2026-09-09 06:20Press release

Xinnate receives FDA Rare Pediatric Disease Designation

From left: Artur Schmidtchen, MD, Prof CMO/Inventor and co-founder, Nina Bladh, Head of CMC Development, Matilda Hugerth, Head of Clinical Development, Anna-Karin Lindqvist, COO, Helene Hartman, CEO and co-founder, and Christian Kjellman, CSO.

Lund, Sweden – Xinnate AB has received Rare Pediatric Disease Designation from the U.S. Food and Drug Administration for its investigational peptide-based topical therapy for Epidermolysis Bullosa (EB). The designation means that the therapy can potentially receive a Priority Review Voucher (PRV) when it is ultimately approved by the FDA.

The FDA grants Rare Pediatric Disease Designation to therapies targeting serious or life-threatening diseases that primarily affect children. Once granted, a PRV could be a valuable strategic asset for Xinnate, providing the opportunity for priority review of a drug candidate. The PRV can also be sold to another sponsor.

EB is a rare and serious genetic disease characterised by extremely fragile skin. It often develops in early childhood and can cause severe wounds, chronic pain and potentially life-threatening complications.

“Together with the Fast Track Designation granted earlier this year, this recognition underscores the significant unmet medical need for children living with EB and the potential of our therapy to address this devastating condition. We remain committed to advancing our clinical programme efficiently to bring a meaningful treatment option to patients and their families,” says Helene Hartman, CEO of Xinnate AB.

“From early innovation to a clinical-stage company with multiple FDA designations, Xinnate’s journey is a great example of what ambitious founders can build with the right support. This latest recognition marks another important milestone as the team advances a much-needed treatment for EB. We are incredibly proud of Helene and the entire Xinnate team.,” says Kushagr Punyani, CBO at SmiLe Venture Hub.

For Xinnate’s press release, please click the link.

For more information, please contact:
Kush Punyani, CBO at SmiLe Venture Hub,
kushagr.punyani@smileventurehub.com, +46 72-229 62 15

About Xinnate:
Xinnate is a Swedish clinical-stage drug development company developing novel therapies based on its unique peptide technology, developed at Lund University, Sweden. The company focuses primarily on improving the lives of patients with Epidermolysis Bullosa, with a therapy currently in a Phase 2/3 study.

Xinnate is a member of SmiLe Venture Hub at Medicon Village in Lund.

Language: English

About SmiLe Venture Hub – Pioneering Life Science and Foodtech Innovations

SmiLe is a leading venture hub that specializes in advancing life science and foodtech startups from concept to commercialization. We offer comprehensive support through every stage of entrepreneurship, including tailored incubation and acceleration programs, a variety of educational courses, and access to top-tier lab facilities. To date, our flagship incubator program has supported over 120 startups, facilitating their collective acquisition of more than EUR 1.19 billion in venture capital and contributing to 21 successful IPOs. Recognized as one of Europe’s leading startup hubs in 2024 by the Financial Times and Statista, SmiLe continues to be a catalyst for innovation in the life sciences sector. As a non-profit entity based in Lund, Sweden, SmiLe is supported by Region Skåne, Lund Municipality, Lund University, and Medicon Village. We are also backed by our partners Agilent, Sony, Sparbanken Skåne, Høiberg, Setterwalls, Zacco, ChemoMetec, Samplix, Qiagen, Bio-Rad, Zeiss, SmartStone Nordics, Säkra, Servier and AbbVie Scandinavia. For more information: www.smileventurehub.com