LEMS

Catalyst Pharmaceuticals Receives U.S. FDA Approval For Increased Maximum Daily Dose For FIRDAPSE®

Retrieved on: 
木曜日, 5月 30, 2024
New Drug Application, Patient, Amifampridine, Caregiver, Food, Acetylcholine, Lambert–Eaton myasthenic syndrome, LEMS, Catalyst Pharmaceuticals, Fatigue, Neuromuscular junction, Muscle weakness, Pharmaceutical industry

The increased maximum daily dose offers healthcare providers and patients greater flexibility in treatment regimens for the management of LEMS.

Key Points: 
  • The increased maximum daily dose offers healthcare providers and patients greater flexibility in treatment regimens for the management of LEMS.
  • FIRDAPSE is currently the only U.S. approved treatment for LEMS and this approval broadens the approved dosing options for prescribers treating LEMS.
  • “We are pleased to receive the approval for the increased maximum daily dose of FIRDAPSE,” said Richard J. Daly, President and CEO of Catalyst.
  • “This pivotal achievement further underscores our dedication to meeting the evolving needs of LEMS patients and their healthcare providers.

Catalyst Pharmaceuticals Reports Solid First Quarter 2024 Financial Results and Provides Business Update

Retrieved on: 
水曜日, 5月 8, 2024
Lambert–Eaton myasthenic syndrome, LEMS, Catalysis, Research, Webcast, Patient, Acquisition, Bank statement, Duchenne muscular dystrophy, Accounting, GAAP, Growth, Ageing

These non-GAAP financial measures are intended to enhance an overall understanding of Catalyst's current financial performance.

Key Points: 
  • These non-GAAP financial measures are intended to enhance an overall understanding of Catalyst's current financial performance.
  • Total revenues: In the first quarter of 2024, total revenues were $98.5 million, compared to $85.4 million for the first quarter of 2023, representing an increase of approximately 15.4%.
  • Our Form 10-Q for the first quarter of 2024, filed with the U.S. Securities and Exchange Commission on May 8, 2024, provides more detailed financial information and analysis of our financial condition and results of operations.
  • The Company will host a conference call and webcast on May 9, 2024, at 8:30 AM ET to discuss the financial results and provide a business update.

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

Retrieved on: 
木曜日, 3月 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."

NASA Selects First Lunar Instruments for Artemis Astronaut Deployment

Retrieved on: 
火曜日, 3月 26, 2024
Sun, University, JAXA, Growth, LEAF, Character, Artemis 3, History, Science, LDA, Human, LEMS, Plant, NASA, Engineering, Frost, Ice, Multimedia, Photosynthesis, Science Mission Directorate, Communications satellite

WASHINGTON, March 26, 2024 /PRNewswire/ -- NASA has chosen the first science instruments designed for astronauts to deploy on the surface of the Moon during Artemis III.

Key Points: 
  • WASHINGTON, March 26, 2024 /PRNewswire/ -- NASA has chosen the first science instruments designed for astronauts to deploy on the surface of the Moon during Artemis III.
  • Once installed near the lunar South Pole, the three instruments will collect valuable scientific data about the lunar environment, the lunar interior, and how to sustain a long-duration human presence on the Moon, which will help prepare NASA to send astronauts to Mars.
  • "These three deployed instruments were chosen to begin scientific investigations that will address key Moon to Mars science objectives."
  • The instruments will address three Artemis science objectives: understanding planetary processes, understanding the character and origin of lunar polar volatiles, and investigating and mitigating exploration risks.

Catalyst Pharmaceuticals Reports Strong Fourth Quarter and Full Year 2023 Financial Results and Provides Business Update

Retrieved on: 
水曜日, 2月 28, 2024
Acquisition, Catalysis, Research, New Drug Application, Accounting, Neuroscience, Amifampridine, Annual report, FDA, Epilepsy, Growth, Duchenne muscular dystrophy, Capital, Government, Yoy, Safety, GAAP, PMDA, LEMS, Webcast, Patient, Fasting, Quarter, Asset, Bank statement, Ageing, Pharmaceutical industry

Research and development expenses: In the fourth quarter of 2023, research and development expenses were $2.0 million, compared to $4.1 million in the fourth quarter of 2022.

