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CGON Stock Up 60.8% in Six Months: Here's What You Need to Know
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Key Takeaways
CG Oncology stock jumped ~60.8% in six months amid strong momentum for lead drug cretostimogene.
CGON advanced the PIVOT-006 data timeline to H1 2026, after early enrollment completion across 90 sites.
CGON reported a 41.8% response rate in BOND-003 and built ~$903M liquidity to fund trials through 2029.
Shares of CG Oncology (CGON - Free Report) have surged 60.8% over the past six months compared with the industry’s 8.6% growth, driven by accelerating clinical momentum, a robust balance sheet and growing investor sentiment around its lead asset, cretostimogene.
Image Source: Zacks Investment Research
Accelerated Data Timeline Boosts Investor Confidence
CGON’s pipeline is centered on cretostimogene, an investigational, intravesically delivered oncolytic immunotherapy, which is being studied both as a monotherapy and in combination regimens across several mid- and late-stage studies targeting bladder cancer. The candidate has shown strong clinical progress in multiple studies.
The company is evaluating adjuvant intravesical cretostimogene grenadenorepvec in the phase III PIVOT-006 study versus active surveillance in more than 360 adult patients with intermediate-risk non muscle invasive bladder cancer (IR NMIBC) following tumor resection. Top-line data are now expected in the first half of 2026, nearly a year ahead of the prior guidance, driven by the early completion of patient enrollment across more than 90 clinical sites. 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.
Strong Late-Stage Data & Regulatory Progress
In the second half of 2025, the phase III BOND-003 study demonstrated that cretostimogene delivered strong and lasting results in patients with high risk non-muscle invasive bladder cancer unresponsive to Bacillus Calmette Guerin (BCG). The treatment achieved a 41.8% complete response rate at 24 months, along with a high progression-free rate of 96.6%, while maintaining a favorable safety profile.
The company expects to complete a biologics license application submission in 2026 for cretostimogene as a treatment for high risk, BCG-unresponsive NMIBC patients, including those with carcinoma in situ with or without Ta/T1 disease.
With no currently available FDA-approved therapies for IR NMIBC patients after surgery, cretostimogene is emerging as a potential backbone bladder-sparing therapy. The accelerated PIVOT-006 timeline, coupled with durable efficacy data from BOND-003, has reinforced investor confidence. Additional upside may come from the phase II CORE-008 Cohort CX study, which is evaluating cretostimogene in combination with gemcitabine, with initial data expected in the first half of 2026.
Strong Financial Position
From a financial standpoint, the company remains well capitalized. CG Oncology ended 2025 with $742.2 million in cash, cash equivalents and marketable securities, which was further bolstered by disciplined use of its at-the-market (ATM) facility—raising $98.4 million in the fourth quarter of 2025 and an additional $188.0 million in January 2026—bringing total liquidity to $903 million as of February 2026. The substantial cash runway is expected to extend into the first half of 2029, providing flexibility to fund ongoing phase III trials, regulatory activities and potential commercialization without near-term dilution risk.
Over the past 60 days, estimates for Catalyst Pharmaceuticals’ 2026 earnings per share have risen from $2.55 to $2.87. Over the same period, EPS estimates for 2027 have surged from $2.85 to $3.25. CPRX shares have gained 12.3% year to date.
Catalyst Pharmaceuticals’ earnings beat estimates in each of the trailing four quarters, with the average surprise being 35.19%.
Over the past 60 days, estimates for Indivior Pharmaceuticals’ 2026 earnings per share have risen from $2.89 to $3.08. Over the same period, EPS estimates for 2027 have surged from $3.22 to $3.41. INDV shares have lost 8.1% year to date.
Indivior Pharmaceuticals’ earnings beat estimates in each of the trailing four quarters, with the average surprise being 74.53%.
Over the past 60 days, estimates for ANI Pharmaceuticals’ 2026 earnings per share have increased from $8.22 to $8.99. Over the same period, EPS estimates for 2027 have risen from $9.90 to $10.10. Year to date, shares of ANIP have lost 0.8%.
ANI Pharmaceuticals' earnings beat estimates in each of the trailing four quarters, with the average surprise being 22.21%.
