After stocks imploded in late trading on Friday, investors opened June undeterred, sending the Dow Jones Industrial Average (DJINDICES: ^DJI ) up 138 points, or 0.9%. The gains came from hopes that the Fed would hold back plans to cut its stimulus program because of two weak economic reports today, a pattern we saw last Thursday as well. The Institute of Supply Management said its manufacturing index dropped from 50.7 in April to 49.0 in May, indicating a contraction to its level since June 2009 and well below expectations of 50.9. Construction spending for April also grew less than expected, coming in at 0.4% on projections of a 1.1% increase.
Still, concerns about the Fed have dominated investor mentality recently since the most recent Fed minutes were released on May 22, and the market bizarrely seems to be hoping for bad news to stave off the eventual winding down of the bond-buying program.
Intel (NASDAQ: INTC ) also helped propel the Dow higher today as the chip maker gained 4% after Samsung said it would use Intel processors in a new model of one of its top-selling tablets, which will come out later this month. The announcement marks the first time that Intel chips will be used in a major tablet, and helps assuage investor concerns that Intel will have trouble prospering as the PC market declines further.
Best Biotech Companies To Invest In Right Now: Prosensa Holding NV (RNA)
Prosensa Holding N.V., formerly Prosensa Holding B.V., is a biotechnology company engaged in the discovery and development of ribonucleic acid-modulating (RNA)-modulating, therapeutics for the treatment of genetic disorders. The Company’s primary focus is on rare neuromuscular and neurodegenerative disorders with a large unmet medical need, including Duchenne muscular dystrophy, myotonic dystrophy and Huntington’s disease. The Company’s clinical portfolio of RNA-based product candidates is focused on the treatment of Duchenne muscular dystrophy (DMD). The Company’s platform technology allows the development of RNA-modulating therapeutics that either interferes with splicing (exon skipping, exon inclusion, or splice mutation correction), remove mutant RNA, or block RNA expression, for different indications.
DMD is a rare, severe muscle wasting disease that occurs in up to 1 in 3,500 male births. It is commonly diagnosed between the ages of three to five , when boys begin to show signs of impaired motor development. PRO044, the Company’s product candidate, addresses a separate sub-population of DMD patients. The Company developed PRO044 using its exon-skipping technology to generate a product candidate with the same mechanism of action that is used by drisapersen.
- [By Monica Gerson]
Prosensa Holding NV (NASDAQ: RNA) soared 25.89% to $8.51 in the pre-market trading after the company reported 48-week data from Phase 2 placebo-controlled study of drisapersen in 51 DMD boys.
- [By Leo Sun]
However, these three biotech stocks — Amarin (NASDAQ: AMRN ) , Dendreon (NASDAQ: DNDN ) , Prosensa (NASDAQ: RNA ) — don’t fit that category at all. Read on to understand why these dogs of the sector should never be mistaken as underdogs.
- [By Sean Williams]
Shares of Sarepta climbed to a 52-week high of $55.61 in September shortly after an experimental rival drug, drisapersen, developed by Prosensa (NASDAQ: RNA ) and GlaxoSmithKline (NYSE: GSK ) , missed its primary end point by a mile in late-stage trials. However, Sarepta also tanked just weeks later after the Food and Drug Administration decided against supporting an accelerated drug approval for eteplirsen; the agency would not make the connection that increased dystrophin production led to its remarkable trial results. Also, given the recent failure of drisapersen in a phase 3 study, the FDA felt it pertinent that Sarepta engage in a broader study. Shares ultimately dipped as low as $12.12.
- [By John Udovich]
It should also be mentioned that earlier in the week, GlaxoSmithKline plc (NYSE: GSK) returned full rights of Duchenne muscular dystrophy drug drisapersen to their partner Prosensa Holding NV (NASDAQ: RNA) and that news sent shares down 12.48% on Monday. Moreover, Prosensa Holding also sank some 70% last fall when Drisapersen failed a phase 3 trial by missing a primary endpoint measuring for how far patients could walk over the course of six minutes (the improvement wasn’t significantly better than the placebo). However, Prosensa Holding also rose 24.37% yesterday after announcing initial findings from further analyses from the aggregate data for drisapersen, with the CEO saying:
Best Biotech Companies To Invest In Right Now: 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 John Kell var popups = dojo.query(“.socialByline .popC”); popups.forEach(func]
Among the companies with shares expected to actively trade in Wednesday’s session are American Apparel Inc.(APP), Exelixis Inc.(EXEL) and Francesca’s Holdings Corp.(FRAN)
- [By Jake L’Ecuyer]
Shares of Exelixis (NASDAQ: EXEL) were down 37.89 percent to $4.00 after the company issued an update on ongoing COMET-1 phase 3 pivotal trial in men with metastatic castration-resistant prostate cancer. Stifel Nicolaus lowered the price target on the stock from $11.00 to $9.00.
