As the the year comes to end, there is still a steady flow of interesting news coming from small cap biotech stocks like Organovo Holdings Inc (NYSEMKT: ONVO), Advanced Cell Technology, Inc (OTCMKTS: ACTC) and TNI BioTech (OTCMKTS: TNIB)�plus still largely private biotech companies like Genocea Biosciences (NASDAQ: GNCA), Retrophin (OTCMKTS: RTRX), Auspex Pharmaceuticals (NASDAQ: ASPX) and GlycoMimetics (NASDAQ: GLYC) who have filed to become the next potentially hot biotech IPOs���presumably some time early�next year. Just consider the following biotech news:
Organovo Holdings Inc Wants to Use 3D Printing to Print a Liver Next Year. ComputerWorld has reported that San Diego-based small cap bio-printing company Organovo Holdings is now expecting to unveil the world's first printed organ, a human liver, next year. However, the article is quick to add that Organovo Holdings is only�planning to print liver tissue�for research use only and that the tissue will be used in the laboratory for medical studies and drug research. Nevertheless, there�are about 120,000 people on the organ waiting list in the US and those who do receive organs face the possibility of rejection���something that would not happen if a patient�� own stem cells are used to create a new organ. But research into whole organ regeneration currently receives less than $500 million in funding a year in the US verses�$5 billion for cancer research and $2.8 billion for HIV and AIDS. Organovo Holdings is one of this year�� best performing stocks because�its up 248.1% since the start of the year and up 483.9% since February 2012.Top 10 Medical Companies To Own For 2015: OncoSec Medical Inc (ONCS)
OncoSec Medical Incorporated, incorporated on February 8, 2008, is an emerging drug-medical device company. The Company focused on designing, developing and commercializing medical approaches for the treatment of solid cancers. In March 2011, the Company acquired from Inovio Pharmaceuticals, Inc. (Inovio) certain assets related to the use of drug-medical device combination products for the treatment of different cancers.
The Company�� acquired assets relate to certain non-deoxyribonucleic acid (DNA) vaccine technology and property relating to selective tumor ablation technologies, which it refers to as the OncoSec Medical System (OMS), a therapy which uses an electroporation device to facilitate delivery of chemotherapy agents, or nucleic acids encoding cytokines, into tumors and/or surrounding tissue for the treatment and diagnosis of various cancers. As of January 24, 2012, the Company had not generated any revenue from operations.
Advisors' Opinion:- [By John Udovich]
Small cap biotech stocks AVEO Pharmaceuticals, Inc (NASDAQ: AVEO), OncoSec Medical Inc (OTCMKTS: ONCS) and MetaStat Inc (OTCBB: MTST) are focused on or are developing treatments or diagnostic technologies for metastatic cancers. In case you aren�� familiar with the term metastasis or metastatic, it�� the�spread of cancer from its primary site to other places in the body as cancer cells break away from a primary tumor, penetrate into lymphatic and blood vessels, circulate through the bloodstream and then grow in a new focus (metastasize) in normal tissues elsewhere in the body. In other words, it�� a dangerous form of cancer, but there are some small cap biotech stocks targeting it for diagnostics or treatment:
Top 10 Medical Companies To Own For 2015: International Stem Cell Corp (ISCO)
International Stem Cell Corporation, incorporated on June 7, 2005 is a developmental-stage biotechnology company. The Company focused on therapeutic and biomedical product development. The Company�� wholly owned subsidiary Lifeline Cell Technology, LLC (LCT) develops, manufactures and commercializes over 130 human cell culture products, including frozen human primary cells and the reagents (media) needed to grow, maintain and differentiate the cells, in order to address this market opportunity. The Company�� scientists have used a technology called basal medium optimization to systematically produce optimized products designed to culture specific human cell types and to elicit specific cellular behaviors. The Company�� wholly owned subsidiary Lifeline Skin Care, Inc. (LSC) develops, manufactures and markets cosmetic skin care products using an extract derived from its pluripotent stem cells.
Therapeutic Product Candidates
Using the Company's technologies and know-how, the Company is exploring and creating a range of cell types that is useful in therapeutic treatments, which include Liver cells (hepatocytes) that may be used to treat a range of congenital and acquired liver diseases. Neuronal cells for potential treatment of Parkinson's disease and other central nervous system disorders, such as traumatic brain injury, stroke and Alzheimer�� disease. Three-dimensional eye structures to treat degenerative retinal diseases, corneal blindness, and to accelerate corneal healing.
