BALTIMORE (Stockpickr) — Phew, good thing that’s over. August was the worst month for stocks in more than a year: the S&P 500 shed a whopping 3.13% for the month. That little statistic says quite a bit about what kind of environment investors have been enjoying since last May.
>>5 Stocks Setting Up to Break Out
Just in case anyone is unclear, 15 straight months without a 5% dip is a bull market.
And it’s “new month, new market” again in September. While the S&P has only climbed 1.4% since the calendar flipped over last week, the tenor of the market has changed. Investors appear willing to step in and buy in the face of scary headlines again. And it couldn’t have happened at a better time — broad market indices were testing their intermediate-term trendline last week. Yes, the uptrend remains intact.
That’s creating some buying opportunities this week, and it’s why we’re turning to a new set of Rocket Stocks.
>>4 Red-Flag Stocks to Sell This Fall
10 Best Biotech Stocks For 2014: Epizyme Inc (EPZM)
Epizyme, Inc., incorporated on November 1, 2007, is a clinical stage biopharmaceutical company that discovers, develops and plans to commercialize personalized therapeutics for patients with genetically defined cancers. The Company systematically identify the genetic alterations that create cancer causing genes, called oncogenes, select patients in whom the identified genetic alteration is found and then design small molecule therapeutics to inhibit the oncogene. The clinical development plan for each of its product candidates is directed towards patients with a particular genetically defined cancer.The Company is conducting a Phase I clinical trial of its advanced product candidate, EPZ-5676, an inhibitor targeting the DOT1L HMT, for the treatment of mixed lineage leukemia (MLL-r). The Company has identified its two lead product candidates using its product platform.
EPZ-5676 is an intravenously administered small molecu le inhibitor of DOT1L. The Company is developing EPZ-5676 for the treatment of MLL-r, an aggressive subtype of the two most common forms of acute leukemia, ALL and AML. Patients with MLL-r are routinely diagnosed with existing technologies that are commonly used in clinical setting. The Company’s Phase 1 clinical trial of EPZ-5676 is an open label, multicenter trial that has two phases.
The Company is developing EPZ-6438 as an orally available small molecule inhibitor of EZH2 for the treatment of non-Hodgkin lymphoma patients who have an oncogenic point mutation in EZH2. EZH2 is an HMT that can become oncogenic and cause non-Hodgkin lymphoma and a range of other solid tumors. Two types of non-Hodgkin lymphoma, diffuse large B-cell lymphoma of germinal-center origin, or DLBCL, and follicular lymphoma, or FL, are particularly associated with an EZH2 point mutation. There are no therapies approved specifically for the treatmen t of cancer associated with an EZH2 point mutation.
- [By John Udovich]
Follow-on Stock Offerings From Small Cap Biotech Stocks. Thanks to the boom in biotech IPOs along with the sector’s overall performance, already listed biotechs have the option to ask investors for more cash in the form of a follow-on offering. Recently, FierceBiotech.com noted how four small cap biotechs raised $276 million from follow-on offerings in just one day last week. These small caps included Epizyme Inc (NASDAQ: EPZM) which raised $88 million, Halozyme Therapeutics, Inc (NASDAQ: HALO) which raised $100 million, Agenus Inc (NASDAQ: AGEN) which raised $52 million and Idera Pharmaceuticals Inc (NASDAQ: IDRA) which raised $36 million. FierceBiotech.com noted that the steady flow of about $4.5 billion a year in venture cash along with more than $3.5 billion from IPOs last year plus all of the follow-ons are helping to foster both company growth and accelerate drug development programs. Mixed Bag for Biotech IPOs. Last Wednesday also saw two small cap biotech IPOs fizzle in one day with small cap T cell vaccine developer Genocea Biosciences Inc (NASDAQ: GNCA) raising $60 million but then ending the day down 8.3% to close at $11 while Dutch drug developer uniQure NV (QURE) raised $81.9 million but fell more than 14% to $14.61. However, orphan drug stock Auspex Pharmaceuticals Inc (NASDAQ: ASPX), which is developing drugs to treat orphan diseases like Tourette syndrome, saw a 30.5% gain to close at $15.66 and raise $84 million. The Boston Globe quoted Michael Ringel, a partner and managing director at Boston Consulting Group who focuses on health care business, as saying:
“The mood is incredibly positive. Capital is flowing. [The biotech IPOs]… have been burning hot. I think it’s too early to suggest that is changing. I can’t predict the overall economy any better than anyone else, but I would expect a pretty good year for IPOs.”