- [By Jake L’Ecuyer]
Equities Trading DOWN
Shares of Exelixis (NASDAQ: EXEL) were down 36.18 percent to $4.11 after the company issued an update on ongoing COMET-1 phase 3 pivotal trial in men with metastatic castration-resistant prostate cancer. Stifel Nicolaus lowered the price target on the stock from $11.00 to $9.00.
Best Biotech Companies To Invest 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. It s 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’s own blood. Using the patient’s own platelets as a therapeutic agent, AutoloGel harnesses the body’s 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 d evice for the production of a concentrated, aseptic platelet! -based bioactive therapy derived from a small sample of the patient’s 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’s 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’s 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.
- [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.
- [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.
Best Biotech Companies To Invest In Right Now: Merck & Company Inc.(MRK)
Merck & Co., Inc. provides various health solutions through its prescription medicines, vaccines, biologic therapies, animal health, and consumer care products. The company?s Pharmaceutical segment provides human health pharmaceutical products, such as therapeutic and preventive agents for the treatment of human disorders in the areas of bone, respiratory, immunology, dermatology, cardiovascular, diabetes and obesity, infectious diseases, neurosciences and ophthalmology, oncology, vaccines, and women’s health and endocrine. This segment also offers human health vaccines, such as preventive pediatric, adolescent, and adult vaccines. Its Animal Health segment discovers, develops, manufactures, and markets animal health products. This segment offers antibiotics, anti-inflammatory products, vaccines, products for the treatment of fertility disorders, and parasiticides for cattle, swine, horses, poultry, dogs, cats, salmons, and fish. The Consumer Care segment develops, manufac tures, and markets over-the-counter, foot care, and sun care products. Its over-the-counter product line includes non-drowsy antihistamines; treatment for occasional constipation; decongestant-free cold/flu medicine for people with high blood pressure; nasal decongestant spray; and treatment for frequent heartburn. This segment?s foot care products comprise topical antifungal, and foot and sneaker odor/wetness products; and sun care products include sun care lotions, sprays and dry oils; and sunburn relief products. The company serves drug wholesalers and retailers, hospitals, government agencies, physicians, physician distributors, veterinarians, animal producers, and managed health care providers, as well as food chain and mass merchandiser outlets in the United States and Canada. Merck & Co., Inc. was founded in 1891 and is headquartered in Whitehouse Station, New Jersey.
- [By Todd Campbell]
That could be particularly true for these three dividend-paying health-care companies: GlaxoSmithKline (NYSE: GSK ) , Merck (NYSE: MRK ) , and Quest Diagnostics (NYSE: DGX ) . They not only pay healthy dividend yields that can blunt the pain of a sell-off, but they’re also strong performers during the coming quarter. That suggests investors may not want to sell them, and investors who have been considering them may want to step in and buy them.
- [By Ben Levisohn]
Stocks bounced back from yesterday’s losses–and it was blue chips like International Business Machines (IBM), Johnson & Jonson (JNJ), Caterpillar (CAT), Merck (MRK) and 3M (MMM) that led the market higher.
Best Biotech Companies To Invest In Right Now: Elite Pharmaceuticals Inc (ELTP)
Elite Pharmaceuticals, Inc. (Elite), incorporated on October 1, 1997, is a specialty pharmaceutical company principally engaged in the development and manufactures of oral, controlled-release products, using technology and the development and manufacture of generic pharmaceuticals. Elite has four products: Phentermine 37.5 milligram tablets, Methadone 10 milligram tablets, Lodrane D Immediate Release capsules and Hydromorphone Hydrochloride 8 milligram tablets. During the fiscal years ended March 31, 2012 (Fiscal 2011), the Company manufactured and sold Lodrane 24 and Lodrane 24D (the Lodrane Extended Release Products).
