Shares of Kala Pharmaceuticals, Inc. (KALA) are rising more than 5% Wednesday morning after the company said it received FDA fast track designation for KPI-012, a human mesenchymal stem cell secretome (MSC-S) therapy for persistent corneal epithelial defect (PCED).
Fast Track designation for a drug candidate makes the company eligible for more frequent interactions with the FDA to discuss the product development plan. Therapeutic candidates with Fast Track designation may also be eligible for priority review and accelerated approval if supported by clinical data, the company said.
In March this year, Kala had announced positive safety data from the first cohort of 2 patients treated with KPI-012 in CHASE Phase 2b study. A second cohort study is underway, from which topline results are expected in the first quarter of 2024.
KALA, currently at $18.04, has been trading in the range of $3.54-$56.72 in the last 52 weeks.
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