Johnson & Johnson highlights promising first-in-human Erda-iDRS (formerly TAR-210) results in intermediate-risk non-muscle-invasive bladder cancer

Rhea-AI Summary

Johnson & Johnson (NYSE:JNJ) presented Phase 1 Erda-iDRS data at EAU 2026 showing an 89% complete response rate in intermediate-risk non–muscle-invasive bladder cancer with a median complete-response duration of 18 months (95% CI, 14–25). Median recurrence-free survival in high-risk patients was 20 months.

Treatment met its primary safety endpoint, showed predominantly local adverse events, limited systemic exposure, and supports ongoing Phase 2 and Phase 3 MoonRISe studies.

Positive

• Complete response rate 89% in intermediate-risk NMIBC
• Median CR duration 18 months (95% CI, 14–25)
• Median recurrence-free survival 20 months in high-risk cohort
• No dose-limiting toxicities; limited systemic exposure observed

Negative

• Treatment-related adverse events led to 9% discontinuation rate
• Grade ≥3 treatment-related adverse events occurred in 5% of patients
• Most frequent TRAEs were hematuria 32% and dysuria 22%

Key Figures

Complete response rate: 89% Intermediate-risk patients: 62 patients High-risk patients: 26 patients +5 more

8 metrics

Complete response rate 89% Intermediate-risk NMIBC Phase 1 cohort initial treatment period

Intermediate-risk patients 62 patients Recurrent intermediate-risk NMIBC treated with Erda-iDRS

High-risk patients 26 patients Recurrent BCG-experienced high-risk NMIBC treated with Erda-iDRS

Median CR duration 18 months Responders in intermediate-risk cohort (95% CI 14–25)

Median recurrence-free survival 20 months High-risk cohort treated with Erda-iDRS (95% CI 15–30)

12-month RFS rate 83% High-risk NMIBC cohort (95% CI 62–93)

Grade ≥3 TRAEs 5% Four patients in combined cohorts with Grade 3 or higher TRAEs

FGFR alteration prevalence 70% / 40% Intermediate-risk vs high-risk NMIBC tumors with FGFR alterations

Market Reality Check

Price: $241.52 Vol: Volume 7,629,956 vs 9,044...

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$241.52 Last Close

Volume Volume 7,629,956 vs 9,044,783 20-day average suggests slightly lighter-than-normal trading interest. normal

Technical Shares at 242.04, trading above 200-day MA of 192.03 and within 3.84% of the 52-week high.

Peers on Argus

While JNJ slipped 0.39%, peers were mixed: ABBV up 0.08%, AZN, LLY, NVS and NVO ...

While JNJ slipped 0.39%, peers were mixed: ABBV up 0.08%, AZN, LLY, NVS and NVO down between 0.19% and 1.71%. With no peers in the momentum scanner, the move looks company-specific rather than a coordinated sector rotation.

Historical Context

5 past events · Latest: Mar 12 (Positive)

Pattern 5 events

Date	Event	Sentiment	Move	Catalyst
Mar 12	Device FDA approval	Positive	-0.4%	FDA approval of TECNIS PureSee intraocular lens for U.S. cataract patients.
Mar 05	Oncology FDA approval	Positive	-2.3%	FDA approval of TECVAYLI plus DARZALEX FASPRO for earlier-line multiple myeloma.
Mar 03	Fast Track designation	Positive	-0.7%	Nipocalimab granted U.S. FDA Fast Track status in systemic lupus erythematosus.
Mar 03	Press correction	Neutral	-0.7%	Correction release reiterating nipocalimab Fast Track designation and trial plans.
Mar 02	Investor conference notice	Neutral	-0.7%	Announcement of first-quarter earnings call and webcast logistics for April 14, 2026.

Pattern Detected

Recent history shows a pattern of negative price reactions following positive regulatory and clinical milestones, suggesting investors have sold into good news.

Recent Company History

Over the past two weeks, Johnson & Johnson has reported multiple positive regulatory and clinical milestones, including FDA approvals for TECNIS PureSee IOL on Mar 12 and TECVAYLI plus DARZALEX FASPRO earlier in March, as well as Fast Track status for nipocalimab. Despite these supportive updates and an upcoming Q1 investor call on Apr 14, 2026, shares reacted negatively after each event. Today’s strong Phase 1 Erda-iDRS bladder cancer data fits this pattern of fundamentally positive news against a cautious share-price backdrop.

