The biotech sector has been pretty exciting this year�with small cap biotech stocks Prana Biotechnology Limited (NASDAQ: PRAN) and TNI BioTech (OTCMKTS: TNIB) having recently produced noteworthy news for investors�while Acceleron Pharma, Inc (NASDAQ: XLRN), Ophthotech (NASDAQ: OPHT) and BIND Therapeutics (NASDAQ: BIND) have just�set term sheets for their upcoming IPOs. Just consider all of the following recent news:
Surge in Biotech IPOs. Unquote.com has noted�a surge in biotech IPOs this year as there have been�almost 30 biotech IPOs since January - marking a 13-year high and sparking some concerns about a bubble. More specifically and according to the National Venture Capital Association (NVCA), there was just one venture capital-backed biotech IPO in the US in the first quarter of this year, but this was followed by a massive increase of 20 in�the second quarter and a�further six since July. There has also been a small uptick in�venture capital-backed European biotech companies going public (four) with�a listing on the Nasdaq appearing to be the most popular or rather the safest option. � New IPO Term Sheets. This month, a couple of small cap biotech companies announced their terms for upcoming IPOs, including 1)�Acceleron Pharma, Inc, a clinical stage biotech developing protein therapeutics for cancer and rare diseases, plans to raise $65 million by offering 4.7 million shares at a price range of $13 to $15; 2) Ophthotech, a clinical-stage biotech developing therapeutics for eye diseases, plans to raise $100 million by offering 5.7 million shares at a price range of $16 to $19; and 3) BIND Therapeutics, a clinical-stage biotech developing a platform of targeted and programmable therapeutics, plans to raise $71 million by offering 4.7 million shares at a price range of $14 to $16. Biotechs Invest More on R&D. The 2013 BDO Biotech Briefing examined the most recent 10-K SEC filings of publicly traded companies listed on the Nasdaq Biotechnology Index and�found that companies spent on average $54 million on R&D in 2012, up from $50 million in 2011 and $48 million in 2010. Moreover, biotech companies also saw an average 13% revenue jump in 2012, but it was larger cap�biotechs (revenues over $50 million) who were the primary contributors to the increase. On average, the saw a�28% increase in revenue, while smaller biotechs reported a 27% decline in average revenue last year. Nevertheless, smaller�biotechs saw a 9% increase in average overall R&D spending while�average R&D spending as a percentage of revenue increased to 215% in 2012 from 143% in 2011. Australia and New Zealand�� Hot Biotech Market. Thebull.com.au has a lengthy article about the biotech sector downunder which noted that the�Aussie Biotech Sector is the largest in the world as a proportion of GDP while the Australian Life Sciences Index has generated consistently better returns than both the US NASDAQ Composite Index and�Australia���All Ordinaries Index since mid-2006. The big winners as of the beginning of September have been New Zealand-based Neuren Pharmaceuticals Limited (ASX: NEU), which has a drug to treat Traumatic Brain Injury investors that�could be the first drug of its type to get US FDA approval, as it was up�300%; and Australia-based and NASDAQ listed Prana Biotechnology Limited which�focuses on developing drugs to treat degenerative processes associate with aging (it has clinical trial of a treatment for Alzheimer�� underway). Prana Biotechnology Limited. And speaking of Prana Biotechnology Limited, its shares were sliding after announcing last week that the results from a study of its most advanced experimental drug will be delayed. Prana Biotechnology Limited said it now expects to report results from�a trial�which evaluated PBT2 as a treatment for Huntington's disease, in early 2014 instead of the fourth quarter of 2013. Nevertheless and as of this week, Prana Biotechnology Limited is still up about 99% since the start of the year. � TNI BioTech Makes a Couple of Important Announcements. Formed in 2012 to acquire patents, develop treatments, market and license immunotherapies for the treatment of cancer, HIV/AIDS and autoimmune diseases using methionine enkephalin (MENK) and low dose naltrexone (LDN), small cap TNI BioTech�� first patents and therapies were acquired from Dr. Nicholas P. Plotnikoff and Dr. Fengping Shan. This month, TNI BioTech announced a manufacturing and supply�agreement with Laboratorios Ramos for the production of Low Dose Naltrexone (��DN�� for commercial use. FDA-approved naltrexone, in a low dose, can normalize the immune system and help those suffering from�HIV/AIDS, cancer, autoimmune diseases and central nervous system disorders. Last week, TNI BioTech also gave a financing update where it noted that the company has�received $826,250 as consideration for the exercise of the previously-issued warrants and $531,250 for the purchase of common stock under the Private Placement, for an aggregate sum of $1,357,500.Given the above, it looks like the small cap biotech sector is set to stay hot and get even hotter.
