Covered Companies

Navidea (NAVB) Note 03-05-14

downloadreportFDA Sets October 16th PDUFA for 2nd sNDA for Lymphoseek 2-Day Protocol
FDA Sets June 16th PDUFA for Lymphoseek® sNDA for Sentinel Lymph Node

 

Download Full 12-Page Note with Important Updates: Morning Note 03-05-14 NAVB

NOTE: Navidea Q4 Conference Call Tomorrow 8:30am Eastern Webcast: http://www.media-server.com/m/p/dh2x4bbc U.S. Dial-In: 1-800-708-4539 Int. Dial-In: 1-847-619-6396 Passcode: 36792037

Second sNDA Filing Gets October 16th PDUFA for Lymphoscintigraphy and 2-Day Prior Injection: Navidea announced the FDA accepted for review an additional sNDA (Supplemental New Drug Application) for Lymphoseek® with a standard review PDUFA data of October 16, 2014. The expanded label claims include lymphoscintigraphy imaging and flexible timing of Lymphoseek administration allowing for a 2-day protocol.

June 16th PDUFA for H&N and Sentinel Lymph Node: On December 17, 2013, Navidea submitted their Lymphoseek® sNDA (Supplemental New Drug Application) with the FDA for SLN (Sentinel Lymph Node) detection in patients with head and neck cancer, which was also granted FDA Fast Track designation. On February 18, 2014, the FDA granted the sNDA Priority Review status with a PDUFA decision date of June 16th. If approved, Lymphoseek would be the only approved agent for Sentinel Lymph Node detection in these patients. We also believe this would drive additional adoption of Lymphoseek in breast cancer and melanoma which was approved for lymphatic mapping in the U.S. We also note that Navidea Management indicated during their presentation at BIO CEO 2014 on Monday that they expect Lymphoseek® to achieve greater than 50% market share next year which would result in the de facto standard of care.

Download Full 12-Page Note with Important Updates: Morning Note 03-05-14 NAVB

Echo (ECTE) Note 02-28-14

downloadreportEcho Relents – Michael Goldberg Appointed to Board
Files for CE Mark in Europe – Expects Limited Launch in EU
Waiting on Full $5 Million Investment from MTIA – March 10th Deadline

Download Full 5-Page Note with Important Disclosures: Morning Note 02-28-14 ECTE

This morning, Echo announced that Michael M. Goldberg, M.D., has been appointed to Echo’s Board of Directors. We believe this a significantly positive event as he is representing the single largest shareholder in Echo and whose interests have been consistently aligned with those of smaller shareholders. Dr. Goldberg was a Managing Partner of Montaur Capital Partners from January 2007 to December 2013. Prior to that, Dr. Goldberg was with Emisphere Technologies, Inc., serving as Chief Executive Officer from August 1990 to January 2007, Chairman of the Board of Directors from November 1991 to January 2007, and President from August 1990 to October 1995. Before joining Emisphere, Dr. Goldberg served as Vice President of The First Boston Corp., where he was a founding member of the Healthcare Banking Group. Dr. Goldberg currently serves on the board of Navidea Biopharmaceuticals. He has been a Director of Alliqua, Inc., Urigen Pharmaceuticals, Inc., Adventrx Pharmaceuticals Inc. and several private companies. Dr. Goldberg received a B.S. from Rensselaer Polytechnic Institute, an MD from Albany Medical College of Union University and an MBA from Columbia University Graduate School of Business.

Maintaining Neutral for Now: We believe that Dr. Goldberg’s appointment to the Board of Directors represents a significant first step in regaining shareholder confidence in Echo. However, we are remaining neutral until we have better visibility on financial and operational issues. We continue to believe in the basic science of the Symphony tCGM system and that it should ultimately be successful. However, the near-term unknowns combined with the anticipated volatility surrounding both the product development, clinical data and future financings prevent us from modeling Echo with any degree of confidence at this time.

