News Related to Serine Protease Inhibitor Kazal-Type 5

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FDA Grants Fast Track Designation to QRX003, Supports NRX-100 NDA

Jul 29, 2026

The FDA granted Fast Track Designation to Quoin's QRX003 for Netherton Syndrome and supported NRx's NRX-100 NDA path under Fast Track for treatment-resistant depression, addressing serious unmet needs.

FDA Grants Fast Track Designation to Multiple Therapies for Rare Diseases and Hematologic Malignancies

Mar 11, 2026

The FDA has granted fast track designation to QRX003 for Netherton Syndrome and IBI3003 for relapsed or refractory multiple myeloma, while also accepting regulatory applications for other therapies addressing serious conditions with unmet medical needs.