New York, January 11, 2026, 07:42 EST — Market closed
- CG Oncology shares jumped 29% on Friday after the company moved up the release of Phase 3 PIVOT-006 topline data to the first half of 2026
- Morgan Stanley bumped up its price target and increased the success probability for the intermediate-risk program
- Investors are turning to JPMorgan Healthcare Conference week for new clues on timelines and strategies
CG Oncology shares jumped 29.26% on Friday, finishing at $54.20, setting a strong tone for Monday’s open. The boost came after the company announced it now anticipates Phase 3 PIVOT-006 topline results in the first half of 2026. (Poteau Daily News)
The company said the quicker readout comes after enrollment finished ahead of schedule and could accelerate a possible adjuvant treatment for intermediate-risk non‑muscle invasive bladder cancer, or NMIBC—a type that hasn’t invaded the bladder muscle. “Our goal is to bring forward a potential indication … for which there are currently no U.S. FDA approved options,” CEO Arthur Kuan said. (SEC)
PIVOT-006 pits intravesical cretostimogene—delivered directly into the bladder—against surveillance following tumor removal, or TURBT. CG Oncology laid out the study in an investor deck as a 364-patient, 1:1 randomized, open-label trial focusing on recurrence-free survival as the main endpoint. The slide also outlined key 2026 milestones, including further data releases and a planned biologics license application (BLA) submission targeting high-risk disease. (SEC)
Morgan Stanley bumped its price target on CG Oncology to $93 from $89 while maintaining an Overweight rating on Friday. Analyst Jeffrey Hung highlighted the “accelerated timeline signals strong execution and high physician engagement,” prompting the firm to raise its probability-of-success estimate for the intermediate-risk program to 70% from 60%. (Investing)
A filing on Friday referred back to earlier topline results from other cretostimogene studies in NMIBC. CG Oncology reported that, as of the Sept. 1, 2025 data cut, there were no grade 3 or higher treatment-related adverse events in BOND‑003 Cohort P. The company also noted that no patients had progressed to muscle‑invasive bladder cancer in that dataset. (SEC)
The NMIBC market is heating up quickly. Johnson & Johnson snagged U.S. approval in September for Inlexzo, its bladder‑delivered gemcitabine system. Earlier in June, UroGen secured FDA clearance for Zusduri, an intravesical mitomycin therapy targeting recurrent low‑grade intermediate‑risk NMIBC. (Reuters)
The wider market is in focus this week as well. The J.P. Morgan Healthcare Conference kicks off January 12‑15 in San Francisco. It’s a crucial annual event for biotech timelines and gauging investor interest. (JPMorgan Chase)
CG Oncology will present on January 15 at 8:15 a.m. PT (11:15 a.m. ET). The company confirmed that Kuan and President Ambaw Bellete will be the speakers. (BioSpace)
Speed alone won’t secure a win. If PIVOT-006 doesn’t demonstrate a clear advantage over surveillance, or if safety concerns grow with longer patient follow-up, the rally on Friday could vanish just as fast as it appeared.
Traders are also waiting to see if the company provides more detail on how a positive readout might lead to a filing timeline, and whether the heavy volume on Friday signals genuine buying interest or just short-term churn.
