Although we don't believe in timing the market or panicking over market movements, we do like to keep an eye on big changes -- just in case they're material to our investing thesis.
What: Shares of air medical transportation company Air Methods (NASDAQ: AIRM ) sank 12% today after its preliminary quarterly results disappointed�Wall Street. �
So what: The stock has soared over the past year on rebounding demand, but downbeat guidance for the first quarter is forcing analysts to recalibrate their valuation estimates. Of course, management blamed the drop in transported patients and high number of cancellations largely on bad weather, suggesting that the problem is short-term in nature. �
Now what: Management now sees a first-quarter loss of $0.14 to $0.16 per share, well below the average analyst estimate of a $0.34 profit. "We remain hopeful that flight volume and payer mix will return to historical levels in future quarters once weather and other seasonal factors moderate," CEO Aaron Todd reassured�investors. With the stock now off about 20% from its 52-week highs and trading at a forward P/E discount to several of its peers, buying into that turnaround talk might not be a bad idea.
10 Best Machinery Stocks To Buy For 2015: Five Prime Therapeutics Inc (FPRX)
Five Prime Therapeutics, Inc., incorporated on December 20, 2001, is a clinical-stage biotechnology company focused on discovering and developing protein therapeutics. Protein therapeutics is antibodies or drugs developed from extracellular proteins or protein fragments that block disease processes, including cancer and inflammatory diseases. The Company�� advanced product candidates include FP-1039/GSK3052230 (FP-1039), FPA008 and FPA144. FP-1039 is a protein therapeutic that traps and neutralizes cancer-promoting fibroblast growth factors (FGFs), involved in cancer cell proliferation and new blood vessel formation. FPA008 is an antibody that inhibits colony stimulating factor-1 receptor (CSF1R), and is being developed to treat patients with inflammatory diseases, including rheumatoid arthritis (RA). FPA144 is an antibody that inhibits FGF receptor 2b (FGFR2b), and is being developed to treat patients with gastric cancer and potentially other solid tumors.
FP-1039
FP-1039 is a protein therapeutic, which includes the extracellular part of FGFR1. FP-1039 acts as an inhibitor of FGFs, because the FGFR1 portion of the molecule binds to FGFs and prevents them from binding to FGFR1 on tumor and blood vessel cells. Because FGF proteins circulating in the blood are called ligands, FP-1039 is called a ligand trap. FP-1039 also includes a portion of an antibody called the Fc region. In preclinical testing, it observed inhibition of tumor growth with single-agent FP-1039, particularly in tumors withFGFR1 gene amplification, including squamous NSCLC and SCLC.
FPA008
FPA008 is an antibody that inhibits CSF1R and is being developed to treat patients with RA. FPA008 also has the potential to treat patients with other inflammatory diseases, including lupus nephritis, psoriatic arthritis, ankylosing spondylitis, fibrosis, inflammatory bowel disease and multiple sclerosis. These are chronic, incurable disorders with serious medical complications and disability for ! which better therapies with novel mechanisms of action are needed. FPA008 is an anti-CSF1R antibody, which it designed to block the ability of IL-34 and CSF1 to bind to and activate CSF1R. FPA008 reduces the numbers and activity of monocytes and macrophages that cause disease, and prevents the production and release of inflammatory factors. The Company and others has demonstrated that both IL-34 and CSF1 are present at increased levels in the inflamed joints of patients with RA.
FPA144
FPA144 is a monoclonal antibody directed against a form of FGFR2, or FGFR2b. When the FGFR2 gene is amplified by cancer cells, the FGFR2b protein is expressed at abnormally high levels on the tumor�� surface. This occurs in some patients with gastric and lower esophageal cancers. The tumor cells that have too much FGFR2b protein on their surface can be identified by special staining tests performed on the tumor. Because FGFR2b is the target for FPA144, patients��tumors can be screened for this protein, helping to identify the patients most likely to respond to FPA144 treatment.