- [By John Udovich]
It’s a new year and the first one and a half trading weeks of 2014 has not disappointed biotech investors as the sector and mid cap or small cap biotech or pharma stocks like Intercept Pharmaceuticals Inc (NASDAQ: ICPT), Epizyme Inc (NASDAQ: EPZM), Tonix Pharmaceuticals Holding Corp (NASDAQ: TNXP) and TNI BioTech Inc (OTCQB: TNIB) either surging or producing some news plus there have been IPO filings for future listings for Flexion Therapeutics (NASDAQ: FLXN), Aldexa Therapeutics (NASDAQ: ALDX), Retrophin (NASDAQ: RTRX) and Dicerna Pharmaceuticals (NASDAQ: DRNA). Consider the following news so far this year:
10 Best Biotech Stocks For 2014: Exelixis Inc.(EXEL)
Exelixis, Inc., a biotechnology company, develops small molecule therapies for the treatment of cancer. It focuses on developing Cabozantinib, an inhibitor of tumor growth, metastasis, and angiogenesis that target MET, VEGFR2, and RET, which are key kinases involved in the development and progression of various cancers. The cabozantinib is in Phase III clinical trial for the treatment for medullary thyroid cancer. The company also engages in various clinical programs for cabozantinib focused on the treatment of metastatic castration-resistant prostate cancer, ovarian cancer, breast cancer, renal cell carcinoma, non-small cell lung cancer, hepatocellular cancer, and melanoma. In addition, Exelixis, Inc. involves in developing a portfolio of other novel compounds to address serious unmet medical needs through collaborations with various pharmaceutical and biotechnology companies, including Bristol-Myers Squibb Company, sanofi-aventis, Genentech, Inc., Boehringer Ingelheim Gm bH, and GlaxoSmithKline and Daiichi Sankyo Company Limited. Its products under development through collaborations include XL475, XL281, XL139, and XL413 inhibitors; ROR antagonists; therapies targeted against LXR, a nuclear hormone receptor implicated in various cardiovascular and metabolic disorders; XL147, XL765, and isoform-selective PI3K inhibitors; XL518, a small-molecule inhibitor of MEK; sphingosine-1-phosphate type 1 receptor; XL880 inhibitor; and therapies targeted against the mineralocorticoid receptor, a nuclear hormone receptor implicated in various cardiovascular and metabolic diseases. The company was formerly known as Exelixis Pharmaceuticals, Inc. and changed its name to Exelixis, Inc. in February 2000. Exelixis, Inc. was founded in 1994 and is headquartered in South San Francisco, California.
- [By Selena Maranjian]
Companies that stand a good chance of surging in coming years are also good Roth candidates. Exelixis (NASDAQ: EXEL ) , for example, is a smallish biotech company tackling various cancers. It even has an approved thyroid cancer drug on the market, and the formula may end up approved to treat other conditions, as well. The downside, though, is that the drug is expensive, and the segment of thyroid-cancer patients who might take it is very small.
- [By Sean Williams]
Where investment dollars are headed
Thyroid cancer is treated in nearly every case with a full or partial thyroid removal since the majority of thyroid cancers aren’t aggressive. However, in those rare cases where surgery isn’t an option or the disease has metastasized to other parts of the body, there are two drugs approved by the Food and Drug Administration to choose from.