The Company has a pipeline of additional generic drug candidates under active development, including, without limitation, ELI-154, a once-a-day oxycodone product and ELI-216, an abuse resistant oxycodone product which utilizes the Company’s propriety formulation for abuse resistant products utilizing the pharmacological approach (Elite’s A buse Resistant Technology). ECR Pharmaceuticals (ECR), a wholly owned subsidiary of Hi-Tech Pharmacal, Inc. and the owner and marketer of the Lodrane Extended Release Products. Elite also purchased from Mikah Pharma LLC, an approved Abbreviated New Drug Application (ANDA) for Naltrexone 50 milligram tablets.
For ELI-154, Elite has developed a once-daily oxycodone formulation using its technology. An investigational new drug application (IND) has been filed and Elite has completed two pharmacokinetic studies in healthy subjects that compared blood levels of oxycodone from dosing ELI-154 and the twice-a-day product that is on the market, OxyContin marketed in the United States by Purdue Pharma LP. ELI-216 utilizes the Company’s abuse-deterrent technology that is based on a pharmacological approach. ELI-216 is a combination of a narcotic agonist, oxycodone hydrochloride, in a sustained-release formulation intended for use in patients with moderate to severe chronic pain, and an antagonist, naltrexone hydrochloride, formulat! ed to deter abuse of the drug. Products utilizing the pharmacological approach to deter abuse such as Suboxone, a product marketed in the United States by Reckitt Benckiser Pharmaceuticals, Inc., and Embeda, a product marketed in the United States by Pfizer, have been approved by the United States Food & Drug Administration (FDA). ELI-216 demonstrates a euphoria-blocking effect when the product is crushed. Elite has developed ELI-154 and ELI-216 and retains the rights to these products.
The Company competes with Collegium Pharmaceuticals, Inc., Purdue Pharma LP, Acura Pharmaceuticals, Inc., Durect Corporation, Mylan Laboratories, Inc., Par Pharmaceuticals, Inc., Alkermes, Inc., Teva Pharmaceuticals Industries Ltd., Aptalis Pharma, Impax Laboratories, Inc., and Watson Pharmaceuticals.
- [By James E. Brumley]
Judging from the company it’s keeping Green Automotive Co. (OTCMKTS:GACR) may have just made its way into the upper echelon of small cap stock opportunities. The electric car company joins Elite Pharmaceuticals Inc. (OTCBB:ELTP), Amarantus Bioscience Holdings, Inc. (OTCBB:AMBS), and only three other companies as Wall-Street.com’s “Best 6 Stocks” for January of 2014. As one of the top information resources for investors – particularly in terms of information regarding small and micro cap stocks – being named among the site’s top pick is an accolade for AMBS, ELTP, and GACR. Even more impressive is that Green Automotive Co. was the only consumer-goods name among those six. Amarantus Bioscience Holdings and Elite Pharmaceuticals are biotechnology names… an industry that can and often does attract a lot of attention just by the nature of the business. The other three names making the “Best 6” list were an energy explorer, a power-management technology manufacturer, and presc ription/medical food producer. For an electric car manufacturer to make the list speaks quite highly of GACR.
- [By James E. Brumley]
Exactly one month ago today I penned some bullish thoughts on Elite Pharmaceuticals Inc. (OTCBB:ELTP). If you’re familiar with the company – or a regular reader of this site – then you may know why that sounds a little “off.” See, at the time, ELTP shares were falling rather quickly, giving up all the gains they had made just a few days before. Almost needless to say, my premise was not a well received one. Let’s just say I received some “colorful disagreements” by being optimistic about the biopharma company.
- [By CRWE]
Today, ELTP has shed (-8.01%) down -0.009 at $.101 with 4,629,899 shares in play thus far (ref. google finance Delayed: 1:00PM EDT September 16, 2013).
Elite Pharmaceuticals, Inc. previously reported the first quarter of fiscal year 2014 ended June 30, 2013. Manufacturing and profit split revenues comprised almost all of Elite’s quarterly revenues and totaled $717k for the quarter, an increase of 41% from the prior year. This growth is attributed to the launch of two new products during the quarter, Phentermine 15mg and 30mg capsules, combined with strong year-on-year growth of the Elite’s Hydromorphone 8mg tablets and contract manufactured Methadone 10mg product lines.
