# An exciting regulatory update 🙌 | Sempresto

- Canonical URL: https://wefunder.com/feed/389530
- Entity ID: wefunder:feed_item:389530
- Published at: 2026-09-17 20:19:17 UTC
- Updated at: 2026-09-17 22:36:43 UTC

## Author
Elizabeth Reczek

## Subject
Sempresto

## Content
Sempresto reached an important regulatory milestone this month: we received written feedback from the FDA following our Type B pre-IND meeting for our investigational smartphone-integrated epinephrine auto-injector.What this means: A pre-IND interaction gives a company the opportunity to engage with the FDA early in development, ask focused questions, and better understand the agency’s perspective before committing significant resources to a particular development plan.We were very encouraged by the FDA’s constructive and informative response. The feedback provided valuable clarity regarding our proposed 505(b)(2) regulatory pathway, our strategy for bridging to an approved reference drug, and the data that may be needed to support a future submission. Reaching this point required a comprehensive briefing package addressing a set of focused questions about our proposed regulatory pathway, clinical development approach, and other considerations associated with this innovative combination product. We are proud of the work that went into this process and grateful to the team and partners who helped make it possible.This matters because anaphylaxis does not wait and an epinephrine auto-injector can only help if it is available when it is needed. That reality is what drives us to develop a solution designed around something people already carry with them every day: their smartphone.There is still important work ahead. We will apply the FDA’s valuable feedback as we advance the device through development and continue building a separate companion app and connected-care capabilities that support our vision.We are excited about this progress and look forward to keeping you updated as we move into the next phase. 💪Now would be an opportune time to invest or increase your investment in Sempresto!Liz Elizabeth Reczek, PhD Co-Founder & CEO, SemprestoSempresto’s product is investigational and has not been approved or cleared by the FDA