Catalyst Pharmaceuticals

Santhera Announces Preliminary Unaudited 2023 Annual Results and Provides Corporate Update Ahead of Full Report Publication in May

Retrieved on: 
Thursday, April 25, 2024
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As permitted by SIX Exchange Regulation, the Company will publish the full 2023 Annual Report in May.

Key Points: 
  • As permitted by SIX Exchange Regulation, the Company will publish the full 2023 Annual Report in May.
  • Financially, Santhera reported a 2023 revenue of CHF 103.4 million and net income of CHF 54.8 million, driven by the Catalyst licensing deal.
  • After closing of the transaction in July 2023, Santhera received an upfront payment of USD 90 million (USD 75 million in cash and USD 15 million equity investment).
  • SIX Exchange Regulation has permitted Santhera to publish its 2023 Annual Report by May 31, 2024, at the latest.

Catalyst Pharmaceuticals to Report First Quarter 2024 Financial Results on May 8, 2024

Retrieved on: 
Monday, April 22, 2024
Catalyst Pharmaceuticals, Patient, Webcast

CORAL GABLES, Fla., April 22, 2024 (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 and difficult-to-treat diseases, today announced that it will release its first quarter 2024 financial results after the market close on Wednesday, May 8, 2024.

Key Points: 
  • CORAL GABLES, Fla., April 22, 2024 (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 and difficult-to-treat diseases, today announced that it will release its first quarter 2024 financial results after the market close on Wednesday, May 8, 2024.
  • Catalyst's management team will host a conference call and webcast on Thursday, May 9, 2024, at 8:30 AM ET to discuss the Company's financial results and provide a business update.

Parent Project Muscular Dystrophy Celebrates 30th Anniversary with Launch of PPMD Together Meeting Series in Cincinnati, Ohio

Retrieved on: 
Wednesday, April 17, 2024
City, Hope, PTC Therapeutics, Today, Series, Empowerment, Becker muscular dystrophy, Parent, Research, Human, Catalyst Pharmaceuticals, Policy, Family, PPMD, Sarepta Therapeutics, Diagnosis, Duchenne muscular dystrophy, Grandparent, Therapy

CINCINNATI, April 17, 2024 /PRNewswire/ -- Parent Project Muscular Dystrophy (PPMD), a nonprofit organization leading the fight to end Duchenne muscular dystrophy (Duchenne), proudly marks its 30th anniversary at the launch of the PPMD Together meeting series, taking place April 19-20, 2024, in Cincinnati, Ohio. Founded three decades ago by a small group of passionate parents and grandparents within the Duchenne community, PPMD has grown into a beacon of hope, driven by the unwavering dedication of parents, families, and individuals living with Duchenne and Becker.

Key Points: 
  • CINCINNATI, April 17, 2024 /PRNewswire/ -- Parent Project Muscular Dystrophy (PPMD) , a nonprofit organization leading the fight to end Duchenne muscular dystrophy (Duchenne) , proudly marks its 30th anniversary at the launch of the PPMD Together meeting series, taking place April 19-20, 2024, in Cincinnati, Ohio.
  • In April 1994, Cincinnati served as the birthplace of PPMD, where a handful of determined families joined forces to confront the challenges posed by Duchenne.
  • PPMD selected the location and date of the first PPMD Together meeting to celebrate the 30th anniversary of the organization in its hometown of Cincinnati, April 19-20, 2024.
  • Sponsorship for the PPMD Together meeting has been provided by Catalyst Pharmaceuticals, Edgewise Therapeutics, NS Pharma, Pfizer, PTC Therapeutics, and Sarepta Therapeutics in accordance with PPMD's Corporate Relations Policy .

Catalyst Pharmaceuticals Announces Support for the Inaugural Lambert-Eaton Myasthenic Syndrome (LEMS) Awareness Day

Retrieved on: 
Thursday, March 28, 2024
Diagnosis, Lambert–Eaton myasthenic syndrome, Catalyst Pharmaceuticals, Patient, Research, Family, LEMS, Neuromuscular disease, Pharmaceutical industry

CORAL GABLES, Fla., March 28, 2024 (GLOBE NEWSWIRE) -- Catalyst Pharmaceuticals, Inc. ("Catalyst") (Nasdaq: CPRX), a commercial-stage, patient-centric biopharmaceutical company focused on in-licensing, developing, and commercializing novel high-quality medicines for patients living with rare and difficult-to-treat diseases, today announced its endorsement of the inaugural Lambert-Eaton myasthenic syndrome ("LEMS") Awareness Day.

