The biotechnology industry is renowned for it boom and bust cycle; investment in this area is not for the faint of heart, cautions Cynthia Andrade, contributing editor to MoneyLetter.
The industry has been on a tear. Over the past year, it has advanced almost 66%, and despite its boom and bust pattern, the sector has trounced the Nasdaq over the past ten years, gaining 231% versus the 126% gain in the Nasdaq.
Biotech stocks soared in 2013, as FDA approvals of new drugs escalated, and investors become more willing to embrace risk. Meanwhile, the IPO market for biotech firms has also been robust; 46 biotech firms completed IPOs in 2013.
Another factor behind the surge is the Affordable Care Act, which will increase the number of health-insured Americans and thereby increase the demand for pharmaceuticals.
This increased access to healthcare is not limited to the United States, as governments worldwide seek to increase healthcare benefits.
Top Promising Stocks To Own For 2015: Sucampo Pharmaceuticals Inc (SCMP)
Sucampo Pharmaceuticals, Inc., incorporated on December 9, 2008, is a global biopharmaceutical company focused on research, discovery, development and commercialization of drugs based on ion channel activators known as prostones. The Company�� prostone-based compounds target the ClC-2 and big potassium (BK), ion channels. It is focused on developing prostones to treat gastrointestinal, ophthalmic, neurologic, and oncology-based inflammatory disorders, and is also considering other therapeutic applications of its drug technology. The Company�� products include AMITIZA (lubiprostone) and RESCULA (unoprostone isopropyl).
AMITIZA
The Company�� AMITIZA is being marketed in the United States for three gastrointestinal indications under a license agreement, or the Takeda Agreement, with Takeda Pharmaceutical Company Limited, or Takeda. The three gastrointestinal indications include chronic idiopathic constipation (CIC), in adults, irritable bowel syndrome with constipation (IBS-C), in adult women, and opioid-induced constipation (OIC), in adult patients with chronic, non-cancer pain. AMITIZA for OIC received approval from the United States Food and Drug Administration (FDA), in April 2013. In Japan, AMITIZA is marketed under a license, commercialization and supply agreement, or the Abbott Agreement, with Abbott Japan Co. Ltd. (Abbott), for the gastrointestinal indication of chronic constipation (CC), excluding constipation caused by organic diseases. In Switzerland, the Company is marketing AMITIZA.
RESCULA
The Company holds license agreements for RESCULA in the United States and Canada and the rest of the world, with the exception of Japan, Korea, Taiwan and the People�� Republic of China. The Company is commercializing RESCULA (unoprostone isopropyl ophthalmic solution) 0.15% for the lowering of intraocular pressure (IOP), in patients with open-angle glaucoma or ocular hypertension in the United States. RESCULA may be used as an agent or concomit! antly with other topical ophthalmic drug products to lower intraocular pressure. RESCULA is a BK channel activator and has a different mechanism of action than other IOP lowering agents on the market.
Advisors' Opinion:- [By James Brumley]
Still, for the nimble who know when to get out, OREX is one of the few cheap stocks worth a closer look.
Sucampo Pharmaceuticals (SCMP)Finally, though the price of $7.60 clearly qualifies it as one pf the cheapest of the cheap stocks out there in the pharmaceutical world, that’s not the reason Sucampo Pharmaceuticals (SCMP) may be worth a look here. It’s the 30% slide we’ve seen SCMP stock suffer since peaking in mid-January. It’s not a pullback that’s bound to go unchallenged by the bulls.
- [By Roberto Pedone]
Another under-$10 stock that's starting to trend within range of triggering a major breakout trade is Sucampo Pharmaceuticals (SCMP), which is engaged in the discovery, development and commercialization of proprietary drugs based on prostones, and other novel drug technologies. This stock is off to a decent start in 2013, with shares up by 26%.
If you take a look at the chart for Sucampo Pharmaceuticals, you'll notice that this stock has been downtrending badly for the last four months, with shares dumping hard from its high of $10.48 to its recent low of $5.40 a share. During that downtrend, shares of SCMP have been consistently making lower highs and lower lows, which is bearish technical price action. That said, the downside volatility for SCMP looks to be over in the short-term since the stock has started to reverse its downtrend and enter an uptrend. That reverse is quickly pushing shares of SCMP within range of triggering a major breakout trade above a key downtrend line.
