CG Oncology has moved the topline readout for its Phase 3 PIVOT‑006 study to the first half of 2026, a full year ahead of the original schedule. The change follows the rapid completion of patient enrollment, which finished in September 2025 across more than 90 sites and over 360 participants in the intermediate‑risk non‑muscle invasive bladder cancer (NMIBC) population.
The PIVOT‑006 trial is the first randomized Phase 3 study in this underserved group, for which no FDA‑approved intravesical therapy currently exists. The study compares adjuvant intravesical cretostimogene grenadenorepvec to surveillance after transurethral resection, and the accelerated timeline positions CG Oncology to file a regulatory submission and potentially launch earlier than initially planned.
Management emphasized the strategic significance of the accelerated schedule. CEO Arthur Kuan said the company’s goal is to bring forward a potential indication in adjuvant intermediate‑risk NMIBC, a market that has no U.S. FDA‑approved options. He added that the rapid enrollment “underscores the immense unmet need that exists for intermediate‑risk NMIBC patients,” highlighting the company’s strong clinical execution and physician engagement.
The announcement has drawn positive analyst attention. Morgan Stanley raised its price target to $93 from $89, Wedbush initiated coverage with an Outperform rating and a $70 target, and Bank of America lifted its target from $60 to $62. Analysts cited the accelerated timeline, the lack of competing FDA‑approved therapies, and the potential to capture a $2 billion U.S. market for high‑risk and intermediate‑risk NMIBC as key drivers of the upgraded outlook.
CG Oncology’s cretostimogene has already received FDA Fast Track and Breakthrough Therapy designations, and the company maintains a robust cash position of roughly $680 million as of Q3 2025. The early readout, combined with regulatory designations and a sizable addressable market, positions the company to become a first‑in‑class therapy in a high‑need segment, potentially transforming its commercial trajectory and providing a new revenue stream for a clinical‑stage biopharmaceutical firm.
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