Humacyte Confirms Plans For ATEV Supplemental BLA Filing
– Supplemental Biologics License Application (BLA) expected to be filed with the Food and Drug Administration (FDA) in November 2026 –– Supplemental BLA will be supported by results from three Phase 3 studies of ATEV,
Humacyte says it will ask the FDA for permission to use its heart-valve medicine in new ways, based on testing results coming in late 2026. This shows the company is moving forward with its plans, so watch whether the FDA approves it and how patients do in the tests.
Last session drawn · prints held ~15 minutes · licensed exchange data
Source: Benzinga · Read the original report at the publisher. Headline and figures shown for context; data may be delayed.
Disclosure: Educational and informational purposes only — not financial advice. We educate, not advise. Market data may be delayed up to 15 minutes unless marked real-time. Past performance is not indicative of future results.