Key Points: 
  • CORAL GABLES, Fla., March 28, 2024 (GLOBE NEWSWIRE) -- Catalyst Pharmaceuticals, Inc. ("Catalyst") (Nasdaq: CPRX), a commercial-stage, patient-centric biopharmaceutical company focused on in-licensing, developing, and commercializing novel high-quality medicines for patients living with rare and difficult-to-treat diseases, today announced its endorsement of the inaugural Lambert-Eaton myasthenic syndrome ("LEMS") Awareness Day.
  • "Creating an awareness day for LEMS is a huge win for our community," said Price Wooldridge, Founder and Board Member of the LEMS Family Association.
  • "This brings us one step closer to our goal, improving the awareness of our rare condition in the larger population.
  • We couldn't be more thrilled to celebrate the milestone of this first LEMS Awareness Day together."

Catalyst Pharmaceuticals to Participate in the 2024 Cantor Virtual Muscular Dystrophy Symposium

Retrieved on: 
Wednesday, March 27, 2024
Patient, Catalyst Pharmaceuticals

CORAL GABLES, Fla., March 27, 2024 (GLOBE NEWSWIRE) -- Catalyst Pharmaceuticals, Inc. ("Catalyst") (Nasdaq: CPRX), a commercial-stage biopharmaceutical company focused on in-licensing, developing, and commercializing novel medicines for patients living with rare and difficult-to-treat diseases, today announced that Richard J. Daly, CEO of Catalyst, along with other members of Catalyst’s management team, will participate in the 2024 Cantor Virtual Muscular Dystrophy Symposium taking place virtually on April 2-3, 2024.

Key Points: 
  • CORAL GABLES, Fla., March 27, 2024 (GLOBE NEWSWIRE) -- Catalyst Pharmaceuticals, Inc. ("Catalyst") (Nasdaq: CPRX), a commercial-stage biopharmaceutical company focused on in-licensing, developing, and commercializing novel medicines for patients living with rare and difficult-to-treat diseases, today announced that Richard J. Daly, CEO of Catalyst, along with other members of Catalyst’s management team, will participate in the 2024 Cantor Virtual Muscular Dystrophy Symposium taking place virtually on April 2-3, 2024.
  • The presentation webcast will be available on the Investors section of the Company's website , and a replay will be accessible for at least 14 days.

Santhera’s Partner Catalyst Pharmaceuticals Launches AGAMREE® (Vamorolone) in the United States

Retrieved on: 
Thursday, March 14, 2024
Catalyst Pharmaceuticals, Patient, Duchenne muscular dystrophy, Vamorolone, Food, FDA, Catalysis, DMD, Fine chemical

AGAMREE is the first DMD treatment approved across the U.S., EU and UK

Key Points: 
  • AGAMREE is the first DMD treatment approved across the U.S., EU and UK
    Pratteln, Switzerland, March 14, 2024 – Santhera Pharmaceuticals (SIX: SANN) is pleased to note the launch of AGAMREE® (vamorolone) for the treatment of Duchenne muscular dystrophy (DMD) in the United States (U.S.) by Catalyst Pharmaceuticals, Inc. (NASDAQ: CPRX), the Company’s commercialization partner for North America.
  • “Congratulations to our partner Catalyst on the launch of AGAMREE® in the United States.
  • According to the license agreement between the companies, first announced in June 2023 , Catalyst holds an exclusive North American license to commercialize AGAMREE for DMD and all potential future indications.
  • Under the agreement, Catalyst will pay Santhera sales-based milestones of up to USD 105 million as well as up to low-teen percentage royalties and will assume Santhera's corresponding third-party royalty obligations on AGAMREE sales in all indications in North America.

Catalyst Pharmaceuticals Announces AGAMREE® Now Commercially Available in the U.S. for the Treatment of Duchenne Muscular Dystrophy (DMD)

Retrieved on: 
Wednesday, March 13, 2024
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CORAL GABLES, Fla., March 13, 2024 (GLOBE NEWSWIRE) -- Catalyst Pharmaceuticals, Inc. ("Catalyst") (Nasdaq: CPRX), a commercial-stage biopharmaceutical company, today announced the U.S. commercial launch of AGAMREE® (vamorolone) oral suspension 40 mg/mL for the treatment of Duchenne Muscular Dystrophy ("DMD") in patients aged two years and older. Following the U.S. Food and Drug Administration ("FDA") approval on October 26, 2023, AGAMREE is now available by prescription and dispensed throughout the United States through a specialty pharmacy network.

