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Catalyst Pharmaceuticals, Inc.

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Catalyst has reached an agreement with the FDA on a Special Protocol Assessment (SPA) for its second phase III study on Firdapse for the treatment of LEMS. Positive data would allow the company to resubmit the regulatory application for Firdapse in the second half of 2017. The company released topline data from the phase II/III trial on Firdapse for the symptomatic treatment of MuSK-antibody positive MG that showed statistically significant results and showed a large clinical benefit to patients. The shares of the company rose following this news. The company’s share price movement shows that the stock has outperformed the Zacks classified Medical-Drugs industry year to date. However, Catalyst is highly dependent on Firdapse’s approval for growth. The company suffered a setback when it received a refusal to file letter for Firdapse from the FDA.


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