Take that Goldman Sachs. Nomura’s started covering biotech companies–and boy are its analysts feeling bullish. Of the 11 stocks it covers, eight get a Buy rating, including large-caps Gilead (GILD), Celgene (CELG) and�Biogen (BIIB).
APEarlier this week, remember, Goldman Sachs came out and panned the biotech industry, citing valuation. Nomura’s M. Ian Somaiya and team explain why they feel more optimistic:
A combination of increased productivity (i.e., positive Phase III data and new product launches) and a muted impact from Obamacare has reinvigorated top-line growth at large-cap biotechs and spurred an increasing number of profitable companies. The net result has been renewed interest among generalists and significant outperformance for the NASDAQ Biotechnology Index (NBI) over the past three years. We expect upside in the group to continue into 2014 but focus in the new year to be more on commercial execution and less on clinical data, given the record number of potential blockbuster product launches from 2013-2014E.
10 Best Penny Stocks 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 James E. Brumley]
When biotech-savvy investors think of immunology stocks, they tend to gravitate towards a name like Dendreon Corporation (NASDAQ:DNDN), which for all intents and purposes introduced the world's first cancer vaccine, Provenge, as a treatment for prostate cancer. Traders with a better-than-average knowledge of the immunology field may turn their attention to a company like CEL-SCI Corporation (NYSEMKT:CVM). CEL-SCI doesn't have a product on the market yet, but its head and neck cancer drug - which also uses immunology - is in Phase 3 testing right now, and looks very promising. There are other, and smaller, stocks within the world of immunology, however, that deserve a closer look from the market, and one of the most exciting ones further down the size scale is TNI Biotech Inc. (OTCMKTS:TNIB).
- [By Bryan Murphy]
To say that 2014 has been a good year so far for CEL-SCI Corporation (NYSEMKT:CVM) would be an understatement. It's been a great year for the company, and more specifically, its shareholders. CVM is up 96% year-to-date, cutting into a big chunk of the loss that was suffered in 2013. And, though a near-doubling in less than a month would normally be an invitation to a painful wave of profit-taking, in the case of CEL-SCI, the situation says this is one of those rallies that could get hotter the hotter it gets.
Hot Biotech Companies To Invest In Right Now: TESARO Inc (TSRO)
TESARO, Inc. (TESARO), incorporated in March 2010, is a development-stage, oncology-focused biopharmaceutical company for cancer patients. The Company focuses on rolapitant and TSR-011 product. The Company�� marketed products and product candidates in development treat cancer through non-specific damage to cellular components or alter cell metabolism or internal repair mechanisms to the demise of cancer cells.
Rolapitant
Rolapitant is a potent and long-acting neurokinin-1, or NK-1, receptor antagonist is in Phase III clinical trials for the prevention of chemotherapy induced nausea and vomiting (CINV). It is in Phase III clinical trials. CINV, if not prevented by prophylaxis, has the potential to afflict up to 90% or more of cancer patients undergoing chemotherapy, depending upon the type of chemotherapy administered the dosing schedule of the chemotherapy, and the patients' age and gender, among other predisposing factors. Prolonged nausea and vomiting may result in unwanted weight loss, dehydration and malnutrition, as well as hospitalization. The Company has in-licensed the rights to rolapitant from OPKO Health, Inc.
TSR-011
TSR-011 is an orally available ALK inhibitor in preclinical development. ALK is known to be involved in certain types of cancers, including subsets of NSCLC, neuroblastoma and lymphoma. For patients in these subsets, the ALK gene is fused to an activating partner or contains point mutations, resulting in constitutive activation of ALK and the growth of cancer cells and tumor development. Inhibition of ALK in these cancer cells results in cell death and tumor growth inhibition or regression. In August 2011, the United States Food and Drug Administration approved the first ALK inhibitor, developed by Pfizer Inc., Xalkori (crizotinib), which was approved for the treatment of patients with locally advanced or metastatic NSCLC that are ALK positive.
The Company competes with GlaxoSmithKline plc, Roche Holding Ltd! . and Sanofi S.A.