Skin Care Products
The Company�� research scientists developed two skin care products, Defensive Day Serum and Recovery Night Serum, using an extract derived from human parthenogenic stem cells. Defensive Serum contains sunscreen, along with stem cell-derived ingredients. The day serum not only protects the skin from the aging effects of harsh light, but it continues to nurture the skin�� collagen and fibroblasts to give noticeably firmer, smoother, younger-looking ! skin. The Recovery Night Serum is a nighttime therapy that complements the Defensive Day Serum. The night serum nurtures the skin�� collagen and elastin and contains ingredients to defend against damaging free radicals, to help build firmer, smoother, younger and healthier-looking skin.
Research Products
The Company�� Lifeline subsidiary produces and sells over 250 human cell culture products. These products include frozen human cells and stem cells and the reagents needed to grow, maintain and differentiate the cells. These human cell-based products are used domestically and internationally by research scientists in pharmaceutical, academic and government research organizations to study human disease and basic cell biology.
The Company competes with Genzyme Corporation, StemCell, Advanced Cell Technology Inc., Aastrom Biosciences, ViaCyte, Obagi, SkinCeuticals, SkinMedica, Murad, Lonza, Chemicon, Life Technologies, StemCell Technologies, Merck, BioTime and Specialty Media.
Advisors' Opinion:- [By John Udovich]
From stem cell burgers to earnings reports, the stem cell industry and small cap players in it like NeoStem Inc (NASDAQ: NBS), International Stem Cell Corp (OTCMKTS: ISCO) and BioRestorative Therapies (OTCBB: BRTX) have been producing some news lately that has probably been overlooked by investors and traders alike given its August. Nevertheless, you might want to pay attention to the following stem cell news:
- [By John Udovich]
The results of a recent Pew Center Poll regarding attitudes towards abortion and various forms of stem cell research could be a good sign for the stem cell industry along with small cap stem cell stocks like StemCells Inc (NASDAQ: STEM), NeoStem Inc (NASDAQ: NBS), Neuralstem, Inc (NYSEMKT: CUR),�International Stem Cell Corp (OTCMKTS: ISCO) and BioRestorative Therapies (OTCBB: BRTX). Basically, Americans think that having an abortion is a moral issue with 49% of American adults believing abortion is morally wrong, 23%�view it not as a moral issue and and 15% view it as morally acceptable. However and when Americans were asked about issues surrounding�human embryos, such as stem cell research or in vitro fertilization, as a matter of morality, their views were different.
Top 5 Information Technology Companies To Own For 2015: Biodel Inc (BIOD)
Biodel Inc. (Biodel), incorporated on December 3, 2003, is a development-stage speciality biopharmaceutical company focused on the development and commercialization of treatments for diabetes. The Company develops its product candidates by applying its formulation technologies to existing drugs. Its advanced program involves developing formulations of injectable recombinant human insulin (RHI). In addition to its ultra-rapid-acting insulin formulations, the Company has developed prototype formulations of a liquid glucagon, a basal insulin and a glucose responsive insulin, in each case for use by patients with diabetes. RHI-based formulation known as Linjeta was the subject of a New Drug Application (NDA).
The Company has two pivotal Phase III clinical trials with its preferred commercial formulation of Linjeta prior to re-submitting the NDA. In August 2011, it completed patient visits and analyzed top-line data from the first Phase 1 clinical trial of two RHI-based formulations. The trial was a single-center, randomized, double-blind, three-period crossover trial in 18 subjects with Type 1 diabetes. The purpose of the trial was to evaluate the pharmacokinetic and pharmacodynamic characteristics and injection site toleration of BIOD-105 and BIOD-107, as compared to the insulin analog marketed as Humalog. The Company conducted Phase I, Phase II and Phase III clinical trials comparing the performance of its Linjeta formulation of RHI to either Humulin, which is a branded formulation of RHI or Humalog. Its pivotal Phase III clinical trials were open-label, parallel group, randomized trials conducted at centers in the United States, Germany and India.
The Company competes with Eli Lilly, Novo Nordisk, Sanofi-Aventis, Halozyme Therapeutics, Inc. and MannKind Corporation.
Advisors' Opinion:- [By Monica Gerson]
Biodel (NASDAQ: BIOD) is expected to post a Q1 loss at $0.24 per share.
First Majestic Silver (NYSE: AG) is estimated to post its Q1 earnings at $0.10 per share on revenue of $63.35 million.
