After rallying yesterday, biotech stocks are getting pounded, as Gilead (GILD), Amgen (AMGN) and Celgene (CELG) slide today.
The iShares Nasdaq Biotech ETF (IBB) fell 5.6% to $221.89 today, while the SPDR S&P Biotechnology ETF (XBI) dropped 6.5% to $129.79. Gilead Sciences fell 7.3% to $65.48, Amgen declined 4.9% to $114.11 and Celgene finished down 5% at $139.98.
What’s causing the slide? Nothing fundamental. Sure, the market’s worried about how much Gilead Sciences will be allowed to charge for Solvadi but there’s nothing screaming sell now beyond market sentiment.
Matarin Capital considers the roll of sentiment in the biotech selloff:
While the biotechnology stocks came into March like a lion, they went out like a lamb. They were extremely weak during the last few weeks of the month, when sentiment worsened as Federal Reserve Chairwoman Yellen shifted the criteria for future rate hikes. (High expectation stocks are more prone to suffer with rising interest rates, because of the sensitivity of the valuation of their future cashflows to the level of the discount rate. In this sense they are very similar to zero coupon bonds.) Another hit to biotech investor sentiment came when questions were raised in the U.S. Congress about the pricing of industry leader Gilead�� newest drug at $1,000/pill. The reason for the shift in sentiment may, at the end of the day, be of little matter. Once sentiment shifted, selling brought more selling. As is often the case with momentum stocks, an investor wants to ride the wave of momentum until it comes crashing down, and then head for shore��quickly.
Best Airline Companies To Invest In 2015: 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 Garrett Cook]
Receptos (NASDAQ: RCPT) shares shot up 46.35 percent to $99.14 after the company announced positive Phase 2 results for TOUCHSTONE Trial of RPC1063 in Ulcerative Colitis.
Top 10 Biotech Companies To Invest In Right Now: Hemispherx Biopharma Inc (HEB)
Hemispherx Biopharma, Inc. (Hemispherx) is a specialty pharmaceutical company engaged in the clinical development of new drugs therapies based on natural immune system enhancing technologies for the treatment of viral and immune based chronic disorders. Hemispherx focuses on two core pharmaceutical technology platforms Ampligen and Alferon N Injection.The commercial focus for Ampligen includes application as a treatment for Chronic Fatigue Syndrome (CFS) and as an influenza vaccine enhancer (adjuvant) for both therapeutic and preventative vaccine development. Alferon N Injection is a United States Food and Drug Administration (FDA) approved product with an indication for refractory or recurring genital warts. Alferon LDO (Low Dose Oral) is a formulation under development targeting influenza. It has three subsidiaries BioPro Corp., BioAegean Corp., and Core BioTech Corp. The Company's foreign subsidiary is Hemispherx Biopharma Europe N.V./S.A.
Ampligen
Ampligen is an experimental drug, which is undergoing clinical development for the treatment of Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS). Over 1,000 patients have participated in the Ampligen clinical trials representing the administration of more than 90,000 doses of this drug. The Company is also engaged in ongoing, experimental studies assessing the efficacy of Ampligen against influenza viruses.
Alferon N Injection
Alferon N Injection is the registered trademark for the Company's injectable formulation of natural alpha interferon. Interferons are a group of proteins produced and secreted by cells to combat diseases. The Company's natural alpha interferon is produced from human white blood cells. Alferon N Injection [Interferon alfa-n3 (human leukocyte derived)] is a highly purified, natural-source, glycosylated, multi-species alpha interferon product.
Alferon LDO (Low Dose Oral)
Alferon LDO [Low Dose Oral Interferon Alfa-n3 (Human Leukocyte Derived)]! is an experimental low-dose, oral liquid formulation of Natural Alpha Interferon and like Alferon N Injection should not cause antibody formation, which is a problem with recombinant interferon. It is an experimental immunotherapeutic that works by stimulating an immune cascade response in the cells of the mouth and throat, enabling it to bolster systemic immune response through the entire body by absorption through the oral mucosa.
The Company competes with Pfizer, GlaxoSmithKline, Merck, AstraZeneca, Baxter International, Fletcher/CSI, AVANT Immunotherapeutics, AVI BioPharma and Genta.
Advisors' Opinion:- [By MONEYMORNING]
Hemispherix Biopharma Inc. (NYSE: HEB) is a specialty pharmaceutical company. It engages in the clinical development of new drug therapies based on natural immune system enhancing technologies and targets the treatment of viral and immune-based clinical disorders. The Philadelphia, Pa.-headquartered company gained widespread attention over the last several months for its work on flu research. Its flagship products include Alferon N Injection, approved by the FDA for a category of sexually transmitted disease infection. Experimental treatments include Ampligen and Oragens, in development stages for the potential treatment of global viral diseases and disorders of the immune system including human papilloma virus, human immunodeficiency virus, chronic fatigue syndrome, hepatitis, and influenza. Shares have traded as low as $0.18 and as high as $0.55 over the last year. At last check, shares were changing hands around $0.50 on volume of 2 million shares.
