Kala Pharmaceuticals Stock Continues To Soar: What's Going On?

Kala Pharmaceuticals Inc KALA shares are trading higher Thursday. The stock appears to be moving on continued momentum after the company on Wednesday announced FDA acceptance of an investigational new drug (IND) application for KPI-012 for the treatment of persistent corneal epithelial defect.

What Happened: The FDA 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.

"We are now turning our focus to clinical execution. We are working closely with investigators to initiate our Phase 2b clinical trial of KPI-012 for PCED in the first quarter of 2023," said Kim Brazzell, Head of R&D and Chief Medical Officer of Kala Pharmaceuticals.

The Phase 2b clinical trial will 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 is a clinical-stage biopharmaceutical company dedicated to the research, development and commercialization of innovative therapies for rare diseases of the eye.

See Also: US Stocks Poised For Higher Open But Analyst Says 'Exhausted' Market Looking To End 2022 Without 'Further Meaningful Losses'

KALA Price Action: At publication time, Kala shares are up 45.3% at $18.13 after surging more than 200% on Wednesday, according to Benzinga Pro.

Photo: Tumisu from Pixabay.