Top 10 Medical Companies To Own For 2015: Tonix Pharmaceuticals Holding Corp (TNXP)
Tonix Pharmaceuticals Holding Corp., incorporated on November 16, 2011, is a specialty pharmaceutical company focused on developing novel pharmaceutical products for disorders of the central nervous system (CNS). The Company develops TNX-102 sublingual tablet, or TNX-102 SL. TNX-102 SL is a novel dose and formulation of cyclobenzaprine (CBP), the active pharmaceutical ingredient of two prescribed muscle relaxant products, Flexeril and Amrix. TNX-102 SL is also intended for chronic use. It develops TNX-102 SL for the treatment of FM under a United States Investigational New Drug application (IND), and under three clinical trial applications (CTAs), filed in Canada. It also develops TNX-102 SL for the treatment of post-traumatic stress disorder (PTSD). As of January 25, 2013, the Company focuses on product development, and had not generated any revenues.
The Company searches for potential therapeutic solutions among known pharmaceutical agents that lack regulatory approval for the indications it seeks, but may be approved for use in other indications. It seeks to create new dose and formulation options that are tailored to the therapeutic uses to which it applies these agents. TNX-102 SL is a small, rapidly disintegrating tablet containing CBP for sublingual administration at bedtime. The Company designed TNX-102 SL for delivery of CBP to the systemic circulation through sublingual transmucosal absorption and to avoid first-pass liver metabolism.
CBP is the active pharmaceutical ingredient in its lead product candidate, TNX-102 SL. In addition to CBP, TNX-102 SL contains inactive ingredients, called excipients, which are approved for pharmaceutical use. In addition to TNX-102 SL, it develops other formulations of CBP, including TNX-102 promicellar gelatin capsule, or TNX-102 gelcap. It developed TNX-102 gelcap under an agreement with Lipocine, Inc. (Lipocine), a contract formulation developer and small-scale manufacturer. In addition it has other pipeline of other product cand! idates, including TNX-201 and TNX-301. TNX-201 is based on isometheptene mucate and is under development as a treatment for certain types of headaches.
Advisors' Opinion:- [By John Kell]
Tonix Pharmaceuticals Holding Corp.(TNXP) is planning to offer some shares to raise money to fund clinical trials and the continued development of the specialty pharmaceutical company’s treatments. Shares edged up 2.1% to $16.75 premarket.
- [By John Udovich]
It�� a new year and the first one and a half trading weeks of 2014 has not disappointed biotech investors as the sector and mid cap or small cap biotech or�pharma stocks like Intercept Pharmaceuticals Inc (NASDAQ: ICPT), Epizyme Inc (NASDAQ: EPZM), Tonix Pharmaceuticals Holding Corp (NASDAQ: TNXP) and TNI BioTech Inc (OTCQB: TNIB) either surging or producing some news plus there have been IPO filings for future listings for�Flexion Therapeutics (NASDAQ: FLXN), Aldexa Therapeutics (NASDAQ: ALDX), Retrophin (NASDAQ:�RTRX) and Dicerna Pharmaceuticals (NASDAQ: DRNA). Consider the following news so far this year:
Top 10 Medical Companies To Own For 2015: Foundation Medicine Inc (FMI)
Foundation Medicine, Inc., incorporated on November 12, 2009, is a commercial-stage company. The Company is focused on fundamentally changing the way patients with cancer are treated. The Company�� platform includes methods and algorithms for analyzing tumor tissue samples across all types of cancer, as well as information aggregation and concise reporting capabilities. Its products provide genomic information about each patient�� individual cancer, enabling physicians to optimize treatments in clinical practice and enabling biopharmaceutical companies to develop targeted oncology therapies more effectively.
FoundationOne, its first clinical product, is, to its knowledge, the only commercially available comprehensive molecular information product designed for use in the routine care of patients with cancer. In addition, the Company is considered a non-contracting provider by commercial third-party payors because it has not entered into specific contracts to provide FoundationOne to their covered patients, and as a result it takes on primary responsibility for obtaining reimbursement on behalf of patients.
Advisors' Opinion:- [By James E. Brumley]
It wouldn't be fair to say there's nothing like it "out there", because there is. A company called Foundation Medicine Inc. (NASDAQ:FMI) has developed a similar/comparable app. The CLRX version of the solution appears superior in most ways, however, if for no other reason than because of the projected revenue growth the company is apt to see.
- [By John Udovich]
If you have not been watching the biotech sector lately, you should start paying attention as the sector along with small cap biotech stocks like Cell Therapeutics Inc (NASDAQ: CTIC), BIND Therapeutics Inc (NASDAQ: BIND) and TNI BioTech (OTCMKTS: TNIB) continue to produce a steady stream of good news for investors thanks to positive industry trends. Moreover, Ophthotech Corp (NASDAQ: OPHT), Foundation Medicine Inc (NASDAQ: FMI), Evoke Pharma and Fate Therapeutics Inc (NASDAQ: FATE) are this week's biotech IPOs that will no doubt be watched closely by Wall Street and industry observers in general. With that in mind, consider the following biotech news or recent articles about the industry and the small cap players in it:
- [By RedChip]
According to Walter Isaacson�� biography, Steve Jobs paid a reported $100,000 to learn the DNA sequence of his cancer. This work, completed at MIT and Harvard, led to the launch of Foundation Medicine (NASDAQ: FMI). Foundation Medicine has grabbed headlines over the past couple of weeks as it entered the capital markets with a high-profile IPO led by Goldman Sachs.
