Navidea Biopharmaceuticals (NAVB) puts up a pretty substantial top-line miss for Q3.
Lymphoseek sales for the period: $144K.
NAVB emphasizes a 600% Q/Q increase in unit dose sales and a "repeat-order rate of approximately 90%."
Cash as of September 30: $44.6M.
CEO Mark Pykett says the company is "seeing good momentum in many ... key parameters [including] multi-fold increases in unit sales Q/Q, a high frequency of repeat and multi-dose ordering, an increase in total accounts ordering, strong new user accrual, and encouraging formulary placement activity." (PR)
Navidea BioPharma (NAVB) +7.4% premarket following release of Phase 3 clinical trial data for its Lymphoseek injection in patients with head and neck squamous cell carcinoma.
The now-completed full study indicates Lymphoseek met all pre-specified study endpoints, including sensitivity, negative predictive value and overall accuracy relative to the pathology status of non-SLNs.
Navidea Biopharmaceuticals (NAVB) reaches an agreement with the FDA over the design, endpoints and statistical analysis for two Phase III trials of the company's NAV5001 imaging agent in diagnosing Parkinsonian Syndromes from non-Parkinsonian tremor.
The trial wills run in parallel and enroll a total of around 550 patients who exhibit early stage tremor. (PR)
Navidea Biopharmaceuticals (NAVB +9%) signs an agreement for Siemens Petnet Solutions (SI) to manufacture Navidea's NAV4694 PET imaging agent, which is in Phase II and Phase III trials for evaluating patients with signs of Alzheimers disease and mild cognitive impairment.
Siemens Petnet Solutions operates the world's largest network of PET (positron emission tomography) radiopharmaceutical drug manufacturing facilities and dispensing nuclear pharmacies. (PR)
Navidea Biopharmaceuticals (NAVB) reports Lymphoseek sales of $128K including initial stocking at radiopharmacies. The figure looks woefully light versus the Street's consensus estimate of $366,667 in Q2 sales.
Product development costs for NAV4694 and NAV5001 resulted in a 76% Y/Y increase in R&D expense.
Cash and equivalents at quarter's end were $9.8M.
NAVB also says it is "formally closing its Phase 3 clinical study in subjects with head and neck cancer."