Best Biotech Companies For 2014: Rexahn Pharmaceuticals Inc (RNN)
Rexahn Pharmaceuticals, Inc. (Rexahn) is a development-stage biopharmaceutical company. The Company focuses on the development of cures for cancer to patients worldwide. The Company�� pipeline features one drug candidate in Phase II clinical trials. The Company also has several other drug candidates in pre-clinical development. In addition, the Company has two renal cell carcinoma (CNS) candidates, Serdaxin, CNS Disorders drug for depression and neurodegenerative diseases and Zoraxel, which is a erectile dysfunction (ED) and sexual dysfunction drug that are in clinical stages and the Company is are exploring options for further development . The Company�� drug candidate, Archexin is an anticancer Akt inhibitor.
Archexin
Archexin is potent inhibitor of the Akt protein kinase (Akt) in cancer cells. Archexin has FDA orphan drug designations for five cancers (RCC, glioblastoma, and cancers of the ovary, stomach and pancreas). Multiple indications for other solid tumors can also be pursued. Archexin inhibit both activated and inactivated forms of Akt, and to reverse the drug resistance observed with the protein kinase inhibitors. Archexin is an antisense oligonucleotide (ASO) compound that is complementary to Akt mRNA, and selective for inhibiting mRNA expression and production of Akt protein. As of December 31, 2011, Archexin was in Phase II clinical trials for the treatment of pancreatic cancer with enrollment completed in September, 2011.
Serdaxin
Serdaxin is an extended release formulation of clavulanic acid, which is an ingredient present in antibiotics approved by the FDA. The Company had been developing Serdaxin for the treatment of depression and neurodegenerative disorders. From January to September, 2011, the Company conducted a randomized, double-blind, placebo-controlled study compared two doses of Serdaxin, 0.5 milligram and 5 milligram, to placebo over an eight-week treatment period for major depressive disorder (MDD) patients. As of Dec! ember 31, 2011, the Company had not made a determination of Serdaxin�� future paths or resource allocations to further develop Serdaxin to treat MDD.
Zoraxel
Zoraxel is an orally administered, on-demand tablet to treat sexual dysfunction. Zoraxel is a dual enhancer of neurotransmitters in the brain that play a key role in sexual activity phases of motivation and arousal, erection and release, and may be the ED drug to affect all three of these phases of sexual activity. As of December 31, 2011, the Company was evaluating how to proceed with the Phase IIb study of Zoraxel.
The Company�� Pre-clinical Pipeline Drug Candidates includes RX-1792, which is a small molecule anticancer EGFR inhibitor; RX-5902, which is a small molecule anticancer ribonucleic acid (RNA) helicase regulator; RX-3117, which is a Small molecule anticancer deoxyribonucleic acid (DNA) synthesis Inhibitor; RX-8243, which is a small molecule anticancer aurora kinase inhibitor; RX-0201-Nano, which is a nanoliposomal anticancer Akt inhibitor; RX-0047-Nano, which is an nanoliposomal anticancer HIF-1 alpha inhibitor and RX-21101, which is a nano-polymer Anticancer.
Advisors' Opinion:- [By Roberto Pedone]
One under-$10 biopharmaceutical player that's just starting to move into breakout territory is Rexahn Pharmaceuticals (RNN), which is engaged in the development of novel treatments for cancer to patients. This stock has been on fire so far in 2013, with shares up sharply by 62%.
If you take a look at the chart for Rexahn Pharmaceuticals, you'll notice that this stock has been uptrending strong for the last month, with shares moving higher from its low of 36 cents per share to its intraday high of 53 cents per share. During that uptrend, shares of RNN have been making mostly higher lows and higher highs, which is bullish technical price action. That move has now pushed shares of RNN into breakout territory above some near-term overhead resistance levels at 49 cents to 50 cents per share. It's worth noting that volume today is tracking in extremely strong with over 3 million shares traded, versus its three-month average action of 1.22 million shares.
Traders should now look for long-biased trades in RNN if it manages to break out above Thursday's intraday high of 53 cents per share with high volume. Look for a sustained move or close above that level with volume that hits near or above its three-month average action of 1.22 million shares. If that breakout hits soon, then RNN will set up to re-test or possibly take out its next major overhead resistance levels at 64 cents to its 52-week high at 66 cents per share. Any high-volume move above 66 cents to 67 cents per share could then send RNN towards its next major overhead resistance levels at 81 cents per share.