Caprelsa: AstraZeneca’s (NYSE: AZN ) Caprelsa was approved to treat unresectable, locally advanced, or metastatic medullary thyroid cancer in April 2011. In trials, AstraZeneca’s pill increased progression-free survival over the placebo and delivered an overall response rate of 44%, compared with just 1% for the placebo — although it should be noted that all responses were partial. However, Caprelsa also comes with a laundry list of side effects that range from something as simple as rash, nausea, and hypertension, to having resulted in death from respiratory arrest and cardiac failure with arrhythmia. Cometriq: Exelixis’ (NASDAQ: EXEL ) Cometriq was approved last November to treat progressive metastatic medullary thyroid cancer. The capsules work by inhibiting multiple tyrosine kinases, which are crucial to blood vessel growth in solid and metastasizing tumors. In late-stage trials, patients receiving Cometriq demonstrated an astounding 11.2 months of progression-free survival compared with just four months for the placebo. Further, the objective response rate was 27% in the Cometriq arm and a goose egg for the placebo arm. Similar to AstraZeneca’s Caprelsa, severe adverse reactions tended to increase for Cometriq users relative to the placebo.
Just as we’ve witnessed with every previous cancer in this series, not every drug trial proves successful. Pfizer’s (NYSE: PFE ) Sutent, for instance, is a very successful treatment for kidney cancer, gastrointestinal stromal tumors, and pancreatic endocrine tumors, but it didn’t fare as wel
- [By Selena Maranjian]
The biggest new holdings are The Finish Line and Aeropostale. Other new holdings of interest include biotech company Exelixis (NASDAQ: EXEL ) , which received FDA approval last year for its thyroid cancer drug, Cometriq. The drug may also get approved to treat prostate cancer, and the company is looking at treating as many as nine different cancers with it. On the other hand, Cometriq is expensive, and the company’s debt has been growing, along with its share count.
10 Best Biotech Stocks 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.
- [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.
10 Best Biotech Stocks For 2014: Horizon Pharma Inc (HZNP)
Horizon Pharma, Inc. (Horizon), incorporated on March 23, 2010, is a biopharmaceutical company that develops and commercializes medicines to target unmet therapeutic needs in arthritis, pain and inflammatory diseases. On April 23, 2011, the United States Food and Drug Administration, approved DUEXIS (formerly HZT-501), a tablet formulation containing a fixed-dose combination of ibuprofen and famotidine in a single pill. The Company’s other product, LODOTRA (NP-01), is a programmed release formulation of low-dose prednisone that is marketed in Europe by the Company’s distribution partner, Mundipharma International Corporation Limited (Mundipharma). As of December 31, 2010, Horizon completed multiple Phase III clinical trials of LODOTRA. In addition to these product candidates, the Company has a pipeline of earlier-stage product candidates to treat pain-related diseases and chronic inflammation. On April 1, 2010, Horizon effected a recapitalization and acquisition pursua nt to which Horizon Pharma, Inc. became a holding company, that operates through its wholly owned subsidiaries, Horizon Pharma USA, Inc. (formerly Horizon Therapeutics, Inc.) and Horizon Pharma AG (formerly Nitec Pharma AG (Nitec)).
DUEXIS is a combination of 800 milligram ibuprofen and 26.6 milligram famotidine in a single pill and is indicated for the relief of signs and symptoms of rheumatoid arthritis (RA), and osteoarthritis (OA), and to decrease the risk of developing upper gastrointestinal (GI), ulcers in patients who are taking ibuprofen for those indications. The Company has completed two Phase III clinical trials in a total of over 1,500 patients with mild to moderate pain or arthritis that demonstrated a significant reduction in the incidence of non-steroidal anti-inflammatory drugs (NSAID)-induced upper GI ulcers when treated with DUEXIS versus ibuprofen alone.
LODOTRA is a programmed release for mulation of low-dose prednisone, a well-established drug use! d to inhibit the production of various pro-inflammatory cytokines, which are proteins associated with joint inflammation in RA. LODOTRA has received regulatory approval in Europe for the treatment of moderate to severe, active RA in adults when accompanied by morning stiffness. As of December 31, 2010, the Company had completed two pivotal Phase III clinical trials of LODOTRA in a total of over 600 patients with RA. The first pivotal Phase III trial supported the approval of LODOTRA in Europe in March 2009, where it is approved for marketing in 14 European countries. LODOTRA achieved significant results and met the primary endpoint in each of the two pivotal Phase III clinical trials. Its LODOTRA product was developed and is owned by Horizon Pharma AG. As of December 31, 2010, the Company markets LODOTRA in Europe through three separate agreements. Pursuant to two separate agreements, it granted Merck Serono GmbH and Merck GesmbH, an affiliate of Merck Serono, the rights to distribute and market LODOTRA in each of Germany and Austria, respectively, and pursuant to the third agreement, it granted Mundipharma rights to distribute and market LODOTRA in the rest of Europe. The Company also has a manufacturing and supply agreement with Jagotec AG under which Jagotec or its affiliates manufacture and supply LODOTRA to the Company as bulk tablets.
