This week, these five stocks have the worst ratings in Earnings Momentum, one of the eight Fundamental Categories on Portfolio Grader.
FNB United () is a bank holding company. FNBN also gets F’s in Equity and Cash Flow. .
Top Specialty Retail Companies To Watch For 2015: CEL-SCI Corp (CVM)
CEL-SCI Corporation (CEL-SCI), incorporated on March 22, 1983, is engaged in the business of Multikine cancer therapy; New cold fill manufacturing service to the pharmaceutical industry, and ligand epitope antigen presentation System (LEAPS) technology, with two products, hemagglutinin type 1 and neuraminidase type 1 (H1N1) swine flu treatment for H1N1 hospitalized patients and CEL-2000, a rheumatoid arthritis treatment vaccine.
Multikine
CEL-SCI's Multikine, is being developed for the treatment of cancer. It is a cancer immunotherapy drugs called Combination Immunotherapy because it combines active and passive immunity in one product. It is the only cancer immunotherapy that both kills cancer cells and activates the general immune system to destroy the cancer. Multikine target the tumor micro-metastases for treatment failure. Multikine is also applicable in many other solid tumors.
New Manufacturing Facility
CEL-SCI's facility manufactures Multikine for CEL-SCI's Phase III clinical trial. CEL-SCI offers the use of the facility as a service to pharmaceutical companies and others, particularly those that need to fill and finish their drugs in a cold environment. Fill and finish is the process of filling injectable drugs in a sterile manner.
LEAPS
CEL-SCI's patented T-cell Modulation Process uses heteroconjugates to direct the body to choose a specific immune response. The heteroconjugate technology, referred to as LEAPS, is intended to stimulate the human immune system to fight bacterial, viral and parasitic infections, as well as autoimmune, allergies, transplantation rejection and cancer. Administered like vaccines, LEAPS combines T-cell binding ligands with small, disease associated and peptide antigens.
Using the LEAPS technology, CEL-SCI has created a peptide treatment for H1N1 (swine flu) hospitalized patients. This LEAPS flu treatment is designed to focus on the conserved, non-changing epitopes of the di! fferent strains of Type A Influenza viruses, including swine, avian or bird, and Spanish Influenza. CEL-SCI's LEAPS flu treatment contains epitopes.
Advisors' Opinion:- [By Bryan Murphy]
Look out AbbVie Inc. (NYSE:ABBV), and Gilead Sciences, Inc. (NASDAQ:GILD), you may want to look over your shoulder as well. There's a new immunology player coming to town, and its name is CEL-SCI Corporation (NYSEMKT:CVM). Yes, AbbVie may be the name behind blockbuster drug Humira - with nearly $10 billion in sales in 2012 - while Gilead Sciences is saving HIV patients' lives with immunological therapies Stribild and Complera. But, small cap company CEL-SCI may be closer to launching its own immunology drug sooner than most investors realize.
- [By Bryan Murphy]
Names like Amgen, Inc. (NASDAQ:AMGN) and CEL-SCI Corporation (NYSEMKT:CVM) may have pioneered and even mainstreamed the idea of cancer immunology, but the nature of the branch of biotechnology means any company could send CEL-SCI or Amgen back-pedaling. See, it's not about size or deep pockets in the world of biotech anymore. It's about know-how and an idea, which can just as easily be discovered and developed by a small company as they can be a large company. That's why AMGN and CVM at least need to keep a close eye on budding immunology competitor TNI Biotech Inc. (OTCMKTS:TNIB).
- [By Bryan Murphy]
It may not have blazed a trail into the young, immunology segment of the biotech industry the way Dendreon Corporation (NASDAQ:DNDN) did back in 2010 with the debut of Provenge. It may not have the same immunology pipeline (and company size) that ImmunoGen, Inc. (NASDAQ:IMGN) boasts. One thing is pretty certain about cancer-immunotherapy developer CEL-SCI Corporation (NYSEMKT:CVM) right now, however - its stock may be poised to dole out a much bigger foreseeable-future reward than DNDN or IMGN are.
Top Biotech Stocks To Buy For 2014: Pain Therapeutics Inc (PTIE)
Pain Therapeutics, Inc., incorporated in May 1998, is a biopharmaceutical company that develops drugs. The Company has four drug candidates in clinical programs, including REMOXY, abuse-resistant hydromorphone, abuse-resistant hydrocodone and a radio-labeled monoclonal antibody to treat metastatic melanoma. It is also working on a new treatment for patients with hemophilia. The Company�� lead drug candidate is REMOXY, which is a painkiller. It has collaboration agreement with King Pharmaceuticals, Inc. (King) develops and commercializes REMOXY and other opioid painkillers. The Company and King jointly managed a Phase III clinical program and New Drug Application (NDA) submission for REMOXY. It is also developing a pipeline of drug candidates in the area of oncology and hematology. It owns all commercial rights to its pipeline of drug candidates in oncology and hematology. As of December 31, 2010, the Company leased approximately 30,700 square feet of space in San Mateo, California and all of its operations are located in San Mateo.