- [By Dan Caplinger]
In the following video, Dan Caplinger, director of investment planning for The Motley Fool, looks at whether the IPO market is overheating once more. Dan points to some huge gains from recent IPOs, with FireEye (NASDAQ: FEYE ) rising 80% in its first day while Rocket Fuel (NASDAQ: FUEL ) and Foundation Medicine (NASDAQ: FMI ) both posted gains of between 90% and 100%. Dan also highlights Sprouts Farmers Market� (NASDAQ: SFM ) , which climbed a whopping 123% in its first day as a public company.
Top 10 Medical Companies To Own For 2015: Rexahn Pharmaceuticals Inc (RNN)
Rexahn Pharmaceuticals, Inc. (Rexahn) is a development-stage biopharmaceutical company. The Company focuses on the development of cures for cancer to patients worldwide. The Company�� pipeline features one drug candidate in Phase II clinical trials. The Company also has several other drug candidates in pre-clinical development. In addition, the Company has two renal cell carcinoma (CNS) candidates, Serdaxin, CNS Disorders drug for depression and neurodegenerative diseases and Zoraxel, which is a erectile dysfunction (ED) and sexual dysfunction drug that are in clinical stages and the Company is are exploring options for further development . The Company�� drug candidate, Archexin is an anticancer Akt inhibitor.
Archexin
Archexin is potent inhibitor of the Akt protein kinase (Akt) in cancer cells. Archexin has FDA orphan drug designations for five cancers (RCC, glioblastoma, and cancers of the ovary, stomach and pancreas). Multiple indications for other solid tumors can also be pursued. Archexin inhibit both activated and inactivated forms of Akt, and to reverse the drug resistance observed with the protein kinase inhibitors. Archexin is an antisense oligonucleotide (ASO) compound that is complementary to Akt mRNA, and selective for inhibiting mRNA expression and production of Akt protein. As of December 31, 2011, Archexin was in Phase II clinical trials for the treatment of pancreatic cancer with enrollment completed in September, 2011.
Serdaxin
Serdaxin is an extended release formulation of clavulanic acid, which is an ingredient present in antibiotics approved by the FDA. The Company had been developing Serdaxin for the treatment of depression and neurodegenerative disorders. From January to September, 2011, the Company conducted a randomized, double-blind, placebo-controlled study compared two doses of Serdaxin, 0.5 milligram and 5 milligram, to placebo over an eight-week treatment period for major depressive disorder (MDD) patients. As of Dec! ember 31, 2011, the Company had not made a determination of Serdaxin�� future paths or resource allocations to further develop Serdaxin to treat MDD.
Zoraxel
Zoraxel is an orally administered, on-demand tablet to treat sexual dysfunction. Zoraxel is a dual enhancer of neurotransmitters in the brain that play a key role in sexual activity phases of motivation and arousal, erection and release, and may be the ED drug to affect all three of these phases of sexual activity. As of December 31, 2011, the Company was evaluating how to proceed with the Phase IIb study of Zoraxel.
The Company�� Pre-clinical Pipeline Drug Candidates includes RX-1792, which is a small molecule anticancer EGFR inhibitor; RX-5902, which is a small molecule anticancer ribonucleic acid (RNA) helicase regulator; RX-3117, which is a Small molecule anticancer deoxyribonucleic acid (DNA) synthesis Inhibitor; RX-8243, which is a small molecule anticancer aurora kinase inhibitor; RX-0201-Nano, which is a nanoliposomal anticancer Akt inhibitor; RX-0047-Nano, which is an nanoliposomal anticancer HIF-1 alpha inhibitor and RX-21101, which is a nano-polymer Anticancer.
Advisors' Opinion:- [By James E. Brumley]
If you were lucky enough to step into Rexahn Pharmaceuticals, Inc. (NYSEMKT:RNN) when your truly suggested it was a budding buy back on December 23rd, then congratulations - you're now up a little more than 60% (assuming you bought into RNN after the break above a key resistance line on the 27th). Now get out. Instead, use your profits from the Rexahn to take on a stake in GTx, Inc. (NASDAQ:GTXI). No, GTXI may not look like much at first, but when you take a step back and look at a chart of GTx, Inc. through a longer-term lens, the upside potential becomes clear.
