LEMS

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."

NASA Selects First Lunar Instruments for Artemis Astronaut Deployment

Retrieved on: 
Tuesday, March 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: 
Wednesday, February 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: 
Monday, December 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: 
Friday, October 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: 
Wednesday, August 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: 
Tuesday, July 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: 
Thursday, June 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.

NMD Pharma appoints Daniel Brennan as SVP, Corporate and Commercial Strategy

Retrieved on: 
Thursday, June 1, 2023
Daniel, Pharma, LEMS, Lundbeck, University, Senior, Psychology, NMD, Catalyst Pharmaceuticals, Chief commercial officer, Myasthenia gravis, DSM-IV codes, Catalysis, Business, MBA, CNS, Eli Lilly, Lambert–Eaton myasthenic syndrome, Patient, Corporation, Notre Dame, SVP, Therapy, Amifampridine, Northwestern University, BA, Pharmaceutical industry

Aarhus, Denmark, 1 June 2023 – NMD Pharma A/S, a clinical-stage biotech company developing first-in-class, small molecule ClC-1 inhibitors for neuromuscular disorders, today announces the appointment of Daniel Brennan as Senior Vice President, Corporate and Commercial Strategy with immediate effect.

Key Points: 
  • Aarhus, Denmark, 1 June 2023 – NMD Pharma A/S, a clinical-stage biotech company developing first-in-class, small molecule ClC-1 inhibitors for neuromuscular disorders, today announces the appointment of Daniel Brennan as Senior Vice President, Corporate and Commercial Strategy with immediate effect.
  • Daniel joins NMD Pharma with over 25 years of strategic commercial experience in the biopharmaceutical industry, having held various senior management roles across the sector.
  • Daniel Brennan, newly appointed SVP, Corporate and Commercial Strategy at NMD Pharma, said: “NMD Pharma is at an exciting point of its journey as it progresses clinical trials for both its potential neuromuscular disease assets, NMD670 for myasthenia gravis and NMD1343.
  • It is with great pleasure that we welcome Dan to the company as SVP, Corporate and Commercial Strategy as we build out our commercial capabilities in line with our clinical programmes.

Catalyst Pharmaceuticals Reports Record First Quarter 2023 Results, Achieving 98% Total Revenue Growth Year-over-Year

Retrieved on: 
Wednesday, May 10, 2023
LEMS, Anticipation, Bank statement, Medicines and Healthcare products Regulatory Agency, New Drug Application, COVID-19, Intangible asset, NDA, GAAP, Accounting, Medication, Development, Acquisition, Lambert–Eaton myasthenic syndrome, Administration, PMDA, Intangibles, Webcast, Biophysical environment, Depreciation, ESG, Yoy, Research, Amifampridine, Catalysis, Pharmaceuticals and Medical Devices Agency, Bank, Video game, Beauty salon, Reinsurance, Cryptocurrency

Achieved Q1 2023 FIRDAPSE® net product revenue of $57.5 Million, representing a substantial 34% YoY increase.

Key Points: 
  • Achieved Q1 2023 FIRDAPSE® net product revenue of $57.5 Million, representing a substantial 34% YoY increase.
  • Research and Development Expenses: Research and development expenses in the first quarter of 2023 were $3.6 Million, compared to $3.4 Million in the first quarter of 2022.
  • Amortization of Intangible Assets: Amortization of intangible assets was $6.5 Million in the first quarter of 2023, compared to $0.00 in the first quarter of 2022.
  • 2023 Financial Guidance: The Company forecasts full-year 2023 total revenues, including FYCOMPA®, to be between $375 Million and $385 Million, representing a 75% - 80% increase in total revenues compared to 2022.