Acurx Reports Outcome Of FDA End-of-Phase 2 Meeting And Phase 3 Readiness For Ibezapolstat For Treatment Of C. difficile Infection
Portfolio Pulse from Benzinga Newsdesk
Acurx Pharmaceuticals has reported a successful FDA end-of-Phase 2 meeting and is ready to advance ibezapolstat into Phase 3 clinical trials for treating C. difficile Infection. The company has also received SME designation from the EMA, which provides fee incentives and support for EU Marketing Authorization.
May 15, 2024 | 1:02 pm
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Acurx Pharmaceuticals has reached an agreement with the FDA on key elements for moving forward with Phase 3 clinical trials for ibezapolstat, aimed at treating C. difficile Infection. The company has also received SME designation from the EMA, which provides fee incentives and support for EU Marketing Authorization.
The successful FDA meeting and readiness for Phase 3 trials are significant milestones for Acurx Pharmaceuticals. Additionally, the SME designation from the EMA provides financial and regulatory support, which is likely to positively impact the company's stock price in the short term.
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