Akebia Therapeutics (AKBA) R&D Day 2026 summary

Pipeline overview and program updates

• Focus on advancing praliciguat for FSGS, AKB-097 for complement-mediated kidney diseases, and AKB-9090 for cardiac surgery-associated AKI, with Vafseo positioned as the revenue engine.

• Vafseo, an oral treatment for anemia due to CKD in dialysis, launched in January 2025, targets a $1 billion U.S. market and is positioned for significant growth as access expands.

• The pipeline targets high unmet needs in severe kidney diseases, including FSGS, IgAN, LN, C3G, and CS-AKI, representing multi-billion-dollar opportunities.

• Praliciguat phase II trial in FSGS began in December 2025; AKB-097 basket trial to start in 2H 2026; AKB-9090 phase I in healthy volunteers to begin soon.

Clinical trial data and development milestones

• Praliciguat demonstrated efficacy in preclinical models and a phase II diabetic nephropathy study, showing 20–25% reduction in albuminuria.

• Praliciguat phase II in FSGS is a 24-week, randomized, placebo-controlled study with crossover, focusing on proteinuria reduction and partial remission rates, targeting up to 60 patients.

• AKB-097 phase I showed tissue-targeted complement inhibition with minimal systemic effects and favorable safety; phase II basket trial for IgAN, LN, and C3G will initiate in 2H 2026.

• AKB-9090 showed promising preclinical efficacy in ischemia-reperfusion AKI models; phase I for CS-AKI to start in Q2 2026, with top-line data in Q1 2027.

• Vafseo access has expanded to 290,000 patients, with improved refill rates and broader clinic adoption; VOCAL and VOICE trial data expected by 2027.

R&D strategy and innovation priorities

• Strategy centers on building a differentiated pipeline in kidney disease, leveraging unique mechanisms such as tissue-targeted complement inhibition, HIF-PH inhibition, and NO pathway targeting.

• Emphasis on expanding indications, combining therapies, and matching technologies to diseases for broader impact and safety.