Otsuka's VOYXACT Shows Kidney Function Stabilization in Phase 3 Trial; BioNTech Cuts Revenue Forecast on Weak COVID Vaccine Demand

Otsuka Pharmaceutical announced that its drug VOYXACT met its key secondary endpoint in a Phase 3 trial, demonstrating unprecedented stabilization of kidney function decline in IgA nephropathy patients over two years. The data will support Otsuka's FDA application for full approval. Meanwhile, BioNTech slashed its 2026 revenue guidance by €400 million to a range of €1.6 billion to €1.9 billion, citing a sharp decline in global COVID-19 vaccine demand, particularly in Germany, alongside widening net losses.

VOYXACT Phase 3 trial results

• ▪In the Phase 3 VISIONARY trial, Otsuka's VOYXACT (sibeprenlimab-szsi) met its key secondary endpoint, showing an annualized estimated eGFR slope of +0.3 mL/min/1.73 m²/year compared to -4.2 mL/min/1.73 m²/year for placebo over two years.
• ▪The overall safety profile of VOYXACT remained comparable to placebo over two years, with adverse event rates of 90.7% versus 90.0% and serious infection rates of 1.9% versus 4.0% respectively.
• ▪At two years in the Phase 3 VISIONARY trial, VOYXACT demonstrated a least square mean change from baseline in eGFR of +1.3 mL/min/1.73 m² compared to -7.9 mL/min/1.73 m² for placebo, representing a treatment difference of +9.2 mL/min/1.73 m².

IgA nephropathy disease modification

• ▪VOYXACT is a humanized monoclonal antibody that selectively binds to and blocks APRIL, a key immune driver that promotes the production of pathogenic galactose-deficient IgA1 complexes in IgA nephropathy.
• ▪VOYXACT is the first IgA nephropathy treatment to achieve the KDIGO therapeutic goal of limiting progressive kidney function decline to a physiologic rate of less than 1 mL/min/1.73 m²/year.

VOYXACT FDA regulatory pathway

• ▪VOYXACT received accelerated approval from the U.S. FDA on November 25, 2025, based on a statistically significant reduction in proteinuria compared to placebo at nine months in the VISIONARY trial.
• ▪Otsuka has initiated a rolling submission of a supplemental Biologics License Application to the U.S. FDA for traditional approval of VOYXACT, incorporating the newly completed 24-month VISIONARY trial dataset.

BioNTech revenue forecast cut

• ▪In response to falling revenues, BioNTech is reining in spending by lowering its projected full-year adjusted R&D costs to between €2.0 billion and €2.3 billion, down from a previous estimate of up to €2.5 billion.
• ▪BioNTech lowered its full-year 2026 sales guidance by €400 million to a new range of €1.6 billion to €1.9 billion ($1.84 billion to $2.19 billion), down from its previous forecast of €2.0 billion to €2.3 billion.
• ▪BioNTech's second-quarter 2026 revenue fell to €105.6 million from €260.8 million in the prior-year period, while its quarterly net loss expanded to €820.8 million.

COVID vaccine demand decline

• ▪BioNTech attributed approximately 80% of its sales outlook reduction to deteriorating global demand for its COVID-19 vaccine, with the remaining 20% caused by the deferral of an outlicensed R&D program milestone payment.
• ▪BioNTech announced Guido Oelkers as its next CEO to lead its oncology pipeline strategy, as founders Ugur Sahin and Özlem Türeci depart to launch a new mRNA biotechnology startup.
• ▪BioNTech faces acute sales pressure in Germany, which will use previously manufactured vaccine stockpiles for the upcoming vaccination season, and from an EMA decision allowing the use of older vaccine formulas.