CG Oncology Announces New Board Member and Board Transition
Rhea-AI Summary
CG Oncology (NASDAQ: CGON) appointed Christina Rossi to its Board of Directors and reported the resignation of Simone Song effective November 22, 2025. The company noted it has initiated a BLA for cretostimogene, positioning the firm to prepare for a potential commercial launch upon FDA approval.
Ms. Rossi brings >25 years of global pharma and biotech experience, including roles as Chief Operating Officer and Chief Commercial Officer at Blueprint Medicines and prior commercial leadership at Sanofi Genzyme and Biogen. The company emphasized commercial launch readiness and thanked Ms. Song for over a decade of board service.
Positive
- BLA initiation for cretostimogene (Nov 2025)
- Added Christina Rossi with 25+ years commercial and launch experience
Negative
- Board turnover: Simone Song resigned effective Nov 22, 2025
News Market Reaction
On the day this news was published, CGON declined 1.47%, reflecting a mild negative market reaction.
Data tracked by StockTitan Argus on the day of publication.
Key Figures
Market Reality Check
Peers on Argus
CGON slipped 0.31% while close peers were mixed: FOLD up 0.61%, TARS up 0.12%, CELC down 0.22%, IBRX down 4.78%, LQDA down 0.28%, indicating stock-specific trading rather than a broad sector move.
Historical Context
| Date | Event | Sentiment | Move | Catalyst |
|---|---|---|---|---|
| Dec 05 | Clinical data update | Positive | -3.7% | Promising BOND‑003 and CORE‑008 topline efficacy and tolerability data for cretostimogene. |
| Nov 26 | Board/management change | Positive | -1.5% | Appointment of experienced commercial executive to board and confirmation of BLA initiation. |
| Nov 25 | Conference presentation | Positive | -1.5% | Announcement of multiple SUO presentations highlighting cretostimogene clinical results and durability. |
| Nov 14 | Earnings and pipeline | Positive | +8.6% | Q3 results, strong cash of <b>$680.3M</b>, BLA start, and early completion of PIVOT‑006 enrollment. |
| Sep 05 | Clinical durability data | Positive | +6.9% | 24‑month BOND‑003 Cohort C data showing durable CR and low progression to invasive disease. |
Recent news often generated strong moves, with 3 divergences where positive clinical/strategic updates were followed by share price declines and 2 aligned positive reactions on major data and earnings updates.
Over the last six months, CG Oncology has focused on advancing cretostimogene in high‑risk NMIBC and progressing toward a BLA. Notable milestones included strong BOND‑003 durability data on Sep 5, 2025, initiation of a rolling BLA and early PIVOT‑006 completion reported with Q3 results on Nov 14, 2025, and multiple SUO and topline data updates in November and December. The current board transition and emphasis on commercial launch readiness build on this shift from pure clinical execution toward commercialization planning.
Market Pulse Summary
This announcement highlights CG Oncology’s transition toward commercialization, pairing recent BLA initiation for cretostimogene with the appointment of a director who has more than 25 years of pharmaceutical and biotech commercial experience. It follows recent financial filings and leadership changes, suggesting an emphasis on launch and governance readiness. Investors may watch future updates on BLA progress, pivotal trial readouts, and further board or finance leadership changes to gauge execution strength.
Key Terms
FDA approval regulatory
AI-generated analysis. Not financial advice.
- Appoints Accomplished Life Sciences Executive Christina Rossi to its Board of Directors -
IRVINE, Calif., Nov. 26, 2025 (GLOBE NEWSWIRE) -- CG Oncology, Inc. (NASDAQ: CGON), a late-stage clinical biopharmaceutical company focused on developing and commercializing a potential backbone bladder-sparing therapeutic for patients with bladder cancer, today announced the appointment of Christina Rossi to its Board of Directors. Additionally, Simone Song, Senior Partner, ORI Capital, has resigned from the Board effective November 22, 2025.
“We are at a critical juncture in CG Oncology’s history with our recent BLA initiation for cretostimogene. Now we are laying the foundation for a successful launch upon FDA approval, which includes adding Christy to our Board of Directors. Christy has a proven track record for building high-performing commercial organizations, launching new medicines, and delivering impactful programs to HCPs and most importantly to patients. We are positioned to address the broadest range of NMIBC patients to date, thanks to the hard work and dedication of our employees and Board over the years. I want to especially thank Simone for more than a decade of service on our Board and her many contributions to our strategy and direction,” said Arthur Kuan, Chairman and Chief Executive Officer of CG Oncology.
