Acurx announces fda has granted an end of phase 2 meeting for ibezapolstat for c. difficile infection and the european medicines agency granted sme designation for ibezapolstat eu development

As previously announced, planning is underway with fda to advance ibezapolstat into international phase 3 clinical trials for treatment of c. difficile infection (cdi) as anticipated, an end of phase 2 meeting (eop2) with fda is now confirmed to occur in late april 2024 to finalize the phase 3 development plan per fda guidance, acurx also announced it has submitted the required pre-meeting briefing document to fda yesterday, february 26, 2024 sme (small and medium-sized enterprise) designation has been granted by the ema (european medicines agency) which allows acurx to benefit from fee incentives and other support from the ema for eu marketing authorization ibezapolstat has previously received fda qidp and fast-track designation staten island, n.y.
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