The Company competes with Pfizer Inc., Pozen Inc., Abbott Laboratories and Amgen Inc.
- [By Jake L’Ecuyer]
Leading and Lagging Sectors
Wednesday morning, the healthcare sector proved to be a source of strength for the market. Leading the sector was strength from Horizon Pharma (NASDAQ: HZNP) and Pernix Therapeutics Holdings (NASDAQ: PTX). In trading on Wednesday, telecommunications services shares were relative laggards, down on the day by about 0.39 percent. Top decliners in the sector included Shenandoah Telecommunications Co (NASDAQ: SHEN), off 3.3 percent, and CalAmp (NASDAQ: CAMP), down around 2.4 percent.
- [By Lisa Levin]
Horizon Pharma (NASDAQ: HZNP) shares reached a new 52-week high of $17.12 after the company announced its plans to acquire privately held Vidara Therapeutics International for around $660 million.
- [By Lisa Levin]
Horizon Pharma (NASDAQ: HZNP) shares gained 24.15% to $18.23 after the company announced its plans to acquire privately held Vidara Therapeutics International for around $660 million.
10 Best Biotech Stocks For 2014: Regulus Therapeutics Inc (RGLS)
Regulus Therapeutics Inc., incorporated on September 5, 2007, is a biopharmaceutical company focused on discovering and developing microRNAs to treat a range of diseases. microRNAs are naturally occurring ribonucleic acid (RNA), molecules that play a critical role in regulating key biological pathways. The Company uses its microRNA product platform to develop chemically modified, single-stranded oligonucleotides that the Company calls anti-miRs. As of December 31, 2012, the Company’s operations included acquiring and in-licensing intellectual property rights, developing its microRNA, undertaking basic research around microRNA targets and conducting preclinical studies for its initial programs.
The Company is developing RG-101 for the treatment of HCV and is advancing other microRNA therapeutics toward clinical development in several areas, including oncology, fibrosis and metabolic diseases. The Company intends to focus its resources on product opportunitie s in therapeutic areas where development and commercialization activities are appropriate for its size and financial resources, which the Company anticipates will include niche indications and orphan diseases.
The Company competes with Groove Biopharma, Inc., miRagen Therapeutics, Inc., Mirna Therapeutics, Inc., and Santaris Pharma A/S.
- [By Sean Williams]
A blast to the past
It’s occasionally very difficult to value biotech stocks, because of the wide range of outcomes possible given their pipelines. Other times, as in the case with Regulus Pharmaceuticals (NASDAQ: RGLS ) , I bang my head against a table and wonder what the heck investors are thinking.
- [By Brian Orelli]
Partners like this investment idea
When Regulus Therapeutics (NASDAQ: RGLS ) went public last year, investors weren’t the only ones buying the share offering; Regulus’ partners and founders clearly thought it was a good investment idea, because they bought more shares. Lots of them. AstraZeneca, Biogen Idec, Sanofi, GlaxoSmithKline and Isis combined to purchase more than 70% of the shares that raised nearly $81 million for the biotech.
- [By Sean Williams]
Regulus Therapeutics (NASDAQ: RGLS )
Since presenting at the Deutsche Bank Healthcare Conference two weeks ago, shares of Regulus Therapeutics have been absolutely on fire. A mixture of ASCO and IPO fever have revived the love for newer issues, and having big name pharmaceutical companies gobbling up a majority of its IPO’d shares certainly helps its cause.
