The biotech roller-coaster continues for investors into 2014 with small cap Chelsea Therapeutics International Ltd (NASDAQ: CHTP) set to more than double when the market opens today, meaning its time to take a closer look at what in the world is going on with the stocks plus take a closer look at the performance of biotech peers like the iShares NASDAQ Biotechnology Index ETF (NASDAQ: IBB) and SPDR S&P Biotech ETF (NYSEARCA: XBI).
What is Chelsea Therapeutics International?Small cap Chelsea Therapeutics International is a development stage biopharmaceutical company seeking to�acquire, develop and commercialize innovative products for the treatment of a variety of human diseases. More specifically, the company�� development strategy is to balance the product development portfolio with early (preclinical) and late-stage (clinical) products through a combination of product acquisitions and partnering with pharmaceutical and biotechnology companies.
Top 10 Biotech Stocks To Buy For 2015: Inovio Pharmaceuticals Inc (INO)
Inovio Pharmaceuticals, Inc., incorporated on June 29, 1983, is engaged in the development of a new generation of vaccines, called synthetic vaccines, focused on cancers and infectious diseases. The Company's SynCon technology enables the design of universal vaccines capable of providing cross-protection against existing or changing strains of pathogens, such as influenza and human immunodeficiency virus (HIV). The Company's electroporation delivery technology uses brief, controlled electrical pulses to increase cellular uptake of the vaccine. Its clinical programs include cervical dysplasia (therapeutic), avian influenza (preventive), prostate cancer (therapeutic), leukemia (therapeutic), hepatitis C virus (HCV) and HIV vaccines. It is advancing preclinical research and clinical development for a universal seasonal/pandemic influenza vaccine, as well as preclinical work for other products, including malaria and prostate cancer vaccines. Its partners and collaborators include University of Pennsylvania, Drexel University, National Microbiology Laboratory of the Public Health Agency of Canada, Program for Appropriate Technology in Health/Malaria Vaccine Initiative (PATH/MVI), National Institute of Allergy and Infectious Diseases (NIAID), Merck, ChronTech, University of Southampton, United States Military HIV Research Program (USMHRP), the United States Army Medical Research Institute of Infectious Diseases (USAMRIID) and HIV Vaccines Trial Network (HVTN). As of December 31, 2011 it owned 16.1% interest in VGX Int��.
Inovio�� Solution
The Company�� synthetic vaccine platform consists of its SynCon vaccine design process and electroporation delivery technology. It has developed a preclinical and clinical stage pipeline of vaccines. The Company�� synthetic vaccines are designed to prevent a disease (prophylactic vaccines) or treat an existing disease (therapeutic vaccines). Its synthetic vaccine consists of a deoxyribonucleic acid (DNA) plasmid encoding a selected antigen! (s), which is introduced into cells of humans or animals with the purpose of evoking an immune response to the encoded antigen. The Company�� synthetic vaccines are designed to generate specific antibody and/or T-cell responses.
The Company�� SynCon technology provides processes that employ bioinformatics, which combine extensive genetic data and sophisticated algorithms. Its design process uses the genetic make-up of a common antigen(s) from multiple strains of a virus within a viral sub-type or taxonomic group (family) of pathogens, such as HIV, hepatitis C virus (HCV), human papillomavirus (HPV), influenza and other diseases to synthetically create a new antigen for the desired pathogen target that does not exist in nature. Its synthetic vaccine candidates are being delivered into cells of the body using its electroporation (EP) DNA delivery technology.
Cancer Synthetic Vaccines
The Company has two broad types of cancer vaccines: preventive (or prophylactic) vaccines, which are intended to prevent cancer from developing in healthy people, and treatment (or therapeutic) vaccines, which are intended to treat an existing cancer by strengthening the body�� natural defenses against the cancer. Two types of cancer preventive vaccines are available in the United States. The United States Food and Drug Administration (the FDA) has approved two vaccines, Gardasil and Cervarix that protect against infection by the two types of HPV-types 16 and 18-that cause approximately 70% of all cases of cervical cancer worldwide. In addition, Gardasil protects against infection by two additional HPV types, 6 and 11, which are responsible for about 90% of all cases of genital warts in males and females but do not cause cervical cancer.
Cervarix manufactured by GlaxoSmithKline, is composed of virus-like particles (VLPs) made with proteins from HPV types 16 and 18. Cervarix is approved for use in females��ages 10 to 25 for the prevention of cervical cancer caused by! HPV type! s 16 and 18. Gardasil manufactured by Merck, is approved for use in females for the prevention of cervical cancer, and some vulvar and vaginal cancers, caused by HPV types 16 and 18 and for use in males and females for the prevention of genital warts caused by HPV types 6 and 11. The vaccine is approved for these uses in females and males ages 9 to 26. The FDA has also approved a cancer preventive vaccine that protects against hepatitis B virus (HBV) infection.