Key Points: 
  • "Today, we proudly announced the U.S. commercial availability of AGAMREE, an innovative alternative steroid treatment for Duchenne Muscular Dystrophy.
  • Our Catalyst Pathways, a personalized program, is readily available to assist Duchenne Muscular Dystrophy patients and their families with the one‐on‐one education and financial support they need, thereby enhancing the access and affordability of AGAMREE for every patient.
  • For more information, caregivers and healthcare professionals can call 1-833-422-8259 or visit the Catalyst Pathways® website at www.yourcatalystpathways.com .
  • Duchenne Muscular Dystrophy, DMD, the most common form of muscular dystrophy, is a rare and life-threatening neuromuscular disorder characterized by progressive muscle dysfunction, ultimately leading to loss of ambulation, respiratory failure, and fatality.

Catalyst Pharmaceuticals to Participate at the Barclays 26th Annual Global Healthcare Conference

Retrieved on: 
Tuesday, March 5, 2024
Catalyst Pharmaceuticals, Patient, Conference

CORAL GABLES, Fla., March 05, 2024 (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 and difficult to treat diseases, today announced that Richard J. Daly, CEO of Catalyst, along with other members of Catalyst's management team, will participate at the upcoming Barclays 26th Annual Global Healthcare Conference being held in Miami on March 12-14, 2024.

Key Points: 
  • CORAL GABLES, Fla., March 05, 2024 (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 and difficult to treat diseases, today announced that Richard J. Daly, CEO of Catalyst, along with other members of Catalyst's management team, will participate at the upcoming Barclays 26th Annual Global Healthcare Conference being held in Miami on March 12-14, 2024.
  • Format: Catalyst's management will host 1x1 meetings and a fireside discussion at 1:35 pm ET.
  • A live webcast of the fireside will be available on the Company's website , and a replay will be accessible for at least 14 days.

Catalyst Pharmaceuticals to Present at MDA Clinical & Scientific Conference Details of Registry for Study of Long-Term Safety and Quality of Life in Duchenne Muscular Dystrophy Patients Treated with AGAMREE

Retrieved on: 
Tuesday, February 27, 2024
Vamorolone, Catalyst Pharmaceuticals, Physician, Quality of life, DMD, Duchenne muscular dystrophy, Conference, Doctor of Philosophy, Safety, Patient, Poster, Male, Episcopal conference, Pharmaceutical industry

The poster will detail the establishment of a multicenter, observational, prospective, longitudinal registry at approximately 25 U.S. sites.

Key Points: 
  • The poster will detail the establishment of a multicenter, observational, prospective, longitudinal registry at approximately 25 U.S. sites.
  • Investigators will assess the progress of 250 male patients who are at least 2 years old at week 12 and then every 12 months for up to five years.
  • The first interim analysis is expected in May 2025.
  • "We encourage physicians treating patients with DMD to consider enrolling eligible patients in this registry."

Catalyst Pharmaceuticals Announces Publication of Santhera Pharmaceutical’s VISION-DMD Vamorolone (AGAMREE®) Study Results in the Peer-Reviewed Journal Neurology

Retrieved on: 
Wednesday, February 21, 2024
Vamorolone, Catalyst Pharmaceuticals, NSAA, Safety, Prednisone, DMD, Growth, Duchenne muscular dystrophy, Neurology, Biomarker, BMI, Patient, LSM, JAMA Neurology, Pharmaceutical industry

Catalyst holds the exclusive rights to commercialize AGAMREE® (vamorolone) in North America.

Key Points: 
  • Catalyst holds the exclusive rights to commercialize AGAMREE® (vamorolone) in North America.
  • Based on the published study, Santhera has reported that the results of the VISION-DMD study support the long-term efficacy and safety profile of vamorolone and conclude that vamorolone was generally well tolerated, consistent with the 24-week study findings, as published previously in JAMA Neurology [2].
  • This study [VISION-DMD] was conducted to determine the efficacy and safety of vamorolone over 48 weeks and to study crossover participants (prednisone to vamorolone; placebo to vamorolone).
  • Improvements of motor outcomes seen with 6 mg/kg/d of vamorolone at 24 weeks of treatment were maintained to 48 weeks of treatment.