10 Best Biotech Stocks For 2014: Conatus Pharmaceuticals Inc (CNAT)
Conatus Pharmaceuticals Inc., incorporated on July 13, 2005, is a biotechnology company focused on the development and commercialization of medicines to treat liver disease. The Company is developing its lead compound, emricasan, for the treatment of patients in orphan populations with chronic liver disease and acute exacerbations of chronic liver disease. The Company has designed a clinical program to demonstrate the therapeutic benefit of emricasan across the spectrum of fibrotic liver disease. The Company’s initial development strategy targets indications for emricasan with high unmet clinical need in orphan patient populations, such as patients with acute-on-chronic liver failure (ACLF), chronic liver failure (CLF), and patients who have developed liver fibrosis post-orthotopic liver transplant due to Hepatitis C virus infection (HCV-POLT).
The Company has completed two placebo-controlled Phase II trials in patients with liver disease showing reductions in ALT levels that occur rapidly, within as little as one day after initiation of therapy, and are maintained throughout the treatment period. In the Company’s 204-patient Phase 2b trial, it also measured cCK18, an important biomarker of apoptosis and disease severity. Emricasan has been generally well-tolerated in all of the clinical studies. As of July 23, 2013, the Company had not generated any revenue.
- [By Lauren Pollock]
Conatus Pharmaceuticals Inc.’s(CNAT) shares jumped 26% to $7.75 premarket after the biotechnology firm said its treatment for chronic liver disease has been granted a status that could mean quicker approval.
10 Best Biotech Stocks 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’s 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’s human liver cells as a therapeutic product.
The Company in its CNS Program, is in cli nical 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’s 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’s 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’s 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 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’s 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 a nd 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’s 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 an tibody that recognizes human glial fibrillary acidic protein (GFAP).
The Company’s 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.
- [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.
10 Best Biotech Stocks For 2014: 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’s product candidates span three specialty disease areas. The Company’s 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’s 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.
- [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).
- [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.
10 Best Biotech Stocks For 2014: Ophthotech Corp (OPHT)
Ophthotech Corporation, incorporated on January 05, 2007, is a biopharmaceutical company specializing in the development of therapeutics to treat diseases of the eye. The Company’s advanced product candidate is Fovista, which the Company is developing for use in combination with anti-VEGF drugs that represent the current standard of care for the treatment of wet age-related macular degeneration (wet AMD). Wet AMD is a serious disease of the central portion of the retina, known as the macula, which is responsible for detailed central vision and color perception. It is characterized by abnormal new blood vessel formation and growth, referred to as neovascularization, which results in blood vessel leakage, retinal distortion and scar formation. If untreated, the progressive retinal damage results in rapid, irreversible and severe vision loss. Wet AMD is the cause of blindness in patients over the age of 55 in the United States and the European Union.
The anti-V EGF market for the treatment of wet AMD consists predominantly of two drugs that are approved for marketing and primarily prescribed for the treatment of wet AMD, Lucentis and Eylea, and off-label use of the cancer therapy Avastin. The use of anti-VEGF drugs has significantly improved visual outcomes for patients with wet AMD who have been treated with these drugs as compared to untreated patients.
- [By John Udovich]
Yesterday, small cap biotech Acceleron Pharma Inc (NASDAQ: XLRN) rose 9.76% plus shares are up 183.6% for retail investors since its September IPO, meaning its worth taking a closer look at the stock along with the performance of other biotech IPOs like BIND Therapeutics Inc (NASDAQ: BIND), Ophthotech Corp (NASDAQ: OPHT) and Foundation Medicine Inc (NASDAQ: FMI) which also debuted at the same time.