Download Full 5-Page Note with Important Disclosures: Morning Note 02-28-14 ECTE

Navidea (NAVB) Note 02-19-14

downloadreportNavidea Adds Board Member from Celgene Corporation
FDA Sets June 16th PDUFA for Lymphoseek® sNDA for Sentinel Lymph Node
NEJM Confirms 10-Year Benefit of Sentinel Lymph Node in Melanoma
Management Expects >50% Market Share Next Year for Lymphoseek®

Download Full 12-Page Note with Important Disclosures: Morning Note 02-19-14 NAVB

Navidea Adds New Board Member from Celgene: Navidea announced that Perry A. Karsen has been appointed to the Board of Directors and increases the number of directors on Navidea’s Board to seven. Mr. Karsen is currently Executive Vice President and Chief Operations Officer at Celgene Corporation (Nasdaq:CELG MktCap:$68 Billion Rating:Not Rated) and Chief Executive Officer of Celgene Cellular Therapeutics. Previously, Mr. Karsen was Senior Vice President and Head of Worldwide Business Development at Celgene, and was also responsible for emerging businesses as President, Asia/Pacific Region. He also served as President and Chief Executive Officer at Pearl Therapeutics and he held executive roles at Human Genome Sciences, Bristol-Myers Squibb, Genentech and Abbott Laboratories. In addition, Mr. Karsen was a General Partner at Pequot Ventures. Mr. Karsen is a member of the Board of Directors of the Biotechnology Industry Organization (BIO); a member of the Board of Directors of BayBio; and a member of the Board of Directors for the Life Sciences Foundation. He is also a member of the Board of Directors of Agios Pharmaceuticals and Alliqua, Inc. Mr. Karsen has a Masters of Management degree from Northwestern University’s Kellogg Graduate School of Management, a Masters in Teaching of Biology from Duke University, and a B.S. in Biological Sciences from the University of Illinois, Urbana.

Reiterating Strong Speculative Buy: With Navidea’s June 16th PDUFA date for their Lymphoseek® sNDA (Supplemental New Drug Application) with the FDA for SLN (Sentinel Lymph Node) detection in patients with head and neck cancer and expected >50% market share in 2015 along with the permanent A-code for reimbursement, we believe Lymposeek is on its way to becoming the standard of care for these patients. Furthermore, we anticipate European CHMP positive recommendation in a few months for breast cancer, melanoma and head & neck cancer with SLN. In the longer term, the Phase III trials for NAV4694 Alzheimer’s imaging and NAV5001 Parkinson’s imaging along with their NAV1800 RIGScan monoclonal antibody entering the clinic should unlock additional value. Finally, Navidea’s Manocept platform utilizing the CD206 mannose receptor technology used in Lymphoseek is expect to mature over the coming months. We are reiterating our Strong Speculative Buy rating with a 12-18 month price target of $3.75 based on a 35x multiple on projected fiscal year 2017 EPS and discounted 25% for cumulative risk.

Download Full 12-Page Note with Important Disclosures: Morning Note 02-19-14 NAVB

Navidea (NAVB) Note 02-18-14

downloadreportFDA Sets June 16th PDUFA for Lymphoseek® sNDA for Sentinel Lymph Node
NEJM Confirms 10-Year Benefit of Sentinel Lymph Node in Melanoma
Management Expects >50% Market Share Next Year for Lymphoseek®
Europe Incorporates H&N SLN Data to Existing MAA

Download Full 11-Page Note with Important Disclosures: Morning Note 02-18-14 NAVB

FDA Grants Priority Review – June 16th PDUFA: On December 17, 2013, Navidea submitted their Lymphoseek® sNDA (Supplemental New Drug Application) with the FDA for SLN (Sentinel Lymph Node) detection in patients with head and neck cancer, which was also granted FDA Fast Track designation. If approved, Lymphoseek would be the only approved agent for Sentinel Lymph Node detection in these patients. We also believe this would drive additional adoption of Lymphoseek in breast cancer and melanoma which was approved for lymphatic mapping in the U.S. We also note that Navidea Management indicated during their presentation at BIO CEO 2014 on Monday that they expect Lymphoseek® to achieve greater than 50% market share next year which would result in the de facto standard of care.

