Wednesday, August 7, 2013

10 Best Biotech Stocks To Buy Right Now

With the�SPDR S&P Biotech Index�up 32% over the trailing-12-month period, it's evident that investment dollars are willingly flowing into the biotech sector. Keeping that in mind, let's have a look at some of the rulings, studies, and companies that made waves in the sector last week.

Just as we've seen in previous weeks, it was relatively quiet in the beginning, but wow, did things pick up in a big way on Friday. In fact, Friday is the basis for this week's three most important biotech stories.

On the bright side, GlaxoSmithKline (NYSE: GSK  ) and Theravance (NASDAQ: THRX  ) received a much-expected drug approval for once-daily inhaled COPD maintenance treatment Breo Ellipta from the Food and Drug Administration. Having proved non-inferior to the placebo in trials, and delivering a favorable safety profile while reducing flare-ups and helping relieve air flow obstruction, Breo Ellipta has a good shot at being a blockbuster drug within the next couple of years. Breo Ellipta is expected to be available to patients next quarter. In addition, as I've alluded to on numerous occasions, it could be the impetus that encourages Glaxo to gobble up Theravance's Royalty Management -- one of two proposed entities that Theravance plans to split into. This is certainly a big win for both companies.

10 Best Biotech Stocks To Buy Right Now: RXi Pharmaceuticals Corp (RXII)

RXi Pharmaceuticals Corporation (RXi), incorporated on September 8, 2011, is a development-stage company. The Company is a biotechnology company focused on discovering, developing and commercializing therapies addressing medical needs using RNA interference (RNAi)-targeted technologies. As of July 12, 2012, RXi was focusing on its internal therapeutic development efforts in fibrosis. RXI-109 is its RNAi product candidate, which is a dermal anti-scarring therapy that targets connective tissue growth factor (CTGF). The Company�� therapeutic platform consists of two main components: RNAi Compounds (rxRNA) and Advanced Delivery Technologies. RNAi compounds include rxRNAori, rxRNAsolo and sd-rxRNA, or self-delivering RNA. On April 26, 2012, it completed the spin-off transaction from Galena Biopharma, Inc. (Galena).

In January 2011, the Company announced research results in collaboration with Generex Biotechnology Corporation, and RXi�� wholly owned subsidiary Antigen Express, Inc., in developing vaccine formulations for immunotherapy. In January 2011, it announced initial results as part of its collaboration with miRagen Therapeutics, Inc. in creating microRNA mimics, or artificial copies of microRNAs, using the Company�� sd-rxRNA technology. In February 2011, it announced the initiation of RXi�� development program for RXI-109.

10 Best Biotech Stocks To Buy Right Now: OncoGenex Pharmaceuticals Inc.(OGXI)

OncoGenex Pharmaceuticals, Inc., a biopharmaceutical company, engages in the development and commercialization of new cancer therapies that address treatment resistance in cancer patients. The company?s clinical stage products include Custirsen, a phase III clinical stage product for treatment in men with metastatic castrate-resistant prostate cancer; OGX-427, which is in phase II clinical development stage is designed to inhibit heat shock protein 27; and SN2310 that completed phase I stage of clinical development is designed to evaluate safety in patients with advanced cancer. Its pre clinical stage products include GX-225 that is focused on reducing the production of IGFBP-2 and IGFBP-5; and CSP-9222, lead compound from a family of caspase activators. OncoGenex Pharmaceuticals, Inc. is based in Bothell, Washington.

5 Best Small Cap Stocks To Buy Right Now: Vertex Pharmaceuticals Incorporated(VRTX)

Vertex Pharmaceuticals Incorporated engages in discovering, developing, manufacturing, and commercializing small molecule drugs for the treatment of serious diseases worldwide. Its products include telaprevir, a prescription medicine used for the treatment of patients with genotype 1 hepatitis C virus (HCV) infection; and Ivacaftor, a prescription medicine used for the treatment of cystic fibrosis. The company markets its products under the INCIVEK brand name in the United States and Canada; INCIVO brand in the United Kingdom, Germany, France, Sweden, Austria, Finland, Denmark, Switzerland, and Norway; KALYDECO brand in the United States; and TELAVIC brand in Japan. Its drug candidates comprise VX-222, a Phase II clinical trial drug candidate, and ALS-2200 and ALS-2158, a Phase I clinical trial drug candidates that are designed to inhibit the replication of HCV; VX-809 and VX-661, a Phase II clinical trial drug candidates that improve the function of defective cystic fibro sis; VX-509, a Phase II clinical trial drug candidate for the treatment of patients with rheumatoid arthritis and other immune-mediated inflammatory diseases; VX-765, a Phase II clinical trial drug for the treatment of epilepsy; and VX-787, an investigational drug candidate for the treatment of influenza A. The company was founded in 1989 and is headquartered in Cambridge, Massachusetts.