Traders should now look for long-biased trades in SCMP if it manages to break out above some near-term overhead resistance levels at $6.33 to $6.66 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 115,383 shares. If that breakout triggers soon, then SCMP will set up to re-test or possibly take out its next major overhead resistance levels at $7.09 to $7.67 a share. Any high-volume move above those levels will then give SCMP a chance to tag $8 to $9 a share.
Traders can look to buy SCMP off weakness to anticipate that breakout and simply use a stop that sits right below some key near-term support levels at $5.58 to $5.40 a share. One can also buy SCMP off strength once it clears those breakout levels with volume and then simply use a stop that sits a comfortable percentage from your entry point.
Top 10 Biotech Companies To Own 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 Own In Right Now: PTC Therapeutics Inc (PTCT)
PTC Therapeutics, Inc., incorporated on March 31, 1998 , is a biopharmaceutical company focused on the discovery and development of orally administered, small-molecule drugs that target post-transcriptional control processes. The Company�� lead product candidate includes ataluren, which is used for the treatment of patients with genetic disorders that arise from a type of genetic mutation known as a nonsense mutation. Ataluren is in late stage clinical development for the treatment of Duchenne muscular dystrophy caused by nonsense mutations (nmDMD) and cystic fibrosis caused by nonsense mutations (nmCF).
Ataluren is orally administered small-molecule compound that targets nonsense mutations. The Company is engaged in the development of ataluren for the treatment of genetic disorders in, which a nonsense mutation is the cause of the disease. Genetic tests are available for many genetic disorders, including Duchenne muscular dystrophy and cystic fibrosis, to determine if the underlying cause is a nonsense mutation. The EMA has designated ataluren as an orphan medicinal product for the treatment of nmDMD and nmCF. During the year ended December 31, 2012, the Phase III clinical trial completed. The Company�� Ataluren clinical trials in patients with nonsense mutation genetic disorders include Ataluren for nmDMD: Phase 2b clinical trial complete; Confirmatory Phase III clinical trial initiated, and Ataluren for nmCF: Phase III trial completed.
Advisors' Opinion:- [By John Kell]
PTC Therapeutics Inc.(PTCT) said the European Medicines Agency’s Committee for Medicinal Products for Human Use issued a negative opinion on the biopharmaceutical company’s marketing authorization application for its muscular dystrophy treatment. Shares slumped 21% to $20.60 in premarket trading.
- [By WWW.DAILYFINANCE.COM] Records fell on Wall Street Friday as another solid report on housing lifted the market for the second day in a row. There's a three-day weekend coming up -- something that often prompts investor caution -- but the gains were broad-based even though volume was fairly light. The VIX, which measures volatility, fell to its lowest level this year. The Dow Jones industrial average (^DJI) gained 63 points, the Nasdaq composite (^IXIC) rose 31, and the Standard & Poor's 500 index (^GPSC) added 8, topping the record high set last week. The Dow Transportation average also raced to an all-time high, lifted by airline stocks. United (UAL) soared more than 4 percent; Delta (DAL) gained more than 1 percent and Southwest (LUV) gained 2 percent. Southwest is at an all-time high, up 79 percent from a year ago. New home sales bounced back with a better than expected 6.4 percent increase last month. Lennar (LEN) and D.R. Horton (DHI) both rose 4 percent. Pulte (PHM), Beazer (BZH) and Hovnanian (HOV) also solid posted gains. Earnings continue to drive retail stocks. Gap (GPS) edged higher even though net fell. Foot Locker (FL) gained 1½ percent after topping expectations. GameStop (GME) rose 4 percent. Its net rose, helped by the rollout last year of new Xbox and PlayStation consoles. Zumiez (ZUMZ) rose 5½ percent on an earnings beat. But Aeropostale (ARO) tumbled 24 percent. Its loss widened and sales declined. The retailer continues to struggle with teen fashion trends. Also on the earnings front, TiVo (TIVO) rose 2 percent as it swung to a profit from a year ago loss. It also reported an increase in the number of subscribers. Hewlett-Packard (HPQ) rose 6 percent on news the company plans to eliminate up to 16,000 additional workers in an effort to cut costs. And several stocks extended big moves from yesterday. Best Buy (BBY) rose more than 3 percent for the second straight day after earnings beat expectations. Isis Pharmaceuticals (ISIS) jumped
Top 10 Biotech Companies To Own In Right Now: TESARO Inc (TSRO)
TESARO, Inc. (TESARO), incorporated in March 2010, is a development-stage, oncology-focused biopharmaceutical company for cancer patients. The Company focuses on rolapitant and TSR-011 product. The Company�� marketed products and product candidates in development treat cancer through non-specific damage to cellular components or alter cell metabolism or internal repair mechanisms to the demise of cancer cells.