Best Biotech Companies To Invest In Right Now: Oncolytics Biotech Inc (ONCY)
Oncolytics Biotech Inc. (Oncolytics), incorporated on April 2, 1998, is a development-stage company. The Company is focused on its research and development of REOLYSIN, which is its cancer therapeutic. REOLYSIN is developed from the reovirus. This virus has been demonstrated in tumour cells bearing an activated Ras pathway. Oncolytics is directing a clinical trial program with the focus of developing REOLYSIN as a human cancer therapeutic. The clinical program includes clinical trials, which it sponsors directly along with Third Party Clinical Trials. Third Party Clinical Trials are clinical trials that are being sponsored by other institutions. As of December 31, 2011, the United States National Cancer Institute (NCI), the University of Leeds and the Cancer Therapy & Research Center at the University of Texas Health Center in San Antonio (CTRC) were sponsoring part of its clinical trial program.
The Company’s clinical trial program has included human trials using REOLYSIN alone, and in combination with radiation and chemotherapy, and delivered via local administration and/or intravenous administration. Oncolytics uses contract toll manufacturers to produce REOLYSIN. On December 31, 2011, the Company had two wholly owned subsidiaries, Oncolytics Biotech (Barbados) Inc. (OBB) and Valens Pharma Ltd. Oncolytics Biotech (US) Inc. and Oncolytics Biotech (U.K.) are wholly owned subsidiaries of OBB.
- [By John Udovich]
The biotech sector along with small cap biotech stocks Cardiome Pharma Corp (NASDAQ: CRME), Oncolytics Biotech, Inc (NASDAQ: ONCY), Vital Therapies Inc (NASDAQ: VTL) and TNI BioTech (OTCMKTS: TNIB) have all been producing their share of news this week for investors and traders alike to trade on. Moreover and while some 42 “life sciences” companies have gone public raising about $3 billion from investors so far this year, there are a growing number of biotechs pulling the plug on upcoming IPOs who are citing market conditions. With that in mind, here is a look at important news from the biotech sector and small cap biotech stocks this week:
- [By Maxx Chatsko]
T-VEC is not your traditional biologic drug. It is actually a bioengineered form of the herpes virus that, once injected into cancerous tumors, replicates, and produces an immune-stimulating protein that puts a bulls eye on cancer cells throughout the body. Despite its promise and intriguing mechanism of action, T-VEC is not in further development at Amgen. However, Oncolytics (NASDAQ: ONCY ) has shown promising results for its bioengineered form of reovirus called Reolysin. Initial phase 3 results showed that 86% of patients taking the drug had reduced tumor mass or growth after six weeks of treatment.
- [By Sean Williams]
With this in mind, I feel it’d be prudent of biotech-savvy investors to give Oncolytics Biotech (NASDAQ: ONCY ) a closer look.
The big risks
I’m quite aware that there are a lot factors that’d raise a red flag with Oncolytics. Similar to Affymax, you could say that Oncolytics has put all of its eggs in one basket with its lead experimental drug, reolysin. According to Oncolytics’ website, including its U.K., Canadian, and U.S. studies, reolysin as either a monotherapy or combination therapy is the basis for all 31 clinical trials! Obviously, if reolysin proves ineffective or unsafe, Oncolytics is going to be a world of hurt
Best Biotech Companies To Invest In Right Now: 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:
Best Biotech Companies To Invest In Right Now: 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’s 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’s drug candidate, Archexin is an anticancer Akt inhibitor.
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 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 pe riod for major depressive disorder (MDD) patients. As of Dec! ember 31, 2011, the Company had not made a determination of Serdaxin’s future paths or resource allocations to further develop Serdaxin to treat MDD.
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’s 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.
- [By John Udovich]
So far this year, Rexahn Pharmaceuticals, Inc (NYSEMKT: RNN), Imprimis Pharmaceuticals Inc (NASDAQ: IMMY) and Arrowhead Research Corp (NASDAQ: ARWR) are up 186.3%, 157.2% and 142.5%, respectively, since the start of the year – making them the best performing small cap biotech stocks for 2014. But given their lackluster performance over the past few years, what is the secret behind their phenomenal 2014 rise and will they keep rising? For starters, none of these small caps have really produced anything in the way of blockbuster news:
- [By James E. Brumley]
If you were lucky enough to step into Rexahn Pharmaceuticals, Inc. (NYSEMKT:RNN) when your truly suggested it was a budding buy back on December 23rd, then congratulations – you’re now up a little more than 60% (assuming you bought into RNN after the break above a key resistance line on the 27th). Now get out. Instead, use your profits from the Rexahn to take on a stake in GTx, Inc. (NASDAQ:GTXI). No, GTXI may not look like much at first, but when you take a step back and look at a chart of GTx, Inc. through a longer-term lens, the upside potential becomes clear.
Best Biotech Companies To Invest In Right Now: 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.