CG Oncology Provides Updated Timeline for PIVOT-006 Phase 3 Topline Data in Intermediate-Risk NMIBC

CG Oncology (NASDAQ: CGON) announced that topline Phase 3 data from the PIVOT-006 study in intermediate-risk non-muscle invasive bladder cancer (IR NMIBC) is now expected in 1H 2026, roughly one year earlier than previously planned due to expedited enrollment.

Rhea-AI Summary

CG Oncology (NASDAQ: CGON) announced that topline Phase 3 data from the PIVOT-006 study in intermediate-risk non-muscle invasive bladder cancer (IR NMIBC) is now expected in 1H 2026, roughly one year earlier than previously planned due to expedited enrollment. The randomized, open-label registrational trial compares adjuvant intravesical cretostimogene grenadenorepvec versus surveillance after tumor removal in >360 patients across 90+ sites. PIVOT-006 is described as the first Phase 3 randomized trial in this IR NMIBC population and includes the broadest range of patient types per AUA/SUO guidelines.

Positive

• Topline data now expected in 1H 2026
• Enrollment completed rapidly across 90+ sites
• Study includes >360 randomized patients
• First Phase 3 randomized trial in IR NMIBC

Negative

• Efficacy and safety topline results are not yet reported

Argus Jan 9 session

+29.26% close to close Open Argus

Details

News Market Reaction – CGON

In the Jan 9 session, CGON gained 29.26%, reflecting a significant positive market reaction.

Data tracked by StockTitan Argus on the day of publication.

Market Context

The stock surged +29.3% in the session following this news. A strong positive reaction aligns with t...

Analysis

The stock surged +29.3% in the session following this news. A strong positive reaction aligns with the company’s accelerated progress, as PIVOT-006 Phase 3 topline data moved up to 1H 2026 and enrollment exceeded 360 patients across 90+ sites. Historical data show that even robust clinical updates have not always produced lasting gains, so investors may have weighed prior divergences. Elevated liquidity of $680.3 million and ongoing BLA work could support sentiment, but past pullbacks after good news suggest that enthusiasm might have faced bouts of consolidation.

Key Figures

Topline data timing: 1H 2026 Patients enrolled: more than 360 patients Trial sites: over 90 sites +5 more

Topline data timing

1H 2026

PIVOT-006 Phase 3 readout timeline, nearly one year ahead of schedule

Patients enrolled

more than 360 patients

PIVOT-006 trial in intermediate-risk NMIBC

Trial sites

over 90 sites

PIVOT-006 rapid enrollment across academic and community centers

US IR NMIBC population

greater than 50,000 patients

Estimated intermediate-risk NMIBC population in the US

Q3 2025 revenue

$1.666 million

Total revenues reported in Q3 2025 10-Q

Q3 2025 net loss

$43.808 million

Net loss for quarter ended September 30, 2025

Cash & securities

$680.3 million

Cash, cash equivalents and marketable securities as of September 30, 2025

Working capital

$665.3 million

Working capital as of September 30, 2025

Historical Context

5 past events · Latest: Jan 06

5 events

1. Jan 06

   Conference appearance

   24h Move

   +0.8%

   Announcement of J.P. Morgan Healthcare Conference presentation and webcast access.

2. Dec 18

   Research fellowship

   24h Move

   +1.7%

   Launch of second annual NMIBC research fellowship with two $50,000 grants.

3. Dec 05

   Clinical data update

   24h Move

   -3.7%

   Promising BOND-003 and CORE-008 efficacy and safety data in NMIBC cohorts.

4. Nov 26

   Board and BLA update

   24h Move

   -1.5%

   New director appointment and note that a BLA for cretostimogene was initiated.

5. Nov 25

   Conference presentations

   24h Move

   -1.5%

   Planned SUO meeting presentations and posters on multiple cretostimogene cohorts.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Key Terms

phase 3, topline data, non-muscle invasive bladder cancer (nmibc), adjuvant, +2 more

6 terms

phase 3 medical

"PIVOT-006 Phase 3 topline data evaluating cretostimogene monotherapy"

Phase 3 is the late-stage clinical testing step for a new drug or medical treatment, where the product is given to large groups of patients to confirm effectiveness, monitor side effects, and compare it to standard care. Successful Phase 3 results are often the final scientific hurdle before regulators decide on approval and market launch—like passing a final exam before graduation—and can sharply change a company's valuation and future revenue prospects.

topline data medical

"announced an expedited timeline for the topline data readout now expected"

Topline data are the initial, high-level results from a clinical study that show whether the main goals of the trial were met, much like the headline of a news story that summarizes the most important point. Investors care because these early outcomes quickly indicate a drug’s commercial potential and regulatory path — positive topline results can boost a company’s value, while disappointing ones can sharply reduce expected future revenue.

non-muscle invasive bladder cancer (nmibc) medical

"patients with intermediate-risk non-muscle invasive bladder cancer (IR NMIBC)."