Rolapitant
Rolapitant is a potent and long-acting neurokinin-1, or NK-1, receptor antagonist is in Phase III clinical trials for the prevention of chemotherapy induced nausea and vomiting (CINV). It is in Phase III clinical trials. CINV, if not prevented by prophylaxis, has the potential to afflict up to 90% or more of cancer patients undergoing chemotherapy, depending upon the type of chemotherapy administered the dosing schedule of the chemotherapy, and the patients' age and gender, among other predisposing factors. Prolonged nausea and vomiting may result in unwanted weight loss, dehydration and malnutrition, as well as hospitalization. The Company has in-licensed the rights to rolapitant from OPKO Health, Inc.
TSR-011
TSR-011 is an orally available ALK inhibitor in preclinical development. ALK is known to be involved in certain types of cancers, including subsets of NSCLC, neuroblastoma and lymphoma. For patients in these subsets, the ALK gene is fused to an activating partner or contains point mutations, resulting in constitutive activation of ALK and the growth of cancer cells and tumor development. Inhibition of ALK in these cancer cells results in cell death and tumor growth inhibition or regression. In August 2011, the United States Food and Drug Administration approved the first ALK inhibitor, developed by Pfizer Inc., Xalkori (crizotinib), which was approved for the treatment of patients with locally advanced or metastatic NSCLC that are ALK positive.
The Company competes with GlaxoSmithKline plc, Roche Holding Ltd! . and Sanofi S.A.
Advisors' Opinion:- [By Jake L'Ecuyer]
Equities Trading UP
Tesaro (NASDAQ: TSRO) shares shot up 20.78 percent to $29.00 after the company reported successful primary and secondary endpoints in final Phase 3 trial for rolapitant. - [By Keith Speights]
Positive response
Clovis wasn't the only company to bring good news about an ovarian cancer drug to ASCO. TESARO� (NASDAQ: TSRO ) announced phase 1 results for�niraparib. Shares of the biotech jumped 16% for the week.
Top 10 Biotech Companies To Own 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.
Top 10 Biotech Companies To Own In Right Now: 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]
I mean, just look at these returns: Gilead Sciences (GILD) has gained 41% so far this year as investors appear to have put their Sovaldi worries behind them; InterMune (ITMN) has quintupled in 2014 after Roche agreed to purchase it for $8.3 billion; and Intercept Pharmaceuticals (ICPT) has surged 350% as drug trials have been surprisingly good. All told, the iShares Nasdaq Biotechnology ETF (IBB) has risen 21%, more than double the S&P 500′s 8.3% rise.
- [By Jake L'Ecuyer]
Shares of InterMune (NASDAQ: ITMN) got a boost, shooting up 14.31 percent to $39.22 after the company presented Phase 3 ASCEND study of Pirfenidone in idiopathic pulmonary fibrosis. Leerink upgraded the stock from Market Perform to Outperform.
- [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.
Top 10 Biotech Companies To Own In Right Now: Cytomedix Inc (CMXI)
Cytomedix, Inc. (Cytomedix), incorporated in April 29, 1998, is a regenerative therapies company marketing and developing products within the United States and internationally .The Company commercializes cell-based technologies that harness the regenerative capacity of the human body to trigger natural healing. The Company is a commercial operation, and a robust clinical pipeline representing a logical extension of its commercial technologies in the evolving field of regenerative medicine. Cytomedix primarily operates in the United States. Its commercial offerings are centered on its point of care platform technologies for the safe and efficient separation of blood and bone marrow to produce platelet based therapies or cell concentrates.
The Company markets and selsl two distinct platelet rich plasma (PRP) technologies, the AutoloGel System for wound care and the Angel concentrated Platelet Rich Plasma (cPRP) Sytem in orthopedic and cardiovascular markets. Its clinical pipeline includes the ALDH, which are cell-based therapies (Bright Cells). In February 2012, the Company acquired Aldagen, Inc.
