Acurx shares drop despite approval for new antibiotic trials
Shares of Acurx Pharmaceuticals, a small company specializing in the development of new antibiotics, fell 10% in after-hours trading on January 6 following the announcement of a planned secondary offering. The news dampened investor enthusiasm sparked earlier that day by regulatory approval of the company’s trial plan for its lead drug candidate: during regular trading hours, Acurx shares soared over 20%, hitting a one-month high. Meanwhile, analysts are recommending Acurx stock, projecting a price target 11 times higher than its current level.
Details
Acurx shares plummeted 10% to $0.98 per share in after-hours trading on Monday, January 6. The company announced its plans to directly offer investors 2.4 million common shares at just over $1 per share. Alongside, it will issue an equal number of five-year warrants with an exercise price of $0.90 per share.
This announcement overshadowed earlier optimism surrounding European Medicines Agency (EMA) approval of the phase 3 clinical trial plan for ibezapolstat, Acurx’s lead antibiotic candidate. The drug is designed to treat Clostridioides difficile infections (CDI), which cause inflammation of the colon. At-risk groups include cancer and diabetes patients, older adults, post-surgery patients, and those who have taken antibiotics. The EMA’s approval boosted Acurx shares more than 22% during regular trading, pushing them to $1.09 per share — a one-month high.
The trial plan for ibezapolstat had already been approved by the U.S. FDA, the company noted. This dual approval enables Acurx to commence phase 3 trials in both Europe and the United States. Phase 3 trials are the final stage before a potential regulatory green light and market launch. Acurx also plans to seek regulatory guidance to initiate clinical trials in Japan, Canada, and the United Kingdom.
About Acurx
Acurx Pharmaceuticals is dedicated to developing a new class of antibiotics for hard-to-treat bacterial infections. In addition to ibezapolstat, its pipeline includes ACX-375C, a compound targeting gram-positive infections such as streptococci, staphylococci, enterococci, and clostridia. Currently, ACX-375C is in preclinical development and has not yet been tested in humans.
Antibiotic resistance is a pressing global issue. According to research published in The Lancet, drug-resistant infections could claim over 39 million lives by 2050, The Washington Post reports. In response, global leaders at a United Nations General Assembly meeting on antimicrobial resistance endorsed a political declaration. By 2030, at least 60% of participating nations aim to establish and fund national action plans to combat antibiotic resistance.
Several countries have already implemented such plans. Acurx highlighted that ibezapolstat has been granted both QIDP (Qualified Infectious Disease Product) and Fast-Track designations by the FDA. The QIDP designation incentivizes the development of new antibiotics and antifungal drugs by granting an additional five years of market exclusivity, during which no generics can be introduced. Fast-Track status is designed to expedite the development and review of treatments for serious conditions.
The EMA has also granted Acurx SME (Small and Medium Enterprise) status, offering the company benefits and support to facilitate obtaining approval for drug sales within the European Union.
Analyst insights
Over the last year, Acurx’s stock has lost 72% of its value. However, the two analysts covering the company remain optimistic, recommending the stock as a buy, according to MarketWatch. The average price target is $11 per share — nearly 11 times its last closing price.
