Navidea price target raised to $6 from $4 at H.C. Wainwright » 12:2105/2205/22/20
H.C. Wainwright analyst…
H.C. Wainwright analyst Vernon Bernardino raised the firm's price target on Navidea to $6 from $4 and keeps a Buy rating on the shares after the company announced "positive" preliminary results from its second interim analysis of its ongoing NAV3-31 Phase 2b study with tilmanocept. Bernardino believes the interim data analysis further corroborates the company's hypotheses that tilmanocept imaging can provide "robust, quantitative" imaging in healthy controls and in patients with active rheumatoid arthritis. The analyst added that he is positive on the results, as they boost the technology's chances of success for approval as a new imaging tool in RA.
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Navidea surges nearly 30% after 'positive' arthritis study results » 16:5105/2105/21/20
Shares of Navidea…
Shares of Navidea Biopharmaceuticals (NAVB) jumped 29.9% after the company announced "positive" results from the company's second interim analysis of its ongoing NAV3-31 Phase 2B study. Navidea said that analysis shows that these interim data further corroborate its hypotheses that Tc99m tilmanocept imaging can provide robust, quantitative imaging in healthy controls and in patients with active rheumatoid arthritis, and that this imaging can provide an early indicator of treatment efficacy in patients with active RA. Michael Rosol, Chief Medical Officer for Navidea, said, "We are encouraged by these interim results, which are in line with our hypotheses, support the continuation of the current Phase 2B study, and will be fundamental to speaking with the FDA about moving forward into the Phase 3 trial later this year." Dr. Rosol continued, "We are excited that we are on track to possibly providing rheumatologists and those suffering with RA a noninvasive, quantifiable, early indicator of whether or not an anti-TNF alpha treatment is working. This could bring enormous benefit to these patients by assisting physicians in putting them on the right course of treatment earlier than would otherwise be possible today."
Navidea reports 'positive' preliminary results from ongoing Phase 2B RA study » 16:3105/2105/21/20
Navidea Biopharmaceuticals announced "positive" preliminary results from the Company's second interim analysis of its ongoing NAV3-31 Phase 2B study. Analysis demonstrates that these interim data further corroborate Navidea's hypotheses that Tc99m tilmanocept imaging can provide robust, quantitative imaging in healthy controls and in patients with active rheumatoid arthritis, and that this imaging can provide an early indicator of treatment efficacy in patients with active RA. A total of 15 subjects with active moderate-to-severe RA were included in this interim analysis, each of which was set to begin a new or first-time treatment regimen with an anti-TNF alpha therapy. Whole body and hand/wrist planar gamma camera images were obtained at baseline prior to initiation of new treatment, again at 5 weeks post therapy initiation, and then again at 12 weeks on 8 of the 15 subjects. The remaining 7 subjects had received baseline and 5-week scans only at the time of this analysis. A panel of established clinical assessments was performed at each time point as well, in order to compare imaging results with clinical standards over the 12-week time course. Results of the preliminary analysis demonstrate: Tc99m tilmanocept imaging from baseline to week 5 was predictive of clinical outcome at 12 weeks in 7 out of 8 subjects with 12-week clinical assessment available at the time of the interim analysis. The one subject who did not demonstrate concordance of signal quantification and clinical assessment had undergone a change in treatment regime while enrolled in the trial that may have impacted the trajectory of the clinical response. Combined data from all 15 subjects in Arm 3 suggest a wide dynamic range of more than one order of magnitude (greater than10-fold) for calculated global Tc99m tilmanocept uptake values in joints with RA-involved inflammation. In the subjects with 12-week follow up data available, global Tc99m tilmanocept signals declined by an average of 58% from baseline to week 5 in those who responded significantly to anti-TNF alpha treatment by week 12. In those subjects who did not have a significant clinical response to anti-TNF alpha treatment by week 12, Tc99m tilmanocept signals increased by an average of 79% from baseline to 5 weeks. These preliminary results indicate that marked changes in Tc99m tilmanocept global uptake values by week 5 are in agreement with clinical efficacy evaluations made at week 12 of treatment. The wide dynamic range of global Tc99m tilmanocept signal readout combined with the low variability of imaging signal quantification established in Arms 1 and 2 of this trial are supportive of the idea that clinically meaningful changes in signal localization can be detected. These interim data are supportive of Navidea's hypotheses that Tc99m tilmanocept imaging can provide quantifiable imaging assessment of RA-involved joints that enables early prediction of clinical response as well as longitudinal monitoring of clinical status.
