Caribou Biosciences Says Met With FDA And Reached Alignment On Pivotal Trial; Plans To Initiate Phase 3 Pivotal Trial By YE 2024
Portfolio Pulse from Benzinga Newsdesk
Caribou Biosciences announced that it has met with the FDA and reached an agreement on the design of a pivotal Phase 3 trial for its treatment. The FDA has accepted the proposed comparator arm involving platinum-based immunochemotherapy, HDCT, and ASCT. Caribou plans to initiate the Phase 3 trial by the end of 2024.
December 12, 2023 | 9:04 pm
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POSITIVE IMPACT
Caribou Biosciences has reached alignment with the FDA on its upcoming Phase 3 trial, which is a significant regulatory milestone. The trial is expected to begin by the end of 2024.
The news of FDA alignment on a pivotal trial is a strong positive signal for Caribou Biosciences, indicating regulatory progress and a clear path forward for its treatment. This typically instills investor confidence and can lead to a positive short-term impact on the stock price.
CONFIDENCE 85
IMPORTANCE 90
RELEVANCE 100