Pharma

Navidea Biopharma: FDA pushes back PDUFA date of cancer drug

Radiopharmaceuticals company Navidea Biopharmaceuticals (NYSE Amex:NAVB) announced that the PDUFA date for its cancer diagnostics […]

Radiopharmaceuticals company Navidea Biopharmaceuticals (NYSE Amex:NAVB) announced that the PDUFA date for its cancer diagnostics drug Lymphoseek has been pushed back three months to Sept. 10.

The reason Dublin, Ohio-based Navidea gave for the U.S. Food and Drug Administration’s request was that the agency sought more data related to chemistry and manufacturing, according to a statement from Navidea.

Navidea’s stock predictably took a hit after the news was announced and fell about 9 percent to around $3 a share in early trading Monday.

Meanwhile, the company sought to downplay any concerns. “Neither this FDA decision nor the [new drug application] review-to-date has raised questions on Lymphoseek’s safety or efficacy,” the company said.

Lymphoseek is a targeting agent used by surgeons to identify lymph nodes in patients with breast cancer or melanoma and to indicate whether cancer has spread to a particular lymph node. The company is also investigating it for the detection of head and neck cancer.

Steve Brozak, president of New Jersey-based research firm WBB Securities, said the pushed-back PDUFA date shouldn’t be cause for concern. “In the long-term, it’s inconsequential,” he said.

He characterized the stock’s drop as a “buying opportunity,” and noted that “the government takes its sweet time” during drug reviews. (Brozak said his company owns shares of Navidea.)

Martin Shkreli of New York hedge fund MSMB Capital has been an outspoken critic of Lymphoseek, but largely echoed Brozak in saying the delayed PDUFA date wasn’t of much consequence.

“Sometimes the FDA pushes reviews back when they haven’t had time to review the application and realize they won’t be able to make the deadline,” he said. “That’s generally what happens with a three-month review delay.”

That said, Shkreli is still bearish on Lymphoseek’s prospects: “I still believe the FDA will refuse to approve the product, or the product will be a very small seller,” he said.

Separately, Navidea issued another news release describing a study that provided a favorable comparison of Lymphoseek in breast cancer patients to the current standard of care for lymphatic mapping, sulfur colloid.

Brozak said the study demonstrated that Lymphoseek is a “highly superior product.”

[Photo from flickr user misteraitch]

 

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