|Over a week ago|
Navidea regains commercialization, distribution rights in EU for LYMPHOSEEK » 07:3605/1105/11/20
Navidea Biopharmaceuticals announces that the company has regained the commercialization and distribution rights in Europe for LYMPHOSEEK injection from Norgine B.V. Navidea and Norgine have decided, by mutual agreement, to end the existing license agreement between the two companies. The Agreement was originally entered in March 2015, and provided Norgine with the exclusive rights in Europe for LYMPHOSEEK. As a result of today's transaction, Navidea has regained all the rights, economics, and intellectual property of LYMPHOSEEK in Europe.
|Over a month ago|
Navidea issues statement, clinical trial update amid COVID-19 pandemic » 07:3504/2204/22/20
Navidea announced the…
Navidea announced the following statement regarding the impact of the COVID-19 pandemic on the company's ongoing clinical development efforts: "First, we would like to express our sincerest gratitude for all of the healthcare workers and other responders on the frontlines who are working tirelessly to combat this global pandemic. This has affected us all. We wanted to share Navidea's response during this time of crisis and provide an update on our research and development activities. Navidea is on track to deliver interim data from arm 3 of the Company's Phase 2b clinical trial (NAV3-31) in the timeframe previously communicated on the March 11, 2020 quarterly update call. Navidea has enrolled sufficient patients to meet these previously communicated timelines." In regards to the company's planned meeting with the FDA, management has made no changes to its internal forecast of an FDA meeting in late Q2/early Q3. Management believes that sufficient patients have been enrolled to maintain the previous forecast. The NAV3-33 trial, pivotal Phase 3 trial for rheumatoid arthritis, remains on track for a second-half 2020 launch. This goal echoes guidance previously provided on the March 11 quarterly update call. Analysis of the data from the company's Cardiovascular Phase 2b study remains on track. Results provided to Navidea thus far have paralleled data in our earlier published article. These data are supportive of Navidea's hypothesis that Tilmanocept can provide marked signal to background in a host of cardiovascular disease applications. Navidea continues to anticipate meeting with the FDA in the coming months to discuss upcoming clinical trial designs.
Navidea signs LOI to partner with WorldCare for RA clinical imaging workflow » 07:4303/3103/31/20
Navidea announced that it…
Navidea announced that it has signed a letter of intent, or LOI, to partner with WorldCare Clinical for the company's rheumatoid arthritis, or RA, diagnostic clinical imaging workflow. Per the agreement, WorldCare would serve as Navidea's central imaging service provider following FDA approval of Navidea's RA diagnostic. WorldCare Clinical is an independent contract research organization dedicated to imaging in clinical trials and brings with it over 25 years of clinical trial imaging, commercial clinical imaging and large-scale data management experience. WorldCare and Navidea will work in conjunction during the completion of Navidea's ongoing and planned RA diagnostic trials. The partnership will work to develop the commercial workflow and infrastructure to support the full-scale commercialization plan for Navidea's RA diagnostic. It is anticipated that WorldCare will be the vendor managing the imaging aspects of the upcoming Phase 2b and Phase 3 clinical trials, and will work in parallel to develop an optimized workflow in preparation for commercial launch in indications in RA. The company's audited financial statements contained a going concern explanatory paragraph in the audit opinion from its independent registered public accounting firm. This announcement is required pursuant to NYSE American Company Guide Sections 401 and 610, and does not represent any change or amendment to the company's financial statements or to its annual report on Form 10-K for FY19.
Navidea announces extension certificate for Lymphoseek patent from USPTO » 07:0403/2003/20/20
Navidea (NAVB) announced…
Navidea (NAVB) announced that the U.S. Patent and Trademark Office, or USPTO, issued a certificate to extend the duration of U.S. patent 6,409,990 for an additional five years through May 12, 2025. This certificate was based on the FDA recommendation for a five-year extension under the Hatch-Waxman Act for patent term lost in regulatory review. This patent claims and protects Lymphoseek and has been exclusively licensed with varying geographical and medical indication coverages to Cardinal Health (CAH) and Navidea. Allowance of this patent extension will permit Cardinal Health and Navidea to extend their exclusive rights to manufacture and commercialize Lymphoseek until the end of the extended patent term in 2025.
|Over a quarter ago|
Navidea trading resumes 12:1002/1402/14/20
Navidea regains compliance with NYSE American listing standards » 12:0502/1402/14/20
Navidea Biopharmaceuticals announced that following its recently announced funding transactions, the company is back in compliance with the NYSE American's continued listing standards. Following the funding transactions, the company now has stockholders' equity of $6.0M, and therefore has regained compliance with the NYSE American's continued listing standards.