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 Developm...
Acurx Pharmaceuticals, Inc. (ACXP)
Company Research
Source: Yahoo! Finance
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. Feb. 27, 2024 /PRNewswire/ -- Acurx Pharmaceuticals, Inc. (NASDAQ: ACXP) ("Acurx" or the "Company"), a late-stage biopharmaceutical company developing a new class of small molecule antibiotics for difficult-to-treat bacterial infections, today announced that an EOP2 meeting has been granted by FDA to discuss the overall Phase 3 clinical and non-clinical development plan to support an NDA (New Dr
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ACXP
News
- Acurx Pharmaceuticals Announces Presentation of Ibezapolostat Phase 2 Clinical Trial Results at upcoming ESCMID 2024 Scientific ConferencePR Newswire
- Acurx Pharmaceuticals, Inc. to Discuss First Quarter 2024 Financial Results on May 15, 2024 Conference Call and Provide Business UpdatePR Newswire
- Acurx Pharmaceuticals, Inc. Announces Participation in the LD Micro Invitational XIV [Yahoo! Finance]Yahoo! Finance
- Acurx Pharmaceuticals, Inc. (NASDAQ:ACXP) Q4 2023 Earnings Call Transcript [Yahoo! Finance]Yahoo! Finance
- Acurx Pharmaceuticals, Inc. (NASDAQ: ACXP) had its price target lowered by analysts at HC Wainwright from $14.00 to $12.00. They now have a "buy" rating on the stock.MarketBeat
ACXP
Earnings
- 3/18/24 - Miss
ACXP
Analyst Actions
- 2/28/24 - HC Wainwright
ACXP
Sec Filings
- 4/17/24 - Form RW
- 4/3/24 - Form 4
- 4/3/24 - Form 4
- ACXP's page on the SEC website