• Three abstracts to be presented at the 101st Annual Meeting of the Western Section of the American Urological Association, including baseline characteristics and demographics for patients enrolled in the ADSTILADRIN in BLadder CancEr (ABLE)-41 real-world study
  
  
  
  
• Independent analysis based on billing records to report on the durability of ADSTILADRIN use in patients with high-risk Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle invasive bladder cancer (NMIBC)
  
  
  
  
• First real-world case series to highlight ADSTILADRIN re-induction in patients without a complete response to initial treatment

Ferring Pharmaceuticals announced today that three abstracts featuring ADSTILADRIN^® (nadofaragene firadenovec-vncg) will be presented at the 101^st Annual Meeting of the Western Section of the American Urological Association (AUA) being held November 2-6 in Napa, CA. ADSTILADRIN is the first and only intravesical non-replicating gene therapy approved by the U.S. Food and Drug Administration (FDA) for patients with high-risk Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors (±Ta/T1).

A Ferring-sponsored study will present baseline characteristics and demographics from the initial patient cohort enrolled in ABLE (ADSTILADRIN in BLadder CancEr)-41, a Phase 4 multicenter non-interventional study examining the use of ADSTILADRIN in a real-world setting. In addition, two independent real-world studies will be presented. This includes a study analyzing electronic billing records for 101 patients from 19 U.S. medical centers who received ADSTILADRIN and is exploring durability of remaining on ADSTILADRIN, and lack of progression to radical cystectomy. A third abstract is a case series evaluating re-induction with ADSTILADRIN among 17 patients across 8 academic and community settings, the findings of which were published recently in The Journal of Urology.

“Real-world evidence provides an important view of how a treatment like ADSTILADRIN is being used in routine practice,” said Sia Daneshmand, MD, Professor of Urology and Medicine (Oncology) and Director of Urologic Oncology at Keck School of Medicine of University of Southern California. “The ABLE-41 study will add to this evidence by capturing early insights from a broader, more diverse patient population than prior trials, helping us understand patient experiences and inform care for those with BCG-unresponsive NMIBC.”

“ADSTILADRIN is an important option for uro-oncologists, offering an effective and convenient quarterly dosing schedule administered in the urologist’s office, and a non-chemotherapy alternative to radical cystectomy,” said Daniel A. Shoskes, MD, FRCS(C), Vice President, Global Medical Director- Uro-Oncology, Ferring Pharmaceuticals. “The ongoing research exploring the real-world use of ADSTILADRIN adds to the body of evidence in NMIBC patients who no longer respond to BCG. I am thrilled that this research is also exploring treatment re-induction, helping to build on the strong foundation of our Phase 3 program and further inform care for NMIBC patients.”

About ADSTILADRIN Presentations at the Western Section AUA

ADSTILADRIN poster titles and presentation times at 101st Annual Meeting of the Western Section AUA, November 2-6, 2025, are:

• ABLE-41, a real-world evidence study for bladder cancer patients treated with nadofaragene firadenovec: baseline patient characteristics and demographics. Abstract #257 (Poster #23), November 2, 2025, 7:00-9:00 a.m. PST
• Real-world utilization of ADSTILADRIN in patients with BCG-unresponsive non-muscle invasive bladder cancer. Abstract #242 (Poster #18), November 2, 2025, 7:00-9:00 a.m. PST
• Re-induction with nadofaragene firadenovec for BCG-unresponsive NMIBC: real-world data from a multicenter cohort. Abstract #301 (Poster #11), November 2, 2025, 7:00-9:00 a.m. PST

About ABLE-41

ABLE-41 is a non-interventional study following NMIBC patients aged 18 years or older who are being treated with ADSTILADRIN in a clinical setting and had not previously received this therapy in a clinical trial. In September 2023, Ferring announced the first patient enrolled in ABLE-41. Eligible patients include those who were prescribed and scheduled to receive treatment, per their physician’s discretion, or patients who received their first instillation (per physician discretion) after September 5, 2023, but before the site was activated in the trial.

The primary objective is to assess whether patients achieve a complete response (CR) at three months and/or at any time within a year of their first instillation.