Non-muscle invasive bladder cancer (NMIBC) is a form of bladder cancer that is confined to the inner lining of the bladder and has not grown into the deeper muscle layer; think of it as a superficial patch on wallpaper rather than a stain that has soaked through the wall. It matters to investors because NMIBC often requires repeated treatments and monitoring, drives demand for outpatient therapies and diagnostics, and creates a sizable, ongoing market for drugs, devices, and procedures due to high recurrence and long-term care costs.

adjuvant medical

"compares adjuvant intravesical cretostimogene grenadenorepvec versus surveillance"

An adjuvant is an ingredient added to a vaccine or other therapy to strengthen or shape the body’s response to the main active component, like a helper that makes the primary ingredient work better or longer. For investors, adjuvants matter because they can change how well a product performs, alter dosing and safety profiles, affect regulatory review, and therefore influence clinical success, market size and competitive advantage.

intravesical medical

"compares adjuvant intravesical cretostimogene grenadenorepvec versus surveillance"

Intravesical describes a medical treatment or procedure where a drug or therapy is placed directly into the bladder through a catheter rather than taken by mouth or injected into the bloodstream. For investors, it signals a focused delivery method that can increase local effectiveness and reduce whole‑body side effects, often affecting a product’s clinical value, patient convenience, regulatory path, and market niche — like watering a plant at its roots instead of spraying its leaves.

aua/suo guidelines medical

"per AUA/SUO Guidelines including HG Ta solitary lesions < 3cm."

Clinical practice recommendations produced jointly by the American Urological Association (AUA) and the Society of Urologic Oncology (SUO) that summarize best practices for diagnosing and treating urological cancers and related conditions. Investors watch these guidelines because they shape which tests, drugs, and devices become standard care—similar to a recipe that hospitals and insurers follow—which affects sales, reimbursement, regulatory attention, and long‑term market adoption.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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- PIVOT-006 Phase 3 topline data evaluating cretostimogene monotherapy for intermediate-risk NMIBC now expected in 1H 2026, nearly one year ahead of schedule

- First randomized registrational trial to evaluate an investigational therapy in intermediate-risk NMIBC

IRVINE, Calif., Jan. 09, 2026 (GLOBE NEWSWIRE) -- CG Oncology, Inc. (NASDAQ: CGON) today announced an expedited timeline for the topline data readout now expected in the first half of 2026 for the Phase 3 PIVOT-006 clinical trial comparing adjuvant intravesical cretostimogene grenadenorepvec versus surveillance in patients with intermediate-risk non-muscle invasive bladder cancer (IR NMIBC). PIVOT-006 is the first Phase 3 randomized trial in this patient population, encompassing the broadest range of patient types per AUA/SUO Guidelines including HG Ta solitary lesions < 3cm.

“We are thrilled to announce that we now expect PIVOT-006 topline Phase 3 data in the first half of 2026, which is nearly one year ahead of schedule thanks to the unprecedented early completion of enrollment. Our goal is to bring forward a potential indication in adjuvant IR NMIBC, for which there are currently no U.S. FDA approved options. Broad participation across academic and community sites supports the real‑world relevance of this trial, and the rapid enrollment underscores the immense unmet need that exists for intermediate-risk NMIBC patients,” said Arthur Kuan, Chairman & Chief Executive Officer, CG Oncology. “The IR population is estimated to be greater than fifty thousand patients in the US alone, and we look forward to broadening our potential reach to individuals living with IR NMIBC.”

PIVOT-006 Topline Data Expected in 1H 2026
CG Oncology now plans to share topline data from the Phase 3, randomized, open-label PIVOT-006 registrational study in the first half of 2026. This expedited timeline is due to the rapid study enrollment across over 90 sites. The PIVOT-006 study compares adjuvant intravesical cretostimogene grenadenorepvec versus surveillance following bladder tumor removal in more than 360 patients with intermediate-risk non-muscle invasive bladder cancer (IR NMIBC). PIVOT-006 is the first Phase 3 randomized trial in this patient population, encompassing the broadest range of patient types per AUA/SUO Guidelines including HG Ta solitary lesions < 3cm.

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, the anticipated timeline of topline data of the PIVOT-006 study, the potential therapeutic benefits of cretostimogene for high-risk and intermediate-risk NMIBC patients, cretostimogene’s potential as a backbone immunotherapy across the NMIBC spectrum, the IR patient population is estimated to be greater than fifty thousand patients in the United States, and that we may broaden our potential market reach to patient living with IR NMIBC. 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, as supplemented by “Risk Factors” of our quarterly report on Form 10-Q for the quarter ended June 30, 2025 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

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

When will CG Oncology (CGON) report PIVOT-006 Phase 3 topline data?

Topline data from PIVOT-006 is expected in 1H 2026.

What does the PIVOT-006 trial compare in intermediate-risk NMIBC (CGON)?

PIVOT-006 compares adjuvant intravesical cretostimogene grenadenorepvec versus surveillance after tumor removal.

How many patients and sites were enrolled in CGON's PIVOT-006 study?

The study enrolled more than 360 patients across over 90 sites.

Why is PIVOT-006 significant for intermediate-risk NMIBC investors following CGON (CGON)?

It is described as the first Phase 3 randomized registrational trial in the IR NMIBC population, expanding potential evidence for an unmet need.

Does the PIVOT-006 announcement include clinical efficacy results for CGON's therapy?

No; the announcement confirms an expedited timeline but does not report efficacy or safety topline results.