PITTSBURGH, Oct. 14, 2025 – Krystal Biotech, Inc. (NASDAQ: KRYS) announced today that the U.S. Food and Drug Administration (FDA) granted platform technology designation to the company’s genetically modified, non‑replicating herpes simplex virus type 1 (HSV‑1) viral vector used in its redosable eye‑drop gene therapy KB801.
The designation applies to the HSV‑1 vector that delivers the therapeutic transgene in KB801, which is currently being evaluated in a randomized, placebo‑controlled trial for the treatment of neurotrophic keratitis (NK). The FDA’s platform designation is intended to accelerate the development of therapies that use the same vector platform, potentially reducing regulatory review time and costs for future products.
This milestone underscores the FDA’s confidence in Krystal’s HSV‑1 platform and may enhance the company’s ability to bring additional gene‑therapy products to market more efficiently, thereby supporting future revenue growth and strengthening its competitive position in the rare‑disease gene‑therapy space.
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