Advisors' Opinion:- [By Monica Gerson]
Breaking news
Alcoa (NYSE: AA) is investing US$13 million to expand its wheel manufacturing plant in Europe, to meet growing demand for its lightweight, durable, low-maintenance aluminum truck wheels. To read the full news, click here. L & L Energy (NASDAQ: LLEN) announced today that its Special Independent Committee has appointed Mr. Nicholas Chen, Managing Partner at Pamir Law Group, to replace Mr. Mark Bartlett. To read the full news, click here. Five Prime Therapeutics (NASDAQ: FPRX) and Bristol-Myers Squibb (NYSE: BMY) announced today that they have signed a collaboration agreement for the discovery, development and commercialization of immuno-oncology therapies directed toward targets identified in two undisclosed immune checkpoint pathways using Five Prime's proprietary target discovery platform. To read the full news, click here. First Solar (NASDAQ: FSLR) on Sunday announced the completion of the 1.3MW(DC) solar photovoltaic (PV) power plant at Kitakyushu-shi. Powered by First Solar FS Series 3 Black PV modules, the plant will generate approximately 1,400 MWh of clean and safe solar electricity per year. To read the full news, click here.Posted-In: Credit Suisse US Stock FuturesNews Eurozone Futures Global Pre-Market Outlook Markets
- [By John Kell and Tess Stynes var popups = dojo.query(".socialByline .popC"); p]
Among the companies with shares expected to actively trade in Monday’s session are Keurig Green Mountain Inc.(GMCR), JA Solar Holdings Co.(JASO) and Five Prime Therapeutics Inc.(FPRX)
Best Medical Stocks To Watch Right Now: Biota Pharmaceuticals Inc (BOTA)
Biota Pharmaceuticals, Inc., formerly Nabi Biopharmaceuticals, incorporated on March 14, 1969, is an anti-infective drug development company, with key expertise in respiratory diseases, particularly influenza. Biota developed the neuraminidase inhibitor, zanamivir, subsequently marketed by GlaxoSmithKline as Relenza. The Company�� researches include a series of candidate drugs aimed at treatment of respiratory syncytial virus (RSV) disease and Hepatitis C (HCV) virus infections. In addition, Biota and Daiichi Sankyo co-own a range of second generation influenza anti-virals, of which the lead product lnavir, is approved for marketing in Japan.
The Company�� products include Zanamivir, Inavi, Phoslyra, BioStar OIA FLU and BioStar OIA FLU A/B. Zanamivir is a neuraminidase inhibitor for the treatment and prophylaxis of influenza marketed as Relenza by GlaxoSmithKline. Inavi (laninamivir) is a neuraminidase inhibitor marketed by Daiichi Sankyo in Japan. Phoslyra is a phosphate binder indicated to reduce serum phosphorus in patients with end stage renal disease (ESRD). BioStar OIA FLU and BioStar OIA FLU A/B are influenza diagnostic tests, which are marketed by Inverness Medical as part of their BioStar product range.
Relenza is delivered directly to the primary site of infection on the lungs, using a Disk Inhaler device. Relenza is approved in over 50 countries for the treatment of influenza, including in the United States, the European Union, Japan and Australia. Relenza is also approved for use as a preventative (prophylactic) treatment against influenza. Inavir is approved for sale in Japan for the treatment of influenza in adults and children. Daiichi Sankyo has applied to sell Inavir in Japan for the prevention of influenza.
PhosLo and Phoslyra are different dose forms of calcium acetate; a phosphate binder approved in multiple countries for the control of hyperphosphatemia (high serum phosphate) in patients with end stage renal disease (ESRD). PhosLo and Pho! slyra were sold to Fresnius Medical Care. Biota, together with its Japanese based partner, Daiichi Sankyo, have developed an inhaled antiviral compounds for influenza, called long acting inhaled neuraminidase inhibitors (LANI). Biota's human rhinovirus (HRV) drug for the prevention and treatment of the causes of the common cold, BTA798, has completed Phase I, Phase IIa and Phase IIb clinical trials.