Advisors' Opinion:
  • [By Melly Alazraki]

    Vertex Pharmaceuticals (VRTX)topped the list with a 38.4% return as of Wednesday's close of $48.48. This $9.8 billion market capnon-profitablecompany is all promise. It is itspipelinethat's drawing investors, especially thehepatitis C treatment telaprevirandpotential cystic fibrosis drug VX-770.

    Both diseases present large market opportunities: Liver disease caused by the hepatitis C virusaffects 3.2 million individualsin the U.S. and as many as 100 million people worldwide. Cystic fibrosis is an inherited genetic disease that affects about 30,000 people in the U.S. and has few treatment options.

    Analysts ! have favored the stock, with aconsensus buy recommendation. However, just on Thursday, Vertex announcedtwomore telaprevir studyresultsthat did not impress investors and the stock declined 2% to $47.50. Also, Vertex is not without competitors and is in a race with Merck (MRK) and its experime ntal Hep C drug boceprevir to be the first to reach the market.

    The stock's 52-week high of $52.13 was set on March 7, up from a low of $31.25 set on July 1, 2011.

  • [By TheStreet Staff]

    Vertex Pharma's (VRTX ) cystic fibrosis drug Kalydeco will be approved. More importantly, studies testing Kalydeco combined with other Vertex's cystic fibrosis drugs will show strong benefit in a larger swath of patients. Vertex becomes a cystic fibrosis company. Hepatitis C? What's that?

    Correct. Kalydeco was approved in January -- in my opinion, the most important drug approval in 2012. The Kalydeco-VX-809 combination study was successful, even though the Street is still debating the magnitude of the regimen's benefit to cystic fibrosis patients

10 Best Biotech Stocks To Buy Right Now: 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.

10 Best Biotech Stocks To Buy Right Now: Cubist Pharmaceuticals Inc.(CBST)

Cubist Pharmaceuticals, Inc., a biopharmaceutical company, focuses on the research, development, and commercialization of pharmaceutical products that address unmet medical needs in the acute care environment. The company markets CUBICIN (daptomycin for injection), a once-daily, bactericidal, intravenous, antibiotic with activity against gram-positive organisms, including methicillin-resistant staphylococcus aureus. Its clinical development product pipeline consists of CXA-201, which is in the phase III clinical trial for patients with complicated urinary tract infections; and in phase II clinical trial for patients with complicated abdominal infections. The company is also developing CXA-201 for the treatment of hospital acquired pneumonia. In addition, its product under development comprises CB-183,315, an oral, bactericidal lipopeptide with in vitro bactericidal activity against C. difficile, for the treatment of clostridium difficile-associated diarrhea (CDAD). Further , the company?s pre-clinical programs include therapies to treat various bacterial infections and agents to treat acute pain. Additionally, it promotes MERREM I.V. (meropenem for injection), a carbapenem class intravenous antibiotic, in the United States under a commercial services agreement with AstraZeneca Pharmaceuticals, LP; and DIFICID as the treatment for CDAD in adults under the co-promotion agreement with Optimer Pharmaceuticals, Inc. The company also has collaborations with Forma Therapeutics, Inc. to discover and develop antibacterial compounds; an agreement with the Broad Institute to transform natural products discovery; a collaboration with Hydra Biosciences, Inc., to develop ion channel drugs; and a collaboration agreement with Alnylam Pharmaceuticals, Inc., for the development and commercialization of Alnylam's RNAi therapeutics as a therapy for the treatment of respiratory syncytial virus. The company was founded in 1992 and is headquartered in Lexington, Mas sachusetts.