Inovio�� VGX-3100 is designed to raise immune responses against the E6 and E7 genes of HPV types 16 and 18 that are present in both pre-cancerous and cancerous cells transformed by these HPV types. E6 and E7 are oncogenes that play an integral role in transforming HPV-infected cells into cancerous cells. In March 2011, it initiated a randomized, double-blind Phase II study of VGX-3100 delivered using the CELLECTRA intramuscular electroporation device in women with HPV Type 16 or 18 and diagnosed with, but not yet treated for, cervical intraepithelial neoplasia (CIN) 2/3. The study is designed to enroll 148 subjects. In January 2011, it announced the publication of a scientific paper in the journal Human Vaccines detailing potent immune responses in a preclinical study of its SynCon vaccine for prostate cancer targeting two antigens, prostate specific antigen (PSA) and prostate specific membrane antigen (PSMA).
In January 2011, the Company announced the regulatory approval of a Phase II clinical trial (WIN Trial) to treat leukemia utilizing its new ELGEN 1000 automated vaccine delivery device. The single dose level, Phase II study, called WT1 immunity via DNA fusion gene vaccination in haematological malignancies by intramuscular injection followed by intramuscular electroporation. Cancer Vaccines encodes for hTERT, an antigen related to non-small cell lung, breast and prostate cancers. The vaccine is delivered using its electroporation delivery technology.
Infectious Disease Synthetic Vaccines
In Marc! h 2011, the Company announced the initiation of a follow-on open label, single dose Phase II clinical study in collaboration with ChronTech of the ChronVac-C HCV DNA vaccine delivered using its electroporation technology in treatment naive HCV infected individuals. Its HIV vaccines consist of candidates for HIV prevention, as well as therapy or treatment. PENNVAX-B is designed to target HIV clade B (most commonly found in the United States, North America, Australia and the European Union (EU). PENNVAX-G is designed to target HIV clades A, C and D, which are more commonly found in Asia, Africa, Russia and South America. This Phase I clinical study of PENNVAX-B (HVTN-080) vaccinated 48 healthy, HIV-negative volunteers to assess safety and levels of immune responses generated by Inovio�� PENNVAX-B vaccine delivered with its CELLECTRA electroporation device. PENNVAX-B is a SynCon vaccine that targets HIV gag, pol, and env proteins.The Company�� VGX-3400X targets H5N1. The vaccine consists of three distinct DNA plasmids coded for a consensus hemagglutinin (HA) antigen derived from different H5N1 virus strains; a consensus neuraminidase (NA) antigen derived from different N1 sequences; and a consensus nucleoprotein (NP) fused to a small portion of the m2 protein (m2E) based on a broader cross-section of influenza viruses in addition to H5N1 and H1N1. Conventional vaccines are strain-specific and have limited ability to protect against genetic shifts in the influenza strains they target. They are therefore modified annually in anticipation of the next flu season�� new strain(s). It is focused on developing DNA-based influenza vaccines able to provide broad protection against known as well as newly emerging, unknown seasonal and pandemic influenza strains.
Animal Health/Veterinary
VGX Animal Health, Inc. (VGX AH), a majority-owned subsidiary, has licensed LifeTide, a plasmid-based growth hormone releasing hormone (GHRH) technology for swine. LifeTide is one of onl! y four DN! A-based treatments approved for use in animals and is the only DNA-based agent delivered using electroporation that has been granted marketing approval (Australia). VGX AH is also developing a GHRH-based treatment for cancer and anemia in dogs and cats. It is developing a synthetic vaccine for foot-and-mouth disease (FMD) administered by its vaccine delivery technology. The FMD virus is one of the most infectious diseases affecting farm animals, including cattle, swine, sheep and goats, and is a serious threat to global food safety.
The Company competes with Crucell N.V, Sanofi-Aventis, Novartis, Inc., GlaxoSmithKline plc, Merck, Pfizer, AstraZeneca, Inc., Novartis, Inc., MedImmune and CSL.
Advisors' Opinion:- [By MONEYMORNING]
Inovio Zooms: We recommended biotech Inovio Inc. (NYSE: INO) at 71 cents a share back on Feb. 1, 2013, and have re-recommended it a number of times since. With their 15.2% gain yesterday, the shares are now at $3.71, up 414% from where we first told you about them - and we believe there's more to come. In fact, we'll be bringing you an interesting update on this company very soon. Inovio is one of 24 recommendations that have doubled or better since we launched Private Briefing back in August 2011.
