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Recce Pharmaceuticals Ltd. ( (AU:RCE) ) has provided an announcement.
Recce Pharmaceuticals has reported a positive outcome from a routine regulatory inspection by Indonesia’s National Agency of Drug and Food Control of one of its Phase 3 clinical trial sites for diabetic foot infections. The inspection found no issues that would prevent the study from continuing, underscoring the quality of Recce’s clinical operations and compliance with Good Clinical Practice standards.
This clean inspection is considered a key de-risking milestone for Recce’s registrational Phase 3 program in Indonesia and supports its path toward regulatory approval and commercialisation in that market and other ASEAN countries. With interim data expected after 155 patients and potential Indonesian approval targeted in 2026, the program positions Recce to tap into a large regional market for diabetes-related infections, estimated at about US$1.5 billion across Asia-Pacific.
More about Recce Pharmaceuticals Ltd.
Recce Pharmaceuticals Ltd., listed on the ASX, is a biotechnology company developing synthetic anti-infective therapies. The company is currently focused on advancing its lead candidate for the treatment of diabetic foot infections, targeting significant unmet medical need in Indonesia and broader Asia-Pacific markets.
Average Trading Volume: 99,357
Technical Sentiment Signal: Buy
Current Market Cap: A$150.4M
For detailed information about RCE stock, go to TipRanks’ Stock Analysis page.