REMOXY
REMOXY is a controlled-release oral capsule form of oxycodone in a highly viscous liquid formulation matrix that includes excipients. It is formulated to help address issues of abuse and misuse of time-release oxycodone tablets. REMOXY�� capsule dosage form provides therapeutic drug levels of oxycodone on a twice-daily dosing schedule, while resisting the rapid increases in plasma levels of oxycodone associated with common methods of abuse and misuse. Its formulation also resists delivery by unapproved routes of administration, such as injection, snorting or inhalation.
Metastatic Melanoma
The Company is developing a drug candidate called PTI-188 to treat metastatic melanoma, a form of skin cancer. PTI-188 is a monoclonal antibody linked to a radioisotope, intended to deliver doses of radiation lethal to melanoma tumors without harming normal tissue. In March 2010, the Company announced data from two open-label! , dose-escalating Phase I studies conducted in Israel to assess the safety, pharmacokinetics, dosimetry and anti-tumor activity of PTI-188. During the year ended December 31, 2010, the second study was completed. The technology used in this program was developed at the Albert Einstein College of Medicine (AECOM). It had licensed worldwide commercial rights to this technology from AECOM.
Hemophilia
The Company has a gene transfer program, initially developed at Stanford University, focused at correcting a genetic disorder in which patients are unable to stop bleeding. During 2010, it conducted a variety of pre-clinical studies with this technology. The Company has licensed worldwide commercial rights to the technology used in this program from Poetic Genetics, LLC (Poetic).
Other product candidates
The Company�� alliance with King includes development of three other abuse-resistant opioid product candidates: hydromorphone, hydrocodone and oxymorphone. Its abuse-resistant formulations of hydromorphone and hydrocodone have completed Phase I clinical trials. In January 2011, the Company announced that the Food and Drug Administration (FDA) had accepted its investigational IND, for abuse-resistant oxymorphone.
The Company competes with Roxane Laboratories, Purdue Pharma, King Pharmaceuticals, Inc., Abbott Laboratories, Cephalon, Endo Pharmaceuticals, Teva Pharmaceuticals, Elkins-Sinn, Watson Laboratories, Ortho-McNeil Pharmaceutical and Forest Pharmaceuticals.
Advisors' Opinion:- [By Jessica Alling]
Elsewhere, Pfizer is evaluating its continued partnership on an experimental oxycodone capsule, Remoxy. The drug is an extended-release formula that is targeted at reducing abuse of the painkiller. After years of setbacks and postponements for FDA approval, Pfizer is weighing its options. Its partners for the drug, Pain Therapeutics (NASDAQ: PTIE ) and Durect, have both fallen heavily due to the news, with Pain Therapeutics falling more than 50% -- its largest decline ever.
- [By Sean Williams]
However, all isn't well when it comes to the future of abuse-resistant painkiller Remoxy, which was developed by Pain Therapeutics (NASDAQ: PTIE ) , using Durect's�special technology-based gel capsule to prevent abuse, and is licensed by Pfizer (NYSE: PFE ) . Remoxy has been rejected twice by the FDA -- the most recent coming in mid-2011 -- and Pfizer commented this morning that if it were to seek reapproval for the drug it wouldn't be for at least two more years. Given Pfizer's extensive product pipeline, losing Remoxy wouldn't be a big deal. For micro-cap clinical-stage companies like Pain Therapeutics and Durect, it'd be a gigantic blow. Fittingly, Pain Therapeutics and Durect shares imploded by 50% and 34%, respectively, on Friday.
