Acurx Pharmaceuticals stock maintains Buy rating at H.C. Wainwright

Published 01/10/2025, 12:48
Acurx Pharmaceuticals stock maintains Buy rating at H.C. Wainwright

Investing.com - H.C. Wainwright reiterated its Buy rating and $31.00 price target on Acurx Pharmaceuticals (NASDAQ:ACXP) stock, representing significant upside from the current price of $4.29, following a positive regulatory development for its lead drug candidate. According to InvestingPro data, analyst targets range from $20 to $165.80, reflecting strong confidence in the company’s potential despite its current $6.55M market capitalization.

The European Medicines Agency’s Pediatric Committee provided a positive opinion on September 30 on the company’s Pediatric Investigation Plan for ibezapolstat’s use in children with C. difficile infection.

The PIP represents an important regulatory milestone as it is a prerequisite for filing a Marketing Authorization Application in Europe, ensuring necessary data are obtained to support the drug’s authorization and use in pediatric populations.

This development follows previous positive feedback from both the FDA and EMA regarding ibezapolstat’s clinical program, which had already defined requirements for regulatory pathways in both the U.S. and European markets.

Acurx Pharmaceuticals is preparing to initiate an international Phase 3 registrational program for ibezapolstat, positioning the drug candidate for late-stage clinical evaluation.

In other recent news, Acurx Pharmaceuticals received a positive opinion from the European Medicines Agency’s Paediatric Committee on its Pediatric Investigation Plan for ibezapolstat, allowing the company to proceed with Phase 3 clinical trials in the European Union. This regulatory milestone aligns with previous approvals from both the EMA and FDA for the adult population’s clinical trial program. Additionally, Acurx’s stockholders approved an amendment to increase the total number of authorized common shares from 200 million to 250 million, which took immediate effect following a special meeting. The company also announced regaining compliance with Nasdaq’s continued listing requirements, meeting both the minimum bid price and stockholders’ equity thresholds. In another development, H.C. Wainwright raised its price target for Acurx Pharmaceuticals to $31 from $8, maintaining a Buy rating on the stock. This adjustment follows the company’s financial results for the second quarter of 2025, which reported earnings per share of ($1.89) compared to the consensus estimate of ($2.10), and $6.1 million in cash at the quarter’s end. Furthermore, shareholders approved three proposals at a special meeting, contributing to the company’s strategic initiatives.

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