Catalyst Pharmaceuticals Inc (NASDAQ: CPRX) is having an overwhelmingly positive start to the trading session this morning after providing investors with an update on the status of the Firdapse®. Of course, the update was positive, leading to excitement among investors and causing gains in the value of the stock. Currently (9:58), CPRX is trading at $2.89 per share after a gain of $0.12 per share or 4.33% thus far today.
CPRX Gains On Firdapse® Update
As mentioned above, Catalyst Pharmaceuticals is having a strong start to the trading session this morning after announcing an update with regard to the development activities surrounding Firdapse®. The update was a relatively simple one. In a PR, the company said that it is nearing the completion of enrollment into the Phase 3 clinical trial surrounding the treatment. As a result, it expects to announce top-line results from the confirmatory Phase 3 study in the fourth quarter of this year. In a statement, Patrick J. McEnany, CEO of CPRX, had the following to offer...
“We are pleased to report that we have reached an agreement with the FDA under a Special Protocol Assessment (SPA) for the trial design, clinical endpoints and statistical analysis approach of our Phase 3 clinical trial evaluating Firdapse for the treatment of patients with MuSK antibody positive Myasthenia Gravis (MuSK-MG). We appreciate the FDA's engagement and guidance during the SPA process, and we look forward to dosing the first patients in this trial in early 2018.
Over the last few weeks, our management team has carefully examined the timelines for our development plans for Firdapse, including all necessary steps that are required for us to submit a complete new drug application for Firdapse for the treatment of Lambert-Eaton Myasthenic Syndrome. Those efforts have led us to slightly refine our timeline for the planned submission to the FDA of our NDA, which we now expect will be submitted in the first quarter of 2018. Previously we had reported that we expected to submit our NDA by the end of this year.”
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What We'll Be Watching For Ahead
Moving forward, the CNA Finance team will be keeping a close eye on CPRX. In particular, we're interested in following the ongoing development work surrounding Firdapse, and excited to see the results of the Phase 3 clinical trial later this year. Nonetheless, we'll continue to follow the story closely and bring the news to you as it breaks!
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