Top 10 Medical Companies To Own For 2015: Insys Therapeutics Inc (INSY)
Insys Therapeutics, Inc., incorporated on June 15, 1990, is a pharmaceutical company that develops and seeks to commercialize pharmaceutical products that target the unmet needs of cancer patients, with an initial focus on cancer-supportive care. The Company�� pharmaceuticals portfolio consists of one approved product and a number of product candidates targeting cancer-supportive care and cancer therapy. The Company�� product candidate includes Subsys, Dronabinol SG Capsule, Dronabinol RT Capsule, Dronabinol Oral Solution, Dronabinol Inhalation Device, and Dronabinol IV Solution. The Company is also developing cancer therapeutics, which is LEP-ETU, a formulation of paclitaxel, the active ingredient in the cancer drugs Taxol and Abraxane. On August 19, 2011, the Food & Drug Administration (FDA) approved its Dronabinol SG Capsule product, a generic equivalent to Marinol, for the treatment of chemotherapy induced nausea and vomiting (CINV), and anorexia associated with weight loss in patients with acquired immune deficiency syndrome (AIDS).
Subsys
The Company's Subsys is a single-use product that delivers fentanyl, an opioid analgesic, in seconds for transmucosal absorption underneath the tongue. Subsys is a transmucosal product to show pain relief when measuring the sum of pain intensity difference at five minutes in a Phase 3 breakthrough cancer pain (BTCP) clinical trial using fentanyl.
Dronabinol Product Family
The Company has an approved dronabinol product and is developing several dronabinol product candidates for the treatment of CINV and appetite stimulation in patients with AIDS, as well as other indications where dronabinol could have potential therapeutic benefits. Dronabinol, the active ingredient in Marinol, is a synthetic cannabinoid whose chemical name is delta-9-tetrahydrocannabinol (THC). Its portfolio consists of its Dronabinol SG Capsule product and Dronabinol RT Capsule product candidate, which are intended to be generic equi! valents to Marinol, in addition to three formulations, including Dronabinol Oral Solution. Dronabinol SG Capsule is a dronabinol soft gelatin capsule intended to be a generic equivalent to Marinol. Dronabinol RT Capsule is a dronabinol soft gel capsule that is stable at room temperature. Dronabinol Oral Solution is a ynthetic THC in an oral liquid formulation.
Cancer Therapeutics
In addition to its cancer-supportive care products, the Company intends to develop cancer therapeutics targeting limitations of existing commercial products. LEP-ETU, it advanced cancer therapeutic, is a NeoLipid liposomal, or microscopic membrane-like structure created from lipids, formulation that incorporates paclitaxel. LEP-ETU completed a Phase 2 clinical trial of 70 patients with metastatic breast cancer.
The Company competes with Cephalon, Inc., BioDelivery Sciences International, Inc., ProStrakan Group plc, Nycomed International Management GmbH, Archimedes Pharma Ltd., TEVA Pharmaceuticals USA, Watson Pharmaceuticals, Inc., AcelRx Pharmaceuticals, Inc., Akela Pharma Inc., Abbott Laboratories, Pharmaceutical International, Inc., Par Pharmaceutical Companies Inc., sanofi-aventis, Eisai Inc., Helsinn Group, Roche Holding AG, Par Pharmaceutical Companies Inc., GlaxoSmithKline plc, ProStrakan Group plc, Merck & Co, GW Pharmaceutical, A.P. Pharma, Inc., Aphios Corp., Roche Holding, Tesaro, Inc., Cornerstone Pharmaceutical, Inc., Bristol-Myers Squibb, Celgene Corporation, Laboratories, Amgen Inc., AstraZeneca PLC., Bayer AG, Biogen Idec Inc., Eisai Co., Ltd., F. Hoffmann- LaRoche Ltd., Johnson and Johnson, Merck and Co., Inc., Novartis AG, Onyx Pharmaceuticals Inc., Pfizer Inc., and Takeda Pharmaceutical Co. Ltd.
Advisors' Opinion:- [By Chris Preston]
INSYS Therapeutics (INSY) is one recent IPO that jumps out. The Arizona-based pharmaceutical company markets a synthetic marijuana drug to treat cancer pain. It went public in May at $8 per share. It opened at over $46 per share.
- [By David Zeiler]
2. Insys Therapeutics Inc. (Nasdaq: INSY): Insys is a biotech seeking to capitalize on the growing interest in medical marijuana by using a generic form of THC to create drugs to treat cancer pain. INSY had its IPO May 2 with an offer price of $8 a share. The stock rose 19.75% on its first day of trading. But investors really warmed up to Insys later; it currently trades at about $37.54, a 369.25% increase over the offer price.