Regulatory & Risk Context

Active S-3 Shelf

Shelf Active

Active S-3 Shelf Registration 2026-02-11

An effective S-3ASR shelf filed on 2026-02-11 allows Johnson & Johnson to issue unsecured debt securities from time to time under an existing indenture. Terms such as interest structure and maturity will be defined in future prospectus supplements, with proceeds earmarked for general corporate purposes including working capital, capital spending, buybacks, refinancing and acquisitions.

Market Pulse Summary

This announcement highlights promising early-stage Erda-iDRS data in FGFR-altered non–muscle-invasiv...

Analysis

This announcement highlights promising early-stage Erda-iDRS data in FGFR-altered non–muscle-invasive bladder cancer, with an 89% complete response rate and durable 18-month outcomes, plus generally manageable toxicity. It adds to a series of recent positive regulatory and clinical updates across Johnson & Johnson’s portfolio. Investors may monitor progression of the MoonRISe Phase 2 and Phase 3 studies, safety durability, and how this targeted approach complements existing bladder cancer standards of care.

Key Terms

intravesical, non–muscle-invasive bladder cancer, fibroblast growth factor receptor, Bacillus Calmette-Guérin, +4 more

8 terms

intravesical medical

"investigational intravesical drug-releasing system with erdafitinib (Erda-iDRS)"

Intravesical describes a medical treatment or procedure where a drug or therapy is placed directly into the bladder through a catheter rather than taken by mouth or injected into the bloodstream. For investors, it signals a focused delivery method that can increase local effectiveness and reduce whole‑body side effects, often affecting a product’s clinical value, patient convenience, regulatory path, and market niche — like watering a plant at its roots instead of spraying its leaves.

non–muscle-invasive bladder cancer medical

"patients with intermediate-risk and high-risk non–muscle-invasive bladder cancer (NMIBC)"

A form of bladder cancer in which tumors are confined to the inner lining of the bladder and have not grown into the muscle layer; it is generally less aggressive than muscle-invasive disease but prone to recurrence. Investors care because treatments, diagnostics, and clinical trial results for this category shape potential drug approval, recurring revenue from follow-up care, and the size and longevity of the patient market—think of it like treating surface weeds versus deep-rooted ones.

fibroblast growth factor receptor medical

"tumors harbor select fibroblast growth factor receptor (FGFR) alterations"

A fibroblast growth factor receptor (FGFR) is a protein on a cell’s surface that acts like a light switch: when it binds specific signaling molecules, it turns on pathways that control cell growth, division and blood-vessel formation. Changes or overactivity in FGFRs are linked to cancer and other diseases, so drugs that block or modify these receptors are important development targets and can significantly affect the value of biotech and pharmaceutical investments.

Bacillus Calmette-Guérin medical

"recurrent, Bacillus Calmette-Guérin (BCG)-experienced, high-risk non–muscle-invasive"

Bacillus Calmette-Guérin (BCG) is a weakened strain of a bacterium used as a vaccine against tuberculosis and as an immune-stimulating treatment for certain cancers, most notably early-stage bladder cancer. Think of it as a mild coach for the immune system that trains the body to recognize and attack disease; for investors, BCG matters because its supply, regulatory approvals, pricing, or clinical use can affect demand, company revenue, and healthcare costs.

recurrence-free survival medical

"secondary endpoints assessing complete response rate ... and recurrence-free survival"

Recurrence-free survival is the length of time after a treatment during which a patient shows no return of disease. It’s used in clinical trials to measure how well a therapy prevents the illness from coming back — think of it like the time a repaired roof stays leak-free. For investors, longer recurrence-free survival suggests a treatment is more effective, which can improve chances of regulatory approval, commercial uptake, and long-term revenue.

pharmacokinetic analyses medical

"Pharmacokinetic analyses demonstrated prolonged drug levels in the urine"

Pharmacokinetic analyses study how a drug moves through the body—how it is taken in, distributed to tissues, broken down and eliminated—measuring things like how quickly and how long the compound stays at effective levels. For investors, these results act like a route-and-timing map for a medicine: they shape dosing, safety and effectiveness expectations, regulatory approval chances and market potential, so strong pharmacokinetics reduce development risk and uncertainty.

hyperphosphatemia medical

"limited systemic exposure and no observed hyperphosphatemia"

An elevated level of phosphate in the blood, often caused by reduced kidney function or certain medications, that can harm bones, blood vessels and organs if untreated. Investors should care because prevalence, safety concerns and regulatory scrutiny around treatments or diagnostics for this condition can drive demand, affect clinical trial outcomes, influence healthcare spending and change a company’s revenue and risk profile—similar to how a common road hazard can change demand for safety products.

