CG Oncology Inc.

CG Oncology Appoints Proven Biopharmaceutical Commercial Leader Isabel Kalofonos as Chief Commercial Officer

CG Oncology appointed Isabel Kalofonos, a 20-plus-year biopharma commercial executive, as Chief Commercial Officer. She led launches at Crinetics (PALSONIFY), ImmunoGen (ELAHERE), and Takeda (TAKHZYRO), and will head commercial strategy ahead of a potential first launch of cretostimogene grenadenorepvec in bladder cancer. Cretostimogene is in Phase 3 trials BOND-003 and PIVOT-006 with FDA Fast Track and Breakthrough Therapy designations; the hire signals management is building launch infrastructure ahead of a possible approval.

•19d ago

CG Oncology Reports Second Quarter 2026 Financial Results and Provides Business Updates

CG Oncology reported Q2 2026 financial results with revenue of $1.16 million and a net loss of $79.1 million, or $0.90 per share. The company ended the quarter with approximately $1.0 billion in cash and equivalents, which is expected to fund operations into 2029. Operationally, management expects to complete a BLA submission for HR BCG-unresponsive NMIBC in the fourth quarter of 2026, with topline data from the Phase 3 PIVOT-006 study anticipated in the near-term. The company also highlighted the publication of BOND-003 Cohort C results in The Lancet Oncology. In legal news, the Superior Court of Delaware denied ANI's post-trial motion for a new trial, upholding the jury's verdict in favor of CG Oncology regarding the severed royalty provision.

•2mo ago

CG Oncology Announces Publication of Pivotal Phase 3 BOND-003 Cohort C Study Results in The Lancet Oncology

CG Oncology announced the publication of pivotal Phase 3 BOND-003 results in The Lancet Oncology, showing a 75.5% complete response rate for cretostimogene in BCG-unresponsive NMIBC. The data highlighted a median duration of response of at least 27.9 months and bladder preservation rates of 89% at 12 months and 81% at 24 months, with no Grade 3 or higher treatment-related adverse events reported. These results demonstrate best-in-disease durability and safety, supporting the potential for cretostimogene to become a foundational monotherapy pending regulatory review.

•3mo ago

CG Oncology Reports Positive First Results from CORE‑008 Cohort CX Phase 2 Trial Evaluating Intravesical Combination Therapy in High-Risk BCG-Exposed and BCG-Unresponsive Patients

CG Oncology reported positive Phase 2 results from the CORE-008 Cohort CX trial, evaluating intravesical cretostimogene combined with gemcitabine in high-risk non-muscle invasive bladder cancer patients. The study showed high complete response rates of 85.7% in the intent-to-treat population and 92.3% in the efficacy-evaluable population, with high-grade event-free survival of 96.0% at 3 months and 89.5% at 6 months. The combination therapy demonstrated a favorable safety profile with no Grade 3 or greater treatment-related adverse events and no deaths, supporting the potential for scalable bladder-sparing regimens.

•5mo ago

CG Oncology’s Presence at American Urological Association (AUA) Annual Meeting Underscores its Strong Commitment to NMIBC

CG Oncology will present first results from the CORE-008 Cohort CX Phase 2 trial at the American Urological Association (AUA) 2026 Annual Meeting, evaluating intravesical combination therapy in high-risk BCG-exposed and BCG-unresponsive patients. The company will also exhibit at booth #3051, providing an opportunity for attendees to learn more about its clinical development program and commitment to advancing innovative therapies for bladder cancer. Grant recipients of the CG-SUO-CTC NMIBC Research Fellowship will present their research at the SUO 2026 Annual Meeting, further demonstrating CG Oncology's support for clinical cancer research.

•5mo ago