Catalyst Pharmaceuticals, Inc.
Florida
United States
283 articles with Catalyst Pharmaceuticals, Inc.
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KYE Pharmaceuticals and Catalyst Pharmaceuticals Challenge Health Canada’s Decision to Overlook Firdapse® Data ExclusivityNotice of Application for Judicial Review Filed Today in the Federal Court of Canada
8/26/2020
Catalyst Pharmaceuticals, Inc. (Catalyst) (Nasdaq: CPRX), a commercial-stage biopharmaceutical company focused on developing and commercializing innovative therapies for people with rare debilitating, chronic neuromuscular and neurological diseases, and KYE Pharmaceuticals Inc. ("KYE"), a private company headquartered in Mississauga, Ontario and focused on bringing medicines that fulfill clinically significant unmet needs to the Canadian ma
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Catalyst Pharmaceuticals and KYE Pharmaceuticals Announce Agreement to Make Firdapse® (amifampridine phosphate) Available to LEMS Patients in Canada
8/18/2020
Catalyst Pharmaceuticals, Inc. (Catalyst) (Nasdaq: CPRX), a commercial-stage biopharmaceutical company focused on developing and commercializing innovative therapies for people with rare debilitating, chronic neuromuscular and neurological diseases, and KYE Pharmaceuticals Inc. ("KYE"), a private company headquartered in Mississauga, Ontario and focused on bringing medicines that fulfill clinically significant unmet needs to the Canadian ma
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Catalyst Pharmaceuticals Announces Notice of Allowance of a U.S. Patent Application for "Methods of Administering 3,4-Diaminopyridine"
8/11/2020
The allowed claims are directed to methods of treating patients with a 3,4-DAP sensitive disease comprising administering 3,4-DAP or a salt thereof to slow acetylating patients having certain mutations in each allele of the NAT2 gene
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Catalyst Pharmaceuticals Announces Second Quarter 2020 Financial Results and Provides Business Update
8/10/2020
Catalyst Pharmaceuticals, Inc. (Catalyst) (Nasdaq:CPRX), a commercial-stage biopharmaceutical company focused on developing and commercializing innovative therapies for people with rare debilitating, chronic neuromuscular and neurological diseases, today reported financial results for the second quarter ended June 30, 2020 and provided a business update.
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Catalyst Pharmaceuticals’ Firdapse® (amifampridine phosphate) Receives Marketing Approval in Canada for Patients with LEMS
8/6/2020
Catalyst Pharmaceuticals, Inc. (Catalyst) (Nasdaq: CPRX), a commercial-stage biopharmaceutical company focused on developing and commercializing innovative therapies for people with rare debilitating, chronic neuromuscular and neurological diseases, today announced that Canada’s national healthcare regulatory agency, Health Canada, has approved the use of Firdapse® (amifampridine) for the treatment of patients in Canada with Lambert-Eaton myasthenic syndrome (LEMS),
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Catalyst Pharmaceuticals to Hold Second Quarter 2020 Financial Results and Corporate Update Conference Call and Webcast on Tuesday, August 11th, 2020
8/3/2020
Catalyst Pharmaceuticals, Inc. (Catalyst) (Nasdaq: CPRX), a commercial-stage biopharmaceutical company focused on developing and commercializing innovative therapies for people with rare debilitating, chronic neuromuscular and neurological diseases, today announced that it will release second quarter 2020 financial results after market close on Monday, August 10, 2020. Further, Catalyst management will host an investment-community conferenc
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Catalyst Pharmaceuticals Announces Change to a Virtual Meeting Format for the 2020 Annual Meeting of Stockholders
8/3/2020
Catalyst Pharmaceuticals, Inc. (Catalyst) (Nasdaq: CPRX), a commercial-stage biopharmaceutical company focused on developing and commercializing innovative therapies for people with rare debilitating, chronic neuromuscular and neurological diseases, today announced a change in the format of its 2020 Annual Meeting of Stockholders (the "Annual Meeting") from an in-person meeting to a virtual-only meeting format
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Catalyst Pharmaceuticals Appoints Jeffrey Del Carmen as Chief Commercial Officer
