There have been two pops of at least 20% for industrial biotech in the last week -- both on the heels of expected news, nonetheless. Last week Codexis (NASDAQ: CDXS ) announced that it successfully completed a demonstration facility in Italy for its CodeXol detergent alcohols with partner Chemtex. It is a step in the right direction, but more sustainable share movements will come with courting commercial partners. The two still have plenty of work to collect production metric data and move into commercial scale with a bigger partner.
The real news came this morning, when�Gevo (NASDAQ: GEVO ) �announced that it had resumed commercial production of isobutanol at its Luverne biorefinery. The company had outlined its plans in prior conference calls, and its guidance earlier this year. But, given contamination obstacles at Luverne last summer, I suppose investors have reserved the right to remain cautious. Now that commercial production of isobutanol is finally happening, what exactly does this mean for investors?
Top Building Product Companies To Invest In 2015: 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�� 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 opportunities 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.
Advisors' Opinion:- [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. - [By Sean Williams]
What: Shares of Regulus Therapeutics (NASDAQ: RGLS ) , a biopharmaceutical company focused on the development of therapies utilizing its proprietary microRNA product platform, saw its shares skyrocket as much as 127% at one point today after announcing the interim results for its human proof-of-concept trial for its early stage hepatitis C drug RG-101.
- [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.
Top Biotech Companies To Own For 2014: FibroGen Inc (FGEN)
FibroGen, Inc. (FibroGen) is a research-based biopharmaceutical company focused on the discovery, development and commercialization of novel therapeutics to treat unmet medical needs. The Company focuses in the areas of fibrosis and hypoxia-inducible factor (HIF) biology. FibroGen�� products include Roxadustat (FG-4592), which is an oral small molecule inhibitor of HIF prolyl hydroxylases (HIF-PHs), in Phase III clinical development for the treatment of anemia in chronic kidney disease (CKD), and FG-3019, which is a monoclonal antibody in Phase II clinical development for the treatment of idiopathic pulmonary fibrosis (IPF), pancreatic cancer and liver fibrosis. The Company�� subsidiaries include FibroGen Europe Oy (FibroGen Europe) and FibroGen China Anemia Holdings, Ltd. (FibroGen China).
Roxadustat is the HIF-PH inhibitor in Phase III clinical development, which acts by stimulating the body�� natural pathway of erythropoiesis, or red blood cell production. Roxadustat represents a new paradigm for the treatment of anemia in CKD patients and offers injectable erythropoiesis stimulating agents (ESAs). 1,449 subjects have participated in 26 completed Phase I and II clinical studies for roxadustat in North America, Europe and Asia. The Company, along with its collaboration partners, Astellas Pharma Inc., (Astellas) and AstraZeneca AB,(AstraZeneca), has designed a global Phase III program to support regulatory approval of roxadustat in both NDD-CKD and DD-CKD patients in multiple geographies.
FG-3019 is the Company�� fully-human monoclonal antibody that inhibits the activity of connective tissue growth factor (CTGF), a critical common element in the progression of fibrosis and associated diseases. In Phase II IPF clinical studies, FG-3019 demonstrated the stabilization of disease and, in human studies, reversal of lung fibrosis in some patients. In an open-label Phase II pancreatic cancer study of FG-3019 plus gemcitabine and erlotinib, FG-3019 demonstrated a dose-depen! dent improvement in one year survival rate. In 10 Phase I and Phase II clinical studies of FG-3019 to date involving over 340 subjects, FG-3019 has been tolerated across a range of doses studied, and there have been no dose-limiting toxicities observed as of November 13, 2014.
The Company competes with Threshold Pharmaceuticals, Inc., Gilead Sciences, Inc., Halozyme Therapeutics, Inc., Gilead Sciences, Inc., Celgene Corporation, Janssen Biotech, Inc., Johnson & Johnson, Inc., Sanofi, Novartis and Biogen Idec.
