Intel stock spikes after report of possible US government stake
RARITAN, N.J. - Johnson & Johnson (NYSE:JNJ) announced Thursday that the U.S. Food and Drug Administration has granted Priority Review to its New Drug Application for TAR-200, an intravesical gemcitabine releasing system for treating patients with Bacillus Calmette-Guérin (BCG)-unresponsive high-risk non-muscle invasive bladder cancer with carcinoma in situ.
The regulatory submission is supported by data from the Phase 2b SunRISe-1 study, which showed an 82.4 percent complete response rate with 52.9 percent of patients remaining cancer-free for at least one year after achieving complete response. As a prominent player in the pharmaceuticals industry generating over $89 billion in annual revenue, J&J continues to demonstrate its innovative capabilities in oncology treatments.
TAR-200 is designed to provide sustained local delivery of cancer treatment into the bladder, remaining there for three weeks per treatment cycle. The system can be placed by a healthcare professional in an outpatient setting in less than five minutes without requiring general anesthesia.
"The FDA Priority Review for TAR-200 underscores our mission to fundamentally change the way urologists treat certain types of bladder cancer," said Yusri Elsayed, Global Therapeutic Area Head, Oncology at Johnson & Johnson Innovative Medicine, in the press release.
According to the company, the most common adverse reactions included pollakiuria, dysuria, urinary tract infection, and micturition urgency, with most reactions being mild to moderate. No systemic adverse reactions were reported.
The FDA previously granted Breakthrough Therapy Designation to TAR-200 in December 2023 for the treatment of adult patients with BCG-unresponsive high-risk non-muscle invasive bladder cancer with carcinoma in situ who are ineligible for or have elected not to undergo radical cystectomy.
High-risk non-muscle invasive bladder cancer affects approximately 10 percent of patients with non-muscle invasive bladder cancer, and current treatment options are limited for those who fail BCG therapy. With the stock trading near its 52-week high and showing strong momentum, detailed analysis and additional insights are available in the comprehensive Pro Research Report on InvestingPro, which offers expert analysis on J&J’s market position and growth potential.
In other recent news, Johnson & Johnson reported strong second-quarter 2025 earnings, surpassing both top and bottom-line estimates and raising its full-year guidance. The company now anticipates adjusted operational revenue growth of approximately 3.5%, up from the previous estimate of 2.5%, and has revised its full-year earnings per share guidance to a range of $10.80-$10.90. Goldman Sachs raised its price target on Johnson & Johnson to $185, maintaining a Buy rating, while Stifel increased its target to $165 with a Hold rating. Wolfe Research reiterated an Outperform rating with a $175 price target, citing the company’s strong performance despite ongoing talc litigation and tariff concerns. Johnson & Johnson also submitted a supplemental New Drug Application to the FDA for CAPLYTA, aimed at preventing schizophrenia relapse, supported by Phase 3 trial data. The company highlighted significant revenue contributions from its Innovative Medicines segment, particularly from products like Tremfya and Darzalex. Goldman Sachs noted the potential for continued upward revisions to earnings and sales estimates, driven by strong product cycles and less impact from Stelara biosimilar competition. Wolfe Research projects full-year revenues of $91.9 billion, slightly above consensus estimates. Johnson & Johnson’s recent FDA approval for Imaavy for generalized myasthenia gravis and anticipated FDA approval of TAR-200 for bladder cancer further bolster its pharmaceutical portfolio.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.