Amifampridine

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

Retrieved on: 
Wednesday, February 28, 2024
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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 Reports Strong Third Quarter 2023 Financial Results and Corporate Update

Retrieved on: 
Wednesday, November 8, 2023
FDA, Research, Yoy, PDUFA, Catalysis, Intangibles, Anticipation, GAAP, Acquisition, Orange Book, Development, Vamorolone, Bank statement, PMDA, Growth, Amifampridine, COVID-19, Duchenne muscular dystrophy, Webcast, Intangible asset, Lambert–Eaton myasthenic syndrome, IPR, NDA, Epilepsy, Accounting, Administration, Cash, YTD, Bank, Pharmaceutical industry, Beauty salon, Video game, Cryptocurrency

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.
  • Non-GAAP financial measures should not be considered in isolation or as a substitute for comparable GAAP accounting.
  • Intangible assets acquired after the third quarter of 2022 relate to the FYCOMPA rights acquired in the first quarter of 2023.
  • The Company will host a conference call and webcast on Thursday, November 9, 2023, at 8:30 AM ET to discuss the financial results and provide a business update.

Catalyst Pharmaceuticals Receives Two New U.S. Patent Allowances For FIRDAPSE®

Retrieved on: 
Thursday, November 2, 2023
CORAL, Fasting, Patent, Rare, United States Patent and Trademark Office, Orange Book, Catalyst Pharmaceuticals, Amifampridine, Approved Drug Products with Therapeutic Equivalence Evaluations, Lambert–Eaton myasthenic syndrome, Tablet, Patient, NAT2, Pharmaceutical industry, Catalysis

FIRDAPSE is the only approved treatment available in the U.S. for Lambert-Eaton myasthenic syndrome.

Key Points: 
  • FIRDAPSE is the only approved treatment available in the U.S. for Lambert-Eaton myasthenic syndrome.
  • "We are very pleased to receive these patent notifications from the USPTO.
  • "These patent allowances strengthen our cumulative understanding of the uniqueness of FIRDAPSE and bolster its strong intellectual property estate offering enhanced patent protection," stated Dr. Steven Miller, Chief Operating Officer and Chief Scientific Officer of Catalyst.
  • Preparations are already in motion to include these additional FIRDAPSE patents in the FDA Orange Book post-grant, bringing the total listed patent count to eight."

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

Retrieved on: 
Friday, October 13, 2023
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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 Reports Strong Second Quarter 2023 Financial Results and Provides Corporate Update

Retrieved on: 
Wednesday, August 9, 2023
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CORAL GABLES, Fla., Aug. 09, 2023 (GLOBE NEWSWIRE) -- Catalyst Pharmaceuticals, Inc. (“Catalyst” or “the Company”) (Nasdaq: CPRX) today reported financial results for the second quarter of 2023 and provided a corporate update.

Key Points: 
  • Research and Development Expenses: Research and development expenses were $4.0 million in both the second quarter of 2023 and 2022.
  • Selling, General, and Administrative Expenses: Selling, general, and administrative expenses for the second quarter of 2023 were $28.4 million, compared to $12.9 million in the second quarter of 2022.
  • Amortization of Intangible Assets: Amortization of intangible assets was $8.5 million in the second quarter of 2023, compared to $0 million in the second quarter of 2022.
  • Operating Income: Operating income for the second quarter of 2023 was $46.7 million, compared to $28.6 million in the second quarter of 2022, representing an increase of 63.5% year-over-year.

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 .

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

Retrieved on: 
Thursday, June 1, 2023
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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.

Catalyst Pharmaceuticals Advances sNDA Submission Plans To Increase Indicated Maximum Dose For FIRDAPSE® From 80 mg Per Day To 100 mg Per Day

Retrieved on: 
Tuesday, May 9, 2023
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CORAL GABLES, Fla., May 09, 2023 (GLOBE NEWSWIRE) -- Catalyst Pharmaceuticals, Inc. ("Catalyst") (Nasdaq: CPRX), a commercial-stage biopharmaceutical company focused on in-licensing, developing, and commercializing novel high-quality medicines for patients living with rare diseases, today reported that it recently concluded a Type C meeting with the U.S. Food and Drug Administration ("FDA" or "Agency") regarding its plans to file a supplemental New Drug Application ("sNDA") to increase the maximum daily dosage of FIRDAPSE® (amifampridine) from 80mg to 100mg for the treatment of Lambert Eaton myasthenic syndrome ("LEMS"). Based on the feedback received from the meeting, Catalyst believes it now has the information necessary to complete the submission of its sNDA for marketing approval in the U.S. early in the third quarter of 2023.

Key Points: 
  • "The meeting was held for alignment of our strategy to support a proposed maximum 100-milligram daily dose indication of FIRDAPSE," said Patrick J. McEnany, Chairman and Chief Executive Officer of Catalyst.
  • "We thank the Agency for their collaboration in reviewing our submitted materials and providing their feedback.
  • Based on the positive outcome of the meeting, we remain on track to file an sNDA submission early in the third quarter of 2023.
  • These calcium channels are responsible for the transport of charged calcium atoms that activate the biochemical machinery responsible for releasing acetylcholine.