Catalyst Pharmaceuticals Sub-Licensee DyDo Pharma Launches FIRDAPSE® in Japan for Lambert-Eaton Myasthenic Syndrome

Catalyst Pharmaceuticals announces FIRDAPSE launch in Japan by DyDo Pharma for treating Lambert-Eaton myasthenic syndrome.

Quiver AI Summary

Catalyst Pharmaceuticals, Inc. announced that its sub-licensee, DyDo Pharma, has launched FIRDAPSE® (amifampridine) Tablets 10 mg in Japan, aimed at improving muscle weakness in patients with Lambert-Eaton myasthenic syndrome (LEMS). Richard J. Daly, the company’s President and CEO, expressed satisfaction with the launch, emphasizing Catalyst's commitment to health equity and expanding access to life-altering therapies globally. FIRDAPSE is the only FDA-approved treatment for LEMS and is designed to enhance neuromuscular transmission and muscle function. The product has previously received approvals in the U.S., Europe, and Canada and is supported by a comprehensive patient support program. Catalyst aims to continue its growth and accessibility efforts in the rare disease sector.

Potential Positives

• DyDo Pharma has launched FIRDAPSE® in Japan, expanding Catalyst Pharmaceuticals' international market presence.
• FIRDAPSE is the only FDA-approved therapy for LEMS, enhancing Catalyst's reputation as a leader in providing treatments for rare diseases.
• The launch signifies progress in healthcare accessibility and patient care for rare disease treatments in Japan.
• Catalyst was recognized as one of North America's Fastest-Growing Companies on the 2024 Deloitte Technology Fast 500™ List, highlighting its growth and success in the biopharmaceutical industry.

Potential Negatives

• The press release highlights uncertainty regarding the commercial success of FIRDAPSE in Japan, indicating potential risks to Catalyst's revenue from this sub-license.
• Catalyst acknowledges several known and unknown risks that could significantly impact its future results, reflecting broader concerns about the company's stability and financial performance.
• The company is reliant on a third party (DyDo) for the commercialization of FIRDAPSE, which may limit Catalyst's control over its product's success in the Japanese market.

FAQ

What is FIRDAPSE and how is it used?

FIRDAPSE (amifampridine) is an FDA-approved treatment for Lambert-Eaton myasthenic syndrome, improving muscle function in affected patients.

Who launched FIRDAPSE in Japan?

FIRDAPSE was launched in Japan by Catalyst Pharmaceuticals' sub-licensee, DyDo Pharma, Inc.

What disease does FIRDAPSE target?

FIRDAPSE targets Lambert-Eaton myasthenic syndrome (LEMS), a rare autoimmune disorder causing muscle weakness and fatigue.

How does FIRDAPSE work?

FIRDAPSE enhances neuromuscular transmission by increasing acetylcholine release, improving muscle function through its mechanism as a potassium channel blocker.

Where can I find information about FIRDAPSE's prescribing information?

For full prescribing and safety information about FIRDAPSE, please visit www.firdapse.com.

Disclaimer: This is an AI-generated summary of a press release distributed by GlobeNewswire. The model used to summarize this release may make mistakes. See the full release here.

$CPRX Insider Trading Activity

$CPRX insiders have traded $CPRX stock on the open market 21 times in the past 6 months. Of those trades, 0 have been purchases and 21 have been sales.

Here’s a breakdown of recent trading of $CPRX stock by insiders over the last 6 months:

• PATRICK J MCENANY has made 0 purchases and 7 sales selling 800,000 shares for an estimated $18,234,161.
• STEVE MILLER (Chief Op. & Scientific Officer) has made 0 purchases and 4 sales selling 200,000 shares for an estimated $4,149,250.
• GARY INGENITO (Chief Med. & Reg. Officer) has made 0 purchases and 4 sales selling 150,000 shares for an estimated $2,882,216.
• CARMEN JEFFREY DEL (Chief Commercial Officer) has made 0 purchases and 2 sales selling 36,058 shares for an estimated $664,309.
• MOLLY HARPER sold 17,500 shares for an estimated $385,000
• DAVID S TIERNEY sold 15,000 shares for an estimated $301,455
• BRIAN ELSBERND (Chief Compliance/Legal Officer) has made 0 purchases and 2 sales selling 13,256 shares for an estimated $286,703.

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$CPRX Hedge Fund Activity

We have seen 160 institutional investors add shares of $CPRX stock to their portfolio, and 127 decrease their positions in their most recent quarter.

