RARITAN, N.J. - Johnson & Johnson (NYSE: JNJ) revealed new clinical data at the American Urological Association (AUA) 2025 Annual Meeting, indicating positive results for its bladder cancer treatment, TAR-200. The data presented from the Phase 2b SunRISe-1 study’s Cohort 2 suggests that TAR-200, an intravesical gemcitabine releasing system, may offer a complete response in patients with high-risk non-muscle-invasive bladder cancer (HR-NMIBC) that is unresponsive to Bacillus Calmette-Guérin (BCG) therapy.
The 12-month results from Cohort 2 showed that patients with carcinoma in situ (CIS), with or without papillary disease, experienced sustained benefits from the TAR-200 monotherapy. These findings were highlighted in a plenary session on Saturday, April 26, at the AUA meeting in Las Vegas.
In addition to the promising results from Cohort 2, preliminary data from Cohort 4 of the same study was also presented, which evaluated the effectiveness of TAR-200 in patients with papillary-only HR-NMIBC. This patient group typically faces bladder removal as a standard treatment, posing a significant challenge for those who are elderly or have comorbidities, or are unwilling to undergo radical surgery.
TAR-200 is administered directly into the bladder in an outpatient setting without anesthesia and is designed to release medication continuously throughout the day. To date, the treatment has been applied over 10,000 times as part of the SunRISe clinical program.
Johnson & Johnson also discussed the initiation of a new drug application for TAR-200 under the real-time oncology review (RTOR) program earlier in January 2025. The FDA granted Breakthrough Therapy Designation to TAR-200 in December 2023 for BCG-unresponsive HR-NMIBC with CIS in patients ineligible for or who have chosen not to undergo radical cystectomy.
The company emphasized the need for more effective treatments for bladder cancer, a disease that ranks among the top ten most common cancers globally and has seen little change in standard treatment over the past four decades. The safety and efficacy of TAR-200 are currently being evaluated in ongoing Phase 2 and Phase 3 studies. With a robust gross profit margin of 68.82% and trading near its 52-week high, Johnson & Johnson continues to demonstrate strong market performance. Discover more insights about JNJ’s potential with InvestingPro, which offers exclusive access to 10+ additional ProTips and comprehensive financial analysis.
This report is based on a press release statement from Johnson & Johnson.
In other recent news, Johnson & Johnson reported impressive financial results for the first quarter of 2025, surpassing Wall Street expectations. The company posted an adjusted earnings per share (EPS) of $2.77, exceeding the forecast of $2.58, and reported revenue of $21.9 billion, which was above the anticipated $21.57 billion. Despite these strong earnings, Johnson & Johnson is facing challenges, including competition from Stelara biosimilars and a $400 million tariff impact. TD Cowen and UBS both maintained their Buy ratings on the company’s stock, with price targets set at $185 and $180, respectively, reflecting confidence in the company’s strategic growth initiatives.
Analysts at UBS highlighted the robust sales growth of Johnson & Johnson’s innovative medicines and the resilience of its MedTech business as key strengths. The company’s pharmaceutical division continues to grow even with the introduction of biosimilars, and its management has reiterated the 2025 EPS guidance, showcasing confidence in its financial health. Additionally, strategic acquisitions like Abiomed and Shockwave are expected to contribute significantly to growth in segments facing headwinds. Johnson & Johnson’s diversified portfolio is seen as a core strength, particularly valuable in the current volatile market climate.
The company’s performance in the first quarter was also marked by a 4.2% increase in worldwide sales compared to the previous year, driven by its diverse healthcare portfolio. Johnson & Johnson plans substantial U.S. investments and new manufacturing facilities, anticipating stronger growth in the second half of 2025. These developments suggest a stable financial trajectory for the company as it navigates through market uncertainties and potential economic challenges.
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