Advisors' Opinion:
  • [By Dug]

    Cubist Pharmaceuticals(CBST) is a major player in anti-infectives, which prevent and treat diseases, specifically those caused by drug-resistant pathogens. For example, Cubist's major product, Cubicin, is used to treat complicated skin and skin structure infections as well as bacterimia.

    The company has two anti-biotics that are in stage two of FDA approval. Since 2008, Cubist has grown sales and earnings per share 29% and 24% annually, on average. Its stock delivered annualized gains of 8.9% over that period. Recent deterioration of growth has led to a sell-off in Cubist, disconcerting investors.

    Its stock is down 4% over the past three months. Fourth-quarter adjusted earnings decreased 28% year-over-year, but did beat the consensus estimate by 38%. The top-line, down 3%, missed consensus by 1.1%. The operating margin strengthened during the quarter, from 28% to 29%, indicating pricing strength. Jefferies is optimistic about the outcome of a patent litigation lawsuit, which has a trial date in April, and considers the small-cap undervalued, at just 13-times forward earnings, a 39% peer discount. But, it considers reliance on Cubicin a concentrated risk.

    Bullish Scenario: Jefferies expects Varian to rise 39% to $31.

    Bearish Scenario: ThinkEquity foresees a drop of 10% to $20.

10 Best Biotech Stocks To Buy Right Now: Organovo Holdings Inc (ONVO.PK)

Organovo Holdings, Inc. (Organovo), formerly Real Estate Restoration & Rental, Inc., incorporated in 2007, is a development-stage company. The Company has developed and is commercializing a platform technology for the generation of three-dimensional (3D) human tissues that can be employed in drug discovery and development, biological research, and as therapeutic implants for the treatment of damaged or degenerating tissues and organs. On December 28, 2011, Real Estate Restoration and Rental, Inc.�� (RERR) entered into an Agreement and Plan of Merger, pursuant to which RERR merged with its, wholly owned subsidiary, Organovo (Merger Sub). On February 8, 2012, the Company merged with and into Organovo Acquisition Corp. (Acquisition Corp.), a wholly owned subsidiary of Organovo, with the Company surviving the merger as a wholly owned subsidiary of Organovo Holdings (the Merger). As a result of the Merger, Organovo acquired the business of Organovo, Inc.

The C ompany has collaborative research agreements with Pfizer, Inc. (Pfizer) and United Therapeutic Corporation (Unither). As of March 31, 2012, it has five federal grants, including Small Business Innovation Research grants and developed the NovoGen MMX Bioprinter (its first-generation 3D bioprinter). The Company is engaged in the development of specific 3D human tissues to aid Pfizer in discovery of therapies in two areas of interest. In addition, in October 2011, it entered into a research agreement with Unither to establish and conduct a research program to discover treatments for pulmonary hypertension using its NovoGen MMX Bioprinter technology. Additionally, under the research agreement with Unither, the Company granted Unither an option to acquire from the Company a worldwide, royalty-bearing license in certain intellectual property created under the research agreement solely for use in the treatment or prevention of pulmonary hypertension and all other lung diseases.

The Company�� NovoGen MMX Bioprinter is an aut! om! ated device that enables the fabrication of three-dimensional (3D) living tissues comprised of mammalian cells. A custom graphic user interface (GUI) facilitates the 3D design and execution of scripts that direct precision movement of the dispensing heads to deposit cellular building blocks (bio-ink) or supporting hydrogel. The Company is using a third party manufacturer, Invetech Pty., of Melbourne, Australia, to manufacture its NovoGen MMX Bioprinter. Its bioprinting technology and surrounding intellectual property and commercial rights serve as a platform for product generation across multiple markets that employ cell- and tissue-based products and services.

The Company competes with Organogenesis, Advanced BioHealing, Tengion, Genzyme, HumaCyte and Cytograft Tissue Engineering.