6/23/2020
-Pete Curry has been Promoted to Vice President of Sales - Maria Pandolfo has been Promoted to Vice President of Patient Services
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Catalyst Pharmaceuticals to Present at the Jefferies Virtual Healthcare Conference
6/1/2020
Catalyst Pharmaceuticals, Inc. (Catalyst) (Nasdaq: CPRX), a commercial-stage biopharmaceutical company focused on developing and commercializing innovative therapies for people with rare debilitating, chronic neuromuscular and neurological diseases, today announced the Company will be presenting at the Jefferies Virtual Healthcare Conference being held June 2-4, 2020
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Catalyst Pharmaceuticals Announces First Quarter 2020 Financial Results and Provides Corporate Update
5/11/2020
Catalyst Pharmaceuticals, Inc. (Catalyst) (Nasdaq:CPRX), a commercial-stage biopharmaceutical company focused on developing and commercializing innovative therapies for people with rare debilitating, chronic neuromuscular and neurological diseases, today reported financial results for the first quarter ended March 31, 2020 and provided a corporate update.
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Catalyst Pharmaceuticals to Hold First Quarter 2020 Financial Results and Corporate Update Conference Call and Webcast on Tuesday, May 12th, 2020
5/4/2020
Catalyst Pharmaceuticals, Inc. (Catalyst) (Nasdaq: CPRX), a commercial-stage biopharmaceutical company focused on developing and commercializing innovative therapies for people with rare debilitating, chronic neuromuscular and neurological diseases, today announced that it will release first quarter 2020 financial results after market close on Monday, May 11, 2020. Further, Catalyst management will host an investment-community conference cal
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Catalyst Lawsuit Against the FDA Claims Price, Bernie Sanders Played a Role in Approval of a Riva...
2/14/2020
Did the price of a newly-approved treatment for a rare autoimmune disease and pressure from U.S. Sen. Bernie Sanders lead to the approval of a rival treatment? That’s what Florida-based Catalyst Pharmaceutical is attempting to show in court. -
Clinical Catch-Up: October 28-Nov 1
11/4/2019
Even clinical trial announcements don’t slow down for Halloween. It was a typically busy week. Here’s a look. -
Lawsuits against the FDA are fairly common. However, winning the lawsuit will be a tough road for Catalyst, as other pharma companies that challenged the regulatory agency learned.
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The Jacobus LEMS Drug was approved for pediatric patients. However, the approval was based on results from a study of adult patients, which means that doctors could opt to prescribe this medication for adult LEMS patients.
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Catalyst Pharmaceuticals Announces Publication of Phase 3 Clinical Trial Data for Firdapse® for the Treatment of Lambert-Eaton Myasthenic Syndrome
2/26/2019
The positive topline results from this trial were previously announced, but the full results of safety, efficacy, and other clinical data are now available online.
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The Florida-based company points to inaccuracies in the letter Sanders sent earlier this month regarding the price of LEMS treatment Firdapse.
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Catalyst won approval in 2018 for the LEMS treatment and set the price of the drug at $375,000 for the rare disease.
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Florida-based Catalyst Pharma won regulatory approval for its treatment of a rare autoimmune disorder called Lambert-Eaton myasthenic syndrome (LEMS). The U.S. Food and Drug Administration approval of the new oral drug, Firdapse (amifampridine), is the first ever approved for this disease.
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Catalyst Pharmaceuticals to Present at Rodman & Renshaw's 20th Annual Global Investment Conference
8/29/2018
Catalyst Pharmaceuticals, Inc. today announced that Patrick J. McEnany, Chief Executive Officer, and Steven Miller, Ph.D., Chief Operating Officer and Chief Scientific Officer, will be presenting at Rodman & Renshaw’s 20th Annual Global Investment Conference, which is being held on September 4-6, 2018 at the St. Regis New York Hotel in New York City.