Orca Bio has built a centralized 100,000 square foot manufacturing facility to ensure consistent and reliable delivery of high-precision cell therapies at scale, with donor to patient vein-to-vein turnaround times of 72 hours or less. The company completed a Series F financing round in December 2025 led by Lightspeed Venture Partners, raising $250M in new equity capital from its two most recent financing rounds, along with a 2025 amendment to its Silicon Valley Bank credit facility providing up to $100M in additional liquidity.
Cyborg Score Rationale
Orca Bio announced in April 2026 that the FDA extended the review timeline of its Biologics License Application (BLA) for Orca-T, with the new Prescription Drug User Fee Act (PDUFA) target action date of July 6, 2026. The FDA has not requested any additional clinical data, and Orca Bio believes the updated information submitted does not affect the benefit-risk conclusions of the BLA. Strong capital position and manufacturing infrastructure de-risk execution near approval.
Top Insights
Orca-T is approaching an April 6, 2026 Prescription Drug User Fee Act (PDUFA) target action date, though this was subsequently extended to July 6, 2026 in April 2026.
Orca Bio has treated more than 400 patients as part of ongoing clinical trials.
The capital will support the accelerated advancement of Orca Bio's pipeline across multiple clinical programs designed to expand treatment to more patients in need.
Orca Bio intends to develop candidates that combine its high-precision approach with CAR-T technology for the treatment of multiple myeloma and Non-Hodgkin's lymphoma.
Named Competitors
CAR-T — CAR-T cell immunotherapy
Kymriah — Anti-CD19 CAR-T cell therapy
Yescarta — Anti-CD19 CAR-T cell therapy
Recent Developments
(April 2026) FDA extended Orca-T BLA review timeline to July 6, 2026; company submitted updated chemistry, manufacturing and controls information
(January 2026) Completed Series F financing round of $250M led by Lightspeed Venture Partners, securing $100M additional Silicon Valley Bank credit facility
(December 2025) Series F financing round completion establishing commercial readiness infrastructure
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