Kala Pharmaceuticals, Inc. (NASDAQ: KALA) is engaged as a clinical-stage biopharmaceutical company, which is focused on the research, development and commercialization of next-gen therapies for rare eye diseases. Shares of the biopharma company are skyrocketing 283% through early trading on Wednesday, December 28, 2022. Over the past three months, Kala Pharmaceuticals has seen average daily volume of 211,730 shares. However, volume of 28.42 million shares or dollar volume of around $334.5 million, has already exchanged hands through early trading.

Shares of Kala Pharmaceuticals are soaring after the company announced that the U.S. FDA has accepted the company’s investigational new drug (IND) application for its leading drug candidate KPI-012, a human mesenchymal stem cell secretome for the treatment of persistent corneal epithelial defect (PCED).

The IND acceptance now allows Kala Pharmaceuticals to begin preparations for a Phase 2b trial to further clinical development and research. The Phase 2b trial is estimated to launch during the first quarter of 2023, with topline data estimated for the first quarter of 2024.

“The acceptance of the KPI-012 IND is an important milestone for Kala, as we work to translate the promise of our MSC-S platform into better outcomes for people living with rare ocular surface diseases,” said Kim Brazzell, Ph.D., Head of R&D and Chief Medical Officer of Kala Pharmaceuticals. “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.”

In conjunction with the FDA announcement, Kala Pharmaceuticals sold an additional 43,478 shares of Series E Convertible Non-Redeemable Preferred Stock at a price of $575 per share for total gross proceeds of $25 million. The private placement was originally announced in late November 2022 and has now generated aggregate gross proceeds of $31 million for the biopharma company.

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