Catalyst Pharmaceuticals Announces FIRDAPSE New Drug Application Submitted in Japan by Partner DyDo Pharma
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Catalyst Pharmaceuticals' partner DyDo Pharma has submitted a New Drug Application for FIRDAPSE in Japan for treating Lambert Eaton myasthenic syndrome. The submission to Japan's PMDA is based on positive interim data from a safety study. The review period may take at least nine months.
December 18, 2023 | 11:31 am
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Catalyst Pharmaceuticals' partner DyDo Pharma has submitted an NDA for FIRDAPSE in Japan, which could lead to expanded market presence and potential revenue growth for Catalyst if approved.
The submission of the NDA by DyDo Pharma for FIRDAPSE in Japan is a positive development for Catalyst Pharmaceuticals, indicating progress in expanding the drug's global reach. If approved, this could lead to increased sales and market penetration in Japan, which is a significant market. The positive interim data suggests a likelihood of approval, which could positively impact Catalyst's stock price in the short term. However, the review period's length and the uncertainty of final approval temper the potential impact.
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