Diagnostic maker Navidea's winding path leads to Chapter 11 filing

Diagnostic and immunotherapy biopharma Navidea Biopharmaceuticals' long and often tortured journey is coming to an end as it files for bankruptcy.

The Ohio-based company has for the last three years been delisted from trading on the New York Stock Exchange and had its NYSE appeal turned away in 2023.

In addition, the company two years ago settled a longstanding legal tussle with Capital Royalty Partners that had been ongoing since 2016, and, last year, it released itself from reporting under its Securities and Exchange Commission obligations by filing a Form 15.

Now, the filing is for Chapter 11. “The filing is intended to enable the company to pursue an orderly restructuring of its financial obligations while continuing limited operations to preserve value for creditors and stakeholders,” the company said in a brief statement.

“The Company intends to use the Chapter 11 process to evaluate strategic alternatives, protect its assets, and ensure fair treatment of creditors," Navidea added.

Navidea’s only marketed product is Lymphoseek (technetium Tc 99m tilmanocept) injection, a radiopharmaceutical used for lymphatic mapping to diagnose the spread of cancer.

Back in 2017, the company sold the North American rights to the product to Cardinal Health for $83 million at closing, with $227 million at the time earmarked based on certain milestones through 2026.

It’s also been searching for a partner for Lymphoseek in Europe.

It had been working on a pipeline of new products, including diagnostics for arthritis and cardiovascular diseases.