Participants in ABLE-41 will be followed for 24 months, or until study discontinuation or withdrawal. Key secondary outcomes include the following: treatment patterns of use; duration of CR; recurrence-free survival, cystectomy-free survival, progression-free survival, overall survival, and bladder cancer–specific mortality; patient, caregiver, and physician experiences; adjunctive use of molecular markers; and safety. Patient experiences will be assessed with a commonly used quality of life questionnaire (EuroQol 5 Dimension 5 Level), measuring mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Caregiver experiences will be measured with the Work Productivity and Activity Impairment questionnaire, adapted for caregiving, which assesses the impact of health problems on paid and unpaid work.

Results from this prospective, multi-institutional study are expected at the end of 2026. Learn more at www.clinicaltrials.gov/study/NCT06026332.

About ADSTILADRIN

ADSTILADRIN^® (nadofaragene firadenovec-vncg) is the first and only FDA-approved intravesical non-replicating gene-therapy for the treatment of adult patients with high-risk Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors. It is a non-replicating adenovirus vector-based therapy containing the gene interferon alfa-2b, administered locally as a monotherapy by catheter directly into the bladder once every three months. The vector enters the cells of the bladder wall, releasing the active gene and causing the bladder’s cell walls to secrete high and transient local expression of interferon alfa-2b protein, a naturally occurring protein the body uses to fight cancer. This approach essentially turns the bladder wall cells into interferon microfactories, enhancing the body’s own natural defenses against the cancer.

ADSTILADRIN has been studied in a clinical trial program that includes 157 patients with high-risk, BCG-unresponsive NMIBC who had been treated with adequate BCG previously and did not see benefit from additional BCG treatment (full inclusion criteria published on clinicaltrials.gov: NCT02773849 and final five-year follow-up analysis published in The Journal of Urology®).^1-2

About Ferring Uro-Oncology

Ferring is committed to investing in novel therapies, developing life-changing solutions that address unmet medical needs, and aiding the uro-oncology community in helping patients live better lives. More information is available in the U.S. at FerringUroOncology.com and on the dedicated Ferring Uro-Oncology channels on LinkedIn and X.

About Non-Muscle Invasive Bladder Cancer (NMIBC)

NMIBC is a form of bladder cancer that is found in the inner layer cells of the bladder and does not invade into or beyond the muscle wall.³ In the United States, bladder cancer is the sixth most common cancer,⁴ fourth among men,⁵ and it is estimated that there will be approximately 84,870 new cases of bladder cancer in the U.S. in 2025.⁵ Historically, 75% of bladder cancer presents as NMIBC.⁶ In patients with high-risk NMIBC, intravesical BCG remains the first-line standard-of-care. However, approximately one third of patients with NMIBC will not respond to BCG therapy and 50% of those with an initial response will experience recurrence or progression of their disease.⁷ Current treatment options for BCG-unresponsive patients are very limited, and National Comprehensive Cancer Network (NCCN) guidelines recommend cystectomy (partial or complete removal of the bladder).⁸

INDICATION

ADSTILADRIN is a non-replicating adenoviral vector-based gene therapy indicated for the treatment of adult patients with high-risk Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS: ADSTILADRIN is contraindicated in patients with prior hypersensitivity reactions to interferon alfa or to any component of the product.

WARNINGS AND PRECAUTIONS:

• Risk with delayed cystectomy: Delaying cystectomy in patients with BCG-unresponsive CIS could lead to development of muscle invasive or metastatic bladder cancer, which can be lethal. If patients with CIS do not have a complete response to treatment after 3 months or if CIS recurs, consider cystectomy.

• Risk of disseminated adenovirus infection: Persons who are immunocompromised or immunodeficient may be at risk for disseminated infection from ADSTILADRIN due to low levels of replication-competent adenovirus. Avoid ADSTILADRIN exposure to immunocompromised or immunodeficient individuals.

DOSAGE AND ADMINISTRATION: Administer ADSTILADRIN by intravesical instillation only. ADSTILADRIN is not for intravenous use, topical use, or oral administration.

