Acurx Pharmaceuticals (ACXP) Stock News

Acurx Pharmaceuticals (NASDAQ:ACXP) has received a positive opinion from the European Medicines Agency's (EMA) Paediatric Committee (PDCO) on its Pediatric Investigation Plan (PIP) for ibezapolstat in treating children with C. difficile infection (CDI). This marks a significant regulatory milestone as the company prepares for Phase 3 clinical trials.

The company has already secured FDA QIDP and Fast-Track Designation, along with EMA's SME designation. Both the FDA and EMA are aligned with Acurx's clinical trial program for adults, with clear regulatory pathways established for EU MAA and U.S. NDA submissions. The development addresses a critical need, as CDI affects 20,000 children annually, with a 20-30% recurrence rate.

Upon successful completion, ibezapolstat could receive 11 years of marketing exclusivity in Europe, including an additional year on top of the standard 10-year period for new antibiotics.

[ "Positive EMA opinion received for pediatric investigation plan (PIP)", "FDA QIDP and Fast-Track Designation already secured", "Potential for 11 years of marketing exclusivity in Europe", "Clear regulatory pathway established with both FDA and EMA", "Addresses significant unmet need in pediatric CDI treatment" ]

Acurx Pharmaceuticals (NASDAQ:ACXP), a late-stage biopharmaceutical company focused on developing novel antibiotics, has successfully regained compliance with Nasdaq's listing requirements. The company has met two critical criteria: maintaining a minimum bid price of $1.00 per share and achieving the minimum stockholders' equity threshold of $2.5 million.

This development ensures ACXP's continued listing and trading on the Nasdaq Stock Market, marking a significant milestone for the company's market presence and accessibility to investors.

Acurx Pharmaceuticals (NASDAQ:ACXP), a late-stage biopharmaceutical company, reported its Q2 2025 financial results and business updates. The company ended Q2 with $6.1 million in cash, up from $3.7 million in December 2024. Key developments include securing an Indian patent for DNA polymerase IIIC inhibitors and establishing a $12 million equity line of credit with Lincoln Park Capital.

The company reported a reduced net loss of $2.2 million ($1.89 per share) in Q2 2025, compared to $4.1 million in Q2 2024. R&D expenses decreased to $0.5 million from $1.8 million year-over-year, while G&A expenses reduced to $1.7 million from $2.3 million. In August, ACXP implemented a 1-for-20 reverse stock split to maintain Nasdaq listing compliance.

Acurx Pharmaceuticals (NASDAQ: ACXP) has announced a 1-for-20 reverse stock split effective August 4, 2025, at 4:01 p.m. ET. The company's stock will begin trading on a split-adjusted basis on August 5, 2025, under the same ticker "ACXP" but with a new CUSIP number (00510M 203).

The reverse split will reduce outstanding shares from approximately 30.7 million to 1.5 million. The move aims to increase the per-share trading price to regain compliance with Nasdaq's minimum bid price requirement. Stockholders will receive cash payments for fractional shares based on the closing price on August 1, 2025.

Proportional adjustments will be made to stock options, warrants, and shares under incentive plans. Most shareholders won't need to take action, as positions will be automatically adjusted through their brokers.

Acurx Pharmaceuticals (NASDAQ: ACXP), a clinical stage biopharmaceutical company focused on developing novel antibiotics for difficult-to-treat bacterial infections, has scheduled its Q2 2025 financial results conference call for August 12, 2025, at 8:00 AM ET. The company's leadership team, including CEO David P. Luci and CFO Robert G. Shawah, will host the call to discuss quarterly results and provide a business update.

Investors can access the call toll-free from the U.S. at 1-877-790-1503 using Conference ID: 13755161, with international dial-in numbers available through the company's conferencing system.

Acurx Pharmaceuticals announced a warrant exercise agreement generating $2.67 million in gross proceeds. A holder of existing warrants for 4,445,435 shares with exercise prices of $3.25-$3.26 agreed to exercise them at a reduced price of $0.60 per share. In exchange, the holder received new warrants (G-1 and G-2) to purchase up to 8,890,870 shares at $0.425 per share. The G-1 Warrants (6,223,609 shares) are immediately exercisable, while G-2 Warrants (2,667,261 shares) require shareholder approval. Both new warrants expire in five years. The company plans to use proceeds for working capital and general corporate purposes. The new warrants are issued through private placement under Section 4(a)(2) of the Securities Act.

Acurx Pharmaceuticals (NASDAQ: ACXP) has secured $2.67 million in gross proceeds through a warrant exercise agreement. A warrant holder agreed to exercise existing warrants for 4,445,435 shares at a reduced price of $0.675 per share, down from the original $3.25-$3.26 range. In exchange, the holder received new warrants (G-1 and G-2) to purchase up to 8,890,870 shares at $0.425 per share, with G-1 warrants exercisable immediately and G-2 warrants requiring shareholder approval. The new warrants expire in five years and were issued through private placement. The transaction is expected to close by June 20, 2025, with proceeds intended for working capital and general corporate purposes.

Acurx Pharmaceuticals (NASDAQ: ACXP) announced the publication of Phase 2b clinical trial results for ibezapolstat (IBZ) in Lancet Microbe, showing superior efficacy in treating C. difficile infection (CDI) compared to standard treatment. The trial demonstrated 94% clinical cure rate with IBZ, with 100% of cured patients remaining recurrence-free after one month, versus 14% recurrence rate with vancomycin. IBZ also showed favorable effects on gut microbiome preservation. The drug has received FDA QIDP and Fast-Track Designation, plus EMA SME status. The company is now positioned to advance to Phase 3 international trials, supported by comprehensive data including chemistry, mechanism of action, and microbiological activity. This development is particularly significant as current treatments show lower cure rates and emerging antimicrobial resistance issues.

Acurx Pharmaceuticals (NASDAQ: ACXP) presented results from its collaboration with Leiden University Medical Center (LUMC) regarding DNA pol IIIC inhibitors at the FASEB Scientific Conference. The research focused on ibezapolstat (IBZ), Acurx's lead antibiotic candidate, which is ready to enter Phase 3 clinical trials for C. difficile Infection (CDI). The study revealed a unique inhibitor conformation that selectively targets DNA Polymerase PolC in Gram-positive bacteria. Ibezapolstat has received FDA QIDP and Fast-Track Designations, along with EMA's SME designation. The research provides insights into the drug's mechanism of action and selectivity, supporting the development of new compounds to combat antimicrobial resistance.