Advisors' Opinion:- [By gurujx]
Biota Pharmaceuticals Inc (BOTA) Reached the 3-year Low of $2.42
The prices of Biota Pharmaceuticals Inc (BOTA) shares have declined to close to the 3-year low of $2.42, which is 93.3% off the 3-year high of $34.92.
Best Medical Stocks To Watch Right Now: Navidea Biopharmaceuticals Inc (NAVB)
Navidea Biopharmaceuticals, Inc. (Navidea), formerly Neoprobe Corporation, incorporated in 1983, is a biopharmaceutical company focused on the development and commercialization of precision diagnostic agents. As of December 31, 2011, the Company�� radiopharmaceutical development programs included Lymphoseek (Lymphoseek, Kit for the Preparation of Technetium Tc99m for Injection), a radiopharmaceutical agent for lymph node mapping; AZD4694, an imaging agent, and RIGScan, a tumor antigen-specific targeting agent. In January 2012, the Company executed an option agreement with Alseres Pharmaceuticals, Inc. (Alseres) to license [123I]-E-IACFT Injection, also called Altropane, an Iodine-123 radiolabeled imaging agent, being developed as an aid in the diagnosis of Parkinson�� disease, movement disorders and dementia. In August 2011, the Company sold its gamma detection device line of business (the GDS Business) to Devicor Medical Products, Inc.
Lymphoseek
Navidea�� pipeline includes clinical-stage radiopharmaceutical agents used to identify the presence and status of disease. Lymphoseek (Kit for the Preparation of Technetium Tc99m for Injection) is a lymph node targeting agent intended for use in intraoperative lymphatic mapping (ILM) procedures and lymphoscintigraphy employed in the overall diagnostic assessment of certain solid tumor cancers. The lymph system is a component of the body�� immune system. The key components of the lymph system are lymph nodes-small anatomic structures that contain disease-fighting lymphocytes, filter lymph of bacteria and cancer cells, and signal infection in response to heightened levels of pathogens. In Navidea�� Phase III clinical studies of Lymphoseek, it detected over 99% of positive nodes identified by vital blue dye (VBD). As of December 31, 2011, Navidea, in co-operation with UC, San Diego affiliate (UCSD), completed or initiated five Phase I clinical trials, one multi-center Phase II trial and three multi-center Phase II trials inv! olving Lymphoseek. Two Phase III studies were completed in subjects with breast cancer and melanoma. During the year ended December 31, 2011, data from NEO3-09 were released, which indicated that all primary and secondary endpoints for the study were met. As of December 31, 2011, third Phase III clinical trial for Lymphoseek in subjects with head and neck squamous cell carcinoma (NEO3-06) was in progress.
AZD4694
AZD4694 is a Fluorine-18 labeled precision radiopharmaceutical candidate for use in the imaging and evaluation of patients with signs or symptoms of cognitive impairment such as Alzheimer's disease (AD). It binds to beta-amyloid deposits in the brain that can then be imaged in positron emission tomography (PET) scans. Amyloid plaque pathology is a required feature of AD and the presence of amyloid pathology is a supportive feature for diagnosis of probable AD. Patients who are negative for amyloid pathology do not have AD. AZD4694 has been studied in several clinical trials. Clinical studies through Phase IIa have included more than 80 patients to date, both suspected AD patients and healthy volunteers. No significant adverse events have been observed. Results suggest that AZD4694 has the ability to image patients quickly and safely with high sensitivity.
RadioImmunoGuided Surgery
As of December 31, 2011, RIGScan had been studied in a number of clinical trials, including Phase III studies. Navidea has conducted two Phase III studies, NEO2-13 and NEO2-14, of RIGScan in patients with primary and metastatic colorectal cancer, respectively. Both studies were multi-institutional involving cancer treatment institutions in the United States, Israel, and the European Union.
The Company competes with Pharmalucence, Eli Lilly, Bayer Schering, General Electric and GE Healthcare.
