Acurx Pharmaceuticals (ACXP) Stock Rockets 218% as Phase 3 CDI Trial Gets Green Light

TLDR

• Acurx Pharmaceuticals stock surged over 218% this week after announcing a new clinical trial for its lead antibiotic, ibezapolstat.
• The drug showed a 96% cure rate in Phase 2 trials for C. difficile infection (CDI), with zero recurrences in cured patients.
• The company is launching a 20-patient open-label pilot trial for recurrent CDI, which will feed into a planned Phase 3 registration trial.
• Regulators in both the U.S. and Europe have given Acurx a clear path to begin international Phase 3 studies.
• Full-year 2025 net loss narrowed to $8.0 million from $14.1 million, and cash on hand improved to $7.6 million.

Acurx Pharmaceuticals (ACXP) had one of the more eye-catching weeks in biotech this year. The stock climbed over 218% in five days after the company announced a new clinical trial program for ibezapolstat, its lead antibiotic candidate targeting C. difficile infection.

Acurx Pharmaceuticals, Inc., ACXP

The bulk of the move came after a Monday announcement that set the stage for a Phase 3 run. By Friday morning, the stock added another 3.59% in pre-market trading following its Q4 earnings report.

C. difficile, or CDI, is a bacterial gut infection that tends to come back. For patients who’ve had three or more episodes in a year, treatment options are limited and recurrence is a real problem.

Ibezapolstat’s Phase 2 data gave investors something to work with. The drug posted a 96% clinical cure rate in 26 patients with acute CDI. Perhaps more striking — none of those cured patients saw the infection return during the follow-up period.

That combination of treatment and prevention is what Acurx believes makes ibezapolstat stand out. Most current treatments handle the infection but don’t stop it from coming back.

The company is now launching a 20-patient open-label pilot trial focused specifically on patients with multiply-recurrent CDI — those who have had at least three episodes in the past 12 months. Results from that pilot will shape the design of the full Phase 3 registration trial.

Regulatory Path Cleared

One of the bigger catalysts this week was confirmation that both U.S. and European regulators have given Acurx a clear roadmap to begin international Phase 3 studies. That kind of dual regulatory clarity removes a major uncertainty for a small-cap biotech.

It also signals that the company isn’t just running domestic trials — the plan has international scope built in from the start.

In February 2026, Acurx received a new patent for its Pol IIIC inhibitors, extending protection through December 2039. That’s a long runway if the drug eventually makes it to market.

Q4 Financials: Losses Narrow

On the financial side, Acurx reported a Q4 2025 loss of $5.32 per share, wider than the $3.29 loss in Q4 2024. But the full-year picture tells a different story.

For all of 2025, the net loss came in at $8.0 million compared to $14.1 million in 2024 — a meaningful reduction. R&D expenses dropped to $0.3 million from $0.8 million, and G&A fell to $1.3 million from $2.0 million.

Cash improved too. Acurx ended December 31, 2025 with $7.6 million on hand, up from $3.7 million a year earlier. That’s a healthier position heading into a trial program.

Two Wall Street analysts currently rate ACXP a Moderate Buy, with an average 12-month price target of $17.50.

As of the Friday morning earnings release, the stock was trading with a 3.59% pre-market gain following confirmation of the new rCDI trial launch.

The post Acurx Pharmaceuticals (ACXP) Stock Rockets 218% as Phase 3 CDI Trial Gets Green Light appeared first on CoinCentral.