- [By Traders Reserve]
For example at the end of August, I found a little stock called INSYS Therapeutics (INSY) The company showed up as a top-rated stock using a stock-rating system based on something I call the P/E Gap ��the difference between a stock�� P/E ratio and its expected profit growth rate.
Top 10 Medical Companies To Own For 2015: Navidea Biopharmaceuticals Inc (NAVB)
Navidea Biopharmaceuticals, Inc. (Navidea), formerly Neoprobe Corporation, incorporated in 1983, is a biopharmaceutical company focused on the development and commercialization of precision diagnostic agents. As of December 31, 2011, the Company�� radiopharmaceutical development programs included Lymphoseek (Lymphoseek, Kit for the Preparation of Technetium Tc99m for Injection), a radiopharmaceutical agent for lymph node mapping; AZD4694, an imaging agent, and RIGScan, a tumor antigen-specific targeting agent. In January 2012, the Company executed an option agreement with Alseres Pharmaceuticals, Inc. (Alseres) to license [123I]-E-IACFT Injection, also called Altropane, an Iodine-123 radiolabeled imaging agent, being developed as an aid in the diagnosis of Parkinson�� disease, movement disorders and dementia. In August 2011, the Company sold its gamma detection device line of business (the GDS Business) to Devicor Medical Products, Inc.
Lymphoseek
Navidea�� pipeline includes clinical-stage radiopharmaceutical agents used to identify the presence and status of disease. Lymphoseek (Kit for the Preparation of Technetium Tc99m for Injection) is a lymph node targeting agent intended for use in intraoperative lymphatic mapping (ILM) procedures and lymphoscintigraphy employed in the overall diagnostic assessment of certain solid tumor cancers. The lymph system is a component of the body�� immune system. The key components of the lymph system are lymph nodes-small anatomic structures that contain disease-fighting lymphocytes, filter lymph of bacteria and cancer cells, and signal infection in response to heightened levels of pathogens. In Navidea�� Phase III clinical studies of Lymphoseek, it detected over 99% of positive nodes identified by vital blue dye (VBD). As of December 31, 2011, Navidea, in co-operation with UC, San Diego affiliate (UCSD), completed or initiated five Phase I clinical trials, one multi-center Phase II trial and three multi-center Phase II trials inv! olving Lymphoseek. Two Phase III studies were completed in subjects with breast cancer and melanoma. During the year ended December 31, 2011, data from NEO3-09 were released, which indicated that all primary and secondary endpoints for the study were met. As of December 31, 2011, third Phase III clinical trial for Lymphoseek in subjects with head and neck squamous cell carcinoma (NEO3-06) was in progress.
AZD4694
AZD4694 is a Fluorine-18 labeled precision radiopharmaceutical candidate for use in the imaging and evaluation of patients with signs or symptoms of cognitive impairment such as Alzheimer's disease (AD). It binds to beta-amyloid deposits in the brain that can then be imaged in positron emission tomography (PET) scans. Amyloid plaque pathology is a required feature of AD and the presence of amyloid pathology is a supportive feature for diagnosis of probable AD. Patients who are negative for amyloid pathology do not have AD. AZD4694 has been studied in several clinical trials. Clinical studies through Phase IIa have included more than 80 patients to date, both suspected AD patients and healthy volunteers. No significant adverse events have been observed. Results suggest that AZD4694 has the ability to image patients quickly and safely with high sensitivity.
RadioImmunoGuided Surgery
As of December 31, 2011, RIGScan had been studied in a number of clinical trials, including Phase III studies. Navidea has conducted two Phase III studies, NEO2-13 and NEO2-14, of RIGScan in patients with primary and metastatic colorectal cancer, respectively. Both studies were multi-institutional involving cancer treatment institutions in the United States, Israel, and the European Union.
The Company competes with Pharmalucence, Eli Lilly, Bayer Schering, General Electric and GE Healthcare.
Advisors' Opinion:- [By Sean Williams]
Another prime example here would be Navidea Biopharmaceuticals' (NYSEMKT: NAVB ) Lymphoseek which is an injectable agent used in external lymph-node imaging and intra-operative lymphatic mapping. In English this means it will dramatically improve the staging and treatment options for patients with breast cancer. Being that breast cancer was also listed as a commonly misdiagnosed cancer, this is a big step in the right direction for patient care.
- [By Erin McCarthy]
Navidea Biopharmaceuticals Inc.(NAVB) said Chief Executive Mark Pykett would leave that post around the end of this month as the company restructures its biopharmaceutical product pipeline.
