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CG Oncology Stock Rallies Nearly 32% in a Week: Here is Why
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Key Takeaways
CGON expects PIVOT-006 top-line data a year earlier than previously forecasted.
CGON shares jumped nearly 32% over the past week as the phase III timeline moved up by almost a year.
CG Oncology is advancing cretostimogene across late-stage NMIBC studies, with a rolling BLA planned for 2026.
Shares of CG Oncology (CGON - Free Report) , 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.
Image Source: Zacks Investment Research
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.
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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CG Oncology Stock Rallies Nearly 32% in a Week: Here is Why
Key Takeaways
Shares of CG Oncology (CGON - Free Report) , 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.
Image Source: Zacks Investment Research
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 - Free Report) , Keros Therapeutics (KROS - Free Report) and Amicus Therapeutics (FOLD - Free Report) , 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%.