Advisors' Opinion:- [By Lauren Pollock]
Among the companies with shares expected to actively trade in Tuesday’s session are Toll Brothers Inc.(TOL) and Navidea Biopharmaceuticals Inc.(NAVB)
- [By Keith Speights]
3. Navidea Biopharmaceuticals (NYSEMKT: NAVB )
Some investors were likely befuddled by Navidea's stock action earlier this year. The company received FDA approval in March for Lymphoseek, its radiopharmaceutical agent used for imaging lymph nodes in patients with breast cancer or melanoma. That was great news, but shares dropped quickly and still haven't returned to previous levels. - [By Sean Williams]
Diagnostics can also play an important role in early and late-stage breast cancer diagnoses. Navidea Biopharmaceuticals (NYSEMKT: NAVB ) had Lymphoseek, its external lymph-node imaging and intra-operative lymphatic mapping diagnostic device, approved by the Food and Drug Administration earlier this year to help doctors stage cancer. Discovering whether breast cancer has invaded adjacent lymph nodes has never been easier or safer thanks to Lymphoseek, and it can dramatically aid physicians in determining the best course of action for breast cancer patients.
- [By Sean Williams]
Another prime example here would be Navidea Biopharmaceuticals' (NYSEMKT: NAVB ) Lymphoseek which is an injectable agent used in external lymph-node imaging and intra-operative lymphatic mapping. In English this means it will dramatically improve the staging and treatment options for patients with breast cancer. Being that breast cancer was also listed as a commonly misdiagnosed cancer, this is a big step in the right direction for patient care.
Best Medical Stocks To Watch Right Now: Discount Dental Materials Inc (DDOO)
Discount Dental Materials, Inc. (DDM), incorporated on December 18, 2007, is a development-stage company. The Company focuses on selling disposable dental supply products at discount prices over the Internet. As of November 30, 2011, the Company had not generated any revenues.
The Company focuses on selling a limited number of products including burs (modern dental drills that can rotate at up to 800,000 revolutions per minute (rpm) and generally use hard metal rotary files). Dental burs come in a variety of shapes designed for specific applications. They are often made of steel with a tungsten carbide coating or of tungsten carbide entirely. The bur may also have a diamond coating), bearings, turbines and sterilization pouches. The Company uses a facility in Burbank, California to store and ship products.
The Company competes with Henry Schein and Patterson Dental.
Advisors' Opinion:- [By CRWE]
Today, DDOO remains (0.00%) +0.000 at $1.00 thus far (ref. google finance Delayed: 10:12AM EDT�June 25, 2013).
Bond Laboratories, Inc. previously reported NDS launched two exciting new products at the annual GNC庐 Global Franchise Convention.
Cerebain Biotech Corp. a subsidiary of Discount Dental Materials, Inc. previously reported the appointment of Dr. Surinder Saini as Chairman of its Scientific Advisory Board. The advisory board provides key clinical insight into the company�� efforts to develop and commercialize a novel approach to the treatment for patients suffering from Alzheimer�� disease. Dr. Saini is the lead scientist behind the development of the world’s first medical device specifically designed for the treatment of Alzheimer�� disease utilizing the Omentum
- [By CRWE]
Today, DDOO remains (0.00%) +0.000 at $1.05 thus far (ref. google finance Delayed:� 3:42PM EDT July 1, 2013).
Cerebain Biotech Corp. a subsidiary of Discount Dental Materials, Inc. , previously reported that medical device product development company, Sonos Models, Inc. (��onos��, is set to complete the first prototypes of its medical device solution during the company�� first fiscal quarter, which begins July 1, 2013.
Cerebain�� President, Eric Clemons, stated, ��e are excited with the imminent completion of the first set of prototypes of our Medical Device Product for the treatment of Alzheimer�� Disease. Years of hard work and research will culminate with the introduction of these prototypes which will utilize the Omentum for the treatment of patients with this debilitating disease. With these prototypes, we are introducing a leading edge approach to the treatment of Alzheimer�� Disease.��/p>
- [By CRWE]
Last Friday, DDOO previously surged (+5.00%) up +0.05 at $1.05 with 10,200 shares in play at the close (ref. google finance June 28, 2013 ��Close).
