KALA BIO, Inc. Securities Fraud Investigation

Shamis & Gentile, P.A. is investigating claims on behalf of investors of KALA BIO, Inc. ("KALA BIO" or the "Company") (KALA). Impacted investors are advised to contact the firm now.

The investigation focuses on whether KALA BIO made false or misleading statements and/or omitted material information regarding the clinical and commercial prospects of its lead asset, KPI-012, and the pivotal Phase 2b CHASE trial for persistent corneal epithelial defect (PCED). From late 2024 through most of 2025, KALA BIO allegedly highlighted the supposed “first-in-class” potential and “multifactorial mechanism” of KPI-012 and portrayed the CHASE trial as a pivotal step toward eventual FDA approval.

However, the Company’s public statements may have gave insufficient warning about the significant risk of failure. Further, there may have been a lack of disclosure on adverse data, operational difficulties, timeline delays, and/or the Company’s financial constraints. These omissions allegedly deprived investors of a balanced view of the true prospects for KPI-012 and the CHASE trial. On September 29, 2025, KALA BIO announced that the Phase 2b CHASE trial failed to meet its primary endpoint and all key efficacy measures. On the same day, the Company said it would terminate development of KPI-012 and shut down its MSC-S platform, effectively abandoning its primary growth strategy.

On this news, KALA BIO’s stock price collapsed by about $16.31 per share, or roughly 90%, closing at $1.91, and wiped out an estimated $50 to $60 million in market capitalization, causing substantial losses for investors.

If you purchased KALA BIO (NASDAQ: KALA) shares prior to the announcement of the CHASE trial failure in late September 2025, you may be eligible to seek compensation for your losses. Contact Shamis & Gentile today to discuss your options.

Shamis & Gentile, P.A. stands out as an advocate for investors who are victims of securities fraud. The firm is committed to securing recoveries for investors who have incurred damages due to false and misleading statements or other corporate misconduct by public companies. Shamis & Gentile has recovered over $1 billion for consumers nationwide. Its extensive experience, expertise and resources enable the firm to resolve disputes in a wide range of matters, including class actions, mass torts and mass arbitrations.

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