What Happened: The FDA has accepted Kala's IND application for its lead product candidate, KPI-012, which is a human mesenchymal stem cell secretome initially in development for the treatment of persistent corneal epithelial defect.

The Phase 2b clinical trial will be a multicenter, randomized, double-masked, vehicle-controlled, parallel-group study to evaluate the safety and efficacy of two doses of KPI-012. The trial is expected to enroll approximately 90 adult patients.

Kala expects to initiate enrollment in the trial in the first quarter of 2023 and expects to report topline data in the first quarter of 2024. If the results are positive, Kala believes this trial could serve as the first of two pivotal trials required to support the submission of a Biologics License Application to the FDA.

Kala a clinical-stage biopharmaceutical company dedicated to the research, development and commercialization of innovative therapies for rare diseases of the eye.

See Also: Why Minerva Surgical Shares Are Up More Than 100% Today

KALA Price Action: Kala has a 52-week high of $97 and a 52-week low of $3.54.

The stock was up 64.5% at $6.45 at time of publication, according to Benzinga Pro.

Photo: Tom from Pixabay.