Navidea Biopharmaceuticals prevailed on the regulatory front with an FDA approval for the company's ($NAVB) imaging drug for patients with breast cancer and melanoma.
Yet perhaps due to headline selling after the news hit on Wednesday, The Motley Fool reported, the Dublin, OH-based developer's stock price fell 7.33% on the day and continued to slide through Thursday morning.
Nevertheless, the loss-making biopharma outfit has won an important approval for Lymphoseek, a radioactive imaging agent used to help doctors home in on lymph nodes--also called lymph node mapping--in breast cancer and melanoma patients who undergo procedures to remove them for evaluation. Lymph nodes at tumor sites drain cancer cells, and inspecting lymph nodes taken from cancer patients enables doctors to determine the stage of disease and figure out the next steps for fighting the cancers.
Navidea (formerly Neoprobe) has scored the approval after U.S. regulators in September slapped the company with a denial because of the deficiencies at a third-party manufacturing partner for the product. Yet after addressing those problems, the company bounced back from the setback with a resubmittal in late October and now has an earlier-than-anticipated green light. Lymphoseek is the first new imaging agent for lymphatic mapping to win approval in more than 30 years, according to the FDA.
The blue dye drug approved in 1981 was tested in Navidea's 332-patient pivotal trial for Lymphoseek, which bested its blue dye rival in identifying targeted lymph nodes, which also harbor cancer, the FDA said.
"Removal and pathological examination of lymph nodes draining a primary tumor is an important diagnostic evaluation for some patients with breast cancer or melanoma," Dr. Shaw Chen, deputy director of the Office of Drug Evaluation IV in the FDA's Center for Drug Evaluation and Research, said in a statement. "To use Lymphoseek, doctors inject the drug into the tumor area and later, using a handheld radiation detector, find lymph nodes that have taken up Lymphoseek's radioactivity."
Cardinal Health is the sole U.S. distribution partner for Lymphoseek, facing the obvious challenge of unseating long-used blue dye in the mapping procedures.
Meantime, Navidea has a pipeline of additional imaging agents including a candidate in mid-stage development for diagnosing Alzheimer's disease and an additional compound for Parkinson's diagnosis, among other projects.
- here's the FDA release
- see Motley Fool's article