Collaborations And Real-world DataA one-year milestone-based collaboration with Reliant AI capped at $200,000 and an Expanded Access arrangement with the Gorlin Syndrome Alliance provide capital-efficient development support and opportunities to generate supportive real-world data and visibility ahead of key catalysts.
Regulatory Pathway And IncentivesSubmission for a Commissioner's National Priority Review voucher and FDA alignment on a 505(b)(2) pathway, including bioequivalence study guidance and device improvement recommendations, supports a clearer regulatory path for SkinJect.
Royalty And Intellectual PropertyA license amendment materially reduced the royalty burden while preserving global rights and intellectual property, making the asset more attractive for future licensing or partnering.