Is KALA BIO On The Verge Of A Pivotal Moment With KPI-012?

(RTTNews) - KALA BIO Inc. (KALA) is in focus, as anticipation builds around its upcoming clinical trial data for KPI-012, a novel stem cell-derived therapy targeting persistent corneal epithelial defect or PCED, a rare and debilitating eye condition with no FDA-approved treatments.

The estimated patient population affected by PCED is about 100,000 in the U.S. alone, and 238,000 across the U.S., EU, and Japan combined.

KALA recently completed enrollment for its Phase 2b CHASE trial, which evaluates KPI-012's efficacy in healing PCED across multiple underlying causes. The company expects to release topline results by the end of Q3 2025, and if positive, the trial could serve as a pivotal study supporting a Biologics License Application or BLA.

KPI-012 has already received both Orphan Drug and Fast Track designations from the FDA, signaling regulatory confidence and a potential path to accelerated approval.

The stock, KALA, touched a 52-week high of $15.80 on Thursday, before closing at $14.53, down 3.20% from the previous session. In the pre-market trading on Friday, the stock edged lower to $14.25, a further decline of 1.93%.

Despite the pullback, KALA remains up more than 140% year-over-year, fueled by growing momentum around its lead candidate, KPI-012, currently in Phase 2b trials for persistent corneal epithelial defects. The stock has traded between $2.92 and $15.80 over the past 12 months, reflecting its sharp rise from microcap territory to biotech breakout.