Advisors' Opinion:- [By Jake L'Ecuyer]
Equities Trading UP
Tesaro (NASDAQ: TSRO) shares shot up 20.78 percent to $29.00 after the company reported successful primary and secondary endpoints in final Phase 3 trial for rolapitant. - [By Brian Orelli]
Tesaro (NASDAQ: TSRO ) is also up today after announcing that it established a partnership with clinicians to run the phase 3 development of its PARP inhibitor, niraparib. The trial will enroll about 300 breast cancer patients with BRCA mutations, comparing niraparib to investigators' choice of other breast cancer treatments.
- [By Brian Pacampara]
Based on the aggregated intelligence of 180,000-plus investors participating in Motley Fool CAPS, the Fool's free investing community, biopharmaceutical company TESARO (NASDAQ: TSRO ) has received the dreaded one-star ranking.
Hot Biotech Companies To Invest In Right Now: ANI Pharmaceuticals Inc (ANIP)
ANI Pharmaceuticals, Inc., incorporated on April 11, 2001, is an integrated specialty pharmaceutical company developing, manufacturing, and marketing branded and generic prescription pharmaceuticals. In two facilities with combined manufacturing, packaging and laboratory capacity totaling 173, 00 square feet, the Company manufactures oral solid dose products, as well as liquids and topicals, including narcotics. Its other products include The Food and Drug Administration (FDA) approved testosterone gel, which is licensed to Teva Pharmaceuticals USA. In December 2013, the Company acquired 31 generic drug products from Teva Pharmaceuticals, which includes 20 solid-oral immediate release products, four extended release products and seven liquid products.
The Company performs contract manufacturing for other pharmaceutical companies. It has launched three products and has 11 products in development. The Company�� targeted areas of product development include narcotics, anti-cancers and hormones (potent compounds), and extended release niche generic product opportunities.
Advisors' Opinion:- [By Ben Levisohn]
ANI Pharmaceuticals (ANIP) has climbed 8.9% to $18.80 after it said it would buy 31 generic drugs from Teva Pharmaceuticals (TEVA). Teva’s shares are little changed in pre-open trading.
Hot Biotech Companies To Invest In Right Now: Celgene Corp (CELG)
Celgene Corporation is a global biopharmaceutical company primarily engaged in the discovery, development and commercialization of therapies designed to treat cancer and immune-inflammatory related diseases. The Company is engaged in the research and development, which is designed to bring new therapies to market, and is engaged in research in several scientific areas that may deliver therapies, focusing areas, such as intracellular signaling pathways in cancer and immune cells, immunomodulation in cancer and autoimmune diseases, and therapeutic application of cell therapies. The Company�� primary commercial stage products include REVLIMID, VIDAZA, THALOMID, ABRAXANE and ISTODAX. Additional sources of revenue include a licensing agreement with Novartis, which entitles it to royalties on FOCALIN XR and the entire RITALIN family of drugs, the sale of services through its Cellular Therapeutics subsidiary and other miscellaneous licensing agreements. In March 2012, it acquired Avila Therapeutics.
The Company invests in research and development, and the drug candidates in its pipeline at various stages of preclinical and clinical development. These candidates include pomalidomide and apremilast, its oral anti-cancer and anti-inflammatory agents, PDA-001, its cellular therapy, oral azacitidine, CC-223 and CC-115 for hematological and solid tumor malignancies, CC-122, its anti-cancer pleiotropic pathway modifier, and ACE-011 and ACE-536 biological products for anemia in several clinical settings of unmet need. Celgene product candidates include Pomalidomide (CC-4047), Oral Anti-Inflammatory: Apremilast (CC-10004), CC-11050, Kinase Inhibitors:Tanzisertib (CC-930), Cellular Therapies: PDA-001, Activin Biology: Sotatercept (ACE-011) ACE-536, and Anti-tumor Agents: CC-22, CC-115, CC-122 and Oral Azacitidine. It owns and operates a manufacturing facility in Zofingen, Switzerland. The Company also owns and operates a drug product manufacturing facility in Boudry, Switzerland.
