- XORTX Therapeutics (XRTX) has submitted a request for scientific advice review to the European Medicines Agency (EMA) about its XRx-008 program
- This submission is intended to initiate discussions regarding the status of XORTX’s XRx-008 program for autosomal dominant polycystic kidney disease
- The company recently reported topline results showing substantially increased bioavailability of XRx-008 formulation candidates in people
- The next step is initiating a scientific review process with the EMA regarding its scientific status, developmental assumptions and plans for recruiting people in the upcoming phase 3 registration trial
- XORTX Therapeutics Inc. (XRTX) is down 3.33 per cent, trading at C$2.03 as of 1:30 pm ET
XORTX Therapeutics (XRTX) has submitted a request to the European Medicines Agency (EMA) for a scientific advice review about its XRx-008 program.
This submission is intended to initiate discussions regarding the status of XORTX’s XRx-008 program for autosomal dominant polycystic kidney disease (ADPKD) and plans for its global phase 3 registration trial. It includes scientific advice pertaining to marketing approval in the E.U.
The company has completed the research and development activities leading to this request and is advancing its XRx-008 program for treating ADPKD.
XORTX has received approval from the FDA and Health Canada to commence its OXY-XRX-101 bridging pharmacokinetic study; the company recently reported topline results showing substantially increased bioavailability of XRx-008 formulation candidates in people.
The next step is initiating a scientific review process with the EMA CHMP regarding its scientific status, developmental assumptions and plans for recruiting people for the upcoming phase 3 registration trial.
XORTX CEO Allen Davidoff stated, “This request is a critical component of our global regulatory plan to enhance the potential for approvability of our drug candidate, which includes a potential Special Protocol Assessment discussion with the US Food and Drug Administration.”
XORTX is a clinical-stage pharmaceutical company focused on developing innovative therapies to treat progressive kidney disease.
XORTX Therapeutics Inc. (XRTX) is down 3.33 per cent, trading at C$2.03 as of 1:30 pm ET.