Bond Laboratories, Inc. previously reported NDS launched two exciting new products at the annual GNC庐 Global Franchise Convention.
Cerebain Biotech Corp. a subsidiary of Discount Dental Materials, Inc. previously reported the appointment of Dr. Surinder Saini as Chairman of its Scientific Advisory Board. The advisory board provides key clinical insight into the company�� efforts to develop and commercialize a novel approach to the treatment for patients suffering from Alzheimer�� disease. Dr. Saini is the lead scientist behind the development of the world’s first medical device specifically designed for the treatment of Alzheimer�� disease utilizing the Omentum
Best Medical Stocks To Watch Right Now: StemCells Inc (STEM)
StemCells, Inc. (StemCells), incorporated in August 1988, is engaged in the research, development, and commercialization of stem cell therapeutics and related tools and technologies for academia and industry. The Company is focused on developing and commercializing stem and progenitor cells as the basis for therapeutics and therapies, and cells and related tools and technologies to enable stem cell-based research and drug discovery and development. The Company�� primary research and development efforts are focused on identifying and developing stem and progenitor cells as potential therapeutic agents. The Company has two therapeutic product development programs, including its CNS Program, which is developing applications for HuCNS-SC cells, its human neural stem cell product candidate, and its Liver Program, which is characterizing the Company�� human liver cells as a therapeutic product.
CNS Program
The Company in its CNS Program, is in clinical development with its HuCNS-SC cells for a range of disorders of the central nervous system. The CNS includes the brain, spinal cord and eye. In February 2012, the Company had completed a Phase I clinical trial in Pelizeaus-Merzbacher Disease (PMD), a fatal myelination disorder in the brain.
The Company�� CNS Program is focused on developing clinical applications, in which transplanting HuCNS-SC cells protect or restore organ function of the patient before such function is irreversibly damaged or lost due to disease progression. The Company�� initial target indications are PMD, and more generally, diseases in which deficient myelination plays a central role, such as cerebral palsy or multiple sclerosis; spinal cord injury, disorders in which retinal degeneration plays a central role, such as age-related macular degeneration or retinitis pigmentosa. The Company�� product candidate, HuCNS-SC cells, is a purified and expanded composition of normal human neural stem cells. Its HuCNS-SC cells can be directly transp! lanted.
Liver Program
Liver stem or progenitor cells offer an alternative treatment for liver diseases. A liver cellular therapy or cell-based therapeutic provide or support liver function in patients with liver disease. The Company held a portfolio of issued and allowed patents in the liver field, which cover the isolation and use of both hLEC cells and the isolated subset, as well as the composition of the cells themselves.
The Company�� range of cell culture products, which are sold under the SC Proven brand, includes iSTEM, GS1-R, GS2-M, RHB-A, RHB-Basal, NDiff N2, and NDiff N2B27. Its iSTEM is a serum-free, feeder-free medium that maintains mouse embryonic stem cells in their pluripotent ground state by using selective small molecule inhibitors to block the pathways, which induce differentiation. RHB-A is a defined, serum-free culture medium for the selective culture of human and mouse neural stem cells and their maintenance and expansion as adherent cell populations. RHB-Basal is a defined, serum-free basal medium. When supplemented with specific growth factors, this media is formulated for the propagation and differentiation of adherent neural stem cells. RHB-Basal can also be tailored to specific-cell type requirements by the addition of customer preferred supplements.
The Company�� NDiff N2 is a defined serum-free scell culture supplement for the derivation, maintenance, expansion and/or differentiation of human and mouse embryonic stem (ES) cells and tissue-derived neural stem cells supplement. Its NDiff N2-AF is a serum-free and animal component-free version of NDiff N2. Its NDiff N2B27 is a defined, serum-free medium for the differentiation of mouse embryonic stem cells to neural cell types. NDiff N27-AF is a serum-free and animal component-free version of NDiff N27. Its GS1-R is a serum-free media formulation shown to enable the derivation and long-term maintenance of true, germline competent rat embryonic stem cells without the add! ition of ! cytokines or growth factors. Its GS2-M is a defined, serum- and feeder-free medium for the derivation and long-term maintenance of true, germline competent mouse iPS cells.
