Mon, Apr. 27, 11:45 AM
- As part of its ongoing efforts to divest non-core neuroimaging assets and refocus on the Manocept platform, Lymphoseek and immuno-oncology therapeutics, Navidea Biopharmaceuticals (NAVB +1.3%) terminates its sub-license agreement with Alseres Pharmaceuticals for NAV5001, an imaging agent in Phase 3 development for early detection of Parkinson's disease.
- Under the terms of the termination agreement, Navidea will transfer all NAV5001-related assets back to Alseres, but will provide clinical support services for NAV5001 on a cost-plus reimbursement basis. It will also receive a milestone payment based on the FDA's approval of NAV5001's New Drug Application (NDA) and a royalty on subsequent commercial sales. Alseres will reimburse Navidea for any maintenance costs of the contract manufacturer retroactive to March 1.
Thu, Mar. 5, 9:15 AM
Thu, Mar. 5, 8:25 AM
- Navidea Biopharmaceuticals (NAVB -1.2%) Q4 results: Revenues: $2.2M (+340.0%); COGS: $0.3M (+50.0%); R&D Expense: $2.3M (-75.5%); SG&A: $4.1M (+2.5%); Operating Loss: ($4.5M) (+65.6%); Net Loss: ($6.9M) (+50.0%); Loss Per Share: ($0.05) (+50.0%).
- FY2014 results: Revenues: $6.3M (+472.7%); COGS: $1.6M (+433.3%); R&D Expense: $16.8M (-29.1%); SG&A: $15.5M (+0.1%); Operating Loss: ($27.6M) (+28.1%); Net Loss: ($35.7M) (+16.4%); Loss Per Share: ($0.24) (+31.4%); Quick Assets: $5.5M (-83.3%).
- 2015 Guidance: Lymphoseek revenue: $10M - 12M.
Thu, Mar. 5, 7:33 AM
Thu, Mar. 5, 7:22 AM
- Navidea (NYSEMKT:NAVB) to receive $2M upfront payment on exclusive sublicense agreement for the commercialization and distribution of Lymphoseek 250 microgram kit in the EU.
- NAVB is eligible to receive additional milestone payments of up to $5M, and royalties on EU net sales.
- Lymphoseek is a receptor-targeted, radiopharmaceutical imaging agent approved by the FDA in 2013 and by the EU in November 2014. It is approved in Europe for imaging and intraoperative detection of sentinel lymph nodes in patients with breast cancer, melanoma, or localized squamous cell carcinoma of the oral cavity.
- Source: Press Release
Wed, Mar. 4, 5:30 PM
Tue, Feb. 17, 9:14 AM
Mon, Feb. 9, 8:07 AM
- On a preliminary basis, Navidea Biopharmaceuticals (NYSEMKT:NAVB) generated $6.3M in total revenue in 2014, including $4.2M for Lymphoseek (technetium Tc 99m tilmanocept). For Q4, the results were $2.2M and $1.5M, respectively. Gross profit was $4.7M and $1.9M, respectively.
- Approximately 22K procedures using Lymphoseek were performed last year. Reorder rate was >80%. The number of customers was greater than 500 as of the end of December.
- CEO Rick Gonzalez will be discussing the company's plans and activities this morning at 10:00 am ET at the 17th Annual BIO CEO & Investor Conference in New York City. Interested parties can access it via a live webcast or archived version on the company's website two hours following.
Mon, Feb. 2, 4:06 PM| 5 Comments
Wed, Jan. 21, 8:11 AM
- Navidea Biopharmaceuticals (NYSEMKT:NAVB) enters into a non-binding term sheet for an initial round of financing for its subsidiary, Macrophage Therapeutics. Navidea director and newly-named Macrophage Therapeutics CEO Michael Goldberg, M.D, leads the group of investors providing $2.5M for a 0.5% stake (implied enterprise value = $500M).
- Proceeds will fund pipeline development based on Navidea's Manocept technology, working capital and the recruitment of a scientific advisory board.
Mon, Jan. 5, 8:49 AM
- Navidea Biopharmaceuticals (NYSEMKT:NAVB) appoints Thomas J. Klima as SVP and Chief Commercial Officer. Previously, he was Head of Sales for Algeta and Senior Director of Marketing for Dendreon.
- The company also appoints Michael Tomblyn, M.D., M.S. as Executive Medical Director. Previously, he was Senior Medical Director at Algeta.
Nov. 20, 2014, 8:29 AM
- The European Commission clears Navidea Biopharmaceuticals' (NYSEMKT:NAVB) Lymphoseek (technetium Tc 99m tilmanocept) for use in imaging and intraoperative detection of sentinel lymph nodes draining a primary tumor in adult patients with breast cancer, melanoma or localized squamous cell carcinoma of the oral cavity.
- The company plans to launch the product in certain major markets in 2015.
Nov. 11, 2014, 7:55 AM
- The FDA refunds Navidea Biopharmaceuticals' (NYSEMKT:NAVB) $1.1M PDUFA filing fee for Lymphoseek (technetium Tc 99m tilmanocept) pursuant to its granting of Orphan Drug status for its use in sentinel lymph node detection in patients with head and neck cancer.
- Separately, the company's major investor, Platinum Partners, reaffirmed its $31.8M line of credit.
Nov. 10, 2014, 12:59 PM
Nov. 6, 2014, 7:34 AM
Nov. 5, 2014, 5:30 PM
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