Catalyst Pharmaceutical Partners, Inc.
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271 articles with Catalyst Pharmaceutical Partners, Inc.
11/4/2019Even 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.
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.
Catalyst Pharmaceuticals Announces Publication of Phase 3 Clinical Trial Data for Firdapse® for the Treatment of Lambert-Eaton Myasthenic Syndrome
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.
The Florida-based company points to inaccuracies in the letter Sanders sent earlier this month regarding the price of LEMS treatment Firdapse.
Catalyst won approval in 2018 for the LEMS treatment and set the price of the drug at $375,000 for the rare disease.
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.
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.
Catalyst Pharmaceuticals, Inc. (Catalyst) (Nasdaq: CPRX), a biopharmaceutical company focused on developing and commercializing innovative therapies for people with rare debilitating, chronic neuromuscular and neurological diseases, today announced the appointment of Stanley Iyadurai, M.D., Ph.D. as Vice President of Clinical Development.
Catalyst Pharmaceuticals Announces Second Quarter 2018 Financial Results and Provides Corporate Update
Catalyst Pharmaceuticals, Inc. (Nasdaq:CPRX), a 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, 2018 and provided a corporate update.
Catalyst Pharmaceuticals, Inc. (Catalyst) (Nasdaq: CPRX), a biopharmaceutical company focused on developing and commercializing innovative therapies for people with rare debilitating, chronic neuromuscular and neurological diseases, today announced the appointment of several key members to its commercial leadership team.
Resubmission of NDA for Firdapse on schedule for end of the first quarter.
The presentation materials for the BIO CEO & Investor conference will be posted at www.catalystpharma.com in the Investor section under Events and Presentations.
These companies are important to follow as they have exponential growth potential and are working on new and innovative drugs.
Piper Jaffray & Co. acted as the lead bookrunner. SunTrust Robinson Humphrey, Inc. also acted as a bookrunner.
All of the shares in the offering are being sold by Catalyst.
This trial had two prospectively defined co-primary endpoints.
Catalyst Pharmaceuticals Announces Phase II Study of Firdapse in Ambulatory Patients With Spinal Muscular Atrophy (SMA)
The study will be conducted by a team of researchers led by Lorenzo Maggi, MD, and Giovanni Baranello, MD, of the Fondazione Istituto Neurologico Carlo Besta in Milan, Italy, a major referral center for SMA patients.
Catalyst Pharmaceuticals Announces Third Quarter 2017 Financial Results and Provides Corporate Update
For the quarter ended September 30, 2017, Catalyst reported a GAAP net loss of $4,177,649, or $0.05 per basic and diluted share, compared to a GAAP net loss of $3,953,981.
Catalyst Pharmaceuticals to Hold Third Quarter Financial Results Conference Call and Webcast on Thursday, November 9th, 2017
Catalyst management will host a conference call at 8:30 a.m. EST to discuss the financial results and to provide a corporate update.