Key Points: 
  • Research and development expenses: In the fourth quarter of 2023, research and development expenses were $2.0 million, compared to $4.1 million in the fourth quarter of 2022.
  • Selling, general, and administrative expenses: Selling, general, and administrative expenses for the fourth quarter of 2023 were $42.0 million compared to $14.1 million in the fourth quarter of 2022.
  • Amortization of intangible assets was $9.1 million in the fourth quarter of 2023), compared to $0.6 million in the fourth quarter of 2022.
  • Operating income: Operating income for the fourth quarter of 2023 was $41.7 million, compared to $30.8 million in the fourth quarter of 2022, representing an increase of approximately 35.4%.

Catalyst Pharmaceuticals Announces FIRDAPSE® New Drug Application Submitted in Japan by Partner DyDo Pharma

Retrieved on: 
月曜日, 12月 18, 2023
Catalyst Pharmaceuticals, NDA, Tablet, LEMS, Amifampridine, Patient, Safety, PMDA, Pharmaceutical industry

The review period is expected to be approximately a minimum of nine months from the submission date.

Key Points: 
  • The review period is expected to be approximately a minimum of nine months from the submission date.
  • “The NDA submission to the PMDA by our partner DyDo represents a pivotal milestone in our mission to broaden FIRDAPSE’s access as a treatment for LEMS patients in Japan,” stated Patrick J. McEnany, Catalyst’s Chairman and CEO.
  • As we continue to collaborate with our partner during the review process, the submission also triggers an expansion of our territorial rights for the product and a milestone payment to Catalyst.
  • Under the terms of the agreement, Catalyst is eligible to receive a regulatory milestone payment from DyDo upon submission of the NDA to the PMDA.

Catalyst Pharmaceuticals Announces FDA Acceptance of the Supplemental New Drug Application for FIRDAPSE®

Retrieved on: 
金曜日, 10月 13, 2023
Lambert–Eaton myasthenic syndrome, Physician, Antibody, Food, Malignancy, Calcium, Shanda, Comorbidity, Nerve, Acetylcholine, Amifampridine, Disease, CORAL, FDA, LEMS, Catalyst Pharmaceuticals, New Drug Application, Carcinoma, Agency, PDUFA, Tablet, Patient, Muscle weakness, Catalysis

CORAL GABLES, Fla., Oct. 13, 2023 (GLOBE NEWSWIRE) -- Catalyst Pharmaceuticals, Inc. ("Catalyst" or "Company") (Nasdaq: CPRX) today announced that the U.S. Food and Drug Administration ("FDA" or "Agency") has accepted for review the Company's supplemental New Drug Application ("sNDA") to increase the indicated maximum daily dosage of FIRDAPSE® (amifampridine) Tablets 10 mg from 80mg to 100mg for the treatment of Lambert-Eaton myasthenic syndrome ("LEMS"). The Agency assigned a Prescription Drug User Fee Act ("PDUFA") action date of June 4, 2024. FIRDAPSE is currently approved in the U.S. for the treatment of LEMS for adults and for children ages six to seventeen.  

Key Points: 
  • The Agency assigned a Prescription Drug User Fee Act ("PDUFA") action date of June 4, 2024.
  • FIRDAPSE is currently approved in the U.S. for the treatment of LEMS for adults and for children ages six to seventeen.
  • We look forward to working collaboratively with the Agency during the application review process."
  • These calcium channels are responsible for the transport of charged calcium atoms that activate the biochemical machinery responsible for releasing acetylcholine.