NEO3-06 Phase III Results
On April 11, 2013, Navidea announced that the interim data from their Phase III clinical trial of Lymphoseek in head and neck squamous cell carcinoma that were so strong that the Data Safety Monitoring Committee (DSMC) recommended the trial be ended early to speed an FDA sNDA submission. The primary endpoint for the NEO3-06 trial was based on the number of subjects with cancer-positive lymph nodes following a multiple level lymph node dissection and required a minimum of 38 patients whose lymph nodes contained pathology-confirmed disease. The results were for 39 patients with cancer-positive lymph nodes and Lymphoseek accurately identified 38 for an overall False Negative Rate (FNR) of 2.56%. This is a particularly strong result considering the goal of the trial was a FNR less than 10%. The results were also statistically significant (p=0.0205). Sensitivity was 97.4% and the Negative Predictive Value was 97.8% yielding an Overall Accuracy of 98.8%. It should also be noted that using Lymphoseek led to the removal of only 4 lymph nodes per patient on average versus an average of 38 lymph nodes per patient in the trial. LymphoSeek has the potential to provide a substantial reduction in lymph-related adverse side-effects for patients with head and neck cancer undergoing sentinel lymph node biopsy.

Download Full 11-Page Note with Important Disclosures: Morning Note 02-18-14 NAVB

Navidea (NAVB) Note 02-13-14

downloadreportNEJM Confirms Importance of Sentinel Lymph Node in Melanoma
Management Expects >50% Market Share Next Year for Lymphoseek®
Lymphoseek® sNDA Filed – FDA Fast Track – May Get Priority Review
Europe Incorporates H&N SLN Data to Existing MAA

Download Full 11-Page Note with Important Disclosures: Morning Note 02-13-14 NAVB

10-Year Data Confirms Importance of Sentinel Lymph Node Management in Melanoma:

Source: Morton, D. et al “Final Trial Report of Sentinel-Node
Biopsy versus Nodal Observation in Melanoma” N Engl J Med
2014; 370:599-609February 13, 2014DOI: 10.1056/NEJMoa1310460

The New England Journal of Medicine published 10-year follow-up data on the impact of Sentinel Lymph Node biopsy in melanoma patients. 1,000 patients underwent wide excision of the primary melanoma plus sentinel-node biopsy and were compared to 661 patients who underwent wide excision plus postoperative nodal observation. The paper titled “Final Trial Report of Sentinel-Node Biopsy versus Nodal Observation in Melanoma” showed the 10-year disease-free survival rates were significantly improved in the sentinel lymph node biopsy group, as compared with the observation group. Intermediate-thickness melanomas rates were 71.3% versus 64.7% and thick melanomas 50.7% versus 40.5%. Sentinel Node Biopsy-based management also improved the 10-year rate of distant disease–free survival and the 10-year rate of melanoma-specific survival for patients with intermediate-thickness melanomas and nodal metastases. The paper may be accessed at http://www.nejm.org/doi/full/10.1056/NEJMoa1310460 or contact the research analyst above for discussion. We also note that Navidea Management indicated during their presentation at BIO CEO 2014 on Monday that they expect Lymphoseek® to achieve greater than 50% market share next year which would result in the de facto standard of care.

Manocept Platform Development Continues:
Data utilizing compounds Navidea’s new Manocept™ platform in models of rheumatoid arthritis will be presented by Thomas Rosol, DVM, PhD, DACVP from The Ohio State University at a Keystone Symposia on Molecular Cell Biology of Macrophages in Human Disease held, February 9-14 in Santa Fe, NM. The data highlighted the identification of immune-mediated inflammation seen in arthritic elbows and knees of arthritis-affected mice but not in control mice or un-affected joints within arthritic mice.

Source: Rosol T., et al “Imaging of macrophages in immune-mediated inflammatory disease and cartilage
antibody-induced arthritis in mice using Cy3-tilmanocept” Keystone Symposia on Molecular Cell Biology of
Macrophages in Human Disease held, February 9-14 in Santa Fe, NM

Download Full 11-Page Note with Important Disclosures: Morning Note 02-13-14 NAVB

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