The AutoloGel System
The AutoloGel System is a point of care device for the production of a platelet based bioactive therapy derived from a small sample of the patient�� own blood. Using the patient�� own platelets as a therapeutic agent, AutoloGel harnesses the body�� natural healing processes to deliver growth factors, chemokines and cytokines known to promote angiogenesis and to regulate cell growth and the formation of new tissue.
Angel Product Line
The Angel concentrated Platelet Rich Plasma (cPRP) System is a multi-functional cell separation device which produces concentrated platelet rich plasma for use in the operating room and clinic and is used in a range of orthopedic and cardiovascular indications. Similar to the AutoloGel System, the Angel System is a point of care device for the production of a concentrated, aseptic platelet! -based bioactive therapy derived from a small sample of the patient�� own blood. The resulting cPRP is applied at the site of injury to promote healing. The Angel product line also includes ancillary products such as phlebotomy and applicator supplies and activAT. activAT is designed to produce autologous thrombin serum from platelet poor plasma and is sold exclusively in Europe and Canada, where it provides a safe alternative to bovine-derived products.
ALDHbr Cell Technology and Development Pipeline
The ALDHbr (Bright Cell) technology is an approach to cell-based regenerative medicine and a logical extension of its commercial technologies in the evolving regenerative medicine market, with potential clinical indications in markets with unmet medical needs such as peripheral arterial disease and ischemic stroke. The Bright Cell technology is in that it utilizes an intracellular enzyme marker to facilitate fractionation of essential regenerative cells from a patient�� bone marrow. The bone marrow fractionation process identifies and isolates active stem and progenitor cells expressing high levels of the enzyme aldehyde dehydrogenase, or ALDH, which is a key enzyme involved in the regulation of gene activities associated with cell proliferation and differentiation.
The Company�� lead product candidate, ALD-401, is an autologous preparation of Bright Cells for the post-acute treatment of ischemic stroke. ALD-401 is being evaluated in the RECOVER-Stroke clinical study, an ongoing 100-patient, double-blind, placebo-controlled Phase 2 study in patients with unilateral, cerebral ischemic stroke with an NIH stroke scale score of less than 22. An additional product candidate, ALD-301, is in clinical development for peripheral arterial disease (PAD), a condition causing reduced flow of blood and oxygen to muscles in the leg. It has completed a Phase 1/2 study of autologous ALD-301 in critical limb ischemia (CLI), a late stage condition caused by PAD. The Phase 2 PACE! (Patient! s with Intermittent Claudication Injected with ALDH Bright Cells) study is an 80 patient, double-blind, placebo-controlled clinical trial intended to demonstrate the safety and efficacy of ALD-301 (Bright Cells) in patients diagnosed with IC.
The Company competes with Harvest Technologies (a subsidiary of Terumo), Biomet, Arteriocyte, and Arthrex.
Advisors' Opinion:- [By Bryan Murphy]
When traders think of post-surgical wound management stocks, they may first think of names like Cytomedix, Inc. (OTCBB:CMXI) or Alliqua Inc. (OTCMKTS:ALQA). And well they should. Both companies have something of a history in the arena. ALQA is the purveyor of SilverSeal and Hydress antibiotic bandages, while CMXI is the developer of the AutoloGel system, which induces an affected patient's on body to do what it's supposed to do if there's a wound that won't heal. Cytomedix also makes the Angel platelet-rich plasma (PRP) delivery system. There's a relatively new name to add to the list of game-changing stocks in wound-management industry, however.... Arch Therapeutics Inc. (OTCBB:ARTH). The company is developing - well, has developed - a product called AC5 that nips post-surgical bleeding in the bud, largely negating the need for other post-surgical bleeding-control measures.
- [By James E. Brumley]
To give credit where it's due, Cytomedix, Inc. (OTCBB:CMXI) and Baxter International Inc. (NYSE:BAX) have both helped shape the landscape of the hemostasis (bleeding control) market with their products, AutoloGel and TISSELL, respectively. Arch Therapeutics Inc. (OTCBB:ARTH) has proverbially taken their concepts "up a notch", however, and its direct solution to a problem that CMXI and BAX can't quite solve may make ARTH the hottest trading candidate in the hemostasis space.
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