10 Best Biotech Stocks To Buy Right Now: ViroPharma Incorporated(VPHM)

ViroPharma Incorporated, a biotechnology company, develops and commercializes therapeutic products that address serious diseases in the United States and internationally. It focuses on developing products used by physician specialists or in hospital settings. The company markets and sells Cinryze, a C1 esterase inhibitor therapy for the routine prophylaxis against angioedema attacks in adolescent and adult patients with hereditary angioedema, a life-threatening genetic disorder; and Vancocin HCl capsule, an oral capsule formulation for the treatment of C. difficile-associated diarrhea (CDAD) and to treat enterocolitis caused by staphylococcus aureus, including methicillin-resistant strains. It also offers Plenadren, an orphan drug for treatment of adrenal insufficiency in adults; Buccolam, a oromucosal solution for treatment of prolonged, acute, and convulsive seizures in infants, toddlers, children, and adolescents; and maribavir, an antiviral compound for the treatment o f CMV disease through a license agreement with GlaxoSmithKline. The company?s primary development programs include Cinryze, a C1 esterase inhibitor for management of hereditary angioedema; and VP 20621, a non-toxigenic strain of C. difficile. Its clinical stage drug candidate comprises VP-20629 for the treatment of Friedreich?s Ataxia. The company sells its products directly to wholesale drug distributors and specialty pharmacies/distributors. ViroPharma Incorporated was founded in 1994 and is headquartered in Exton, Pennsylvania.

Advisors' Opinion:
  • [By Harding]

    ViroPharma Inc. specializes in drug development and commercialization for medications to treat C. difficile, Staph. aureus and other infectious diseases found in hospital settings. Their pipeline includes a number of products in Phase II and III trials, two on the market, and they have strategic relations with giants like EliLilly and GlaxoSmithKline. VPHM stock, worth about $8 in January 2012, is priced at nearly $13 today, and is still steadily climbing. The company, founded in 1994, employs 170 people.

10 Best Biotech Stocks To Buy Right Now: Alnylam Pharmaceuticals Inc.(ALNY)

Alnylam Pharmaceuticals, Inc., a biopharmaceutical company, engages in discovering, developing, and commercializing novel therapeutics based on RNA interference (RNAi). Its core product programs under clinical or pre-clinical development include ALN-TTR, a Phase I clinical trial program for the treatment of transthyretin-mediated amyloidosis; ALN-APC, a Phase I clinical trial program for the treatment of hemophilia; ALN-PCS for the treatment of severe hypercholesterolemia; ALN-HPN, a pre-clinical development for the treatment of refractory anemia; and ALN-TMP, a pre-clinical development for the treatment of hemoglobinopathies, including beta-thalassemia and sickle cell anemia. The company?s partner-based programs comprise ALN-RSV01, a Phase II clinical trial program for the treatment of respiratory syncytial virus infection; ALN-VSP, a Phase I clinical trial completed program for the treatment of liver cancers; and ALN-HTT, a pre-clinical development for the treatment of Huntington?s disease. It has strategic alliances with Novartis Pharma AG; F. Hoffmann-La Roche Ltd; Takeda Pharmaceutical Company Limited; Isis Pharmaceuticals, Inc.; Medtronic Inc.; Kyowa Hakko Kirin Co., Ltd.; and Cubist Pharmaceuticals, Inc. The company was founded in 2002 and is headquartered in Cambridge, Massachusetts.

Advisors' Opinion:
  • [By Glenn]

    A relatively new company, Alnylam Pharmaceuticals was founded in 2002, and their shares have shown steady growth since before January 2005. In early January 2012, the shares were worth about $30 and although there were some dips to less than $20 in October/November of this year, they ended up around $25 at the end of December. Alnylam develops RNAi therapies for respiratory diseases and Huntington's, among others and has a broad spectrum of products in its pipeline. This startup also has agreements with number of large companies including Novartis, Biogen an d Roche.

