JNJ's Bladder Cancer Therapy Meets Key Goal in Early-Stage Study

Johnson & Johnson JNJ reported positive results from an early-stage study evaluating its investigational intravesical drug-releasing system with erdafitinib (Erda-iDRS) in patients with intermediate-risk and high-risk non–muscle-invasive bladder cancer (NMIBC). The study population includes patients whose tumors harbor select FGFR alterations.

J&J’s Erda-iDRS is designed to deliver prolonged, localized erdafitinib, an oral kinase inhibitor, directly to the bladder over three months, potentially allowing targeted therapy with limited systemic exposure. FGFR alterations are relatively common in early-stage bladder cancer, appearing in roughly 70% of intermediate-risk and about 40% of high-risk NMIBC tumors, making them an important therapeutic target.

JNJ’s Early-Stage Bladder Cancer Study Results in Detail

Data from J&J’s phase I study evaluating Erda-iDRS in patients with FGFR-altered NMIBC showed the therapy met its primary safety endpoint while demonstrating encouraging clinical activity.

The study enrolled patients with recurrent intermediate-risk NMIBC and those with Bacillus Calmette-Guérin (BCG)-experienced high-risk disease whose tumors carried FGFR alterations identified through urine or tissue testing. As of Nov. 3, 2025, 62 patients in the intermediate-risk cohort and 26 in the high-risk cohort had received treatment. While safety was the primary endpoint, investigators also assessed complete response (CR) rates and duration of CR in the intermediate-risk group and recurrence-free survival in the high-risk population.

In the past six months, JNJ’s shares have risen 36.3% compared with the industry’s 17.2% growth.

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Results in the intermediate-risk cohort were particularly notable. Erda-iDRS achieved an 89% CR rate during the initial treatment period, with responses proving durable over time. Among responders, the median duration of CR reached 18 months with a similar median follow-up period, suggesting prolonged disease control in a population that typically experiences frequent tumor recurrences and repeated surgical procedures.

In the high-risk cohort, the treatment also demonstrated promising disease-control outcomes. Patients receiving Erda-iDRS therapy recorded a median recurrence-free survival of 20 months, with a 12-month recurrence-free survival rate of 83%. With a median recurrence-free survival follow-up of 24 months, the data suggest encouraging durability of response in this higher-risk setting.

Erda-iDRS was overall well-tolerated in both cohorts and demonstrated a manageable safety profile. No dose-limiting toxicities were observed, and most treatment-related adverse events were localized and mild to moderate in severity. Pharmacokinetic analyses showed sustained drug levels in the bladder with minimal systemic exposure and no observed hyperphosphatemia, supporting the therapy’s localized delivery approach.

JNJ’s Next Steps in the Bladder Cancer Program

Positive findings from the early-stage study support continued development of this targeted approach, with ongoing phase II and phase III studies evaluating Erda-iDRS across different NMIBC risk settings. These studies are part of J&J’s MoonRISe clinical program, which is designed to further assess the therapy’s potential in both intermediate- and high-risk disease and in different treatment settings.

The program includes the phase III MoonRISe-1 study evaluating Erda-iDRS as an adjuvant treatment following tumor resection in intermediate-risk NMIBC. Another study, the phase II MoonRISe-2 study, is also assessing the therapy in intermediate-risk NMIBC in the ablative setting by treating visible tumors without surgery. Meanwhile, the phase III MoonRISe-3 study is investigating Erda-iDRS in patients with high-risk papillary NMIBC who have previously received BCG therapy, including those with BCG-unresponsive disease, in the adjuvant setting. These studies aim to further determine whether targeted intravesical delivery of erdafitinib can provide durable disease control across different patient populations.

Johnson & Johnson Price and Consensus

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JNJ’s Zacks Rank & Stocks to Consider

J&J currently carries a Zacks Rank #3 (Hold).

Some better-ranked stocks in the biotech sector are USANA Health Sciences USNA, Catalyst Pharmaceuticals CPRX and ALX Oncology Holdings ALXO. While USNA and CPRX sport a Zacks Rank #1 (Strong Buy) each, ALXO carries a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.

Over the past 60 days, estimates for USANA Health Sciences’ 2026 earnings per share (EPS) have risen from $1.90 to $2.00. USNA shares have lost 42.6% over the past six months.

USANA Health Sciences’ earnings beat estimates in three of the trailing four quarters and matched once, with the average surprise being 21.92%.

Over the past 60 days, estimates for Catalyst Pharmaceuticals’ 2026 EPS have risen from $2.55 to $2.82. CPRX shares have soared 16% over the past six months.

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 ALX Oncology Holdings’ 2026 loss per share have narrowed from $1.21 to 90 cents. ALXO shares have surged 88.6% over the past six months.

ALX Oncology Holdings’ earnings missed estimates in each of the trailing four quarters, with the average negative surprise being 12.82%.

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