- [By George Budwell]
Inovio Pharmaceuticals (NYSEMKT: INO ) develops DNA-based vaccines and delivers them using a proprietary electroporation technique. Shares of Inovio have been a roller coaster all year long, and have certainly been the playground of day traders. Last week, Inovio shares lost more than 10% of their value on heavy volume, suggesting the stock may continue to experience downward pressure. This rapid move downward is surprising because the company recently signed a licensing deal with Roche (NASDAQOTH: RHHBY ) to commercialize Inovio's multi-antigen DNA immunotherapies for prostate cancer and hepatitis B. As part of the deal, Inovio received $10 million upfront, and milestone payments could go as high as $412 million.
- [By Jake L'Ecuyer]
Equities Trading DOWN
Shares of Inovio Pharmaceuticals (NYSE: INO) were down on Friday's session, falling 13.28 percent to $2.488 despite seemingly little news on the company. - [By Sean Williams]
No fairytale ending
Fairytale endings work great in the movies, but you rarely see them come to fruition in the real world. Small-cap biopharmaceutical Inovio Pharmaceuticals (NYSEMKT: INO ) has seen shares nearly triple since April on the heels of multiple intriguing studies, but will the glass slipper fit over the long term?
Top 10 Biotech Stocks To Buy For 2015: Incyte Corporation(INCY)
Incyte Corporation focuses on the discovery and development of proprietary small molecule drugs for hematologic and oncology indications, and inflammatory and autoimmune diseases. Its product pipe line includes INCB18424, which is in Phase III clinical trial for myelofibrosis; Phase III trial for polycythemia vera; Phase III trial for essential thrombocythemia; Phase I/II trial to treat solid tumors/other hematologic malignancies; and Phase IIb trail for the treatment of psoriasis. The company?s portfolio also includes INCB28050, a Phase IIb clinical trial product for rheumatoid arthritis; INCB28060, a Phase I/II product for solid tumors; INCB7839, a Phase II product for breast cancer; and INCB24360, a Phase I/II product for solid tumors. It has a collaborative research and license agreements with Novartis International Pharmaceutical Ltd.; Eli Lilly and Company; and Pfizer Inc. The company was founded in 1991 and is headquartered in Wilmington, Delaware.
Advisors' Opinion:- [By Jay Silverman]
Steve Halpern: One of your long-standing recommendations is Incyte (INCY), which recently reported some positive news and saw a huge jump in the price-up close to 30% in one day. What happened there and what's your outlook for the stock?
- [By Ben Levisohn]
Somaiya and team named Gilead and�Neurocrine Biosciences (NBIX) their top picks, hile putting Buy ratings on Celgene, Biogen Idec, Alexion (ALXN), Incyte (INCY), Pharmacyclics (PCYC) and Synageva (GEVA). BioMarin (BMRN), Infinity Pharmaceuticals (INFI) and Amgen (AMGN) earned Neutral ratings.
Hot China Companies To Invest In Right Now: Receptos Inc (RCPT)
Receptos, Inc. (Receptos), incorporated on June 9, 2008, is a biopharmaceutical company. The Company is focused on discovering, developing and commercializing therapeutics for immune disorders. The Company�� product candidates span three specialty disease areas. The Company�� lead asset, RPC1063, is being developed as an oral therapy for the treatment of relapsing multiple sclerosis (RMS) and inflammatory bowel disease (IBD). Its second asset, RPC4046, is being developed for the treatment of an allergic/immune-mediated disorder, eosinophilic esophagitis (EoE), which is an orphan disease. RPC1063 is an oral, once daily, selective and potent sphingosine 1-phosphate 1 receptor (S1P1R) modulator. RPC4046 is a monoclonal antibody selective to interleukin-13 (IL-13) and produced by recombinant deoxyribonucleic acid (DNA) technology.
As of December 31, 2012, RPC1063 was being tested in the Phase II portion of an accelerated design, randomized Phase II/III study for the treatment of RMS. In addition, Receptos has obtained special protocol assessment (SPA) agreement from the United States food and drug administration (FDA) on its clinical trial design for the planned Phase III portion of the Phase II/III study, as well as a second planned RMS Phase III study. RPC1063 is also being tested in a randomized Phase II study for the treatment of ulcerative colitis (UC), a gastrointestinal (GI) disea se.
As of December 31, 2012, the Company was enrolling a randomized Phase II study evaluating the ability of RPC1063 to induce clinical remission in patients with moderately-to-severely active UC called TOUCHSTONE. The Company�� second asset, RPC4046 for the treatment of EoE, builds upon its competencies in immunology and GI diseases. In-licensed from AbbVie Bahamas Ltd. and AbbVie Inc. (AbbVie) RPC4046 is a monoclonal antibody directed against the IL-13 target, which has been validated in Asthma, a predominantly allergic/immune-mediated disorder.