10 Best Biotech Stocks To Buy Right Now: Nektar Therapeutics(NKTR)

Nektar Therapeutics, a clinical-stage biopharmaceutical company, engages in developing a pipeline of drug candidates that utilize its PEGylation and polymer conjugate technology platforms. The company?s product pipeline consists of drug candidates across various therapeutic areas, including oncology, pain, anti-infectives, anti-viral, and immunology. Its research and development activities involve small molecule drugs, peptides, and other potential biologic drug candidates. The company?s proprietary drug candidates in clinical development comprise NKTR-118, a peripheral opioid antagonist, which has completed Phase II clinical trail for the treatment of opioid-induced constipation; BAY41-6551 that has completed Phase II clinical trail to treat gram-negative pneumonias; NKTR-102, a topoisomerase I inhibitor-polymer conjugate, which is in Phase II clinical trail for multiple cancer indications, including breast, ovarian, and colorectal; and NKTR-105 that is in Phase I clinica l trail to treat solid tumors. Its preclinical products consists of NKTR-119 (Opioid/NKTR-118 combinations) for the treatment of pain; NKTR-181 (abuse deterrent, tamper-resistant opioid) to treat pain; NKTR-194 (non-scheduled opioid) for the treatment of mild to moderate pain; NKTR-171 (tricyclic antidepressant) to treat neuropathic pain; and NKTR-140 (protease inhibitor candidate) to treat HIV. The company has collaboration with Bayer Healthcare LLC to develop BAY41-6551 (NKTR-061, Amikacin Inhale), which is an inhaled solution of amikacin, an aminoglycoside antibiotic; and a license agreement with AstraZeneca AB for the development and commercialization of Oral NKTR-118 and NKTR-119. In addition, Nektar Therapeutics has various license, manufacturing, and supply agreements for its technology with biotechnology and pharmaceutical companies, such as Affymax, Amgen, Baxter, Roche, Merck, Pfizer, and UCB Pharma. The company was founded in 1990 and is headquartered in San Franc isco, California.

10 Best Biotech Stocks To Buy Right Now: Regeneron Pharmaceuticals Inc.(REGN)

Regeneron Pharmaceuticals, Inc., a biopharmaceutical company, discovers, develops, and commercializes pharmaceutical products for the treatment of serious medical conditions in the United States. The company?s commercial product includes ARCALYST (rilonacept) injection for subcutaneous use for the treatment of cryopyrin-associated periodic syndromes, including familial cold auto-inflammatory syndrome and muckle-wells syndrome in adults and children. Its products under Phase III clinical development stage consist of VEGF Trap-Eye, an aflibercept ophthalmic solution developed using intraocular delivery for the treatment of serious eye diseases; ARCALYST for the prevention of gout flares in patients initiating uric acid-lowering treatment; and Aflibercept (VEGF Trap), which is developed in oncology. The company?s earlier stage clinical programs include various human antibodies, such as REGN727 for low-density lipoprotein cholesterol reduction, REGN88 for rheumatoid arthritis and ankylosing spondylitis; REGN668 for atopic dermatitis and asthma; REGN421 and REGN910 for oncology; REGN475 for the treatment of pain; and REGN728 and REGN846. It also conducts preclinical research programs in the areas of oncology and angiogenesis, ophthalmology, metabolic and related diseases, muscle diseases and disorders, inflammation and immune diseases, bone and cartilage, pain, cardiovascular diseases, and infectious diseases. The company distributes its products through third party service providers. It has strategic collaboration with sanofi-aventis Group to discover, develop, and commercialize human monoclonal antibodies; and Bayer HealthCare LLC to develop and commercialize VEGF Trap. Regeneron Pharmaceuticals, Inc. was founded in 1988 and is based in Tarrytown, New York.

Advisors' Opinion:
  • [By Melly Alazraki]

    Regeneron Pharmaceuticals (REGN)also had an impressive quarter, soaring 36.1% to $44.68 as of Wednesday's close, after setting an intra-day 52-week high of $45.11. This $3.88 billion market cap biopharmaceutical company has been on a tear with a yearly return of 67% as it continued to develop cancer, eye-condition and gout treatments.

    In fact, Regeneron, which sells onlyone product-- Arcalyst (rilonacept), for the treatment of a rare, inherited, inflammatory condition -- last monthsubmitted an applicationto the Food and Drug Administration for its VEGF Trap-Eye for the treatment of the eye disorder that is the leading cause of blindness in patients older than 65 in the U.S. and Europe. If the treatment is approved, Regeneron hopes to take market share from Roche/Novartis's (NVS) Lucentis.

    However, Regeneron'spipelinealsosuffered a setbackrecently. Aflibercept, its candidate drug for non-small-cell lung cancer -- a notoriously difficult-to-treat disease -- failed to increase overall survival time in a late-stage study. For now, analysts favor the stock with a consensus buy recommendation, but this setback follows others, making ongoing studies of aflibercept vital for Regeneron's future. The company co-developed aflibercept with Sanofi-Aventis (SNY).

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