Commercial! Stage Products
REVLIMID (lenalidomide) is an oral immunomodulatory drug marketed in the United States and many international markets, in combination with dexamethasone, for treatment of patients with multiple myeloma who have received at least one prior therapy. It is also marketed in the United States and certain international markets for the treatment of transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes (MDS) associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities. REVLIMID is distributed in the United States through contracted pharmacies under the RevAssist program, which is a risk-management distribution program. Internationally, REVLIMID is distributed under mandatory risk-management distribution programs.
REVLIMID continues to be evaluated in numerous clinical trials worldwide either alone or in combination with one or more other therapies in the treatment of a range of hematological malignancies, including multiple myeloma (MDS) various lymphomas, chronic lymphocytic leukemia (CLL) other cancers and other diseases. VIDAZA (azacitidine for injection) is a pyrimidine nucleoside. VIDAZA is a Category 1 recommended treatment for patients with intermediate-2 and high-risk MDS and is marketed in the United States for the treatment of all subtypes of MDS. In Europe, VIDAZA is marketed for the treatment of intermediate-2 and high-risk MDS, as well as acute myeloid leukemia (AML) with 30% blasts and has been granted orphan drug designation for the treatment of MDS and AML.
THALOMID (thalidomide) is marketed for patients with newly diagnosed multiple myeloma and for the acute treatment of the cutaneous manifestations of moderate to severe erythema nodosum leprosum (ENL) an inflammatory complication of leprosy and as maintenance therapy for prevention and suppression of the cutaneous manifestation of ENL recurrence. THALOMID is distributed in the United States under its System f! or Thalid! omide Education and Prescribing Safety (S.T.E.P.S.) program. Internationally, THALOMID is also distributed under mandatory risk-management distribution programs. ABRAXANE (paclitaxel albumin-bound particles for injectable suspension) is a solvent-free chemotherapy treatment option for metastatic breast cancer, which was developed using its nab technology platform. This protein-bound chemotherapy agent combines paclitaxel with albumin. As of December 31, 2011, ABRAXANE was in various stages of investigation for the treatment of expanded applications for metastatic breast; non-small cell lung; malignant melanoma; pancreatic; bladder and ovarian.
ISTODAX (romidepsin) has received orphan drug designation for the treatment of non-Hodgkin's T-cell lymphomas, which includes CTCL and PTCL. The Company has licensed the worldwide rights (excluding Canada) regarding certain chirally pure forms of methylphenidate for FOCALIN and FOCALIN XR to Novartis. It also licensed to Novartis the rights related to long-acting formulations of methylphenidate and dex-methylphenidate products which are used in FOCALIN XR and RITALIN LA.
Preclinical and Clinical-Stage Pipeline
The product candidates in the Company�� pipeline are at various stages of preclinical and clinical development. Pomalidomide is a small molecule that is orally available and modulates the immune system and other biologically important targets. Pomalidomide is being evaluated in a phase III clinical trial for the treatment of myelofibrosis and a phase III clinical trial evaluating pomalidomide as a treatment for patients with relapsed/refractory multiple myeloma is accruing patients.
The Company is developing a product, ORAL ANTI-INFLAMMATORY AGENTS, which is orally available small molecules that target PDE4, an intracellular enzyme that modulates the production of multiple pro-inflammatory and anti-inflammatory mediators, including interleukin-2 (IL-2), IL-10, IL-12, IL-23, INF-gamma, TNF-a, leukotrienes,! and nitr! ic oxide synthase. Its investigational drug, apremilast (CC-10004), is used for the treatment of moderate to severe psoriasis and active psoriatic arthritis and is being evaluated in a phase II trial for rheumatoid arthritis and six phase III multi-center international clinical trials. In addition, it is investigating its oral PDE4 inhibitor, CC-11050, which is an anti-inflammatory compound that treat a variety of chronic inflammatory conditions, such as Cutaneous Lupus Erythematosus (CLE).
The Company�� oral kinase inhibitor platform includes inhibitors of the c-Jun N-terminal kinase (JNK) mTOR kinase, spleen tyrosine kinase (Syk) c-fms tyrosine kinase (c-FMS) and DNA-dependent protein kinase (DNAPK). Its oral Syk, c-FMS and DNAPK kinase inhibitors are being investigated in pre-clinical studies. The Company�� new second generation JNK inhibitor, tanzisertib (CC-930), is being evaluated in a phase II trial for the treatment of idiopathic pulmonary fibrosis and a phase II trial for the treatment of discoid lupus is accruing patients. Amrubicin is a third-generation fully synthetic anthracycline molecule with potent topoisomerase II inhibition.