Advisors' Opinion:- [By John Udovich]
Recent IPO�FibroGen Inc (NASDAQ: FGEN) surged 22.96% today, reportedly after the journal Hepatology published the results of a workshop between the FDA and the American Association for the Study of Liver Disease (AASLD) which laid out criteria for a phase three study of a treatment for non-alcoholic steatohepatitis (NASH)���meaning its worth taking a closer look at the stock along with the performance of potential small cap or mid cap liver disease stock peers like Conatus Pharmaceuticals Inc (NASDAQ: CNAT), Intercept Pharmaceuticals Inc (NASDAQ: ICPT) and Raptor Pharmaceutical Corp (NASDAQ: RPTP) which rose 24.35%, 10.98% and 2.02%, respectively. According to Investors Business Daily, NASH (the more serious version of fatty liver disease) is potentially an enormous market with about 6 million�US patients but the�lack of previous treatments had left it unclear how the FDA would measure success against the disease while FibroGen Inc doesn't yet have a NASH human trial in the works, it has said it hopes to start one for its lead candidate FG-3019 (its in mid-stage trials for pulmonary fibrosis and liver fibrosis due to hepatitis B infection).
Top Biotech Companies To Own For 2014: ARIAD Pharmaceuticals Inc.(ARIA)
ARIAD Pharmaceuticals, Inc., a biopharmaceutical company, focuses on the discovery, development, and commercialization of small-molecule drugs for the treatment of cancer. The company?s lead cancer product, ridaforolimus is being studied in multiple clinical trials in patients with various types of cancers, including metastatic sarcomas, breast cancer, endometrial cancer, prostate cancer, and non-small cell lung cancer. Its product pipeline also includes ponatinib, a pan BCR-ABL inhibitor in phase 2 clinical trial for applications in various hematological cancers and solid tumors; and AP26113, an anaplastic lymphoma kinase inhibitor in preclinical studies for the treatment of various cancers, including non-small cell lung cancer, lymphoma, and neuroblastoma. In addition, the company focuses on a drug discovery program centered on small-molecule therapies that are molecularly targeted to cell-signaling pathways implicated in cancer. Further, it licenses its ARGENT cell-sign aling regulation technologies to pharmaceutical and biotechnology companies to develop and commercialize therapeutic products, and to conduct drug discovery research. The company has collaboration and license agreements with Merck & Co., Inc. for the development, manufacture, and commercialization of ridaforolimus; and license agreements with Medinol Ltd. and ICON Medical Corp. to develop and commercialize stents and other medical devices to deliver ridaforolimus to prevent restenosis of injured vessels. ARIAD Pharmaceuticals, Inc. was founded in 1991 and is based in Cambridge, Massachusetts.
Advisors' Opinion:- [By Paul Ausick]
Stocks on the Move: Voxeljet AG (NYSE: VJET) is up 121.8% at $28.83 after a blazing hot IPO. Ariad Pharmaceuticals Inc. (NASDAQ: ARIA) is down 40.7% at $2.67 on a failed drug trial. ParkerVision Inc. (NASDAQ: PRKR) is up 17.9% at $6.40 after gaining more than 60% yesterday on a Florida jury�� ruling in the company�� favor in a patent suit against Qualcomm Inc. (NASDAQ: QCOM). J.C. Penney Co. Inc. (NYSE: JCP) is down 4.8% at $7.00, after posting a 33-year low of $6.97 a share earlier today.
- [By Jake L'Ecuyer]
Equities Trading UP
Ariad Pharmaceuticals (NASDAQ: ARIA) shot up 34.05 percent to $3.72 after the company announced positive opinion by EMA on continued availability of Iclusig. - [By Jake L'Ecuyer]
Ariad Pharmaceuticals (NASDAQ: ARIA) shot up 3.19 percent to $7.04. ARIAD will present at the JP Morgan Healthcare Conference on January 14 at 6:00 PM ET.
Top Biotech Companies To Own For 2014: Amarantus Bioscience Holdings Inc (AMBS)
Amarantus BioScience Holdings, Inc., formerly Amarantus BioSciences, Inc., incorporated on March 22, 2013, is focuses on developing intellectual property and proprietary technology in order to develop drug candidates and diagnostic blood tests to diagnose and treat human diseases. The Company owns the intellectual property rights to a therapeutic protein known as Mesencephalic-Astrocyte-derived Neurotrophic Factor (MANF), owns the intellectual property rights to biomarkers related to oncology and neurodegeneration named BC-SeraPro and NuroPro respectively, has a license to an Alzheimer�� disease blood test named LymPro, and owns a number of proprietary cell lines called PhenoGuard. MANF was the first therapeutic protein discovered from a PhenoGuard Cell Line. In December 2012, the Company acquired neurodegenerative diagnostic portfolio from Power3 Medical Products. On March 22, 2013, the Company was merged with into Amarantus Bioscience Inc.
