What's your position on ?
Why are you ish?
You voted ish on Vote again
Posts appear on the My Feed page of subscribers to this ticker
Today, 8:47 AM
- The first patient has been enrolled in a Phase 2 clinical trial evaluating Navidea Biopharmaceuticals' (NYSEMKT:NAVB) Lymphoseek (technetium Tc 99m tilmanocept) injection in women with cervical cancer. The study will assess the use of Lymphoseek in sentinel lymph node biopsy during cervical cancer surgery in support of its current label in lymphatic mapping.
- The trial will enroll up to 40 subjects. Each will receive a single dose of Lymphoseek administered around the tumor 1 - 2 hours before surgery. The primary endpoint is the per-patient false negative rate. According to clinicaltrials.gov, the estimated study completion date is August of this year.
- Lymphoseek is designed for the precise identification of lymph nodes that drain from a primary tumor. These have the highest probability of harboring cancer cells.
Mon, Jan. 11, 3:02 PM
Wed, Jan. 6, 12:34 PM
- The first patient is enrolled in Navidea Biopharmaceuticals' (NAVB -2.3%) Phase 2 study comparing the lymph node-identifying capability of Lymphoseek (technetium Tc 99m tilmanocept) to vital blue dye (VBD) in 32 pediatric patients with melanoma, rhabdomyosarcoma or other solid tumors.
- Lymphoseek, currently approved for use only in adults, is a radiopharmaceutical imaging agent designed to precisely identify lymph nodes that drain from a primary tumor, ones that have the highest probability of harboring cancer cells.
- The study, called NAV3-18, is a prospective, open-label, multicenter trial in pediatric patients with certain cancers who are undergoing lymph node mapping. In addition to safety and tolerability, it will primarily assess the in vivo detection rates of Lymphoseek and VBD in excised lymph node tissue. According to clinicaltrials.gov, the estimated study completion date is July 2018.
Nov. 4, 2015, 10:03 AM
- Navidea Biopharmaceuticals (NAVB -8.2%) Q3 results: Revenues: $4M (+73.9%); COGS: $0.5M (-37.5%); R&D Expense: $3.9M (-7.1%); SG&A: $3.9M (+50.0%); Operating Loss: ($4.3M) (+20.4%); Net Loss: ($8.1M) (-17.4%); Loss Per Share: ($0.05) (unch); Quick Assets: $11.4M (+107.3%).
- No guidance given.
Nov. 4, 2015, 7:36 AM
- Navidea Biopharm (NYSEMKT:NAVB): Q3 EPS of -$0.05 misses by $0.01.
- Revenue of $3.98M (+76.9% Y/Y) beats by $1.2M.
Nov. 3, 2015, 5:30 PM
- AFAM, AGN, AMRN, ARCC, ARCO, ARQL, ARRY, AVA, AVP, AXAS, BDX, BIOS, BSFT, CBB, CDW, CECO, CHK, CLH, CRK, CRL, CRTO, CRZO, CST, CSTE, CTSH, DAVE, DDD, EE, EMES, FOR, FOXA, GDP, HAE, HEP, HMC, HSIC, HSNI, INXN, KELYA, KORS, LINC, LL, MEMP, MFA, MNTA, MSI, MWE, NAVB, NCT, NEWP, NRG, NYLD, REGN, SBGI, SCMP, SE, SHOP, SNH, SODA, SSYS, STNG, TESO, TMHC, TWX, USAK, VG, VOYA, VRTU, VSI, WCG, WD, WEC, WEN, WILN, WIX, WMC
Jul. 30, 2015, 10:07 AM
- Navidea Biopharmaceuticals (NAVB -3.2%) Q2 results: Revenues: $2.9M (+163.6%); COGS: $0.3M (+22.2%); R&D Expense: $2.3M (-54.9%); SG&A: $4M (-18.4%); Operating Loss: ($3.8M) (+58.7%); Net Loss: ($9.7M) (+4.9%); Loss Per Share: ($0.06) (+14.3%); Quick Assets: $15.8M (+187.3%).
- 2015 Guidance: Lymphoseek revenue: $10M - 12M.
Jul. 30, 2015, 7:39 AM
- Navidea Biopharm (NYSEMKT:NAVB): Q2 EPS of -$0.06 misses by $0.02.
- Revenue of $2.87M (+168.2% Y/Y) beats by $0.69M.
Jul. 2, 2015, 9:11 AM
Jun. 11, 2015, 9:09 AM
- BIND Therapeutics (NASDAQ:BIND) and Navidea Biopharmaceuticals (NYSEMKT:NAVB) subsidiary Macrophage Therapeutics enter into a research collaboration to engineer Accurins with the Manocept targeting platform. After completing the proof-of-concept work, the companies plan to expand the partnership to develop Manocept-linked Accurins for the treatment of cancer.
- Accurins are nanoparticles that incorporate a therapeutic payload and are designed to have prolonged circulation in the bloodstream thereby providing controlled and timely release of the therapy to diseased tissue or cells.
- The tilmanocept technology or Manocept, is a platform technology which specifically targets activated macrophages, a type of white blood cell that "eats" cellular debris. Manocept enables the selective binding to a protein found on the surface of disease-associated macrophages called CD206.
- Macrophages play a key role in many diseases so coupling Accurins to them via CD206 may produce a therapeutic benefit.
- Financial terms of the collaboration are not disclosed.
Jun. 9, 2015, 9:17 AM
May 12, 2015, 7:55 AM
- Navidea Biopharmaceuticals (NAVB +1.6%) Q1 results: Revenues: $2.1M (+162.5%); COGS: $0.4M (+100.0%); R&D Expense: $4M (-23.1%); SG&A: $5.5M (+41.0%); Operating Loss: ($7.8M) (+9.3%); Net Loss: ($7.3M) (+37.6%); Loss Per Share: ($0.05) (+37.5%); Quick Assets: $4.9M (-10.9%).
- 2015 Guidance: Lymphoseek revenue: $10M - 12M.
May 12, 2015, 7:31 AM
- Navidea Biopharm (NYSEMKT:NAVB): Q1 EPS of -$0.05 misses by $0.02.
- Revenue of $2.11M (+181.3% Y/Y) misses by $1.16M.
May 11, 2015, 6:37 PM
- Navidea Biopharmaceuticals (NYSEMKT:NAVB) secures a $60M loan from CRG which it will use to retire its debt from Oxford Finance, support the commercialization of Lymphoseek and general corporate purposes.
- Under the terms of the loan, Navidea will receive an initial $50M for a term of six years, the first four interest-only, at a 14% interest rate. An additional $10M will be available under certain conditions. After paying off the Oxford debt, the company will have $18M in new capital.
- In conjunction with the CRG financing, Navidea amends its existing line of credit with Platinum-Montaur Life Sciences that will allow it to remain in place in a subordinated position to the CRG loan. Platinum may convert the company's $7.7M debt into common stock if the average price exceeds $2.53 per share for 10 consecutive trading days. Today's close was $1.35.
May 11, 2015, 5:30 PM
Apr. 27, 2015, 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.
Other News & PR