Phase 3 medical

"Phase 3 MoonRISe-3 study (NCT06919965) in patients with high-risk papillary"

Phase 3 is the late-stage clinical testing step for a new drug or medical treatment, where the product is given to large groups of patients to confirm effectiveness, monitor side effects, and compare it to standard care. Successful Phase 3 results are often the final scientific hurdle before regulators decide on approval and market launch—like passing a final exam before graduation—and can sharply change a company's valuation and future revenue prospects.

AI-generated analysis. Not financial advice.

• Data presented at EAU 2026 show an 89 percent complete response rate in intermediate-risk disease with durable responses observed over 18 months and tolerable safety profile 
• Erda-iDRS has the potential to be the first targeted treatment for early–stage bladder cancer

RARITAN, N.J., March 13, 2026 /PRNewswire/ -- Johnson & Johnson (NYSE:JNJ) today announced results from an open-label, multicenter Phase 1 study evaluating an investigational intravesical drug-releasing system with erdafitinib (Erda-iDRS) in patients with intermediate-risk and high-risk non–muscle-invasive bladder cancer (NMIBC) whose tumors harbor select fibroblast growth factor receptor (FGFR) alterations. The study met its primary safety endpoint and demonstrated complete and durable responses in patients with recurrent intermediate-risk disease, along with encouraging recurrence-free outcomes in high-risk disease. These findings support continued development of this targeted approach with ongoing Phase 2 and Phase 3 studies evaluating Erda-iDRS across risk settings. Data were presented during a late-breaking oral session at the European Association of Urology (EAU) 2026 Annual Meeting (Abstract #LB26-0083).¹

FGFR alterations are common in early-stage bladder cancer, occurring in approximately 70 percent of intermediate-risk and 40 percent of high-risk non–muscle-invasive bladder cancer tumors.^2,3 Because these changes may drive tumor growth, they represent an important therapeutic target in this setting. Erda-iDRS is designed to provide prolonged release of erdafitinib, an oral kinase inhibitor, directly into the bladder via intravesical administration over a three-month period, and may enable localized treatment while aiming to minimize systemic exposure and the risk of adverse events associated with oral administration.

"Intermediate-risk non–muscle-invasive bladder cancer is defined by recurrences, and many patients undergo repeated procedures as their tumors return," said Antoni Vilaseca Cabo,* M.D., adjunct physician of the Urology Service at Hospital Clínic de Barcelona in Spain, and presenting author. "In this study, treatment with Erda-iDRS led most patients with FGFR-altered disease to achieve a complete response by the end of the second treatment cycle, and many of those responses were sustained over time. Achieving and maintaining a complete response is particularly meaningful in this setting, where recurrence is common and requires repeated surgical intervention."

"For patients with FGFR-altered non–muscle-invasive bladder cancer, care has historically not been guided by precision-based approaches," said Christopher Cutie, M.D., Vice President, Disease Area Leader, Bladder Cancer, Johnson & Johnson. "The high and durable complete responses demonstrated with Erda-iDRS highlight the opportunity to deliver a targeted therapy to these patients. Bringing a biology-based approach into earlier stages of this disease has the potential to change how these patients are treated."

