Mirvetuximab soravtansine

DALLAS, Oct. 13, 2026 (GLOBE NEWSWIRE) -- CG Oncology, Inc. (NASDAQ: CGON) today announced the appointment of Isabel Kalofonos as Chief Commercial Officer. A highly accomplished biopharmaceutical executive with more than 20 years of commercial leadership experience, Ms. Kalofonos will lead the Company's commercial strategy and execution as CG Oncology advances toward the potential launch of cretostimogene grenadenorepvec and continues to establish itself as a leader in bladder cancer. "Isabel’s appointment reflects our commitment to ensuring we are well positioned to bring cretostimogene to as many patients as possible upon approval," said Arthur Kuan, Chairman and Chief Executive Officer of CG Oncology. "As we prepare for a potential first commercial launch, we are making deliberate investments in experienced leaders who have successfully built commercial organizations, developed differentiated strategies, and delivered product launches at scale. Isabel brings an outstanding track record of commercial execution across multiple therapeutic areas and stages of growth, and we are confident her expertise will be instrumental as we prepare to deliver on the full potential of cretostimogene." Ms. Kalofonos brings more than 20 years of experience driving successful launches and commercial execution, helping bring innovative therapies to patients at scale across the biotechnology and pharmaceutical industries. Most recently, she served as Chief Commercial Officer of Crinetics Pharmaceuticals (acquired by Vertex Pharmaceuticals), where she played a key role in the company’s transition to the commercial stage, helping to drive the successful launch of PALSONIFY™ (paltusotine) and advance commercial planning across the pipeline. Prior to Crinetics, Ms. Kalofonos served as Chief Commercial Officer at ImmunoGen (acquired by AbbVie), where she led the successful launch of ELAHERE® (mirvetuximab soravtansine) in ovarian cancer. Earlier in her career, Ms. Kalofonos served as Senior Vice President and Global Head of the Prescription Business Unit at Galderma, where she oversaw the build-out of the business unit and pre-launch preparations for NEMLUVIO® (nemolizumab). She also served as Vice President and Head of the Hereditary Angioedema Franchise at Takeda Pharmaceuticals (formerly Shire), leading a multi-billion-dollar business and the successful global launch of TAKHZYRO® (lanadelumab‑flyo). Throughout her career, she has built and led high-performing global commercial organizations across oncology, immunology, rare diseases, and neurology. Ms. Kalofonos holds an M.B.A. in Entrepreneurship and Marketing from Babson College and a bachelor's degree in Industrial Engineering from Pontificia Universidad Javeriana. "CG Oncology is entering an exciting and transformative period, and I am thrilled to join the company at such a pivotal time," said Isabel Kalofonos. "The clinical data generated to date for cretostimogene, the significant unmet need that remains for patients with bladder cancer, and the passion of the CG Oncology team make this a truly compelling opportunity. Having spent much of my career preparing companies for launch and building commercial organizations, I look forward to hitting the ground running, partnering across the organization, and helping ensure we are ready to successfully bring cretostimogene to patients." 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. Cretostimogene has received FDA Fast Track and Breakthrough Therapy designations. 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: . 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 the potential approval and commercial launch of cretostimogene, the timing, progress and success of our commercial launch preparations and commercialization activities, our ability to build and execute our commercial strategy and establish the infrastructure necessary to support a potential commercial launch, the anticipated contributions of our Chief Commercial Officer, our ability to bring cretostimogene to patients, if approved, the potential therapeutic and commercial benefits of cretostimogene, and our ability to advance our position in the treatment of bladder cancer. 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: the timing and outcome of regulatory review of cretostimogene and the possibility that regulatory approval may be delayed, limited or not obtained, uncertainties regarding the timing and success of our commercial launch preparations and commercialization activities, our ability to establish, scale and maintain an effective commercial infrastructure, the scope of any approved indication or labeling for cretostimogene, the rate and degree of market acceptance of cretostimogene, if approved, by patients, healthcare providers and payors, our ability to obtain and maintain adequate pricing, coverage and reimbursement, our ability and the ability of our third-party manufacturers and suppliers to manufacture and supply sufficient quantities of cretostimogene for commercial use, competition from existing and future therapies, unexpected adverse side effects or inadequate efficacy of cretostimogene that may limit its development, regulatory approval or commercialization, our dependence on third parties in connection with manufacturing, shipping, clinical testing and commercialization activities, our ability to attract and retain key personnel, 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 ). 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