catalyst will receive an upfront payment and potential milestones. The partnership aims to address the unmet medical needs for LEMS in Japan.

Catalyst Pharmaceuticals (CPRX) announced a significant ruling from the Canadian Federal Court, which has quashed the Notice of Compliance for Ruzurgi® previously granted by Health Canada. This decision emphasizes the protection of Firdapse®'s data exclusivity, allowing a review of Ruzurgi®'s marketing authorization. As a result, Ruzurgi® currently lacks marketing authorization in Canada, impacting its commercial prospects. The ruling highlights the ongoing complexities in drug submissions and the importance of adhering to data protection regulations.