Detailed Study Results

In this Phase 1 study, Erda-iDRS was evaluated in patients with non–muscle-invasive bladder cancer harboring select FGFR alterations identified by urine and/or tissue testing. As of November 3, 2025, 62 patients with recurrent intermediate-risk non–muscle-invasive bladder cancer and 26 patients with recurrent, Bacillus Calmette-Guérin (BCG)-experienced, high-risk non–muscle-invasive bladder cancer had received treatment. The primary endpoint was safety, with the secondary endpoints assessing complete response rate and duration of CR in the intermediate-risk cohort and recurrence-free survival in the high-risk cohort.¹

In the intermediate-risk cohort, Erda-iDRS was evaluated as a non-surgical treatment for visible tumors. The complete response rate was 89 percent (95 percent confidence interval [CI], 78-95), based on tumor assessments during the initial treatment period. Among responders, the median duration of complete response was 18 months (95 percent CI, 14-25), with a median follow-up of 18 months (range, 15-21), indicating prolonged responses over time. Forty-nine percent of patients remain in follow-up.¹

In the high-risk cohort, patients treated with Erda-iDRS had a median recurrence-free survival of 20 months (95 percent CI, 15-30), with a 12-month recurrence-free survival rate of 83 percent (95 percent CI, 62-93). With a median recurrence-free survival follow-up of 24 months (range, 15-30), 31 percent of patients remain in follow-up.¹

Treatment was generally well tolerated, as evidenced by the absence of dose-limiting toxicities and a safety profile characterized by predominantly local adverse events. In the combined cohorts, the most frequent treatment-related adverse events (TRAEs) were hematuria (32 percent) and dysuria (22 percent). Grade 3 or higher TRAEs occurred in four patients (5 percent). Eight patients (9 percent) discontinued treatment due to adverse events, and two patients (2 percent) experienced serious TRAEs. Pharmacokinetic analyses demonstrated prolonged drug levels in the urine, with limited systemic exposure and no observed hyperphosphatemia.¹

Continued Development

Phase 2 and Phase 3 studies are ongoing to evaluate Erda-iDRS in intermediate- and high-risk non–muscle-invasive bladder cancer. The MoonRISe program includes the Phase 3 MoonRISe-1 study (NCT06319820) in intermediate-risk disease in the adjuvant setting (after tumor resection), the Phase 2 MoonRISe-2 study (NCT05316155) in intermediate-risk disease in the ablative setting (evaluating treatment of visible tumors without surgery), and the Phase 3 MoonRISe-3 study (NCT06919965) in patients with high-risk papillary non–muscle-invasive bladder cancer who received prior BCG therapy, including those with BCG-unresponsive disease, in the adjuvant setting.^4,5,6

About Erdafitinib Intravesical Drug-Releasing System (Erda-iDRS)

Erda-iDRS is an investigational intravesical drug delivery system designed to deliver prolonged, localized erdafitinib, an oral kinase inhibitor, directly to the bladder. The safety and efficacy of Erda-iDRS are being evaluated in a Phase 1 study in patients with non–muscle-invasive bladder cancer (NMIBC), including those with high-risk, BCG-unresponsive disease and intermediate-risk disease with visible tumors. Additional Phase 2 and Phase 3 studies are ongoing to further assess Erda-iDRS across intermediate- and high-risk NMIBC.

In 2008, Janssen Pharmaceuticals entered into an exclusive worldwide license and collaboration agreement with Astex Pharmaceuticals to develop and commercialize erdafitinib.

About Non–Muscle-Invasive Bladder Cancer

Non–muscle-invasive bladder cancer (NMIBC) is an early stage of bladder cancer confined to the lining of the bladder. It accounts for approximately 75 percent of newly diagnosed bladder cancer cases. NMIBC is categorized as low-, intermediate-, or high-risk based on tumor characteristics and likelihood of recurrence or progression.⁷

Patients with intermediate-risk NMIBC experience frequent tumor recurrences that often require repeated procedures and ongoing monitoring. High-risk NMIBC carries a greater likelihood of progression to muscle-invasive disease, which may require radical cystectomy.^8,9,10 Despite available treatments, recurrence and progression remain common across intermediate- and high-risk disease, underscoring the need for durable bladder treatment options.

About Johnson & Johnson

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com/ or at www.innovativemedicine.jnj.com. Follow us at @JNJInnovMed.

Cautions Concerning Forward-Looking Statements

This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 regarding product development and the potential benefits and treatment impact of the intravesical drug-releasing system with erdafitinib (Erda-iDRS). The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; manufacturing difficulties and delays; competition, including technological advances, new products and patents attained by competitors; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory action; changes in behavior and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson's most recent Annual Report on Form 10-K, including in the sections captioned "Cautionary Note Regarding Forward-Looking Statements" and "Item 1A. Risk Factors," and in Johnson & Johnson's subsequent Quarterly Reports on Form 10-Q and other filings with the Securities and Exchange Commission. Copies of these filings are available online at http://www.sec.gov, http://www.jnj.com, or on request from Johnson & Johnson. Johnson & Johnson does not undertake to update any forward-looking statement as a result of new information or future events or developments.  