Traders can look to buy RNN off any weakness to anticipate that breakout and simply use a stop that sits right below its 50-day moving average at 47 cents per share. One can also buy RNN off strength once it clears 53 cents per share with volume and then simply use a stop that sits a comfortable percentage from your entry point.
Best Biotech Companies For 2014: StemCells Inc (STEM)
StemCells, Inc. (StemCells), incorporated in August 1988, is engaged in the research, development, and commercialization of stem cell therapeutics and related tools and technologies for academia and industry. The Company is focused on developing and commercializing stem and progenitor cells as the basis for therapeutics and therapies, and cells and related tools and technologies to enable stem cell-based research and drug discovery and development. The Company�� primary research and development efforts are focused on identifying and developing stem and progenitor cells as potential therapeutic agents. The Company has two therapeutic product development programs, including its CNS Program, which is developing applications for HuCNS-SC cells, its human neural stem cell product candidate, and its Liver Program, which is characterizing the Company�� human liver cells as a therapeutic product.
CNS Program
The Company in its CNS Program, is in clinical development with its HuCNS-SC cells for a range of disorders of the central nervous system. The CNS includes the brain, spinal cord and eye. In February 2012, the Company had completed a Phase I clinical trial in Pelizeaus-Merzbacher Disease (PMD), a fatal myelination disorder in the brain.
The Company�� CNS Program is focused on developing clinical applications, in which transplanting HuCNS-SC cells protect or restore organ function of the patient before such function is irreversibly damaged or lost due to disease progression. The Company�� initial target indications are PMD, and more generally, diseases in which deficient myelination plays a central role, such as cerebral palsy or multiple sclerosis; spinal cord injury, disorders in which retinal degeneration plays a central role, such as age-related macular degeneration or retinitis pigmentosa. The Company�� product candidate, HuCNS-SC cells, is a purified and expanded composition of normal human neural stem cells. Its HuCNS-SC cells can be directly transp! lanted.
Liver Program
Liver stem or progenitor cells offer an alternative treatment for liver diseases. A liver cellular therapy or cell-based therapeutic provide or support liver function in patients with liver disease. The Company held a portfolio of issued and allowed patents in the liver field, which cover the isolation and use of both hLEC cells and the isolated subset, as well as the composition of the cells themselves.
The Company�� range of cell culture products, which are sold under the SC Proven brand, includes iSTEM, GS1-R, GS2-M, RHB-A, RHB-Basal, NDiff N2, and NDiff N2B27. Its iSTEM is a serum-free, feeder-free medium that maintains mouse embryonic stem cells in their pluripotent ground state by using selective small molecule inhibitors to block the pathways, which induce differentiation. RHB-A is a defined, serum-free culture medium for the selective culture of human and mouse neural stem cells and their maintenance and expansion as adherent cell populations. RHB-Basal is a defined, serum-free basal medium. When supplemented with specific growth factors, this media is formulated for the propagation and differentiation of adherent neural stem cells. RHB-Basal can also be tailored to specific-cell type requirements by the addition of customer preferred supplements.
The Company�� NDiff N2 is a defined serum-free scell culture supplement for the derivation, maintenance, expansion and/or differentiation of human and mouse embryonic stem (ES) cells and tissue-derived neural stem cells supplement. Its NDiff N2-AF is a serum-free and animal component-free version of NDiff N2. Its NDiff N2B27 is a defined, serum-free medium for the differentiation of mouse embryonic stem cells to neural cell types. NDiff N27-AF is a serum-free and animal component-free version of NDiff N27. Its GS1-R is a serum-free media formulation shown to enable the derivation and long-term maintenance of true, germline competent rat embryonic stem cells without the add! ition of ! cytokines or growth factors. Its GS2-M is a defined, serum- and feeder-free medium for the derivation and long-term maintenance of true, germline competent mouse iPS cells.
The Company also markets a number of antibody reagents for use in cell detection, isolation and characterization. These reagents are also under the SC Proven brand and it includes STEM24, STEM101, STEM121 and STEM123. Its STEM24 is a human antibody that recognizes human CD24, also known as heat stable antigen (HSA), a glycoprotein expressed on the surface of many human cell types, including immature human hematopoietic cells, peripheral blood lymphocytes, erythrocytes and many human carcinomas. Its CD24 is also a marker of human neural differentiation. Its STEM101 is a human-specific mouse antibody that recognizes the Ku80 protein found in human nuclei. Its STEM121 is a human-specific mouse antibody that recognizes a cytoplasmic protein of human cells. Its STEM123 is a human-specific mouse antibody that recognizes human glial fibrillary acidic protein (GFAP).
