VERA files BLA for atacicept with July 2026 FDA decision; Q1 loss doubles to $121M

Filed May 7, 2026 · Period ending March 31, 2026 · Compared to 10-Q May 7, 2025 · ~1 min read

Key Changes

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  BLA submitted November 2025 for atacicept in IgA nephropathy; FDA granted priority review with July 7, 2026 PDUFA date under accelerated approval pathway, marking first regulatory filing milestone.

  MD&A: BLA submission and FDA priority review verify on EDGAR →
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  Pivotal ORIGIN 3 trial met primary endpoint with 42% reduction in proteinuria versus placebo (p<0.0001); favorable safety profile with no deaths and fewer serious adverse events than placebo.

  MD&A: ORIGIN 3 primary endpoint results verify on EDGAR →
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  Q1 2026 net loss $121M versus $51.7M prior year, driven by $20.9M manufacturing scale-up, $15M BLA-filing milestone payment, and $23.2M increase in G&A for commercial preparation including sales force hiring.

  MD&A: Net loss increase verify on EDGAR →