- [By Matt Egan]
Shares of Hemispherx Biopharma (HEB) soared 11% on Wednesday amid the rising Ebola fears. Earlier this week, the company announced a series of research collaborations aimed at developing treatments to fight Ebola.
Top 10 Biotech Companies To Invest In Right Now: Biodel Inc (BIOD)
Biodel Inc. (Biodel), incorporated on December 3, 2003, is a development-stage speciality biopharmaceutical company focused on the development and commercialization of treatments for diabetes. The Company develops its product candidates by applying its formulation technologies to existing drugs. Its advanced program involves developing formulations of injectable recombinant human insulin (RHI). In addition to its ultra-rapid-acting insulin formulations, the Company has developed prototype formulations of a liquid glucagon, a basal insulin and a glucose responsive insulin, in each case for use by patients with diabetes. RHI-based formulation known as Linjeta was the subject of a New Drug Application (NDA).
The Company has two pivotal Phase III clinical trials with its preferred commercial formulation of Linjeta prior to re-submitting the NDA. In August 2011, it completed patient visits and analyzed top-line data from the first Phase 1 clinical trial of two RHI-based formulations. The trial was a single-center, randomized, double-blind, three-period crossover trial in 18 subjects with Type 1 diabetes. The purpose of the trial was to evaluate the pharmacokinetic and pharmacodynamic characteristics and injection site toleration of BIOD-105 and BIOD-107, as compared to the insulin analog marketed as Humalog. The Company conducted Phase I, Phase II and Phase III clinical trials comparing the performance of its Linjeta formulation of RHI to either Humulin, which is a branded formulation of RHI or Humalog. Its pivotal Phase III clinical trials were open-label, parallel group, randomized trials conducted at centers in the United States, Germany and India.
The Company competes with Eli Lilly, Novo Nordisk, Sanofi-Aventis, Halozyme Therapeutics, Inc. and MannKind Corporation.
Advisors' Opinion:- [By Roberto Pedone]
One under-$10 specialty biopharmaceutical player that's starting to trend within range of triggering a big breakout trade is Biodel (BIOD), which is focused on the development and commercialization of innovative treatments for diabetes. This stock has been hit hard by the bears over the last three months, with shares down by 24%.
If you take a look at the chart for Biodel, you'll notice that this stock is ripping higher here right off its 50-day moving average of $2.32 a share with strong upside volume. Volume on Thursday has so far registered over 750,000 shares, which is well above its three-month average action of 445,084 shares. This move is quickly pushing shares of BIOD within range of triggering a big breakout trade.
Traders should now look for long-biased trades in BIOD if it manages to break out above some near-term overhead resistance levels at $2.52 to $2.60 a share with high volume. Look for a sustained move or close above those levels with volume that hits near or above its three-month average action of 445,084 shares. If that breakout triggers soon, then BIOD will set up to re-test or possibly take out its next major overhead resistance levels $3 to its 200-day moving average of $3.39 a share. Any high-volume move above $3.39 will then give BIOD a chance to tag $4 a share.
Traders can look to buy BIOD off weakness to anticipate that breakout and simply use a stop that sits right below some key near-term support at $2.10 a share. One can also buy BIOD off strength once it starts to clear those breakout levels with volume and then simply use a stop that sits a comfortable percentage from your entry point.
- [By Monica Gerson]
Biodel (NASDAQ: BIOD) is expected to post a Q1 loss at $0.24 per share.
First Majestic Silver (NYSE: AG) is estimated to post its Q1 earnings at $0.10 per share on revenue of $63.35 million.
Top 10 Biotech Companies To Invest In Right Now: Immune Design Corp (IMDZ)
Immune Design Corp, incorporated on February 20, 2008, is a clinical-stage immunotherapy company. The Company has engineered its technologies to activate the immune system�� natural ability to create tumor-specific cytotoxic T cells (CTLs), to fight cancer. The Company is developing multiple product candidates from its two discovery platforms, DCVex and GLAAS. The Company�� product candidates, LV305, CMB305 and G100, utilize multiple immuno-oncology approaches. LV305 was developed from the DCVex platform and it is enrolling patients in a Phase I clinical trial for the treatment of five solid tumor types. CMB305 is a prime-boost approach that combines LV305 with a second agent, G305. G100 was developed from the GLAAS platform and it is enrolling patients with Merkel cell carcinoma in a Phase I clinical trial.