Top Biotech Stocks To Buy For 2014: Exelixis Inc.(EXEL)
Exelixis, Inc., a biotechnology company, develops small molecule therapies for the treatment of cancer. It focuses on developing Cabozantinib, an inhibitor of tumor growth, metastasis, and angiogenesis that target MET, VEGFR2, and RET, which are key kinases involved in the development and progression of various cancers. The cabozantinib is in Phase III clinical trial for the treatment for medullary thyroid cancer. The company also engages in various clinical programs for cabozantinib focused on the treatment of metastatic castration-resistant prostate cancer, ovarian cancer, breast cancer, renal cell carcinoma, non-small cell lung cancer, hepatocellular cancer, and melanoma. In addition, Exelixis, Inc. involves in developing a portfolio of other novel compounds to address serious unmet medical needs through collaborations with various pharmaceutical and biotechnology companies, including Bristol-Myers Squibb Company, sanofi-aventis, Genentech, Inc., Boehringer Ingelheim Gm bH, and GlaxoSmithKline and Daiichi Sankyo Company Limited. Its products under development through collaborations include XL475, XL281, XL139, and XL413 inhibitors; ROR antagonists; therapies targeted against LXR, a nuclear hormone receptor implicated in various cardiovascular and metabolic disorders; XL147, XL765, and isoform-selective PI3K inhibitors; XL518, a small-molecule inhibitor of MEK; sphingosine-1-phosphate type 1 receptor; XL880 inhibitor; and therapies targeted against the mineralocorticoid receptor, a nuclear hormone receptor implicated in various cardiovascular and metabolic diseases. The company was formerly known as Exelixis Pharmaceuticals, Inc. and changed its name to Exelixis, Inc. in February 2000. Exelixis, Inc. was founded in 1994 and is headquartered in South San Francisco, California.
Advisors' Opinion:- [By Jake L'Ecuyer]
Equities Trading DOWN
Shares of Exelixis (NASDAQ: EXEL) were down 36.18 percent to $4.11 after the company issued an update on ongoing COMET-1 phase 3 pivotal trial in men with metastatic castration-resistant prostate cancer. Stifel Nicolaus lowered the price target on the stock from $11.00 to $9.00. - [By Roberto Pedone]
Another under-$10 biotechnology player that's starting to trend within range of triggering a near-term breakout trade is Exelixis (EXEL), which develops small molecule therapies for the treatment of cancer in the U.S. This stock has been crushed by the bears so far in 2014, with shares down sharply by 41%.
If you look at the chart for Exelixis, you'll notice that EXEL has been trending sideways and consolidating for the last two months and change, with shares moving between $3.02 on the downside and $3.84 on the upside. Shares of EXEL are starting to spike higher today right off its 50-day moving average of $3.42 a share. That spike is quickly pushing shares of EXEL within range of triggering a near-term breakout trade above some key overhead resistance levels.
Market players should now look for long-biased trades in EXEL if it manages to break out above some near-term overhead resistance levels at $3.55 to $3.63 a share and then once it clears more resistance at $3.84 a share with high volume. Look for a sustained move or close above those levels with volume that hits near or above its three-month average action of 4.85 million shares. If that breakout kicks off soon, then EXEL will set up to re-test or possibly take out its next major overhead resistance level at its March gap-down-day high of $4.50 a share. Any high-volume move above $4.50 will then give EXEL a chance to re-fill some of its previous gap-down-day zone that started at $6.66 a share.
Traders can look to buy EXEL off weakness to anticipate that breakout and simply use a stop that sits right below some key near-term support levels at $3.18 to $3.02 a share. One can also buy EXEL off strength once it starts to move above those breakout levels with volume and then simply use a stop that sits a comfortable percentage from your entry point.
- [By Sean Williams]
Where investment dollars are headed
Caprelsa: AstraZeneca's (NYSE: AZN ) Caprelsa was approved to treat unresectable, locally advanced, or metastatic medullary thyroid cancer in April 2011. In trials, AstraZeneca's pill increased progression-free survival over the placebo and delivered an overall response rate of 44%, compared with just 1% for the placebo -- although it should be noted that all responses were partial. However, Caprelsa also comes with a laundry list of side effects that range from something as simple as rash, nausea, and hypertension, to having resulted in death from respiratory arrest and cardiac failure with arrhythmia.� Cometriq: Exelixis' (NASDAQ: EXEL ) Cometriq was approved last November to treat progressive metastatic medullary thyroid cancer. The capsules work by inhibiting multiple tyrosine kinases, which are crucial to blood vessel growth in solid and metastasizing tumors. In late-stage trials, patients receiving Cometriq demonstrated an astounding 11.2 months of progression-free survival compared with just four months for the placebo. Further, the objective response rate was 27% in the Cometriq arm and a goose egg for the placebo arm. Similar to AstraZeneca's Caprelsa, severe adverse reactions tended to increase for Cometriq users relative to the placebo.
