Ractigen Therapeutics' saRNA Drug RAG-01 Receives Fast Track Designation from FDA

22 May 2024 | Wednesday | News

Significant Milestone Marks RAG-01 as First saRNA Drug to Achieve FTD, Demonstrating Potential in Treating Non-Muscle Invasive Bladder Cancer
Image Source : Public Domain

Image Source : Public Domain

Ractigen Therapeutics, a pioneering developer of small activating RNA (saRNA) therapeutics, proudly announces that its flagship program, RAG-01, has been granted Fast Track Designation (FTD) by the U.S. Food and Drug Administration (FDA). This notable achievement marks a significant milestone in the advancement of saRNA technology and underscores Ractigen's commitment to addressing critical unmet medical needs. The milestone establishes RAG-01 as the first saRNA drug worldwide to achieve FTD.

RAG-01 is currently undergoing a Phase I clinical trial in Australia for the treatment of non-muscle invasive bladder cancer (NMIBC). The trial, initiated in December 2023, has successfully enrolled and dosed three patients, demonstrating the program's progress in clinical development.

FDA's recent approval of the Investigational New Drug (IND) application for RAG-01 further validates the therapeutic potential of this innovative saRNA therapy. This regulatory milestone not only paves the way for the expansion of clinical trials in the United States but also highlights the FDA's recognition of RAG-01's promise in addressing the urgent medical needs of NMIBC patients.

Fast Track Designation is granted to investigational drugs intended for the treatment of serious conditions with unmet medical needs, facilitating their expedited development and review process. With FTD, Ractigen gains enhanced opportunities for collaboration with the FDA, enabling closer communication and expedited guidance throughout the development and regulatory review process.

Dr. Long-Cheng Li, Founder and CEO of Ractigen Therapeutics, expressed his enthusiasm about the FDA's decision: "We are thrilled to receive Fast Track Designation for RAG-01, marking a significant milestone not only for our program but also for the saRNA field as a whole. This designation underscores the urgency and importance of advancing innovative therapies like RAG-01 to address critical medical needs. We remain dedicated to accelerating the development of innovative saRNA therapies to address a wide range of diseases, including cancer, genetic disorders, and chronic conditions. Through strategic collaborations and pioneering research efforts, the company aims to deliver transformative treatments that improve patient outcomes and quality of life."



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