The Company�� immuno-oncology product candidates are being developed in two separate approaches: Specific Antigen and Endogenous Antigen. The Specific Antigen approach uses selected antigens that are also present in the patient�� tumor so that the immune system will be educated to recognize the tumor antigen and kill tumor cells expressing the antigen. The Endogenous Antigen approach, in contrast, does not require a selected antigen present in the tumor. It instead relies on treatments, such as chemotherapy or local radiation to lyse tumors and release endogenous antigens, which are then captured by neighboring GLAAS-activated dendritic cells, generating a varied immune response. The Company utilizes DCVex and GLAAS to develop product candidates that work in vivo and are designed to create and expand diverse armies of CTLs to fight tumors. DCVex is a discovery platform that uses a first-in-class vector to generate product candidates designed to create CTLs in vivo. The DCVex vector is a delivery system based on a re-engineered virus to carry the genetic information of a tumor antigen safely and selectively to dendritic cells (DCs), in the skin. The GLAAS platform also works in! vivo and is based on a small synthetic molecule called GLA, which stands for glucopyranosyl lipid A. GLA selectively binds to the TLR4 receptor and causes potent activation of the DC.
Advisors' Opinion:- [By WWW.DAILYFINANCE.COM]
www.gopro.com Now that it's nearly over, we can definitively say that 2014 has been one of the best years for initial public stock offerings in history. In terms of proceeds raised from IPOs, 2014 will challenge or even exceed the year 2000. Which is saying something: That was the height of the dot.com frenzy, when seemingly every new company with a website felt compelled to list on the stock exchange. As can be expected of a busy IPO year, some of 2014's new stock market titles have been runaway hits soaring above their issue price, while others have belly-flopped. Since we're heading into the most optimistic time of the year, we'll shine a light on the three best performers. In order of stock price appreciation, they are: GoPro (GPRO) 2014's current IPO front-runner is this company, maker of the popular action photography camera -- the one that's usually responsible for those hairy point-of-view videos posted on Facebook (FB) and other online sharing sites. GoPro's stock hit the market at the end of June priced at $24, and as if this writing it now stands at $70.72 for a muscular 195 percent total return. Although that's impressive, it should be noted that the current price is quite a bit lower than the stock's high of nearly $94, which it touched in early October. But then the camera was effectively blamed for the horrific accident that befell Formula One racing star Michael Schumacher -- although the journalist making the allegation later recanted -- and the shares cratered. The stock recovered after the company reported strong third-quarter earnings, and all seemed well again... until GoPro decided to float a secondary issue of stock. It'll sell 10.3 million fresh shares on the market, adding to the nearly 126 million currently outstanding. When secondary share issues are announced, a company's stock often takes a hit, since investors aren't too crazy about their existing stakes being diluted. Regardless, on a fundamental basis GoPro is a popular, if
Top 10 Biotech Companies To Invest In Right Now: Oramed Pharmaceuticals Inc (ORMP)
Oramed Pharmaceuticals Inc., incorporated on March 10, 2011, is a development-stage pharmaceutical company. The Company is engaged in the research and development of pharmaceutical solutions, including an orally ingestible insulin capsule or tablet to be used for the treatment of individuals with diabetes, use of orally ingestible capsules, tablets or pills for delivery of other polypeptides. The Company owns oral dosage form drug portfolio, it is, on an on-going basis, considering in-licensing and other means of obtaining additional technologies to complement and/or expand the product portfolio. The Company�� products include ORMD-0801 - Oral Insulin Capsule and ORMD-0901 - Oral Exenatide.
The Company focuses to conduct research and development on the technology covered by the patent application Methods and Composition for Oral Administration of Proteins. Through its research and development efforts, it focuses to develop an oral dosage form that will withstand the chemical environment of the stomach and intestines and will be effective in delivering active insulin for the treatment of diabetes. It intends to conduct the clinical trials to file an Investigational New Drug (IND), application with the United States Food and Drug Administration (FDA). It also focuses to conduct research and development by deploying its drug delivery technology for the delivery of other polypeptides in addition to insulin, and to develop other pharmaceutical products.
Advisors' Opinion:- [By Lisa Levin]
Oramed Pharmaceuticals (NASDAQ: ORMP) shares moved up 21.26% to $14.20. The volume of Oramed Pharmaceuticals shares traded was 621% higher than normal. Oramed shares have jumped 187.01% over the past 52 weeks, while the S&P 500 index has gained 28.75% in the same period.
- [By Lisa Levin]
Oramed Pharmaceuticals (NASDAQ: ORMP) shares moved up 15.68% to $17.85. The volume of Oramed Pharmaceuticals shares traded was 971% higher than normal. Oramed received patent allowance in Israel, Australia for platform technology in oral delivery of proteins.
- [By Ben Levisohn]
Oramed Pharmaceuticals (ORMP) has dropped 19% to $12.11 after the company said it would sell nearly 1.6 million shares of stock for $10 a share.
