Gelteq Shares Soar Over 60% on Preclinical Trial Launch
Company advances novel gel-based antihistamine, targeting a $12 billion allergy market via an expedited FDA pathway.
Shares of Gelteq Limited (NASDAQ: GELS), a clinical-stage company specializing in gel-based oral delivery solutions, skyrocketed over 62% following a key development in its product pipeline. The surge was triggered by the company's announcement of the for its novel gel-based formulation of a widely used antihistamine for allergy treatment.
The study, conducted by contract research organization Adgyl Lifesciences, marks a critical first step toward seeking U.S. Food and Drug Administration (FDA) approval. Gelteq plans to utilize the 505(b)(2) regulatory pathway, a streamlined process for drugs that are a new formulation of an existing, approved medication. This approach could potentially reduce development timelines and costs.
"Our gel-based delivery platform is expected to transform traditional pharmaceutical products currently available on the market, especially where patient compliance and dosage control are critical," said Nathan Givoni, CEO of Gelteq. The company's proprietary technology aims to address common challenges with tablets and syrups, such as palatability for children, swallowing difficulties for elderly patients, and the need for precise dosing in veterinary medicine.
The strategic move positions Gelteq to compete in the vast , which was valued at $9 billion in 2023 and is projected to reach $12 billion by 2028. Allergic conditions represent a significant healthcare burden, affecting .
Investor enthusiasm was palpable, with a significant spike in trading volume accompanying the share price rally. While the preclinical trial news is a positive catalyst, Gelteq faces a long road of clinical testing and regulatory hurdles. The company's financials also present a mixed picture, with despite the promising technology. Success will ultimately depend on demonstrating clear clinical advantages over existing allergy treatments.