- [By Lauren Pollock]
Navidea Biopharmaceuticals Inc.(NAVB) said the U.S. Food and Drug Administration has granted a priority review for an expanded use of its Lymphoseek drug for some patients with head and neck cancer. Shares dropped 5.4% to $1.97 premarket.
Top 10 Medical Companies To Own For 2015: Cyberonics Inc (CYBX)
Cyberonics, Inc. (Cyberonics), incorporated in 1987, is a medical device company. The Company is engaged in the design, development, sales and marketing of implantable medical devices that provide a neuromodulation therapy, vagus nerve stimulation therapy (VNS Therapy), for the treatment of refractory epilepsy and treatment-resistant depression (TRD) and other device solutions for the management of epilepsy.VNS Therapy System includes an implantable pulse generator to provide stimulation to the vagus nerve; a lead that connects the generator to the vagus nerve; equipment to assist with implantation surgery; equipment to assist with setting the stimulation parameters for each patient; instruction manuals, and magnets to suspend or induce stimulation manually. The VNS Therapy pulse generator and lead are surgically implanted into patients generally during an outpatient procedure. The VNS Therapy System consists of a pulse generator, a bipolar lead, a programming wand and software and a tunneling tool.
The United States Food and Drug Administration (FDA) approved the Company's VNS Therapy System in July 1997 for use as an adjunctive therapy in epilepsy patients over 12 years of age for reducing the frequency of partial onset seizures that are refractory or resistant to antiepileptic drugs. Regulatory bodies in Canada, the European Economic Area, certain countries in Eastern Europe, Russia, South America, Africa, Australia and certain countries in Asia, including Japan, China and Taiwan, have approved the VNS Therapy System for the treatment of epilepsy, many without age restrictions or seizure-type limitations. In July 2005, the FDA approved the Company's VNS Therapy System for the adjunctive long-term treatment of chronic or recurrent depression for patients 18 years of age or older who are experiencing a depressive episode and have not had an adequate response to four or more adequate anti-depressant treatments. Regulatory bodies in the European Economic Area, Canada and Israel have approv! ed the Company's VNS Therapy System for the treatment of chronic or recurrent depression in patients who are in a treatment-resistant or treatment-intolerant depressive episode without age restrictions.
In February 2011, the Company announced FDA approval of its fifth generation generator, the AspireHC generator. In August 2011, the Company announced that the Company discovered a hardware-related design issue with the AspireHC Model 105 and AspireSR (Seizure Response) Model 106 generators. In December 2011, the FDA approved the Company's re-designed AspireHC generator, and the Company resumed its limited commercial release of the generator in the United States.
Pulse Generator
The pulse generator is an implantable, programmable signal generator designed to be coupled with the bipolar lead to deliver mild electrical pulses to the vagus nerve. The pulse generator is a battery-powered device. Before or upon depletion of the battery, the pulse generator may be removed and a new generator implanted in a short, outpatient procedure. The Model 102 (Pulse), Model 102R (Pulse Duo ), Model 103 (Demipulse), Model 104 (Demipulse Duo) and Model 105 (AspireHC), are the VNS Therapy pulse generators the Company offers and are similar in design and manufactures to a cardiac pacemaker.
Bipolar Lead
The bipolar lead conducts the electrical signal from the pulse generator to the vagus nerve. The lead incorporates electrodes, which are self-sizing, minimizing mechanical trauma to the nerve. The lead's two electrodes and anchor tether wrap around the vagus nerve, and the connector end is tunneled subcutaneously to the upper chest area, where it attaches to the pulse generator. The Company offers three lead models in the United States. The leads are available in two inner spiral diameter sizes to ensure optimal electrode placement on different-sized nerves.
Programming Wand and Software
The Company's programming wand and software are us! ed to int! errogate the implanted pulse generator and to transmit programming information from a handheld computer to the pulse generator via an inductive coupling. Programming capabilities include modification of the pulse generator's programmable parameters (pulse width, amplitude and frequency and stimulation ON and OFF intervals) and storage and retrieval of telemetry data.
Tunneling Tool
The tunneling tool is a single use, sterile, disposable surgical tool designed to be used during surgical placement of the bipolar lead. The tool is used for subcutaneous tunneling of the lead between the nerve site in the neck and the pulse generator site in the upper chest area.
Accessory Pack
The accessory pack includes two resistor assemblies used to test the function of the device prior to implantation, the bipolar lead tie-downs and one hex screwdriver. The patient kit includes two magnets, one watch-style and one pager-style.
The Company competes with Medtronic, Inc., NeuroSigma Inc. and CerboMed GmbH.
