DBV Technologies has provided a comprehensive update on its financial results for the third quarter of 2023 and the status of its Viaskin Peanut programs during an earnings call. The company is developing two separate Viaskin Peanut programs for children aged 1-3 and 4-7, respectively, both of which are expected to support distinct Biologics License Applications (BLAs). Key takeaways from the call include:
- The company has received feedback from the FDA on the protocol design for its two pending supplemental safety studies, COMFORT Toddlers and COMFORT Children.
- The FDA has clarified certain protocol design elements, and DBV Technologies is now preparing to submit the safety protocol for COMFORT Toddlers.
- Enrollment for COMFORT Toddlers is expected to begin in the first quarter of 2024, with COMFORT Children to follow.
- The company's cash and cash equivalents as of September 30, 2023, stood at $149.1 million.
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