The Company also markets a number of antibody reagents for use in cell detection, isolation and characterization. These reagents are also under the SC Proven brand and it includes STEM24, STEM101, STEM121 and STEM123. Its STEM24 is a human antibody that recognizes human CD24, also known as heat stable antigen (HSA), a glycoprotein expressed on the surface of many human cell types, including immature human hematopoietic cells, peripheral blood lymphocytes, erythrocytes and many human carcinomas. Its CD24 is also a marker of human neural differentiation. Its STEM101 is a human-specific mouse antibody that recognizes the Ku80 protein found in human nuclei. Its STEM121 is a human-specific mouse antibody that recognizes a cytoplasmic protein of human cells. Its STEM123 is a human-specific mouse antibody that recognizes human glial fibrillary acidic protein (GFAP).
The Company�� Other products marketed under SC Proven include total cell genomic DNA (gDNA), RNA and protein lysate reagents purified from homogenous stem cell populations for intra-comparative studies, such as Epigenetic fingerprinting, Southern, Western and Northern blots, PCR, RT-PCR and microarrays. This range of purified stem cell line lysates includes mouse embryonic stem (ES) cells propagated in SC Proven 2i inhibitor-based GS2-M media and mouse ES cell-derived and fetal tissue-derived neural stem (NS) cells propagated in SC Proven RHB-A media.
Advisors' Opinion:- [By Garrett Cook]
Healthcare shares gained 0.81 percent in the US market on Friday. Top gainers in the sector included Shire plc (NASDAQ: SHPG), StemCells (NASDAQ: STEM), and Flamel Technologies SA (NASDAQ: FLML).
- [By James E. Brumley]
When an investor thinks of spinal-related stem cell stocks, usually a name like Neuralstem, Inc (NYSEMKT: CUR) or StemCells Inc (NASDAQ: STEM) comes to mind. And well they should. STEM has logged some amazing breakthroughs in the field of spinal cord repair, while CUR has done the same. Not all back problems are spinal cord related though. In fact, most back problems - and therefore the most opportunity - are bone and disc related problems. That's where a young gun like BioRestorative Therapies (OTCBB: BRTX) can step in and make stem cell waves. BRTX has developed an approach to rejuvenate and revive failing spinal discs, potentially ending pain for millions of back-pain sufferers, and circumventing expensive spinal surgeries that are in increasing burden on insurance companies.
- [By John Udovich]
The results of a recent Pew Center Poll regarding attitudes towards abortion and various forms of stem cell research could be a good sign for the stem cell industry along with small cap stem cell stocks like StemCells Inc (NASDAQ: STEM), NeoStem Inc (NASDAQ: NBS), Neuralstem, Inc (NYSEMKT: CUR),�International Stem Cell Corp (OTCMKTS: ISCO) and BioRestorative Therapies (OTCBB: BRTX). Basically, Americans think that having an abortion is a moral issue with 49% of American adults believing abortion is morally wrong, 23%�view it not as a moral issue and and 15% view it as morally acceptable. However and when Americans were asked about issues surrounding�human embryos, such as stem cell research or in vitro fertilization, as a matter of morality, their views were different.
- [By Garrett Cook]
Healthcare shares gained 0.81 percent in the US market on Friday. Top gainers in the sector included Shire plc (NASDAQ: SHPG), StemCells (NASDAQ: STEM), and Flamel Technologies SA (NASDAQ: FLML).
Best Medical Stocks To Watch Right Now: Celgene Corp (CELG)
Celgene Corporation is a global biopharmaceutical company primarily engaged in the discovery, development and commercialization of therapies designed to treat cancer and immune-inflammatory related diseases. The Company is engaged in the research and development, which is designed to bring new therapies to market, and is engaged in research in several scientific areas that may deliver therapies, focusing areas, such as intracellular signaling pathways in cancer and immune cells, immunomodulation in cancer and autoimmune diseases, and therapeutic application of cell therapies. The Company�� primary commercial stage products include REVLIMID, VIDAZA, THALOMID, ABRAXANE and ISTODAX. Additional sources of revenue include a licensing agreement with Novartis, which entitles it to royalties on FOCALIN XR and the entire RITALIN family of drugs, the sale of services through its Cellular Therapeutics subsidiary and other miscellaneous licensing agreements. In March 2012, it acquired Avila Therapeutics.
