KALA BIO, Inc. Securities Lawsuit Investigation

Shamis & Gentile P.A., a law firm that advocates for investors who are victims of securities fraud, is investigating potential claims against KALA BIO, Inc. (KALA)

If you purchased or acquired KALA BIO securities and suffered losses, you may be eligible to join this securities investigation and seek compensation.

About KALA BIO

KALA BIO, headquartered in Middlesex County, Massachusetts, is a clinical-stage biopharmaceutical company focused on developing innovative treatments for eye diseases.

The company’s lead product candidate, KPI-012, was designed as a potential first-in-class therapy for persistent corneal epithelial defect (PCED), a rare and severe ocular condition.

Potential Concerns Under Investigation

Lawyers are investigating whether KALA BIO and its executives may have made misleading statements or omitted crucial information regarding the development and prospects of KPI-012 and the pivotal CHASE clinical trial.

Throughout late 2024 and into 2025, company leadership repeatedly described KPI-012 as a “first-in-class treatment for PCED” and highlighted its potential to “address all underlying etiologies” of the disease. These statements appeared to set high expectations for the trial’s success.

Statements under review include CEO Mark Iwicki’s November 2024 comment that, if successful, the Phase 2b CHASE trial “may serve as the first of two pivotal trials in support of a BLA submission."

In May 2025, interim CEO Todd Bazemore echoed this optimism, suggesting that successful topline results could pave the way for regulatory approval.

Even as the company shifted its timeline for trial data from early 2025 to later in the year, KALA BIO allegedly continued to present a positive outlook, without disclosing any adverse interim data or internal challenges.

On Sept. 29, 2025, KALA BIO announced that the CHASE trial “did not meet the primary endpoint” and failed all key efficacy measures. The company also revealed it would “cease development” of both KPI-012 and its MSC-S platform.

This announcement caused KALA BIO’s stock price to plunge nearly 90% in a single day, erasing tens of millions of dollars in market value. The timing of this decline, which occurred while the broader market was stable, suggests the loss may have been directly tied to the disclosure of the failed trial.

Lawyers are also considering whether the company’s public statements and omissions satisfy the elements of a federal securities fraud claim, including whether investors relied on these statements and suffered losses as a result.

Your Rights and Next Steps

Investors who purchased KALA BIO securities during the proposed class period and suffered losses may have important legal rights. This is an ongoing investigation, not a filed lawsuit, but it could lead to a securities class action if sufficient evidence is found.

Lawyers are ready to help investors understand their options, including the potential to recover losses through a class action.

Investors who acquired shares during the relevant period and experienced losses tied to the company’s alleged corrective disclosure may be eligible to participate. Even if you sold shares before the final disclosure, you may still have claims depending on your purchase and sale dates.

It is important for investors to act promptly, as securities investigations are time-sensitive and may be subject to strict deadlines. By joining the investigation, investors can help ensure their interests are represented and that any potential recovery is maximized.

You May Be Entitled to Compensation

If you purchased or acquired KALA BIO securities and suffered financial losses, you may be entitled to compensation. Securities investigations often move quickly, and joining early can help preserve your rights.

To learn more and see if you qualify, complete the form below to join the investigation.