Clinical trialsCompany release

ProKidney sets rilparencel timeline: Phase 3 readout in Q2 2027, BLA filing in Q1 2028

🇺🇸 Prokidney Corp. (PROK) · Mon 09 Nov 2026

The US cell therapy developer expects eGFR-slope topline data from the PROACT 1 trial in mid-2027 and plans an accelerated approval submission the following year.

ProKidney has set out the expected timeline for rilparencel, its autologous cell therapy, in a corporate presentation dated 9 November 2026. The product is in the Phase 3 PROACT 1 trial in patients with Stage 3b/4 chronic kidney disease and type 2 diabetes.

According to the company, enrolment of more than 500 patients should be complete in the first quarter of 2027. Topline data based on estimated glomerular filtration rate (eGFR) slope are expected in the second quarter of 2027.

ProKidney plans to submit a Biologics License Application (BLA) seeking accelerated approval in the first quarter of 2028, and is targeting a launch in the first half of 2029. The company cites a Regenerative Medicine Advanced Therapy (RMAT) designation for the programme.

The presentation also states that the company's cash should last into mid-2027. That is around the time the topline data are expected, although the summary provided does not say how the company plans to fund the period beyond it.

What it means for your team

  • Regulatory teams tracking cell and gene therapies should note the planned accelerated approval route, which follows eGFR-slope data from PROACT 1 and a BLA filing targeted for Q1 2028.
  • The RMAT designation is cited by the company as supporting the programme. These timelines are company projections, not FDA commitments.
  • Market-access and quality teams have a 2029 target launch window to plan around, subject to trial results and regulatory review.
  • The stated cash runway into mid-2027 is a funding milestone to watch alongside the Q2 2027 readout.

Company's press release (SEC filing): Prokidney Corp. ↗

Article written by VigiEye from the official source (Prokidney Corp.). Claims are the company's own. AI-assisted; check the source before acting.

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