Acurx says FDA open to single Phase 3 trial to support ibezapolstat CDI NDA filing

Reuters2026/08/03 12:04

Bitget offers one-stop trading for cryptocurrencies, stocks, and gold. Trade now!

A welcome pack worth 6200 USDT for new users! Sign up now!

Acurx received FDA guidance on its ibezapolstat Phase 3 plan for C. difficile infection, including a possible single-trial NDA path.
No clinical results were presented; the update reflects July 13, 2026 Type C meeting minutes released Aug. 3, 2026.
FDA signaled it may accept one Phase 3 trial for registration if overall evidence is strong, with a second trial possible.
The planned IBZ-ASPIRE Phase 3 study could support treatment and reduced recurrence labeling if outcomes are successful.
Start-up began for the open-label IBZ-PATHFINDER Phase 2 study in multiply recurrent cases, with enrollment expected in coming months.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Acurx Pharmaceuticals Inc. published the original content used to generate this news brief via PR Newswire (Ref. ID: 202608030800PR_NEWS_USPR_____NY17285) on August 03, 2026, and is solely responsible for the information contained therein.

Disclaimer: The content of this article solely reflects the author's opinion and does not represent the platform in any capacity. This article is not intended to serve as a reference for making investment decisions.

Understand the market, then trade.

Bitget offers one-stop trading for cryptocurrencies, stocks, and gold.

Trade now！

Acurx says FDA open to single Phase 3 trial to support ibezapolstat CDI NDA filing

You may also like

Crypto prices