Acurx Announces Successful FDA End-of-Phase 2 Meeting and Phase 3 Readiness for Ibezapolstat in the Treatment of C. difficile Infection
Acurx Pharmaceuticals, Inc. (ACXP)
Company Research
Source: PR Newswire
Agreement with FDA reached on key elements to move forward with our international Phase 3 clinical trial programAgreement also reached with FDA on complete non-clinical and clinical development plan for filing of a New Drug Application for marketing approvalPlanning continues to advance ibezapolstat into international Phase 3 clinical trials for treatment of C. difficile Infection (CDI)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 AuthorizationAcurx is now preparing to submit requests for guidance to initiate clinical trials in the European Union, the United Kingdom, Japan and CanadaIbezapolstat has previously received FDA QIDP and Fast-Track Designation from FDASTATEN ISLAND, N.Y., May 15, 2024 /PRNewswire/ -- Acurx Pharmaceuticals, Inc. (NASDAQ: ACXP) ("Acurx" or the "Company"), a late-stage biopharmaceutical company develop
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News
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- Acurx Pharmaceuticals, Inc. (NASDAQ: ACXP) had its "buy" rating re-affirmed by analysts at HC Wainwright. They now have a $12.00 price target on the stock.MarketBeat
- Acurx Pharmaceuticals, Inc. Reports First Quarter 2024 Results and Provides Business Update [Yahoo! Finance]Yahoo! Finance
- Acurx Pharmaceuticals, Inc. Reports First Quarter 2024 Results and Provides Business UpdatePR Newswire
ACXP
Earnings
- 5/15/24 - Miss
ACXP
Analyst Actions
- 5/16/24 - HC Wainwright
ACXP
Sec Filings
- 6/18/24 - Form 4
- 6/18/24 - Form 4
- 6/18/24 - Form 4
- ACXP's page on the SEC website