Advisors' Opinion:- [By Roberto Pedone]
Receptos (RCPT) is a biopharmaceutical company engaged in discovering, developing and commercializing therapeutics for immune disorders. This stock closed up 5% at $23.19 in Monday's trading session.
Monday's Volume: 69,000
Three-Month Average Volume: 55,356
Volume % Change: 50%From a technical perspective, RCPT ripped higher here right above some key near-term support at $21 with decent upside volume. This move is quickly pushing shares of RCPT within range of triggering a major breakout trade. That trade will hit if RCPT manages to take out its all-time high at $25 with high volume.
Traders should now look for long-biased trades in RCPT as long as it's trending above support at $21 and then once it sustains a move or close above its all-time high at $25 with volume that's near or above 55,356 shares. If that breakout hits soon, then RCPT will set up to enter new all-time-high territory, which is bullish technical price action. Some possible upside targets off that breakout are $30 to $35.
- [By John Udovich]
Small cap �biopharmaceutical stock Receptos Inc (NASDAQ: RCPT) was one of the many hot biotech IPOs of last year and its also up 72.4% since the start of this year alone, meaning its time to take a closer look at this small cap stock with potential treatments for Relapsing Multiple Sclerosis (RMS) and Inflammatory Bowel Disease (IBD) along with the performance of biotech ETF benchmarks like the iShares NASDAQ Biotechnology Index ETF (NASDAQ: IBB) and SPDR S&P Biotech ETF (NYSEARCA: XBI).
Top 10 Biotech Stocks To Buy For 2015: InterMune Inc.(ITMN)
InterMune, Inc., a biopharmaceutical company, engages in the research, development, and commercialization of therapies in pulmonology and fibrotic diseases. In pulmonology, the company focuses on therapies for the treatment of idiopathic pulmonary fibrosis (IPF), a progressive and fatal lung disease. It markets pirfenidone, an orally active drug that inhibits the synthesis of TGF-beta under the Esbriet name in the European Union, as well as in a Phase III clinical trial in the United States. Pirfenidone is also approved for the treatment of IPF in Japan, where it is marketed by Shionogi & Co. Ltd. under the Pirespa trade name. The company?s research programs focus on the discovery of small-molecule therapeutics and biomarkers to treat and monitor serious pulmonary and fibrotic diseases. InterMune, Inc. was founded in 1998 and is headquartered in Brisbane, California.
Advisors' Opinion:- [By Ben Levisohn]
Intercept Pharmaceutical has surged 576% this year after gaining today, besting InterMune’s (ITMN) 119% spike and Sangamo BioSciences’ (SGMO) 63% advance.
- [By Rich Smith]
On Thursday, the Securities and Exchange Commission charged a former vice president of finance, accounting officer, and controller of InterMune (NASDAQ: ITMN ) with insider trading.
- [By Keith Speights]
Lunging forward
Intermune (NASDAQ: ITMN ) announced second-quarter earnings on Wednesday. Higher-than-expected revenue helped shares advance almost 16% for the week. - [By Sean Williams]
InterMune (NASDAQ: ITMN )
InterMune shares may have exploded higher by 30% over the past week, but there's certain to be a lot of nail-biting on the part of shareholders as we head into earnings season. The reason has been the slow acceptance of the company's idiopathic pulmonary fibrosis drug, Esbriet, based on its pricing in the EU. In previous quarters Esbriet sales have disappointed in a big way, but are expected to rise by 134% to nearly $13 million from last year, though losses are still anticipated to come in at $0.70 per share. Following its recent pop, Esbriet sales had better hit the mark, otherwise InterMune shareholders are probably going to be in for a long day.
Top 10 Biotech Stocks To Buy For 2015: Galena Biopharma Inc (GALE)
Galena Biopharma, Inc. (Galena), formerly RXi Pharmaceuticals Corporation, incorporated on April 3, 2006, is a biotechnology company focused on discovering, developing and commercializing therapies addressing unmet medical needs using targeted biotherapeutics. The Company is pursuing the development of cancer therapeutics using peptide-based immunotherapy products, including its main product candidate, NeuVaxTM (E75), for the treatment of breast cancer and other tumors. NeuVax is a peptide-based immunotherapy intended to reduce the recurrence of breast cancer in low-to-intermediate HER2-positive breast cancer patients not eligible for trastuzumab (Herceptin; Genentech/Roche). On January 19, 2012, the Company initiated enrollment in its Phase 3 PRESENT clinical trial for NeuVax (E75 peptide plus GM-CSF) vaccine in low-to-intermediate HER2 1+ and 2+ breast cancer patients in the adjuvant setting to prevent recurrence (Clinicaltrials.gov identifier NCT01479244). The Prevention of Recurrence in Early-Stage, Node-Positive Breast Cancer with Low to Intermediate HER2 Expression with NeuVax Treatment study is a randomized, multicenter, multinational clinical trial that will enroll approximately 700 breast cancer patients. The Company�� Phase 2 trial of NeuVax achieved its primary endpoint of disease-free survival (DFS). On April 13, 2011, the Company completed its acquisition of Apthera, Inc.,(Apthera).