Thyroid cancer is treated in nearly every case with a full or partial thyroid removal since the majority of thyroid cancers aren't aggressive. However, in those rare cases where surgery isn't an option or the disease has metastasized to other parts of the body, there are two drugs approved by the Food and Drug Administration to choose from.Just as we've witnessed with every previous cancer in this series, not every drug trial proves successful. Pfizer's (NYSE: PFE ) Sutent, for instance, is a very successful treatment for kidney cancer, gastrointestinal stromal tumors, and pancreatic endocrine tumors, but it didn't fare as wel
- [By Jake L'Ecuyer]
Shares of Exelixis (NASDAQ: EXEL) were down 37.89 percent to $4.00 after the company issued an update on ongoing COMET-1 phase 3 pivotal trial in men with metastatic castration-resistant prostate cancer. Stifel Nicolaus lowered the price target on the stock from $11.00 to $9.00.
Top Biotech Stocks To Buy For 2014: NeoStem Inc (NBS)
NeoStem, Inc., incorporated on September 18, 1980, operates in cellular therapy industry. Cellular therapy addresses the process by which new cells are introduced into a tissue to prevent or treat disease, or regenerate damaged or aged tissue, and consists of a separate therapeutic technology platform in addition to pharmaceuticals, biologics and medical devices. The Company�� business model includes the development of novel cell therapy products, as well as operating a contract development and manufacturing organization (CDMO) providing services to others in the regenerative medicine industry. Progenitor Cell Therapy, LLC, the Company�� wholly owned subsidiary (PCT), is a CDMO in the cellular therapy industry. PCT has provided pre-clinical and clinical current Good Manufacturing Practice (cGMP) development and manufacturing services to over 100 clients advancing regenerative medicine product candidates through rigorous quality standards all the way through to human testing.
PCT has two cGMP, cell therapy research, development, and manufacturing facilities in New Jersey and California, serving the cell therapy community with integrated and regulatory compliant distribution capabilities. Its core competencies in the cellular therapy industry include manufacturing of cell therapy-based products, product and process development, cell and tissue processing, regulatory support, storage, distribution and delivery and consulting services. The Company�� wholly-owned subsidiary, Amorcyte, LLC (Amorcyte) is developing its own cell therapy, AMR-001, for the treatment of cardiovascular disease. AMR-001 represents its clinically advanced therapeutic product candidate and enrollment for its Phase II PreSERVE clinical trial to investigate AMR-001's safety and efficacy in preserving heart function after a heart attack in a particular type of post Acute Myocardial Infarction (AMI) patients.
Through the Company�� subsidiary, Athelos Corporation (Athelos), the Company is collaborating w! ith Becton-Dickinson in early stage clinical development of a therapy utilizing T-cells, collaborating for autoimmune and inflammatory conditions, including but not limited to, graft vs. host disease, type 1 diabetes, steroid resistant asthma, lupus, multiple sclerosis and solid organ transplant rejection. The Company�� pre-clinical assets include its Very Small Embryonic Like (VSEL) Technology platform. The Company has basic research and development capabilities, manufacturing facilities on both the east and west coast of the United States.
Advisors' Opinion:- [By John Udovich]
Summer and the slow news for the market that usually comes with it�is over with and both stem cell researchers or small� cap stem cell stocks like Advanced Cell Technology, Inc (OTCBB: ACTC), Neuralstem, Inc (NYSEMKT: CUR), NeoStem Inc (NASDAQ: NBS), International Stem Cell Corp (OTCMKTS: ISCO)�and BioRestorative Therapies (OTCBB: BRTX) having news for investors and traders alike. Consider the following:
Top Biotech Stocks To Buy For 2014: Chromadex Corp (CDXC)
Chromadex Corporation, incorporated on June 19, 2008, is a provider of research and quality-control products and services to the natural products industry. The Company�� products are used by customers worldwide in the dietary supplement, food and beverage, cosmetic and pharmaceutical industries. The Company together with its subsidiaries supplies phytochemical reference standards, which are small quantities of plant-based compounds used to research an array of potential attributes, and reference materials, related contract services, technical consulting and ingredients. On December 3, 2012, ChromaDex Inc. acquired Spherix Consulting Inc. The Company�� principal subsidiaries include ChromaDex, Inc., Chromadex Analytics, Inc. and Spherix Consulting, Inc (Spherix).
The Company provides its clients in the food, supplement and pharmaceutical industries with solutions to manage potential health and regulatory risks. Its science-based solutions are for both new and existing products that may be subject to product liability and/or exposed to changing scientific standards or public perceptions; literature evaluations, and design and assessment of pre-clinical and clinical safety testing. It specializes in regulatory submissions for food and dietary supplement ingredients. For its clients involved in drug development within the pharmaceutical industry, the Company provides similar services, as well as risk-based strategies, including intellectual property data and compliance gap identification, due diligence assessments and investigational new drug writing.