At Celgene Cellular Therapeutics (CCT), it is researching stem cells derived from the human placenta, as well as from the umbilical cord. CCT is the Company�� research and development division. Stem cell based therapies provide disease-modifying outcomes for serious diseases, which lack adequate therapy. It has developed technology for collecting, processing and storing placental stem cells with broad therapeutic applications in cancer, auto-immune diseases, including Crohn's disease, multiple sclerosis, neurological disorders, including stroke and amyotrophic lateral sclerosis (ALS), graft-versus-host disease, and other immunological / anti-inflammatory, rheumatologic and bone disorders.
The Company has collaborated with Acceleron Pharma, Inc. (Acceleron) to develop sotatercept. Two phase I clinical studies have been co! mpleted. ! An additional phase II clinical study has been initiated and is ongoing related to treatments for end-stage renal anemia and to evaluate effects on red blood cell mass and plasma volume.
The Company competes with Abbott Laboratories, Amgen Inc. (Amgen), AstraZeneca PLC., Biogen Idec Inc., Bristol-Myers Squibb Co., Eisai Co., Ltd., F. Hoffmann-LaRoche Ltd., Johnson and Johnson, Merck and Co., Inc., Novartis AG, Pfizer, Sanofi and Takeda Pharmaceutical Co. Ltd. (Takeda).
Advisors' Opinion:- [By Maxx Chatsko]
Rising biotech stars Celgene (NASDAQ: CELG ) , Biogen Idec (NASDAQ: BIIB ) , and Gilead Sciences (NASDAQ: GILD ) have all crushed the market in the last year. Heck, even Amgen has been rewarded by the market for making biologics and biosimilars a top priority. Shares of each company have shot upwards on earnings acceleration expectations thanks to promising late stage pipelines. Multiple potential megablockbusters in the wings could bring in billions in sales by the end of the decade if approved and launched successfully.
- [By Maxx Chatsko]
Biogen's quarter even beat out that of its oft-compared peer Celgene (NASDAQ: CELG ) , which grew at least 17% in revenue, EPS, and income. I think the argument could be made that Biogen had better quarter.
Hot Biotech Companies To Invest In Right Now: Evolva Holding SA (EVE)
Evolva Holding SA (Evolva) discovers and provides ingredients for health, nutrition and wellness. Evolva uses biosynthetic and evolutionary technologies to create small molecule compounds and their production routes. The Company�� nutrition and consumer products include Pomecins, saffron, stevia, vanilla and resveratrol. The Company�� pharmaceuticals products include EV-077 and EV-035. In pharmaceuticals, the Company focuses on oral, small molecule drugs with application in complications of diabetes and infectious diseases. Pomecins are Evolva�� compounds. Evolva is focused on two members of the family - Pomecin A and Pomecin B. EV-035 is a bacterial type II topoisomerase inhibitor. Evolva is developing EV-077 for the treatment of diabetic complications. It is an oral, small molecule compound, belonging to a structural class. Advisors' Opinion:- [By Glenwoods]
Earlier this year the giant food processor, Cargill, partnered with the small Swiss company, Evolva (SIX:EVE), which was developing its own stevia-based fermentation process, also in the pilot stage. As noted earlier in the article, Cargill is in a partnership with Coca-Cola for Truvia, the bestselling stevia product on the market. The success of the Cargill/Evolva partnership could have big implications not just for Cargill and Coca-Cola, but also on the entire stevia and sweetener market. I further believe the success of the partnership could have a major impact on Stevia First. If Cargill�� fermentation method produces a better tasting stevia product at a lower cost it would give Coca-Cola a considerable advantage over the other beverage bottlers, food manufacturers, and stevia producers. Such an outcome would force these companies to scramble to find a similar method in order to compete. There would be a very good chance that rival companies, in order to stay in the game, would have to turn to the other company developing a fermentation-based stevia product-- Stevia First. If that happens Stevia First�� value would rise considerably.