The Company focuses to start a Phase 2 trial comparing NeuVax in combination with trastuzumab (Herceptin) versus trastuzumab, alone, in a 300-patient, randomized study in the adjuvant breast cancer setting. The Company's second product candidate, Folate Binding Protein-E39 (FBP), is a vaccine, consisting of the peptides E39 and J65, aimed at preventing the recurrence of ovarian, endometrial, and breast cancers. On February 14, 2012, the Company announced the initiation of a Phase 1/2 clinical trial in two gynecological cancers: ovarian and endometrial adenocarcinomas. Folate binding protein has ! very limited tissue distribution and expression in non-malignant tissue and is over-expressed in more than 90% of ovarian and endometrial cancers, as well as in 20% to 50% of breast, lung, colorectal and renal cell carcinomas.
In April 2011, the Company acquired Apthera Inc and its NeuVax product candidate. The Company focuses on developing a pipeline of immunotherapy product candidates for the treatment of various cancers based on the E75 peptide, the advanced of which is NeuVax, which is targeted at preventing the recurrence of breast cancer. NeuVax has had positive Phase 1/2 clinical trial results for the prevention of breast cancer recurrence in patients who have had breast cancer and received the standard of care treatment (surgery, chemotherapy, radiotherapy and hormonal therapy as indicated). The Company had also initiated its Phase 3 PRESENT clinical trial of NeuVax for the prevention of breast cancer recurrence in early-stage low-to-intermediate HER2 breast cancer patients. NeuVax directs killer T-cells to target and destroy cancer cells that express HER2/neu, a protein associated with epithelial tumors in breast, ovarian, pancreatic, colon, bladder and prostate cancers. NeuVax is comprised of a HER2/neu-derived peptide called E75. E75 is a nine-amino acid sequence that is immunogenic (produces an immune response) and GM-CSF is a commercially available protein that acts to stimulate and activate components of the immune system such as macrophages and dendritic cells.
The Company also develops novel applications for NeuVax based on preclinical studies and phases 2 clinical trials which suggest that combining NeuVax and trastuzumab (Herceptin; Genentech/Roche) can increase antigen presentation by tumor cells by promoting receptor internalization and subsequent proteosomal degradation of the HER2 protein. The Company also is pursuing additional therapeutic indications for NeuVax that are in Phase 1/2 clinical trials. RXI-109, is a dermal anti-scarring therapy that targets! connecti! ve tissue growth factor (CTGF) and that may inhibit connective tissue formation in human fibrotic disease.
The Company competes with Roche Laboratories, Inc., Pfizer Inc., Bayer HealthCare AG, Sanofi-Aventis, US, LLC, Amgen, Inc., GlaxoSmithKline plc, Renovo Group plc, CoDa Therapeutics, Inc., Sirnaomics, Inc., FirstString Research, Inc., Merz Pharmaceuticals, LLC, Capstone Therapeutics, Halscion, Inc., Garnet Bio Therapeutics, Inc., AkPharma Inc., Promedior, Inc., Kissei Pharmaceutical Co., Ltd., Eyegene, Derma Sciences, Inc., Healthpoint Biotherapeutics, Pharmaxon, Excaliard Pharmaceuticals, Inc., Alnylam Pharmaceuticals, Inc., Marina Biotech, Inc., Tacere Therapeutics, Inc., Benitec Limited, OPKO Health, Inc., Silence Therapeutics plc, Quark Pharmaceuticals, Inc., Rosetta Genomics Ltd., Lorus Therapeutics, Inc., Tekmira Pharmaceuticals Corporation, Arrowhead Research Corporation, Regulus Therapeutics Inc. and Santaris.
Advisors' Opinion:- [By Paul Ausick]
Stocks on the move: Galena Biopharma Inc. (NASDAQ: GALE) is down 15.4% at $1.93 after pricing a secondary offering of 17.5 million units at $2.00. Safeway Inc. (NYSE: SWY) is up 6.1% at $28.21, after an analyst�� upgrade which sent shares to a new 52-week high of $28.88 earlier. Avanir Pharmaceuticals Inc. (NASDAQ: AVNR) is down 18.2% at $4.08.
