Monday, Johnson & Johnson JNJ said it discontinued the Phase 3 SunRISe-2 trial of TAR-200 in combination with cetrelimab versus concurrent chemoradiotherapy for muscle-invasive urothelial carcinoma (MIBC) patients who are not receiving radical cystectomy.
Following an Independent Data Monitoring Committee recommendation and pre-specified interim analysis, SunRISe-2 was discontinued for not showing superiority versus chemoradiation.
“We remain confident in the TARIS platform having over $5 billion potential,” Johnson & Johnson notes.
Data from the SunRISe-4 study recently presented at the 2024 European Society for Medical Oncology Congress show the potential of TAR-200 in MIBC.
Also Read: Johnson & Johnson Ends Phase 2 Study For Dengue Antiviral Amid R&D Reprioritization.
The company says it is on target for the FDA filing of TAR-200 monotherapy (SunRISe-1) in non-muscle invasive bladder cancer in early 2025, with the SunRISe-3 and SunRISe-5 studies underway.
Johnson & Johnson is set to release its third quarter 2024 earnings next Wednesday, 15 October. As per data from Benzinga Pro, the analysts estimate adjusted EPS of $2.20 and revenue of $22.13 billion.
Goldman Sachs has reiterated its Neutral rating while increasing the price target from $155 to $162.
The analyst expects the pharma giant to report third-quarter results in line with consensus expectations on the top line with revenues of $22.26 billion, with year-over-year growth of +4.4%, representing a slight incremental deceleration in the pace of growth from the first half of 2024.
Goldman Sachs’ outlook for the quarter remains mostly consistent overall, with a slight upward revision to the Innovative Medicine forecast compared to estimates following the second-quarter results. This improvement is attributed to potentially less impact from introducing biosimilar Stelara in Europe during the third quarter.
This adjustment helps counterbalance a modest reduction in the MedTech segment forecasts.
“We expect management to reiterate guidance on the FY25 revenue growth outlook of +3% or more, and for longer-term targets (Innovative Medicine growth at a CAGR of 5-7% from 2025-30, and growth at the upper end of the 5-7% CAGR for MedTech from 2023-27) to remain intact,” the analyst writes.
Price Action: JNJ stock is down 0.21% at $159.20 at last check Tuesday.
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