- [By John Udovich]
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:
- [By John Udovich]
If you have not been watching the biotech sector lately, you should start paying attention as the sector along with small cap biotech stocks like Cell Therapeutics Inc (NASDAQ: CTIC), BIND Therapeutics Inc (NASDAQ: BIND) and TNI BioTech (OTCMKTS: TNIB) continue to produce a steady stream of good news for investors thanks to positive industry trends. Moreover, Ophthotech Corp (NASDAQ: OPHT), Foundation Medicine Inc (NASDAQ: FMI), Evoke Pharma and Fate Therapeutics Inc (NASDAQ: FATE) are this week’s biotech IPOs that will no doubt be watched closely by Wall Street and industry observers in general. With that in mind, consider the following biotech news or recent articles about the industry and the small cap players in it:
10 Best Biotech Stocks For 2014: Navidea Biopharmaceuticals Inc (NAVB)
Navidea Biopharmaceuticals, Inc. (Navidea), formerly Neoprobe Corporation, incorporated in 1983, is a biopharmaceutical company focused on the development and commercialization of precision diagnostic agents. As of December 31, 2011, the Company’s radiopharmaceutical development programs included Lymphoseek (Lymphoseek, Kit for the Preparation of Technetium Tc99m for Injection), a radiopharmaceutical agent for lymph node mapping; AZD4694, an imaging agent, and RIGScan, a tumor antigen-specific targeting agent. In January 2012, the Company executed an option agreement with Alseres Pharmaceuticals, Inc. (Alseres) to license [123I]-E-IACFT Injection, also called Altropane, an Iodine-123 radiolabeled imaging agent, being developed as an aid in the diagnosis of Parkinson’s disease, movement disorders and dementia. In August 2011, the Company sold its gamma detection device line of business (the GDS Business) to Devicor Medical Products, Inc.
Navidea’s pipeline includes clinical-stage radiopharmaceutical agents used to identify the presence and status of disease. Lymphoseek (Kit for the Preparation of Technetium Tc99m for Injection) is a lymph node targeting agent intended for use in intraoperative lymphatic mapping (ILM) procedures and lymphoscintigraphy employed in the overall diagnostic assessment of certain solid tumor cancers. The lymph system is a component of the body’s immune system. The key components of the lymph system are lymph nodes-small anatomic structures that contain disease-fighting lymphocytes, filter lymph of bacteria and cancer cells, and signal infection in response to heightened levels of pathogens. In Navidea’s Phase III clinical studies of Lymphoseek, it detected over 99% of positive nodes identified by vital blue dye (VBD). As of December 31, 2011, Navidea, in co-operation with UC, San Diego affiliate (UCSD), completed or initiated five Phase I clinical trials, one multi-cent er Phase II trial and three multi-center Phase II trials inv! olving Lymphoseek. Two Phase III studies were completed in subjects with breast cancer and melanoma. During the year ended December 31, 2011, data from NEO3-09 were released, which indicated that all primary and secondary endpoints for the study were met. As of December 31, 2011, third Phase III clinical trial for Lymphoseek in subjects with head and neck squamous cell carcinoma (NEO3-06) was in progress.
AZD4694 is a Fluorine-18 labeled precision radiopharmaceutical candidate for use in the imaging and evaluation of patients with signs or symptoms of cognitive impairment such as Alzheimer’s disease (AD). It binds to beta-amyloid deposits in the brain that can then be imaged in positron emission tomography (PET) scans. Amyloid plaque pathology is a required feature of AD and the presence of amyloid pathology is a supportive feature for diagnosis of probable AD. Patients who are negative for amyloid pathology do not have AD. AZD4694 has been studied in several clinical trials. Clinical studies through Phase IIa have included more than 80 patients to date, both suspected AD patients and healthy volunteers. No significant adverse events have been observed. Results suggest that AZD4694 has the ability to image patients quickly and safely with high sensitivity.
As of December 31, 2011, RIGScan had been studied in a number of clinical trials, including Phase III studies. Navidea has conducted two Phase III studies, NEO2-13 and NEO2-14, of RIGScan in patients with primary and metastatic colorectal cancer, respectively. Both studies were multi-institutional involving cancer treatment institutions in the United States, Israel, and the European Union.
The Company competes with Pharmalucence, Eli Lilly, Bayer Schering, General Electric and GE Healthcare.
- [By Lauren Pollock]
Navidea Biopharmaceuticals Inc.(NAVB) said the U.S. Food and Drug Administration has granted a priority review for an expanded use of its Lymphoseek drug for some patients with head and neck cancer. Shares dropped 5.4% to $1.97 premarket.
- [By Lauren Pollock]
Among the companies with shares expected to actively trade in Tuesday’s session are Toll Brothers Inc.(TOL) and Navidea Biopharmaceuticals Inc.(NAVB)