- [By Sean Williams]
The waiting game
The tables are clearly stacked against small biotech companies developing cancer drugs. History has shown that few (if any) have successfully had the Food and Drug Administration approve a late-stage cancer drug. While mid-stage trials of Galena Biopharma's (NASDAQ: GALE ) HER2-targeting breast cancer vaccine have been promising thus far, the chances of an approval seem a long way off.
Top 10 Biotech Stocks To Buy For 2015: Agios Pharmaceuticals Inc (AGIO)
Agios Pharmaceuticals, Inc., incorporated on August 7, 2007, is a biopharmaceutical company. The Company is intend to apply its deep understanding of metabolism, coupled with the Company�� ability to create medicines that can inhibit or activate metabolic enzymes, to fundamentally change the way cancer and inborn errors of metabolism (IEMs) are treated. The Company has identified and validated novel and druggable targets in both cancer and IEMs. The Company�� two advanced cancer programs are targeting mutations in the enzymes isocitrate dehydrogenase 1 and 2, referred to as IDH1 and IDH2. The Company�� drug candidates are selective for the mutated forms of IDH1 and IDH2 found in cancer cells versus the normal forms of IDH1 and IDH2 found in all other cells.
The Company focused on developing medicines to address IEMs, with a novel approach to these orphan diseases for which no effective or disease-modifying therapy is available. The Company has also de-validated and terminated numerous programs, including many that have been reported in scientific journals. In the Company�� IEM portfolio, it uses an equally rigorous set of validation techniques.
Advisors' Opinion:- [By Lisa Levin]
Agios Pharmaceuticals (NASDAQ: AGIO) shares touched a new 52-week low of $18.83. Agios Pharmaceuticals' trailing-twelve-month profit margin is -102.87%.
- [By Jake L'Ecuyer]
Shares of Agios Pharmaceuticals (NASDAQ: AGIO) got a boost, shooting up 29.08 percent to $40.84 after the company reported quarterly results.
Stage Stores (NYSE: SSI) was also up, gaining 13.47 percent to $22.41 after the company reported Q4 results and announced the sale of its Steele's off-price division to a new retail unit of Hilco Global.
- [By Jake L'Ecuyer]
Equities Trading UP
Sangamo Biosciences (NASDAQ: SGMO) shot up 16.32 percent to $22.81 announced the publication in the NEJM of the first-in-man study of genome editing using its ZFN technology. Shares of Agios Pharmaceuticals (NASDAQ: AGIO) got a boost, shooting up 27.72 percent to $40.41 after the company reported quarterly results. BJ's (NASDAQ: BJRI) was also up, gaining 21.04 percent to $33.48 after the company was upgraded toa Buy rating at Buckingham research.
Top 10 Biotech Stocks To Buy For 2015: Mast Therapeutics Inc (MSTX)
Mast Therapeutics, Inc., formerly ADVENTRX Pharmaceuticals, Inc., incorporated in December 1995, is a development-stage company biopharmaceutical company focused on developing product candidates. The Company's product candidate is ANX-188, a rheologic, antithrombotic and cytoprotective agent that improves microvascular blood flow and has application in treating a range of diseases and conditions, such as complications arising from sickle cell disease. As of December 31, 2011, the Company also is developing ANX-514, a detergent-free formulation of the chemotherapy drug docetaxel. The Company offers ANX-188 (purified poloxamer 188), ANX-514 (docetaxel for injectable emulsion) and Exelbine (vinorelbine injectable emulsion). In April 2011, the Company acquired SynthRx, Inc. In February 2014, Mast Therapeutics Inc completed its acquisition of Aires Pharmaceuticals, Inc. Aires became a wholly-owned subsidiary of Mast Therapeutics.
ANX-188 (purified poloxamer 188)
ANX-188 is an aqueous solution of a purified form of poloxamer 188. Poloxamer 188 (P1880, is a nonionic, block copolymer that has been found to improve microvascular blood flow by reducing viscosity, particularly under low shear conditions, and by reducing adhesive frictional forces. The Company�� purified form of P188 (purified P188), which is the active ingredient in ANX-188, was designed to eliminate certain low molecular weight substances present in P188 (non-purified), which is primarily responsible for the moderate to moderately severe elevations in serum creatinine levels (acute renal dysfunction) observed in prior clinical studies of P188 (non-purified). Purified P188 has been evaluated in multiple clinical studies by a prior sponsor, including a 255-patient, phase III study.