*Antoni Vilaseca Cabo, M.D., has provided consulting, advisory, and speaking services to Johnson & Johnson; he has not been paid for any media work.

¹ Vilaseca A, et al. Safety and efficacy of the erdafitinib (erda) intravesical delivery system, TAR-210, in patients with non–muscle-invasive bladder cancer (NMIBC) or muscle-invasive bladder cancer (MIBC) harboring select FGFR mutations or fusions: phase 1 first-in-human study. Presented at: 2026 European Association of Urology (EAU); March 13, 2026; London.
² Roupret M, et al. Eur Urol. 2022;87(S 1):A0673
³ Catto JWF, et al. Ann Oncol. 2024;35:98-106
⁴ ClinicalTrials.gov. A Study to Evaluate TAR-210 Versus Single Agent Intravesical Cancer Treatment in Participants With Bladder Cancer (MoonRISe-1). https://clinicaltrials.gov/study/NCT06319820. Accessed March 2026.
⁵ ClinicalTrials.gov. Study of Erdafitinib Intravesical Delivery System for Localized Bladder Cancer. https://clinicaltrials.gov/study/NCT05316155. Accessed March 2026.
⁶ ClinicalTrials.gov. A Study to Evaluate TAR-210 Versus Intravesical Chemotherapy Treatment in Participants With High Risk Non-Muscle-Invasive Bladder Cancer (MoonRISe-3). https://clinicaltrials.gov/study/NCT06919965. Accessed March 2026.
⁷ Johnson & Johnson. Bladder cancer. Johnson & Johnson Innovative Medicine. Published June 30, 2025. https://www.jnj.com/innovativemedicine/oncology/bladder-cancer. Accessed March 2026.
⁸ Babjuk M, Burger M, Capoun O, et al. European Association of Urology Guidelines on Non-muscle-invasive Bladder Cancer (Ta, T1, and Carcinoma in Situ). Eur Urol. 2022;81(1):75-94. doi:10.1016/j.eururo.2021.08.010
⁹ Brooks NA, O'Donnell MA. Treatment options in non–muscle-invasive bladder cancer after BCG failure. Indian J Urol. 2015;31(4):312-319. doi:10.4103/0970-1591.166475
¹⁰ Guancial EA, Roussel B, Bergsma DP, et al. Bladder cancer in the elderly patient: challenges and solutions. Clin Interv Aging. 2015;10:939-949.

Media contact:  Oncology Media Relations   Oncology_media_relations@its.jnj.com

Investor contact: Jess Margevich investor-relations@its.jnj.com U.S. Medical Inquiries +1 800 526-7736

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SOURCE Johnson & Johnson

FAQ

What were the Erda-iDRS results Johnson & Johnson (JNJ) reported at EAU 2026?

Erda-iDRS showed an 89% complete response rate in intermediate-risk NMIBC with median CR duration of 18 months. According to the company, median recurrence-free survival in the high-risk cohort was 20 months with a 12-month RFS rate of 83%.

How safe was Erda-iDRS in the Phase 1 Johnson & Johnson (JNJ) study?

The study met its primary safety endpoint with no dose-limiting toxicities and limited systemic exposure. According to the company, Grade ≥3 TRAEs occurred in 5% and 9% discontinued due to adverse events.

What does the 89% complete response mean for intermediate-risk patients (JNJ)?

An 89% complete response indicates most treated patients had no visible tumor after treatment by second cycle. According to the company, many responses were durable, with median duration of response of 18 months.

Will Johnson & Johnson (JNJ) continue developing Erda-iDRS after these Phase 1 results?

Yes. According to the company, Erda-iDRS is advancing in the MoonRISe program with ongoing Phase 2 and Phase 3 studies across intermediate- and high-risk NMIBC settings, including MoonRISe-1, -2, and -3.

How was Erda-iDRS administered and what is the exposure profile reported by JNJ?

Erda-iDRS was given intravesically to deliver erdafitinib locally over three months with prolonged urine drug levels and limited systemic exposure. According to the company, no hyperphosphatemia was observed in pharmacokinetic analyses.