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• DEERFIELD MANAGEMENT COMPANY, L.P. (SERIES C) removed 2,897,671 shares (-31.7%) from their portfolio in Q3 2024, for an estimated $57,605,699
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• MORGAN STANLEY added 810,595 shares (+80.0%) to their portfolio in Q3 2024, for an estimated $16,114,628
• POINT72 ASSET MANAGEMENT, L.P. removed 618,296 shares (-100.0%) from their portfolio in Q3 2024, for an estimated $12,291,724
• CITADEL ADVISORS LLC removed 557,683 shares (-95.7%) from their portfolio in Q3 2024, for an estimated $11,086,738
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Full Release

CORAL GABLES, Fla., Jan. 21, 2025 (GLOBE NEWSWIRE) -- Catalyst Pharmaceuticals, Inc. ("Catalyst" or "Company") (Nasdaq: CPRX), a commercial-stage biopharmaceutical company focused on in-licensing, developing, and commercializing novel medicines for patients living with rare diseases, today reported that its sub-licensee in Japan, DyDo Pharma, Inc., ("DyDo") has launched FIRDAPSE

^®

(amifampridine) Tablets 10 mg in Japan for the indication of improving muscle weakness in patients living with Lambert-Eaton myasthenic syndrome ("LEMS").

"We are pleased that our sub-licensee, DyDo, has launched FIRDAPSE in Japan. We believe in health equity, and this launch is a testament to our ongoing efforts to increase patient access to life-changing therapies worldwide,” said Richard J. Daly, Catalyst’s President and Chief Executive Officer. “The launch of FIRDAPSE in Japan marks another advancement in our efforts to expand the geographic footprint of our portfolio products and paves the way for healthcare providers and patients in Japan to access this therapy."

FIRDAPSE (amifampridine) is the only U.S. FDA approved, evidence-based therapy for the treatment of LEMS in adults and pediatric patients six years of age and older. LEMS is a rare autoimmune disorder characterized by muscle weakness and fatigue. As a cornerstone of Catalyst's commitment to serving those with rare diseases, FIRDAPSE is supported in the U.S. by a comprehensive patient support program to help ensure accessibility and assistance for eligible U.S. patients.

About FIRDAPSE

^®

(amifampridine) Tablets 10 mg



FIRDAPSE

^®

(amifampridine) Tablets 10 mg is an oral, nonspecific, voltage-dependent, potassium (K+) channel blocker that causes depolarization of the presynaptic membrane and slows or inhibits repolarization. This action results in the opening of slow voltage-dependent calcium (Ca2+) channels, allowing for a subsequent influx of Ca2+. In turn, it induces the exocytosis of synaptic vesicles containing acetylcholine (ACh) to release more ACh into the synaptic cleft, enhancing neuromuscular transmission and providing for improved muscle function. Amifampridine phosphate was granted orphan drug designation by the Ministry of Health, Labor, and Welfare in Japan, and FIRDAPSE has previously been approved for use in the U.S. in adults and pediatric patients six years of age and older and in Europe and Canada for the treatment of adults with LEMS.

For Full Prescribing and Safety Information for FIRDAPSE, please visit

www.firdapse.com

.

About DyDo Pharma



DyDo Pharma is the rare disease pharmaceutical wholly-owned subsidiary of DyDo Group Holdings. DyDo Group Holdings, Inc. operates through the following segments: Domestic Beverage Business, International Beverage Business, Pharmaceutical-related Business, Food Business, and Pharmaceutical Business. The Domestic Beverage Business accounts for more than 60% of total sales (as of FY24, 1-3Q), and beverages are sold through vending machines that are widely prevalent in Japan. The Company was founded on January 27, 1975, and is headquartered in Osaka, Japan.

About Catalyst Pharmaceuticals



Catalyst Pharmaceuticals, Inc. (Nasdaq: CPRX) is a biopharmaceutical company committed to improving the lives of patients with rare diseases. With a proven track record of bringing life-changing treatments to the market, we focus on in-licensing, commercializing, and developing innovative therapies. Guided by our deep commitment to patient care, we prioritize accessibility, ensuring patients receive the care they need through a comprehensive suite of support services designed to provide seamless access and ongoing assistance. Catalyst maintains a well-established U.S. presence while actively seeking to expand its global commercial footprint through strategic partnerships. Catalyst, headquartered in Coral Gables, FL., was recognized as one of North America's Fastest-Growing Companies on the 2024 Deloitte Technology Fast 500™ List.

For more information, please visit Catalyst's website at

www.catalystpharma.com

.

Forward-Looking Statements



This press release contains forward-looking statements, as that term is defined in the Private Securities Litigation Reform Act of 1995. Forward-looking statements involve known and unknown risks and uncertainties, which may cause Catalyst's actual results in future periods to differ materially from forecasted results. A number of factors, including (i) whether DyDo can successfully commercialize FIRDAPSE in Japan, (ii) whether Catalyst's revenues derived in future periods from its sub-license with DyDo will be material to Catalyst, and (iii) those factors described in Catalyst's Annual Report on Form 10-K for the fiscal year 2023, its Quarterly Report on Form 10-Q for the fiscal quarter ended September 30, 2024, and its other filings with the U.S. Securities and Exchange Commission ("SEC"), could adversely affect Catalyst. Copies of Catalyst's filings with the SEC are available from the SEC, may be found on Catalyst's website, or may be obtained upon request from Catalyst. Catalyst does not undertake any obligation to update the information contained herein, which speaks only as of this date.


Source: Catalyst Pharmaceuticals, Inc.

The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.