Acrivon Therapeutics Announces FDA Has Granted Device Designation For ACR-368 OncoSignature Assay For Ovarian Cancer
Portfolio Pulse from Benzinga Newsdesk
Acrivon Therapeutics has announced that the FDA has granted a device designation for its ACR-368 OncoSignature Assay, which is used in a Phase 2 trial to predict patient response to the CHK1/2 inhibitor ACR-368 for ovarian cancer. The assay is part of Acrivon's AP3 platform, which aids in drug design and understanding resistance mechanisms.

November 28, 2023 | 1:03 pm
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POSITIVE IMPACT
Acrivon Therapeutics' ACR-368 OncoSignature Assay has received FDA device designation, potentially boosting the company's profile and credibility in the biotech industry.
The FDA device designation is a positive regulatory milestone for Acrivon Therapeutics, indicating a level of validation for its ACR-368 OncoSignature Assay. This could lead to increased investor confidence and a potential short-term uptick in ACRV's stock price as the market reacts to the news. The designation may also facilitate further development and commercialization of the assay, which is crucial for the company's ongoing Phase 2 trial.
CONFIDENCE 85
IMPORTANCE 90
RELEVANCE 100