Neoprobe

Diagnostics

$NAVB sees mixed reactions from twitterverse after FDA rejects Lymphoseek

Shares of Navidea Biopharmaceuticals (NYSEAMEX:NAVB) went tumbling in after-hours Monday when the company announced that the U.S. Food and Drug Administration did not approve its cancer diagnostic Lymphoseek. Navidea received a complete response letter from the FDA, rather than approval, because of issues related to third-party manufacturing, the company said in a statement. The rejection […]

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 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 […]

Pharma

Navidea Biopharmaceuticals opens Boston commercialization office

Radiopharmaceuticals company Navidea Biopharmaceuticals (NYSE Amex:NAVB) has opened a Boston-area commercialization office. Employees at Navidea’s new Andover, Massachusetts office will focus much of their attention on the expected launch later this year of drug candidate Lymphoseek, a targeting agent used by surgeons to identify lymph nodes in patients with breast cancer or melanoma and to […]

Pharma

Public ethics group calls for SEC inquiry into Navidea short seller

A public ethics group is calling on the U.S. Securities and Exchange Commission to investigate a hedge fund manager who made headlines last year for being an outspoken short seller of Navidea Bioscience‘s (NASDAQ:NAVB) stock. Citizens for Responsibility and Ethics in Washington (CREW) said it’s looking into whether investors such as Martin Shkreli of MSMB […]

Pharma

Navidea signs option to license Parkinson’s imaging agent from Alseres

Radiopharmaceuticals developer Navidea Biopharmaceuticals (NYSE Amex:NAVB) has signed a deal that gives it the option to license a Parkinson’s disease imaging agent from Alseres Pharmaceuticals. Under the terms of the deal, Navidea (formerly known as Neoprobe) pays Alseres $500,000 for exclusive rights during a six-month period when it can perform due diligence and negotiate a […]

Pharma

Navidea formally changes name from Neoprobe, gets $10M in debt financing

Radiopharmaceuticals developer Navidea Biopharmaceuticals (NYSE Amex:NAVB) has secured up to $10 million in debt financing that strengthens the company’s balance sheet and could help with future acquisitions or licensing deals. The debt funding comes from Hercules Technology Growth Capital (Nasdaq:HTGC), a financial firm that provides loans to technology companies, according to a statement from Dublin, […]

Pharma

Neoprobe licenses Alzheimer’s diagnosis imaging agent from AZN

Neoprobe (NYSE Amex:NEOP) has licensed from AstraZeneca (NYSE:AZN) the worldwide rights to an imaging drug candidate that could aid in the diagnosis of Alzheimer’s disease. Neoprobe said it plans to begin a phase 3 clinical program involving the radiopharmaceutical imaging agent, called AZD4694, in early 2013, according to a statement from the Dublin, Ohio-based company. […]

Pharma

Neoprobe unveils new name: Navidea Biopharmaceuticals

Cancer diagnostics company Neoprobe (NYSE Amex:NEOP) has a new name: Navidea Biopharmaceuticals. The Dublin, Ohio company chose the new moniker because it represents Neoprobe’s commitment to “NAVigating IDEAs” that translate innovation into commercial products that improve patient care, according to a statement. The name change became necessary earlier this year when Neoprobe sold off its […]

Pharma

Neoprobe name change to be announced in ‘coming weeks’

After Neoprobe (NYSE Amex:NEOP) sold off its top revenue-producing asset (along with its name) to transform itself into a pure-play radiopharmaceutical company, it had to find itself a new brand. Now, the company is on the verge of announcing that brand, CEO Mark Pykett said in the Dublin, Ohio company’s third-quarter earnings release. “In the […]

Pharma

Neoprobe: FDA accepts Lymphoseek New Drug Application

The U.S. Food and Drug Administration has accepted cancer diagnostics company Neoprobe‘s (NYSE Amex:NEOP) New Drug Application for its radiopharmaceutical Lymphoseek. FDA acceptance of the Lymphoseek NDA is an important milestone for the Dublin, Ohio, company and provides vindication over a once-vocal hedge fund manager critic who raised questions about the design of the drug’s […]