Catalyst Pharmaceuticals Announces Abstract on Lambert Eaton Myasthenic Syndrome (LEMS) to be Presented at the Upcoming IASLC 2023 World Conference of Lung Cancer

Retrieved on: 
水曜日, 8月 16, 2023
Carcinoma, LEMS, SST, Prevalence, Catalyst Pharmaceuticals, International Association, Lung cancer, Weakness, Quality of life, Research, SCLC, Lambert–Eaton myasthenic syndrome, Patient, Diagnosis, Rare, CORAL, Conference, Fatigue, Pharmaceutical industry, Medical imaging, Catalysis

The abstract details the results from a study analyzing real-world data to determine the prevalence of LEMS diagnoses among patients with SCLC in the United States.

Key Points: 
  • The abstract details the results from a study analyzing real-world data to determine the prevalence of LEMS diagnoses among patients with SCLC in the United States.
  • The authors hypothesize non-specific LEMS symptoms, such as fatigue and weakness, may have been attributed to SCLC, leading to underdiagnosis.
  • These data imply that the overall population of LEMS is significantly larger than previous estimates.
  • Title: Lambert-Eaton Myasthenic Syndrome is Underrecognized in Small Cell Lung Cancer: An Analysis of Real-World Data
    Time: 6:00 PM -7:30 PM Singapore Time (SST) / 6:00 AM – 7:30 AM U.S. Eastern Time (ET)
    “The results from the study have brought to light significant insights into the relationship between small-cell lung cancer and Lambert Eaton myasthenic syndrome, or LEMS.

Ruzurgi® is Now Available and Covered by the Vast Majority of Public Health and Private Insurance Plans

Retrieved on: 
火曜日, 7月 11, 2023
LEMS, Federal court, Regroupement QuébecOiseaux, MBA, Organization, Patient, Lambert–Eaton myasthenic syndrome, Amifampridine, Syndrome, News, Health insurance

BLAINVILLE, Quebec, July 11, 2023 (GLOBE NEWSWIRE) -- Médunik Canada, member of Duchesnay Pharmaceutical Group , is pleased to announce that Ruzurgi® (amifampridine) is now covered by the vast majority of provincial and federal public health programs and many private insurance plans through special authorization.

Key Points: 
  • BLAINVILLE, Quebec, July 11, 2023 (GLOBE NEWSWIRE) -- Médunik Canada, member of Duchesnay Pharmaceutical Group , is pleased to announce that Ruzurgi® (amifampridine) is now covered by the vast majority of provincial and federal public health programs and many private insurance plans through special authorization.
  • More than 90% of Canadians suffering from Lambert-Eaton Myasthenic Syndrome (LEMS) will benefit from this extensive coverage.
  • ”We are glad that amifampridine treatment options are available and that some benefit from extended coverage by several public and private plans.
  • More information about provincial and federal health program coverage for Ruzurgi® can be found on Médunik Canada’s website: https://Médunikcanada.com/en/coverage/ruzurgi .

Leclanché SA: ees Europe 2023 Expo in Munich – Leclanché LeBlock Energy Storage System Optimises Renewable Energy Storage

Retrieved on: 
木曜日, 6月 15, 2023
LEMS, Communication, Public utility, CSC, TSO, Recycling, Carbon, Wind, Anomaly, Safety, Renewable energy

Recently, Leclanché installed its first operational multi-MWh LeBlock system for a Greek transmission systems operator (TSO), to maximise the energy consumption of its photovoltaic systems.

Key Points: 
  • Recently, Leclanché installed its first operational multi-MWh LeBlock system for a Greek transmission systems operator (TSO), to maximise the energy consumption of its photovoltaic systems.
  • At the exhibition’s inaugural edition in 2021, the plug and play system was among the finalists for the ees Award.
  • In addition to its fire-resistant construction and fire detection and suppression system, LeBlock features an emergency stop to activate a controlled shutdown, either manually or automatically, when Leclanché Energy Management System (LEMS) detects anomalies.
  • LeBlock is easily installed on site and its energy capacity can also be increased by simply adding more LeBlock units.