ANX-514 (docetaxel for injectable emulsion)
ANX-514 is a detergent-free emulsion formulation of docetaxel, an intravenously-injected chemotherapy drug commonly used to treat solid tumors. Taxotere, a branded form! ulation of docetaxel, is approved to treat breast, non-small cell lung, prostate, gastric, and head and neck cancers. ANX-514 was designed to have clinically comparable release of docetaxel relative to Taxotere while eliminating the presence of polysorbate 80 and ethanol, both of which are used to solubilize docetaxel in the Taxotere formulation. The ANX-514 formulation solubilizes docetaxel using oil droplets consists of a combination of non-toxic excipients. Docetaxel is contained within these oil droplets and can be administered intravenously without using detergents as pharmaceutical vehicles. Once in central circulation, the emulsion is metabolized rapidly, leaving chemically-identical active ingredient to exert its cytotoxic effect. ANX-514 may reduce the incidence and severity of hypersensitivity reactions and delay the onset of fluid retention.
Exelbine (vinorelbine injectable emulsion)
Exelbine is an emulsion formulation of the chemotherapy drug vinorelbine. Navelbine, a branded formulation of vinorelbine, is approved in the United States to treat advanced non-small cell lung cancer as a single agent or in combination with cisplatin, and approved in the European Union to treat non-small cell lung cancer and advanced or metastatic breast cancer.
In August 2011, the Company received a complete response letter from the Food and Drug Administration (FDA) stating that it could not approve the Exelbine Non Disclosure Agreement (NDA) in its present form and that the bioequivalence study would need to be repeated because the authenticity of the drug products used in the bioequivalence trial could not be verified in accordance with FDA standards. However, the Company elected to discontinue independent development of Exelbine and as of December 31, 2011, the Company was seeking a partner or outside investor for the program to complete the necessary bioequivalence study.
The Company competes with GlaxoSmithKline, Provenge and Pfizer.
Advisors' Opinion:- [By Lauren Pollock]
Mast Therapeutics Inc.(MSTX) said the U.S. Food and Drug Administration gave orphan-drug designation to its MST-188 drug for the treatment of acute limb ischemia, providing a boost for the biopharmaceutical firm. Shares surged.
- [By John Udovich]
The start of 2014 shows that biotech is still a hot area with the sector along with small cap biotech stocks like AMAG Pharmaceuticals, Inc (NASDAQ: AMAG), Mast Therapeutics Inc (NYSEMKT: MSTX), Cell Therapeutics Inc (NASDAQ: CTIC), Imprimis Pharmaceuticals Inc (NASDAQ: IMMY) and TNI BioTech (OTCMKTS: TNIB) producing news or returns�plus Auspex Pharmaceuticals (NASDAQ: ASPX), Cara Therapeutics (NASDAQ: CARA), Egalet (NASDAQ: EGLT), Flexion Therapeutics (NASDAQ: FLXN) and Ultragenyx Pharmaceutical (NASDAQ: RARE) are among the (many�� planned biotech IPOs that have recently been announced publicly:
Top 10 Biotech Stocks To Buy For 2015: 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 Dan Carroll]
Biotech's known for volatility, and one of this year's biggest booms suffered a hit on that end this week. Alnylam Pharmaceuticals (NASDAQ: ALNY ) , which has seen shares explode for gains of more than 142% year to date in 2013, lost more than 11% this past week to rank as one of biotech's biggest busts over the last five days.
- [By Sean Williams]
RNAi therapeutics expert Alnylam Phrmaceuticals (NASDAQ: ALNY ) also delivered big gains this week to the tune of 22% after reporting very encouraging mid-stage data for ALN-TTR02, its treatment targeting TTR-mediated amyloidosis. Its experimental drug ALN-TTR02 delivered a 93% reduction in TTR rates in patients, which is perfectly consistent with its early stage results that demonstrated a reduction in TTR rates of 94%. Peak sales estimates, should the drug be approved, range from $800 million to up to $2 billion, but I'd caution investors keep a level head on their shoulders in the meantime.
Top 10 Biotech Stocks To Buy For 2015: Amarantus Bioscience Holdings Inc (AMBS)
Amarantus BioScience Holdings, Inc., formerly Amarantus BioSciences, Inc., incorporated on March 22, 2013, is focuses on developing intellectual property and proprietary technology in order to develop drug candidates and diagnostic blood tests to diagnose and treat human diseases. The Company owns the intellectual property rights to a therapeutic protein known as Mesencephalic-Astrocyte-derived Neurotrophic Factor (MANF), owns the intellectual property rights to biomarkers related to oncology and neurodegeneration named BC-SeraPro and NuroPro respectively, has a license to an Alzheimer�� disease blood test named LymPro, and owns a number of proprietary cell lines called PhenoGuard. MANF was the first therapeutic protein discovered from a PhenoGuard Cell Line. In December 2012, the Company acquired neurodegenerative diagnostic portfolio from Power3 Medical Products. On March 22, 2013, the Company was merged with into Amarantus Bioscience Inc.