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CGON Stock Up 60.8% in Six Months: Here's What You Need to Know
Key Takeaways
Shares of CG Oncology (CGON - Free Report) have surged 60.8% over the past six months compared with the industry’s 8.6% growth, driven by accelerating clinical momentum, a robust balance sheet and growing investor sentiment around its lead asset, cretostimogene.
Image Source: Zacks Investment Research
Accelerated Data Timeline Boosts Investor Confidence
CGON’s pipeline is centered on cretostimogene, an investigational, intravesically delivered oncolytic immunotherapy, which is being studied both as a monotherapy and in combination regimens across several mid- and late-stage studies targeting bladder cancer. The candidate has shown strong clinical progress in multiple studies.
The company is evaluating adjuvant intravesical cretostimogene grenadenorepvec in the phase III PIVOT-006 study versus active surveillance in more than 360 adult patients with intermediate-risk non muscle invasive bladder cancer (IR NMIBC) following tumor resection. Top-line data are now expected in the first half of 2026, nearly a year ahead of the prior guidance, driven by the early completion of patient enrollment across more than 90 clinical sites. 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.
Strong Late-Stage Data & Regulatory Progress
In the second half of 2025, the phase III BOND-003 study demonstrated that cretostimogene delivered strong and lasting results in patients with high risk non-muscle invasive bladder cancer unresponsive to Bacillus Calmette Guerin (BCG). The treatment achieved a 41.8% complete response rate at 24 months, along with a high progression-free rate of 96.6%, while maintaining a favorable safety profile.
The company expects to complete a biologics license application submission in 2026 for cretostimogene as a treatment for high risk, BCG-unresponsive NMIBC patients, including those with carcinoma in situ with or without Ta/T1 disease.
With no currently available FDA-approved therapies for IR NMIBC patients after surgery, cretostimogene is emerging as a potential backbone bladder-sparing therapy. The accelerated PIVOT-006 timeline, coupled with durable efficacy data from BOND-003, has reinforced investor confidence. Additional upside may come from the phase II CORE-008 Cohort CX study, which is evaluating cretostimogene in combination with gemcitabine, with initial data expected in the first half of 2026.
Strong Financial Position
From a financial standpoint, the company remains well capitalized. CG Oncology ended 2025 with $742.2 million in cash, cash equivalents and marketable securities, which was further bolstered by disciplined use of its at-the-market (ATM) facility—raising $98.4 million in the fourth quarter of 2025 and an additional $188.0 million in January 2026—bringing total liquidity to $903 million as of February 2026. The substantial cash runway is expected to extend into the first half of 2029, providing flexibility to fund ongoing phase III trials, regulatory activities and potential commercialization without near-term dilution risk.
CG Oncology, Inc. Price and Consensus
CG Oncology, Inc. price-consensus-chart | 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 Catalyst Pharmaceuticals (CPRX - Free Report) and Indivior Pharmaceuticals (INDV - Free Report) , each currently sporting a Zacks Rank #1 (Strong Buy), and ANI Pharmaceuticals (ANIP - Free Report) , which carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Over the past 60 days, estimates for Catalyst Pharmaceuticals’ 2026 earnings per share have risen from $2.55 to $2.87. Over the same period, EPS estimates for 2027 have surged from $2.85 to $3.25. CPRX shares have gained 12.3% year to date.
Catalyst Pharmaceuticals’ earnings beat estimates in each of the trailing four quarters, with the average surprise being 35.19%.
Over the past 60 days, estimates for Indivior Pharmaceuticals’ 2026 earnings per share have risen from $2.89 to $3.08. Over the same period, EPS estimates for 2027 have surged from $3.22 to $3.41. INDV shares have lost 8.1% year to date.
Indivior Pharmaceuticals’ earnings beat estimates in each of the trailing four quarters, with the average surprise being 74.53%.
Over the past 60 days, estimates for ANI Pharmaceuticals’ 2026 earnings per share have increased from $8.22 to $8.99. Over the same period, EPS estimates for 2027 have risen from $9.90 to $10.10. Year to date, shares of ANIP have lost 0.8%.
ANI Pharmaceuticals' earnings beat estimates in each of the trailing four quarters, with the average surprise being 22.21%.