Clinical holds in SEC filings
Clinical holds that listed life-science companies disclosed in SEC 8-K filings, newest first, each linked to the filing.
5 on file
- 2026-10-06ROCKET PHARMACEUTICALS, INC.: SEC 8-K mentions a clinical hold
- 2026-09-24Glucotrack, Inc.: SEC 8-K mentions a clinical hold
- 2026-09-22Alaunos Therapeutics, Inc.: SEC 8-K mentions a clinical hold
- 2026-09-10Biohaven Ltd.: SEC 8-K mentions a clinical hold
- 2026-09-10Yarrow Bioscience, Inc.: SEC 8-K mentions a clinical hold
What a clinical hold disclosure is
A clinical hold is an FDA order to delay a proposed clinical investigation or to suspend one that is under way. FDA does not publish holds; a listed company discloses one in an 8-K filed with the SEC. A filing can also mention a hold that has been lifted, or one that is only a risk, so the filing itself is the record.
Questions
A clinical hold is an FDA order to delay a proposed clinical investigation or to suspend one that is under way, usually because of a safety concern or a deficiency in the investigational plan. It can apply to one trial or to every trial under an IND. FDA does not publish holds; a listed company discloses one in an SEC filing.
Until FDA lifts it. The sponsor responds to the issues FDA raised, and the agency has 30 days to reply to a complete response. Some holds are lifted within weeks; others take months or end the program. The 8-K filing is the record of what the company said at the time.