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Kala jumps ~21% on new drug application submission to FDA for corneal defect treatment

  • Kala Pharmaceuticals (NASDAQ:KALA) on Monday said it had submitted an investigational new drug (IND) application to the U.S. FDA for its KPI-012 treatment for persistent corneal epithelial defect (PCED).
  • PCED is a corneal defect that does not heal even after standard treatment.
  • KALA also separately announced a private placement financing for up to $31M to partly fund development of KPI-012.
  • Shares of the micro-cap clinical-stage biopharma jumped 20.6% to $6.85 after hours.
  • Subject to the acceptance of the IND by the FDA, KALA remains on track to start a phase 2b clinical trial of KPI-012 for PCED in Q4 2022, the company said in a statement.