Products and Services
The Company offers bulk raw materials for inclusion in dietary supplements, food, beverage and cosmetic products. Through its catalog, it supplies a range of products necessary to conduct quality control of raw materials and consumer products. The Company through Chromadex Analytics, provides a range of contract services ranging from routine contract analysis for the production of dietary sup! plements, cosmetics, foods and other natural products to elaborate contract research for clients in these industries. The Company provides a range of consulting services in the areas of regulatory support, new ingredient or product development, risk management and litigation support. With an addition of Spherix, it provides regulatory approval and scientific advisory services.
The Company competes with Sigma-Aldrich, Phytolab, US Pharmacopoeia, Extrasynthese, Covance, Eurofins, and Silliker Canada Co.
Advisors' Opinion:- [By Peter Graham]
Small cap stocks Chromadex Corp (OTCMKTS: CDXC) and 22nd Century Group Inc (OTCBB: XXII) are, one way or the other, focused on natural products and have been getting some extra attention lately. Moreover, one of these stocks have been the subject of a disclosed investor awareness campaign. Keeping that in mind, are these two small cap stocks natural winners for investors? Here is a quick look:
Top Biotech Stocks To Buy For 2014: PTC Therapeutics Inc (PTCT)
PTC Therapeutics, Inc., incorporated on March 31, 1998 , is a biopharmaceutical company focused on the discovery and development of orally administered, small-molecule drugs that target post-transcriptional control processes. The Company�� lead product candidate includes ataluren, which is used for the treatment of patients with genetic disorders that arise from a type of genetic mutation known as a nonsense mutation. Ataluren is in late stage clinical development for the treatment of Duchenne muscular dystrophy caused by nonsense mutations (nmDMD) and cystic fibrosis caused by nonsense mutations (nmCF).
Ataluren is orally administered small-molecule compound that targets nonsense mutations. The Company is engaged in the development of ataluren for the treatment of genetic disorders in, which a nonsense mutation is the cause of the disease. Genetic tests are available for many genetic disorders, including Duchenne muscular dystrophy and cystic fibrosis, to determine if the underlying cause is a nonsense mutation. The EMA has designated ataluren as an orphan medicinal product for the treatment of nmDMD and nmCF. During the year ended December 31, 2012, the Phase III clinical trial completed. The Company�� Ataluren clinical trials in patients with nonsense mutation genetic disorders include Ataluren for nmDMD: Phase 2b clinical trial complete; Confirmatory Phase III clinical trial initiated, and Ataluren for nmCF: Phase III trial completed.
Advisors' Opinion:- [By John Kell]
PTC Therapeutics Inc.(PTCT) said the European Medicines Agency’s Committee for Medicinal Products for Human Use issued a negative opinion on the biopharmaceutical company’s marketing authorization application for its muscular dystrophy treatment. Shares slumped 21% to $20.60 in premarket trading.
Top Biotech Stocks To Buy For 2014: Lpath Inc (LPTN)
Lpath, Inc. (Lpath), incorporated on September 18, 2002, is a biotechnology company focused on the discovery and development of bio-active lipid-targeted monoclonal antibody (mAb) therapeutics. The Company has three product candidates, iSONEP, ASONEP and Lpathomab. The Company's program, iSONEP, is a mAb against Sphingosine-1-Phosphate (S1P). As of December 31, 2012, it was in phase-II clinical trials for wet Age-Related Macular Degeneration. The Company is also advancing ASONEP, the systemic formulation of the mAb to S1P. ASONEP has completed a phase-I clinical trial and is entering phase-II clinical trials in Renal Cell Carcinoma.
Lpath's third product candidate, Lpathomab, is a mAb to the bioactive lipid, Lysophosphatidic Acid (LPA). The Company also applies its technology platform, ImmuneY2, to discovering mAbs to new bioactive lipid targets.
Advisors' Opinion:- [By Lauren Pollock]
Biotechnology company Lpath Inc.(LPTN) warned Pfizer Inc.(PFE) may divest itself of its exclusive option to co-develop the smaller firm’s leading product candidate. Lpath’s stock fell.
- [By Lauren Pollock]
Lpath Inc.(LPTN) said it is no longer actively seeking to reacquire exclusive rights to its leading product candidate from Pfizer Inc.(PFE), saying the pharmaceutical giant informed the company that its offers weren’t competitive. The biotechnology company in October had warned that Pfizer might may divest itself of its exclusive option to co-develop the smaller firm’s leading product candidate–known as iSONEP.
No comments:
Post a Comment