BP plc (BP) has fallen 0.7% to $47.24 after a U.S. judge refused its request to revise the way damages from the Deepwater Horizon oil spill are calculated.
Top 10 Biotech Companies To Invest In Right Now: Puma Biotechnology Inc (PBYI)
Puma Biotechnology, Inc., incorporated in April 2007, is a development-stage biopharmaceutical company that acquires and develops products for the treatment of various forms of cancer. The Company focuses on in-licensing drug candidates that are undergoing or have already completed initial clinical testing for the treatment of cancer and then seeks to further develop those drug candidates for commercial use. As of December 31, 2011, the Company licensed three drug candidates: PB272 (neratinib (oral)), which the Company is developing for the treatment of advanced breasts cancer patients and gastric cancer patients; PB272 (neratinib (intravenous)), which the Company is developing for the treatment of advanced cancer patients, and PB357.
PB272 (neratinib (oral))-Breast Cancer
Neratinib is a potent irreversible tyrosine kinase inhibitor, or TKI, that blocks signal transduction through the epidermal growth factor receptors (EGFRs), HER1, HER2 and HER4. The Company's initial focus is on the development of neratinib as an oral treatment of patients with HER2 positive metastatic breast cancer.
PB272 (neratinib (intravenous))
The Company develops neratinib as an intravenously administered agent. In pre-clinical studies the intravenous version of neratinib resulted in higher exposure levels of neratinib in pre-clinical models.
PB357
PB357 is an orally administered agent that is an irreversible TKI that blocks signal transduction through the epidermal growth factor receptors, HER1, HER2, and HER4. PB357 is structurally similar to PB272. Pfizer completed single dose Phase I trials of PB357. The Company is evaluating PB357.
The Company competes with Genentech, GlaxoSmithKline, Roche, Boehringer Ingelheim, Takeda, Array Biopharma and Ambit Biosciences.
Advisors' Opinion:- [By Lee Jackson]
Puma Biotechnology Inc. (NYSE: PBYI) is a stock that UBS views as having multiple catalysts. The analysts are positive on the potential for their cancer drug neratinib to demonstrate positive data in neoadjuvant breast, as well as specific genetic mutations for other cancers. Success in either area may lead to strong upside for the stock. The UBS price target is $61, while consensus is at $62.50.
- [By John Udovich]
Recent news surrounding small cap biotech stocks like�Xencor Inc (NASDAQ: XNCR), Prosensa Holding NV (NASDAQ: RNA),�Puma Biotechnology Inc (NYSE: PBYI),�Geron Corporation (NASDAQ: GERN)
and TNI BioTech Inc (OTCQB: TNIB) show that while the sector and appetite for biotech�IPOs may have cooled, lottery tickets can still be found or occur in the sector. Just consider the following recent news or trends: - [By Ben Levisohn]
After big rallies by biotech stocks, the folks at Weeden wondered if the rally getting overdone.�UBS analyst Matthew Roden and team think biotech stocks like Gilead Sciences�(GILD), Celgene�(CELG),�Vertex Pharmaceuticals (VRTX),�Puma Biotechnology (PBYI) and Achillion Pharmaceuticals (ACHN) can keep running. They explain why:
Top 10 Biotech Companies To Invest In Right Now: Synageva BioPharma Corp (GEVA)
Synageva BioPharma Corp., incorporated in 1993, is a clinical-stage biopharmaceutical company. The Company is focused on the discovery, development and commercialization of therapeutic products. It has several protein therapeutics in development, including two enzyme replacement therapies for lysosomal storage disorders and two programs for life-threatening genetic conditions. Its lead program, SBC-102, recombinant human lysosomal acid lipase (LAL), is its advanced pipeline program in clinical development for LAL Deficiency. This enzyme is responsible for the metabolism of cholesteryl esters and triglycerides that are delivered to lysosomes by a variety of routes, including low-density lipoprotein receptor mediated endocytosis. On November 2, 2012, Trimeris, Inc. merged with Synageva BioPharma Corp.
SBC-102 is produced by recombinant deoxyribonucleic acid (DNA) technology in egg white using its protein manufacturing platform. The Company has initiated natural history studies in approximately 20 countries. In addition to SBC-102, it is progressing protein therapeutic programs for other rare diseases, which are at different stages of preclinical development. These include two enzyme replacement therapies for other lysosomal storage disorders and two programs for other rare life-threatening conditions. As of December 31, 2011, its product candidate pipeline included SBC-102, SBC-103, SBC-104, SBC-105 and SBC-106.
SBC-104 is an extracellular protein that targets a severe, rare genetic condition. SBC-105 is an enzyme replacement therapy being developed to treat a severe, rare metabolic disorder. SBC-106 is a protein therapy that targets a severe and rare genetic condition.
Advisors' Opinion:- [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.
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