The Company�� Other products marketed under SC Proven include total cell genomic DNA (gDNA), RNA and protein lysate reagents purified from homogenous stem cell populations for intra-comparative studies, such as Epigenetic fingerprinting, Southern, Western and Northern blots, PCR, RT-PCR and microarrays. This range of purified stem cell line lysates includes mouse embryonic stem (ES) cells propagated in SC Proven 2i inhibitor-based GS2-M media and mouse ES cell-derived and fetal tissue-derived neural stem (NS) cells propagated in SC Proven RHB-A media.
Advisors' Opinion:- [By John Udovich]
The results of a recent Pew Center Poll regarding attitudes towards abortion and various forms of stem cell research could be a good sign for the stem cell industry along with small cap stem cell stocks like StemCells Inc (NASDAQ: STEM), NeoStem Inc (NASDAQ: NBS), Neuralstem, Inc (NYSEMKT: CUR),�International Stem Cell Corp (OTCMKTS: ISCO) and BioRestorative Therapies (OTCBB: BRTX). Basically, Americans think that having an abortion is a moral issue with 49% of American adults believing abortion is morally wrong, 23%�view it not as a moral issue and and 15% view it as morally acceptable. However and when Americans were asked about issues surrounding�human embryos, such as stem cell research or in vitro fertilization, as a matter of morality, their views were different.
- [By James E. Brumley]
When an investor thinks of spinal-related stem cell stocks, usually a name like Neuralstem, Inc (NYSEMKT: CUR) or StemCells Inc (NASDAQ: STEM) comes to mind. And well they should. STEM has logged some amazing breakthroughs in the field of spinal cord repair, while CUR has done the same. Not all back problems are spinal cord related though. In fact, most back problems - and therefore the most opportunity - are bone and disc related problems. That's where a young gun like BioRestorative Therapies (OTCBB: BRTX) can step in and make stem cell waves. BRTX has developed an approach to rejuvenate and revive failing spinal discs, potentially ending pain for millions of back-pain sufferers, and circumventing expensive spinal surgeries that are in increasing burden on insurance companies.
Best Dividend Companies To Invest In 2014: Neoprobe Corporation(NEOP)
Neoprobe Corporation, a biomedical company, engages in the development and commercialization of precision diagnostics that enhance patient care and improve patient benefit. The company is developing and commercializing targeted agents aimed at the identification of occult (undetected) disease. Neoprobe?s two lead radiopharmaceutical agent platforms, Lymphoseek and RIGScan are intended to help surgeons better identify and treat certain types of cancer. Lymphoseek is a diagnostic imaging agent intended for radiolabeling and administration in radiodetection and visualization of the lymphatic system draining the region of injection for delineation of the lymphatic tissue; and RIGScan is an intraoperative biologic targeting agent consisting of a radiolabeled murine monoclonal antibody. The company has a biopharmaceutical development and supply agreement with Laureate Biopharmaceutical Services, Inc. to support the initial evaluation of the viability of the CC49 master working c ell bank, as well as the initial steps in re-validating the commercial production process for the biologic agent used in RIGScan CR. The company was founded in 1983 and is based in Dublin, Ohio.
Best Biotech Companies For 2014: Savient Pharmaceuticals Inc(SVNT)
Savient Pharmaceuticals, Inc., a specialty biopharmaceutical company, focuses on developing KRYSTEXXA, a biologic PEGylated uricase in the United States. The KRYSTEXXA is being developed as a treatment for chronic gout in patients refractory to conventional therapy. The company also sells and distributes branded and generic versions of oxandrolone, a drug used to promote weight gain following involuntary weight loss. It sells its products directly to drug wholesalers. The company, formerly known as Bio-Technology General Corp. and changed its name to Savient Pharmaceuticals, Inc. in June 2003. Savient Pharmaceuticals, Inc. was founded in 1980 and is headquartered in East Brunswick, New Jersey.
Advisors' Opinion:- [By James E. Brumley]
It's still too soon to say Savient Pharmaceuticals Inc. (NASDAQ:SVNT) is off and running. In fact, the stock's decidedly NOT off and running yet. But, it's not too soon to put SVNT on your watchlist of potential breakout candidates, as it's much closer to a breakout than most anyone can see.
