Publicly sharing clinical results can trigger a range of regulatory and compliance obligations, especially for companies approaching or already in the public markets. As scrutiny on life sciences communications increases, companies benefit from understanding how the SEC, FDA, and other regulators view clinical data disclosures.
How SEC Requirements Shape Public Communications
For public life sciences companies, clinical data is often material information. As a result, companies need to ensure that results are shared broadly and not selectively, and that disclosures are complete enough to avoid being misleading. Depending on the circumstances, a data announcement may need to be paired with a Form 8-K, investor presentations and call scripts may need careful drafting, and risk factors may need to be updated as well.
Later-stage private companies thinking about an IPO should begin adopting these practices early, since they will ultimately face similar expectations.
Understanding FDA’s Perspective on Public Statements
FDA rules don’t govern every piece of investor communication, but they do matter, particularly when statements begin to sound like promotional claims. While investor communications aren’t directed at FDA, they are public and FDA has made clear they read these communications companies put out. Companies should take care when describing investigational products, avoiding language that implies safety or efficacy has already been established. The same applies when referencing commercial potential, comparisons to standard of care, or endpoints that have not yet been accepted by the agency.
Balancing scientific enthusiasm with regulatory caution is often where the most thoughtful life sciences companies distinguish themselves.
Internal Review Processes Help Keep Communications Consistent
As organizations grow, the volume of external communications tends to grow as well: press releases, conference abstracts, slide decks, SEC filings, partnering materials, and more. A structured internal review process, whether through a formal disclosure committee or a coordinated cross-functional workflow, helps ensure that all of these materials remain aligned and accurate.
This reduces the risk of discrepancies that could create confusion or raise compliance concerns.
Coordinating Scientific and Corporate Milestones
Data that are destined for a scientific conference or journal publication often come with strict embargo rules. Companies should plan carefully to avoid conflicts between scientific timelines and corporate disclosure obligations. A coordinated approach reduces the risk of inadvertent selective disclosure and helps maintain strong relationships with conference and journal organizers.
Bottom Line
For life sciences companies, effective communication is as much about regulatory awareness as it is about scientific clarity. Understanding the interplay between SEC rules, FDA expectations, and corporate priorities allows companies to share clinical results in a way that is compliant, credible, and aligned with long-term goals.