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FDA Grants Breakthrough Status to Acrivon’s Cancer Assay

2/7/2025

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Summary

Story summary

Acrivon Therapeutics has received FDA breakthrough device designation for its ACR-368 OncoSignature assay, a promising tool for pinpointing endometrial cancer patients who could benefit from ACR-368 treatment. In a phase 2 study, an impressive 62.5% of identified patients responded positively, fueling hope as Acrivon forges ahead with ongoing clinical trials for ACR-368 and ACR-2316.

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Story summary

Acrivon Therapeutics has received FDA breakthrough device designation for its ACR-368 OncoSignature assay, a promising tool for pinpointing endometrial cancer patients who could benefit from ACR-368 treatment. In a phase 2 study, an impressive 62.5% of identified patients responded positively, fueling hope as Acrivon forges ahead with ongoing clinical trials for ACR-368 and ACR-2316.