The Company also owns an inventory of 88 cell lines that Amarantus refers to as PhenoGuard Cell Lines. MANF is a protein that corrects protein misfolding. The Company�� MANF product development effort is centered on a therapy for Parkinson�� disease.
Advisors' Opinion:- [By James E. Brumley]
At first glance, Amarantus Bioscience Holdings, Inc. (OTCBB:AMBS) doesn't look like anything more than a volatile mess. It's up 17% today, but had been up twice that amount this morning. Even more exhausting is the fact AMBS, currently at $0.0529, had been as high as $0.089 and as low as $0.039 within the past three months. Point being, Amarantus Bioscience Holdings has been, and continues to be, all over the map.
Top 10 Biotech Stocks To Buy For 2015: IsoRay Inc (ISR)
IsoRay, Inc. (IsoRay), incorporated on June 15, 2004, develops, manufactures and sells isotope-based medical products and devices for the treatment of cancer and other malignant diseases. IsoRay International LLC (International) is a wholly owned subsidiary of the Company. IsoRay obtained clearance from the Food and Drug Association (FDA) for treatment for all solid tumor applications using Cesium-131. Such applications include prostate cancer; ocular melanoma; head, neck and lung tumors; breast cancer; liver cancer; brain cancer; colorectal cancer; gynecological cancer; esophageal cancer, and pancreatic cancer. The seed may be used in surface, interstitial and intracavity applications for tumors with known radio sensitivity. The Company has an existing distribution agreement with UralDial LLC (UralDial) that allows UralDial to distribute Proxcelan Cs-131 brachytherapy seeds in Russia. The Company, through UralDial, has regulatory approval to sell Cs-131 seeds in Russia.
IsoRay markets the Proxcelan Cesium-131 brachytherapy seed for the treatment of prostate cancer; lung cancer; ocular melanoma; head and neck cancers; colorectal cancer, brain cancer; and gynecological cancer. The Company focuses to market Cesium-131 for the treatment of other malignant disease, such as breast cancer, in the near future through the use of existing technologies that have received FDA-clearance. Cesium-131 is a radioactive isotope that can be produced by the neutron bombardment of Barium-130 (Ba-130). When placed into a nuclear reactor and exposed to a flux of neutrons, Ba-130 becomes Ba-131, the radioactive material that is the parent isotope of Cesium-131. The radioactive isotope Cesium-131 is normally produced by placing a quantity of stable non-radioactive barium (ideally barium enriched in isotope Ba-130) into the neutron flux of a nuclear reactor. The irradiation process converts a small fraction of this material into a radioactive form of barium (Ba-131). The Ba-131 decays by electron capture to the ! radioactive isotope of interest (Cesium-131).
As of June 30, 2011, IsoRay had agreements with several independent radiopharmacies to assay, preload, and sterilize loose seeds. During the fiscal year ended June 30, 2011, the Company loaded approximately 90% of Mick cartridges in the Company's own facility, which accounted for approximately 61% of seeds sold. Approximately 33% of seeds sold are strand configurations, including strands preloaded in needles and the remaining 6% of seeds are sold as loose seeds.
Advisors' Opinion:- [By James E. Brumley]
Ugh. It's fun to be right about a stock, but it's exhausting to be too right, too fast. Case in Point? IsoRay, Inc. (NYSE: ISR). Yours truly posted some bullish comments on ISR just a couple of days ago, explaining how that day's move above a key ceiling meant a new bull trend was underway, and more gains from that price would be far easier to muster. Well, good news for those who heeded the advice - IsoRay shares are up 44% today.
- [By Vanina Egea]
Strengthening portfolio and business stability is to be reinforced by the introduction of new products. Last December, Textron announced the successful first flight of the Scorpion Intelligence, Surveillance and Reconnaissance (ISR)/Strike aircraft. ��he Scorpion compares very favorably to more costly aircraft currently used for low-threat missions,��pilot Dan Hinson said. The new product is expected to accommodate the budget constraints and shifting mission requirements of the US Department of Defense. The same department has granted the firm an additional contract worth $22.5 million to "deprocess" Mobile Strike Force vehicles and train the Afghan Army.
- [By James E. Brumley]
I hate to be the one to say I told you so, but, I told you so. Back on February 26th I suggested IsoRay, Inc. (NYSEMKT:ISR) shares were a budding breakout play. The 48% rally that's played out for ISR in the meantime unfurled right on cue. While overbought in the very short run, this small cap stock looks like it's earning the right to be compared to the likes of bigger brothers in the cancer-treatment space... names like Roche Holding Ltd. (OTCMKTS:RHHBY) or Theragenics Corporation (NYSE:TGX).
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