Ms. Rossi has more than 25 years of global pharmaceutical and biotechnology experience. Most recently, she served as Chief Operating Officer of Blueprint Medicines from 2022 until its acquisition by Sanofi in 2025. Previously, she served as Chief Commercial Officer and has overseen the commercial launches of Blueprint therapies across multiple indications and geographies, including the creation of commercial infrastructure and successful market access efforts in the U.S. and Europe. Prior to joining Blueprint Medicines, she served as the Multiple Sclerosis (MS) Business Unit Head, North America, at Sanofi Genzyme. In this role, she oversaw all aspects of the financial performance of Sanofi Genzyme’s MS franchise and increased market share for existing products, led the launch of new therapies and optimized operations to accelerate patient access. Previously, Ms. Rossi served as Vice President, MS Sales, and Vice President, MS Patient and Provider Services, at Sanofi Genzyme. Prior to joining Sanofi Genzyme, she held various roles at Biogen Inc., including Head, Commercial Strategy for Eidetica Biopharma GmbH, Biogen’s biosimilar-focused venture, and U.S. Brand Leader for TYSABRI® (natalizumab). In addition, she consulted in the healthcare practice at the Boston Consulting Group. Ms. Rossi holds a B.S. in biology, cum laude, from Duke University and an M.B.A. from Harvard Business School.
About Cretostimogene Grenadenorepvec
Cretostimogene is an investigational, intravesically delivered oncolytic immunotherapy that has been studied in a clinical development program, which includes more than 400 patients with Non-Muscle Invasive Bladder Cancer (NMIBC). This program includes two Phase 3 clinical trials: BOND-003 for high-risk BCG-unresponsive NMIBC and PIVOT-006 for intermediate-risk NMIBC. CG Oncology also has a Phase 2 trial, CORE-008, evaluating the safety and efficacy of cretostimogene in high-risk NMIBC. Additionally, we have initiated an Expanded Access Program for cretostimogene in North America for patients who are unresponsive to BCG and meet certain program eligibility requirements. Cretostimogene is an investigational candidate, and its safety and efficacy have not been established by the FDA or any other health authority.
About CG Oncology
CG Oncology is a late-stage clinical biopharmaceutical company focused on developing and commercializing a potential backbone bladder-sparing therapeutic for patients afflicted with bladder cancer. CG Oncology sees a world where urologic cancer patients may benefit from our innovative immunotherapies to live with dignity and have an enhanced quality of life. To learn more, please visit: www.cgoncology.com.
Forward-Looking Statements
CG Oncology cautions you that statements contained in this press release regarding matters that are not historical facts are forward-looking statements. The forward-looking statements are based on our current beliefs and expectations and include, but are not limited to, statements regarding our anticipated cash runway, future results of operations and financial position; the anticipated timing and conduct of our ongoing and planned clinical trials and preclinical studies for cretostimogene, including anticipated next milestones in our development pipeline; the timing and likelihood of regulatory filings and approvals for cretostimogene; and the potential therapeutic benefits of cretostimogene for high-risk and intermediate-risk NMIBC patients. Actual results may differ from those set forth in this press release due to the risks and uncertainties inherent in our business, including, without limitation: interim results of a clinical trial are not necessarily indicative of final results and one or more of the clinical outcomes may materially change as patient enrollment continues, following more comprehensive reviews of the data, and as more patient data becomes available; potential delays in the commencement, enrollment and completion of clinical trials, including the BOND-003 and PIVOT-006 trials; we may use our capital resources sooner than expected and they may be insufficient to allow us to achieve our anticipated milestones; our dependence on third parties in connection with manufacturing, shipping and clinical and preclinical testing; results from earlier clinical trials and preclinical studies not necessarily being predictive of future results; unexpected adverse side effects or inadequate efficacy of cretostimogene that may limit its development, regulatory approval, and/or commercialization; and other risks described in our filings with the Securities and Exchange Commission (SEC), including under the heading “Risk Factors” in our annual report on Form 10-K and other filings that we make with the SEC from time to time (which are available at http://www.sec.gov). You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and we undertake no obligation to update such statements to reflect events that occur or circumstances that exist after the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement, which is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.
Contacts:
Media
Sarah Connors
Vice President, Communications and Patient Advocacy, CG Oncology
sarah.connors@cgoncology.com
Investor Relations
Megan Knight
Vice President, Investor Relations, CG Oncology
megan.knight@cgoncology.com
FAQ
Who did CG Oncology (CGON) appoint to its board on November 26, 2025?
What board change did CG Oncology (CGON) announce effective November 22, 2025?
What regulatory milestone did CG Oncology (CGON) report alongside the board appointment?
What commercial experience does Christina Rossi bring to CG Oncology (CGON)?
How might Christina Rossi's appointment affect CG Oncology's (CGON) launch plans?
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