Recce Pharmaceuticals AGM Presentation Discloses Phase 3 DMC Review Expected Mid-November 2026

Manish Choudhary

06 November 2026 11:23 AM AEDT

Recce Pharmaceuticals AGM Presentation Discloses Phase 3 DMC Review Expected Mid-November 2026

Image Source: Krish Capital Pty Ltd

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Recce Pharmaceuticals (ASX:RCE) has released its Annual General Meeting presentation dated 6 November 2026, disclosing that a 75-patient dataset from its Indonesian Phase 3 clinical trial of RECCE® 327 Gel has been submitted to an independent Data Monitoring Committee, with the committee expected to meet as soon as mid-November 2026.

Key Points

A 75-patient dataset from the Indonesian Phase 3 trial of RECCE® 327 Gel has been submitted to an independent Data Monitoring Committee, expected to meet as soon as mid-November 2026.
Patient dosing is underway for Phase 3 clinical trials in both Indonesia and Australia for the treatment of Diabetic Foot Infections.
An exclusive licensing and commercialisation agreement has been signed with Arrotex Pharmaceuticals for R327G in Australia and New Zealand.
A non-binding term sheet has been signed with a leading Middle Eastern pharmaceutical company for a proposed 10-year exclusive, multi-country licensing agreement.
RECCE® 327 has received Qualified Infectious Disease Product (QIDP) Designation from the U.S. Food and Drug Administration.

Phase 3 Clinical Trial Progress and DMC Submission

According to the AGM presentation, patient dosing is well underway for Phase 3 clinical trials of RECCE® 327 Gel in Indonesia and Australia, targeting the treatment of Diabetic Foot Infections. The company disclosed that a 75-patient dataset from the Indonesian Phase 3 trial has been submitted to an independent Data Monitoring Committee. The DMC is expected to meet as soon as mid-November 2026. The filing also states that RECCE® 327 has been added to the World Health Organization's List of Antibacterial Products in Clinical Development.

Licensing Agreements in Australia, New Zealand and the Middle East

The presentation disclosed that Recce Pharmaceuticals has signed an exclusive licensing and commercialisation agreement with Arrotex Pharmaceuticals covering R327G in Australia and New Zealand. Additionally, the company has signed a non-binding term sheet with a leading Middle Eastern pharmaceutical company for a proposed 10-year exclusive, multi-country licensing agreement. The filing also referenced agreements with the US Defense Burn Research Program and the US Army Medical Research Institute of Infectious Diseases in connection with the company's product development activities.

QIDP Designation and Board Structure

The filing states that RECCE® 327 has received Qualified Infectious Disease Product designation from the U.S. Food and Drug Administration. According to the presentation, if approved in the United States, QIDP provides an additional five years of market exclusivity, and the product is eligible for fast-track designation and priority review. The company's board includes Chairman Dr John Prendergast, Managing Director and CEO James Graham, Chief Medical Advisor and Non-Executive Director Dr Alan Dunton, and Executive Director and Chief Scientific Officer Michele Dilizia, as disclosed in the presentation.

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