- [By James E. Brumley]
Since 2008's implosion from the stock, the interest in Savient Pharmaceuticals Inc. (NASDAQ:SVNT) has been waning. There was a brief burst of bullishness in September of last year, which stirred the bullish pot a little. But, when SVNT started to fade in October of that year - just as quickly as it had perked up - what lingering hopes there were for the stock finally started to melt away. By the middle of this year, pretty much everyone had written Savient Pharmaceuticals off as a lost cause. Big mistake. Over the last few days, SVNT has almost wiggled its way buck into a bullish zone.
Best Biotech Companies For 2014: Gentium SpA(GENT)
Gentium S.p.A., a biopharmaceutical company, focuses on the development and manufacture of its primary product candidate, defibrotide, an investigational drug based on a mixture of single-stranded and double-stranded DNA extracted from pig intestines. It develops defibrotide for the treatment and prevention of hepatic veno-occlusive disease (VOD), a condition that occurs when veins in the liver are blocked as a result of cancer treatments, such as chemotherapy or radiation, that are administered prior to stem cell transplantation. The company has completed a Phase III clinical trial of defibrotide for the treatment of severe VOD in the United States, Canada, and Israel; and a Phase II/III pediatric trial in Europe for the prevention of VOD. It also offers sulglicotide that is developed from swine duodenum, and has ulcer healing and gastrointestinal protective properties in South Korea; and urokinase, which is made from human urine to treat various vascular disorders, such as deep vein thrombosis and pulmonary embolisms. The company was formerly known as Pharma Research S.r.L. and changed its name to Gentium S.p.A. in July 2001. Gentium S.p.A. was founded in 1993 and is headquartered in Villa Guardia, Italy.
Advisors' Opinion:- [By Sean Williams]
A parabolic problem
It has also been a year to remember for shareholders of biopharmaceutical company Gentium (NASDAQ: GENT ) whose share price has catapulted approximately 600% off its lows thanks to growth in its lead drug Defibrotide (known as Defitelio in the European Union).
Best Biotech Companies For 2014: 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 Ben Levisohn]
Shares of Regeneron Pharmaceuticals (REGN) have jumped today as two investment banks released positive comments on the drug maker over the weekend following the release of optimistic data about of one of its drugs on Friday.
EPARBC Capital Markets analysts Adnan Butt and Michael Yee explain:
Detailed 1-year Phase III DME data for Eylea demonstrated statistically significant vision improvement, comparable efficacy between the every 4 and 8 week Eylea arms, and a clean safety profile. Three positive things relative to the Lucentis Phase III program include: 1) efficacy in a more treatment experienced and tougher patient population, 2) potential for safety differences, especially when it comes to APTC and death events, and 3) every two month dosing that could be on the label. Since REGN will file an sBLA for Eylea by YE:13, potential approval in 2014 could reaccelerate Eylea sales growth, especially once two-year data is available. We believe there could be a pool of hard to treat Lucentis� and Avastin patients with [diabetic macular edema], as roughly one-third of patients on Lucentis still had leakage in the Phase III studies.
Butt and Yee raised their price target for Regeneron to $323 from $293.
Cowen’s David Ferreiro, meanwhile, notes that the amount of medicine patients need to take will make a big difference. He writes:
Our diligence suggests that less frequent dosing with Eylea will be key, given the generally low compliance rates among diabetic patients. Currently, we assume only minor market expansion; however, some of our consults suggest Eylea dosing convenience could meaningfully expand the market.
Ferreiro raised his price target to $310 from $300.
Shares of Regeneron have jumped 3.5% to $316.39–and the S&P 500′s best performer today. Novartis (NVS), which makes Lucentis, has dipped 0.5% to $76.73, while Roche (RHHBY), which makes Avastin, has gained 0.2% to $67.54. Vertex Ph
- [By Dan Caplinger]
Regeneron Pharmaceuticals (NASDAQ: REGN ) , up 55%
Interestingly enough, part of the reason for Regeneron's big advance comes from the fact that it wasn't even part of the S&P 500 until a couple weeks ago. The biotech company came into the index at the end of April, replacing MetroPCS after its merger with T-Mobile. Yet even after that, Regeneron's stock has soared 27%, largely because of the misfortunes of rival Allergan and its failed phase 2 study of competing vision-loss drug candidate DARPin. The move should pave the way for Regeneron's Eylea to enjoy even faster growth. - [By Keith Speights]
Sanofi (NYSE: SNY ) and Regeneron Pharmaceuticals (NASDAQ: REGN ) have developed a new drug that could lower LDL even more effectively than popular statin drugs. In November, the two companies announced enrollment in a large late-stage clinical trial to study the effects of an antibody that could lower LDL levels by inhibiting an enzyme called PCSK9 that is involved in the production of cholesterol.
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