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Johnson & Johnson (JNJ) said on Friday that its trial evaluating an investigational intravesical drug-releasing system with its drug erdafitinib in patients with certain forms of non–muscle-invasive bladder cancer met its primary safety endpoint.
The study also demonstrated complete and durable responses in patients with recurrent intermediate-risk disease, along with encouraging recurrence-free outcomes in high-risk disease, the company said.
An investigational intravesical drug-releasing system with erdafitinib is designed to provide prolonged release of erdafitinib directly into the bladder via intravesical administration over a three-month period, and may enable localized treatment, the company said.
The company said that the findings from the trial support continued development of investigational intravesical drug-releasing systems with erdafitinib across risk settings. Later-stage studies will evaluate the system in intermediate- and high-risk non–muscle-invasive bladder cancer.
Johnson is studying the system in patients with intermediate-risk and high-risk non–muscle-invasive bladder cancer (NMIBC) whose tumors harbor select fibroblast growth factor receptor (FGFR) alterations. These alterations are common in early-stage bladder cancer, occurring in approximately 70% of intermediate-risk and 40% of high-risk non–muscle-invasive bladder cancer tumors. These changes may further drive tumor growth, the company noted.
Non–muscle-invasive bladder cancer (NMIBC) is an early stage of bladder cancer confined to the lining of the bladder.
In 2008, JNJ unit Janssen Pharmaceuticals entered into an exclusive worldwide license and collaboration agreement with Astex Pharmaceuticals to develop and commercialize erdafitinib.
On Stocktwits, retail sentiment around JNJ stock fell from ‘bearish’ to ‘extremely bearish’ territory over the past 24 hours, while message volume remained at ‘low’ levels.
JNJ stock has risen by 49% over the past 12 months.
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