Gelteq Limited Stock Price, News & Analysis

Gelteq (ASX:GELS) reported preclinical results showing its proprietary gel platform improved oral delivery of oil-soluble and poorly soluble drugs.

Key findings: a 300% increase in bioavailability within the first hour versus an existing FDA‑approved reference product and >20% higher overall absorption over 24 hours. Studies showed uniform small‑intestinal distribution, controlled GI transit, targeted release, effective absorption, and full clearance of API and gel material.

The company says the platform may reduce emulsifier needs, enhance bioavailability, and help reformulate challenging molecules across multiple therapeutic areas.

Gelteq (Nasdaq: GELS) announced that CEO Nathan Givoni will present at the Q4 Investor Summit Virtual on December 9, 2025 at 4:00 PM ET.

Mr. Givoni will discuss growth strategy, market positioning, and upcoming catalysts. He will also host one-on-one meetings with institutional and high-net-worth investors on December 10, 2025. Investors can request meeting access through the summit registration link or by contacting the conference or Gelteq investor relations at mkreps@darrowir.com. Event contact is fred@investorsummitgroup.com.

Gelteq (ASX:GELS) announced positive preclinical pharmacokinetic results on Nov 24, 2025 showing its proprietary gel formulation produced a 38–45% increase in systemic exposure (AUC) versus a leading marketed antihistamine, plus markedly higher Cmax and a comparable Tmax. The company said the test compound was water-soluble, supporting broader application of the gel platform across other water-soluble drug classes and strengthening plans to pursue an FDA approval pathway for an antihistamine and to engage pharmaceutical partners.

Gelteq (ASX:GELS) announced the commencement of a preclinical animal trial on October 23, 2025 to evaluate its proprietary gel-based oral formulation technology for oily and poorly soluble drugs. The study is being conducted with Monash University Institute of Pharmaceutical Science. The company highlights that >40% of marketed drugs and up to 90% of discovery candidates have low solubility, and notes the global industry spends more than USD $4 billion annually on delivery technologies. Gelteq said successful results could enable pipeline salvage, lifecycle extension, and reduced API dose size for clients.

Gelteq (ASX:GELS) entered a Product Development and Profit Share Agreement with Melbourne Health on October 9, 2025 to develop oral products containing HAMSB (high-amylose maize starch butyrylated), a compound linked in an Australian study to reduced bowel polyp initiation. The partners will use Gelteq's proprietary gel-based oral delivery platform and Gelteq's Clayton, Victoria facility will handle manufacturing, marketing, and commercialisation. The agreement includes a profit-sharing model granting Melbourne Health a share of net profits from future product sales. The program aims to create a ready-to-consume HAMSB product targeting preventive colorectal health and improved patient compliance.

Gelteq Limited (NASDAQ:GELS), a gel-based oral delivery solutions developer, announced the successful launch of its technology-enabled products in the U.S. market through its partnership with Healthy Extracts (OTCQB:HYEX).

This milestone marks Gelteq's transition from R&D to active commercialization in the U.S., with products now reaching their U.S. warehousing facility. The partnership, which began with warehousing and fulfillment arrangements, has progressed to active sales and distribution, demonstrating the potential of Gelteq's proprietary gel technology in the nutraceutical market.

Gelteq (GELS) announced the initiation of a preclinical bioequivalence study for its novel gel-based antihistamine formulation in September 2025. The study, conducted by Adgyl Lifesciences, aims to evaluate the company's proprietary gel technology for allergy treatment targeting FDA approval through the 505(b)(2) pathway.

The company is targeting the global antihistamine market, valued at $9 billion in 2023 with a projected growth to $12 billion by 2028 at a 6% CAGR. The technology aims to address limitations in traditional delivery methods, focusing on improved palatability, administration ease, and precise dosing for pediatric, elderly, and veterinary applications.

Healthy Extracts (OTCQB:HYEX) has launched two groundbreaking wellness products in North America: Hydrate EZ™ and Mynus Sugar™, featuring Gelteq's (NASDAQ:GELS) proprietary gel-based delivery system. Both products come in innovative 2-oz gel packs with no mixing required.

The company reported 20% revenue growth in H1 2025 and recently completed a transformative merger with Gummy USA, which is expected to accelerate growth by over 50%. The new products target significant market opportunities, with the hydration supplement market projected to reach $4.4 billion by 2034 and the carb blocker market expected to hit $2.5 billion by 2033.

The launch follows a distribution agreement with Gelteq announced in June, establishing HYEX as the operational backbone for Gelteq's products in North America. Products are available through Bergametna.com and Amazon, with promotional discounts of up to 20% for subscribers.

Gelteq (GELS) has signed a memorandum of understanding with IDT Australia (ASX: IDT) to establish a dedicated manufacturing facility for its gel-based products. The partnership aims to support the development and scale-up of Gelteq's proprietary gel-based oral delivery platform across pharmaceutical, nutraceutical, and animal health markets.

IDT Australia brings over 50 years of pharmaceutical manufacturing expertise and capabilities in cGMP manufacturing, FDA and TGA approved laboratory testing, and clinical packaging. The agreement includes dedicated facilities, equipment, trained staff, operational support, and necessary regulatory compliance certifications from APVMA, FDA, and TGA.