The Company also owns an inventory of 88 cell lines that Amarantus refers to as PhenoGuard Cell Lines. MANF is a protein that corrects protein misfolding. The Company�� MANF product development effort is centered on a therapy for Parkinson�� disease.
Advisors' Opinion:- [By Bryan Murphy]
I've taken bullish swings on - and been wrong to do so - Amarantus BioScience, Inc. (OTC:AMBS) before. My most recent bullish call on the budding biotech name was in April... a rally that fizzled shortly after I said it was just getting started. Somehow though, I find myself coming back to AMBS as a breakout candidate. This time, however, it's for a slightly different reason.
Top Biotech Companies To Own For 2014: KYTHERA Biopharmaceuticals Inc (KYTH)
KYTHERA Biopharmaceuticals, Inc., incorporated in June 2004, is a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of prescription products for the aesthetic medicine market. The Company�� initial focus is on the facial aesthetics market. The Company�� product candidate, ATX-101, is a injectable drug in Phase III clinical development for the reduction of submental fat, which commonly presents as an undesirable double chin. Based on clinical trials conducted, ATX-101 has exhibited results in the reduction of submental fat. ATX-101 contains a synthetic form of sodium deoxycholate. In the United States and Canada, the Company is conducting two pivotal Phase III trials of ATX-101 for the reduction of submental fat. The Company initiated this pivotal Phase III clinical program, with planned enrollment of 1,000 patients, in March 2012.
In Europe, Bayer, its collaborator outside the United States and Canada, recently completed two pivotal Phase III trials of ATX-101 for the reduction of submental fat. In these multi-center, randomized, double-blind, placebo-controlled pivotal trials involving 723 patients, ATX-101 resulted in a reduction in submental fat, as assessed by a validated clinician scale and a patient satisfaction scale.
ATX-101 contains a synthetic form of sodium deoxycholate. ATX-101 is designed to be a locally-injected drug that causes proximal, preferential destruction of adipocytes, or fat cells, with minimal effect on surrounding tissue. Upon subcutaneous injection under the skin, ATX-101 disrupts cell membranes in protein-poor tissues, such as fat, while being attenuated by interactions with protein-rich tissue, such as skin, muscle and blood vessels. This attenuation by protein-rich tissue results in the preferential destruction of adipocytes by ATX-101. The destruction of adipocytes, or adipocytolysis, elicits a natural response, in which macrophages are attracted to remove cellular debris and fat particles t! hrough the lymphatic system. The macrophages also emit low levels of chemical messengers, known as cytokines, which attract fibroblasts, another cell type, to the area. Fibroblasts produce collagen, and it is believed that new collagen production, or neocollagenesis, promotes retraction of the skin in the areas of fat reduction. The fat removal process with ATX-101 is incremental with each treatment, thereby allowing for control of the aesthetic outcome.
Advisors' Opinion:- [By Lisa Levin]
Kythera Biopharmaceuticals (NASDAQ: KYTH) shares surged 24.40% to touch a new 52-week high of $41.71 after the company reported positive ATX-101 top line phase III trial results for the reduction of submental fat.
- [By Roberto Pedone]
Kythera Biopharmaceuticals (KYTH) is a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of novel prescription products for the aesthetic medicine market. This stock closed up 12.2% to $31.99 in Monday's trading session.
Monday's Volume: 221,000
Three-Month Average Volume: 72,572
Volume % Change: 220%From a technical perspective, KYTH ripped sharply higher here right above its 50-day moving average of $26.92 with heavy upside volume. This move pushed shares of KYTH into new all-time-high territory above its previous all-time high at $31.93, which is bullish technical price action.
Traders should now look for long-biased trades in KYTH as long as it's trending above Monday's low of $28.28 and then once it sustains a move or close above its new all-time high at $32 with volume that hits near or above 72,572 shares. If we get that move soon, then KYTH will set up to enter new all-time-high territory, which is bullish price action. Some possible upside targets off that move are $35 to $37.
Top Biotech Companies To Own For 2014: 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�� propriety formulation for abuse resistant products utilizing the pharmacological approach (Elite�� Abuse 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.
Advisors' Opinion:- [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.
- [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 prescription/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.
No comments:
Post a Comment