CG Oncology Stock Rallies Nearly 32% in a Week: Here is Why

Shares of CG Oncology CGON, a late-stage clinical biopharmaceutical company, have surged nearly 32% over the past week. The upside came after the company announced on Jan. 9 that it expects to report top-line data from its phase III PIVOT-006 study in the first half of 2026, nearly a year earlier than previously projected, driven by early completion of patient enrollment across more than 90 clinical sites.

The phase III PIVOT-006 study is evaluating adjuvant intravesical cretostimogene grenadenorepvec versus active surveillance in more than 360 adult patients with intermediate-risk non-muscle invasive bladder cancer (IR NMIBC) following tumor resection. The primary endpoint of the study is recurrence-free survival (RFS), which measures the length of time patients live without the cancer returning. Secondary endpoints include RFS at specific times and progression-free survival.

Over the past six months, shares of CGON have surged 112.8% compared with the industry’s 22.9% growth.

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Cretostimogene is CG Oncology’s investigational, intravesically delivered oncolytic immunotherapy, which is being evaluated both as monotherapy and in combinations across several mid- and late-stage studies for different bladder cancer indications.

CG Oncology reported encouraging durability and response data in the second half of 2025 from the phase III BOND-003 study in patients with high-risk NMIBC unresponsive to Bacillus Calmette Guerin. The FDA granted both Fast Track and Breakthrough Therapy designations to the candidate in December 2023 for this indication. The company has initiated a rolling biologics license application submission which is expected to be completed in 2026.

A separate phase II CORE-008 study is also assessing cretostimogene’s safety and effectiveness in high-risk NMIBC. In addition, CG Oncology has launched an expanded access program in North America for eligible patients who do not respond to BCG therapy.

With no FDA-approved therapies currently available for patients with IR NMIBC after surgery, the accelerated phase III timeline combined with positive late-stage data from the BOND-003 study has strengthened expectations for eventual regulatory approval, significantly boosting investor confidence.

CG Oncology, Inc. Price

CG Oncology, Inc. price | CG Oncology, Inc. Quote

CG Oncology’s Zacks Rank & Stocks to Consider

CGON currently carries a Zacks Rank #3 (Hold).

Some better-ranked stocks in the biotech sector are MannKind MNKD, Keros Therapeutics KROS and Amicus Therapeutics FOLD, each currently sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Over the past 60 days, estimates for MannKind’s 2026 earnings per share have increased from 7 cents to 9 cents. Shares of MNKD have declined 6.7% over the past year.

MannKind’s earnings beat estimates in two quarters, missed in one and were in line in the remaining quarter with the average surprise being 33.33%.

Over the past 60 days, 2026 loss per share estimates for Keros Therapeutics have narrowed from $3.65 to $3.47. KROS shares have risen 85.7% over the past year.

Keros Therapeutics’ earnings beat estimates in three of the trailing four quarters and missed in the remaining quarter, with the average surprise being 9098.63%.

Over the past 60 days, estimates for Amicus Therapeutics’ 2026 earnings per share have declined from 67 cents to 65 cents. Shares of FOLD have increased 53.7% over the past year.

Amicus Therapeutics’ earnings beat estimates in one quarter and missed in the remaining three trailing quarters, with the negative average earnings surprise being 20.21%.

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This article originally published on Zacks Investment Research (zacks.com).

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