Headquartered in Dallas, TX Fiscal year ends December NASDAQ: CGON cgoncology.com
CG Oncology, Inc. (NASDAQ: CGON) is a late-stage clinical biopharmaceutical company focused on developing and commercializing a potential backbone, bladder-sparing therapy for bladder cancer.
Its lead and sole disclosed candidate is cretostimogene grenadenorepvec, an investigational oncolytic immunotherapy delivered intravesically (directly into the bladder). It has been studied in more than 700 patients with non-muscle invasive bladder cancer (NMIBC) and holds FDA Fast Track and Breakthrough Therapy designations for BCG-unresponsive NMIBC.
The development program includes:
- Two Phase 3 trials: BOND-003 in BCG-unresponsive NMIBC and PIVOT-006 in intermediate-risk and high-grade Ta ≤3cm NMIBC.
- The multi-cohort CORE-008 trial in BCG-exposed high-risk and BCG-unresponsive NMIBC.
- An Expanded Access Program in North America.
The company plans to complete a BLA submission for BCG-unresponsive NMIBC with carcinoma in situ in Q4 2026. It has added a Chief Commercial Officer ahead of a potential launch.
CG Oncology currently generates modest commercial and development revenue and funds its operations mainly from a cash and marketable securities balance of about $984.5 million. Management expects that balance to fund operations through 2029. Updated
The quarter is a sideshow: PIVOT-006 Phase 3 topline data lands this month, and the loss beat expectations against the $0.81 consensus, with $984.5 million in cash funding operations through 2029. A BLA submission for BCG-unresponsive bladder cancer is due by year end, so the next few weeks decide the stock.
The highlight of recent insider buying is an enormous purchase of Tesla shares by CEO Elon Musk. But it wasn't the only notable buy in the past week or so.
As January wound to a close, beneficial owners, executives, and other insiders took advantage of public offerings of stock at these biotech companies.
CG Oncology, Inc. (NASDAQ: CGON) is a late-stage clinical biopharmaceutical company focused on developing and commercializing a potential backbone, bladder-sparing therapy for bladder cancer.
The Wall Street consensus 12-month price target for CGON is $91.46.
