Shares of Kala Pharmaceuticals (NASDAQ: KALA) more than tripled in value on Wednesday, following news that the US Food and Drug Administration (FDA) had accepted an investigational new drug (IND) application for the company’s lead product candidate, KPI-012. The micro-cap clinical-stage biopharma announced the news after hours on Tuesday, stating that the IND application was for the treatment of persistent corneal epithelial defects (PCED).
PCED is a condition that occurs when the cornea, the clear outer layer of the eye, does not heal properly after an injury. This can result in a lack of complete healing and proper closure, leading to ongoing discomfort and potentially affecting vision. KPI-012 is a novel therapeutic candidate that aims to address this issue by promoting the healing of the corneal epithelium, the outermost layer of the cornea.
In a press release, KALA stated that it is on track to start a mid-stage trial of KPI-012 for PCED in Q1 2023. The company also announced that it had received the remaining $25 million of a previously announced private placement financing. This additional funding will help KALA advance the development of KPI-012 and potentially bring it to market.
KALA stock closed at $12.48 on Wednesday, up 218.4% from the previous day. It is worth noting that KALA stock had been on a weak run prior to this news, snapping a ten-day losing streak only last week. The acceptance of the IND application and the influx of financing have led to a significant boost in the company’s stock price.
The IND application process is a critical step in the development of a new drug. It allows a company to begin testing a new drug on humans, provided that certain criteria are met, including the demonstration of sufficient preclinical data and the presence of an acceptable investigational plan. The acceptance of KALA’s IND application is a positive development for the company, indicating that the FDA believes KPI-012 has the potential to be a safe and effective treatment for PCED.
In summary, Kala Pharmaceuticals saw its stock price more than triple on Wednesday following the acceptance of an IND application for its lead product candidate, KPI-012, by the FDA. The company also announced that it had received the remaining $25 million of a previously announced private placement financing. KALA plans to start a mid-stage trial of KPI-012 in Q1 2023, with the goal of bringing the drug to market to help address the unmet need for effective treatments for persistent corneal epithelial defects.