USE IN SPECIFIC POPULATIONS: Advise females of reproductive potential to use effective contraception during ADSTILADRIN treatment and for 6 months after the last dose. Advise male patients with female partners of reproductive potential to use effective contraception during ADSTILADRIN treatment and for 3 months after the last dose.

ADVERSE REACTIONS: The most common (>10%) adverse reactions, including laboratory abnormalities (>15%), were glucose increased, instillation site discharge, triglycerides increased, fatigue, bladder spasm, micturition (urination urgency), creatinine increased, hematuria (blood in urine), phosphate decreased, chills, pyrexia (fever), and dysuria (painful urination).

You are encouraged to report negative side effects of prescription drugs to FDA. Visit www.FDA.gov/medwatch or call 1-800-332-1088. You may also contact Ferring Pharmaceuticals at 1-888-FERRING.

Please click to see the full Prescribing Information.

About Ferring Pharmaceuticals

Ferring Pharmaceuticals is a privately-owned, specialty biopharmaceutical group committed to building families and helping people live better lives. In the United States, Ferring is a leader in reproductive medicine, and in areas of gastroenterology and orthopaedics. We are at the forefront of innovation in microbiome-based therapeutics and uro-oncology intravesical gene therapy. Our company was founded in 1950 and is headquartered in Saint-Prex, Switzerland. Ferring employs more than 7,000 people worldwide and markets its medicines in over 100 countries. Ferring USA is based in Parsippany, New Jersey, and employs more than 900 employees.

For more information, please visit www.ferringusa.com, call 1-888-FERRING (1-888-337-7464), or connect with us on LinkedIn, and X.

References:

1. ADSTILADRIN in Patients With High-Grade, Bacillus Calmette-Guerin (BCG) Unresponsive Non-Muscle Invasive Bladder Cancer (NMIBC). Gov Identifier: NCT02773849. Available at: https://clinicaltrials.gov/ct2/show/NCT02773849. Accessed October 27, 2025.
2. Narayan VM, Boorjian SA, Alemozaffar M, et al. Efficacy of intravesical nadofaragene firadenovec for patients with Bacillus Calmette-Guérin-unresponsive nonmuscle-invasive bladder cancer: 5-year follow-up from a phase 3 trial. J Urol. 2024;212(1):1-12.
3. Urology Care Foundation. Non-muscle Invasive Bladder Cancer. Available at: https://www.urologyhealth.org/urology-a-z/n/non-muscle-invasive-bladder-cancer. Accessed October 27, 2025.
4. National Cancer Institute. Cancer Statistics. Available at: https://www.cancer.gov/about-cancer/understanding/statistics#:~:text=The%20most%20common%20cancers%20%28listed%20in%20descending%20order,pancreatic%20cancer%2C%20leukemia%2C%20thyroid%20cancer%2C%20and%20liver%20cancer. Accessed October 27, 2025.
5. American Cancer Society. Cancer Facts & Figures 2025. Available at: https://www.cancer.org/content/dam/cancer-org/research/cancer-facts-and-statistics/annual-cancer-facts-and-figures/2025/2025-cancer-facts-and-figures-acs.pdf. Accessed October 27, 2025.
6. Babjuk M, Burger M, Capoun O, et al. European Association of Urology Guidelines on Non-muscle-invasive Bladder Cancer. Eur Urol. 2022 Jan;81(1):75-94.
7. Lidagoster S, et al. BCG and Alternative Therapies to BCG Therapy for Non-Muscle-Invasive Bladder Cancer. Curr Oncol. 2024 Feb 16;31(2):1063-1078.
8. National Comprehensive Cancer Network. Bladder Cancer (Version 4.2024). Available at: https://www.nccn.org/professionals/physician_gls/pdf/bladder.pdf. Accessed October 27, 2025.

More information is available at the following:

• Healthcare Providers: If you are interested in ordering ADSTILADRIN, please sign up for information and updates at www.ADSTILADRINHCP.com.
• Patients and Consumers: For more information about ADSTILADRIN, please visit www.ADSTILADRIN.com, or call 1-888-FERRING (888-337-7464), and select option number one.
• Media: Members of the press can contact Carol Ready, Director, Brand Communications by phone at (973) 765-7307, or email at carol.ready@ferring.com.

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