Advisors' Opinion:- [By Seth Jayson]
Calling all cash flows
When you are trying to buy the market's best stocks, it's worth checking up on your companies' free cash flow once a quarter or so, to see whether it bears any relationship to the net income in the headlines. That's what we do with this series. Today, we're checking in on Cyberonics (Nasdaq: CYBX ) , whose recent revenue and earnings are plotted below. - [By Benjamin Shepherd]
The rise of public health services, improvements in sanitation and access to clean drinking water have led to a huge improvement in human life expectancy, which has jumped from only about 30 years five centuries ago to more than 75 years in most industrialized countries today.
Advances in medical science have also played a major role, such as the development of antibiotics to treat once deadly infections, surgical interventions to correct once fatal injuries and medications to treat chronic conditions.
We have yet to reach the limit of human ingenuity and today the trend is towards harnessing technology to break the reliance on long-term medication usage to treat chronic conditions. One area where huge strides are being made in that direction is the treatment of epilepsy.
Epilepsy is the fourth most common neurological disease in the world, affecting more than 9 million people in developed countries alone, and epileptics have a mortality rate more than 25 times higher than the general population. The costs associated with dealing with the disease run in excess of $13.5 billion in the US alone.
The disease is typically treated using a drug regime that includes several pills a day, including anti-convulsants and sedatives which can have unpleasant side effects. Drug therapy is typically successful in controlling seizures in about 70 percent of patients, but about a third of those who don�� respond to medication find themselves undergoing surgery to essentially remove the area of the brain triggering the seizures.
Cyberonics (NSDQ: CYBX) is making headway into an alternative treatment for the disease, called vagus nerve stimulation (VNS) therapy, which can reduce the number or even eliminate the need for the drugs epileptics depend upon and requires only minor surgery.
During an outpatient procedure conducted under general anesthesia, two small incisions are made, one in the upper chest area and the other in the neck. At t - [By James E. Brumley]
Investors who were hoping things would work out for epilepsy treatment company Cyberonics, Inc. (NASDAQ:CYBX) can cross CYBX off their list of epilepsy-oriented stocks to buy, as they did with Acorda Therapeutics Inc. (NASDAQ:ACOR) about a month ago. ACOR saw its epilepsy drug Plumiaz rejected by the FDA in early May, while CYBX announced this morning that the coming fiscal year's (beginning in April) revenue would be weaker than first expected as sales of its epileptic control implant device didn't look quite as promising as hoped.
Top 10 Medical Companies To Own For 2015: SearchCore Inc (SRER)
SearchCore, Inc., formerly General Cannabis, Inc., incorporated in 2003, is a technology service provider. As of December 31, 2011, the Company was engaged in the medicinal cannabis industry. The Company assists the physicians, dispensaries, and end-users within the medicinal cannabis industry in finding each other and in advertising their businesses. All of its operations are conducted through its wholly owned subsidiaries. On January 5, 2012, WeedMaps, LLC (WeedMaps) acquired substantially all the assets of MMJMenu, LLC. On October 31, 2011, General Merchant Solutions, Inc. discontinued all retail credit card processing operations. On January 11, 2011, the Company acquired all the assets of Revyv, LLC. On December 31, 2012, the Company acquired Sports Asylum, Inc. In February 2013, it acquired ModularHomes.com.
WeedMaps Media, Inc. is its wholly owned subsidiary, and its primary operation is the Internet Website, www.weedmaps.com. WeedMaps.com is an online finder site service that allows patients to find local medical cannabis dispensaries, which are also referred to as collectives. Dispensaries are locations where patients who have received letters of recommendation from a healthcare provider can purchase medicinal cannabis, as well as a variety of other non-cannabis related items including, but not limited to, apparel accessories, posters, bumper stickers, concert tickets, books and musical compact disc�� (CD��).
General Marketing Solutions, Inc. is its wholly owned subsidiary, and its primary operation is the Internet Website, www.cannabiscenters.com. General Management Solutions, Inc. is its wholly owned subsidiary that oversees and provides all of the human resources issues for employees, including hiring, terminating and employee benefits. The Company has two additional wholly owned subsidiaries; General Processing Corporation, CannaCenters Corporation (CannaCenters), and two subsidiaries, namely LV Luxuries Incorporated (which operated as makeup.com) and General ! Health Solutions, Inc. (CannaCenters.com).
Advisors' Opinion:- [By Peter Graham]
Small cap communications or Internet stocks American Community Development Group Inc (OTCMKTS: ACYD), Globalstar, Inc (OTCMKTS: GSAT) and SearchCore Inc (OTCMKTS: SRER) have been rather quiet lately for investors after making some noise back in September. Nevertheless, all three are still getting some mentions in various investment newsletters or alerts and not because they are the subject of paid promotions. So are these small cap stocks about to make some noise? Here is a closer look:
No comments:
Post a Comment