The Company invests in research and development, and the drug candidates in its pipeline at various stages of preclinical and clinical development. These candidates include pomalidomide and apremilast, its oral anti-cancer and anti-inflammatory agents, PDA-001, its cellular therapy, oral azacitidine, CC-223 and CC-115 for hematological and solid tumor malignancies, CC-122, its anti-cancer pleiotropic pathway modifier, and ACE-011 and ACE-536 biological products for anemia in several clinical settings of unmet need. Celgene product candidates include Pomalidomide (CC-4047), Oral Anti-Inflammatory: Apremilast (CC-10004), CC-11050, Kinase Inhibitors:Tanzisertib (CC-930), Cellular Therapies: PDA-001, Activin Biology: Sotatercept (ACE-011) ACE-536, and Anti-tumor Agents: CC-22, CC-115, CC-122 and Oral Azacitidine. It owns and operates a manufacturing facility in Zofingen, Switzerland. The Company also owns and operates a drug product manufacturing facility in Boudry, Switzerland.
Commercial! Stage Products
REVLIMID (lenalidomide) is an oral immunomodulatory drug marketed in the United States and many international markets, in combination with dexamethasone, for treatment of patients with multiple myeloma who have received at least one prior therapy. It is also marketed in the United States and certain international markets for the treatment of transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes (MDS) associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities. REVLIMID is distributed in the United States through contracted pharmacies under the RevAssist program, which is a risk-management distribution program. Internationally, REVLIMID is distributed under mandatory risk-management distribution programs.
REVLIMID continues to be evaluated in numerous clinical trials worldwide either alone or in combination with one or more other therapies in the treatment of a range of hematological malignancies, including multiple myeloma (MDS) various lymphomas, chronic lymphocytic leukemia (CLL) other cancers and other diseases. VIDAZA (azacitidine for injection) is a pyrimidine nucleoside. VIDAZA is a Category 1 recommended treatment for patients with intermediate-2 and high-risk MDS and is marketed in the United States for the treatment of all subtypes of MDS. In Europe, VIDAZA is marketed for the treatment of intermediate-2 and high-risk MDS, as well as acute myeloid leukemia (AML) with 30% blasts and has been granted orphan drug designation for the treatment of MDS and AML.
THALOMID (thalidomide) is marketed for patients with newly diagnosed multiple myeloma and for the acute treatment of the cutaneous manifestations of moderate to severe erythema nodosum leprosum (ENL) an inflammatory complication of leprosy and as maintenance therapy for prevention and suppression of the cutaneous manifestation of ENL recurrence. THALOMID is distributed in the United States under its System f! or Thalid! omide Education and Prescribing Safety (S.T.E.P.S.) program. Internationally, THALOMID is also distributed under mandatory risk-management distribution programs. ABRAXANE (paclitaxel albumin-bound particles for injectable suspension) is a solvent-free chemotherapy treatment option for metastatic breast cancer, which was developed using its nab technology platform. This protein-bound chemotherapy agent combines paclitaxel with albumin. As of December 31, 2011, ABRAXANE was in various stages of investigation for the treatment of expanded applications for metastatic breast; non-small cell lung; malignant melanoma; pancreatic; bladder and ovarian.
ISTODAX (romidepsin) has received orphan drug designation for the treatment of non-Hodgkin's T-cell lymphomas, which includes CTCL and PTCL. The Company has licensed the worldwide rights (excluding Canada) regarding certain chirally pure forms of methylphenidate for FOCALIN and FOCALIN XR to Novartis. It also licensed to Novartis the rights related to long-acting formulations of methylphenidate and dex-methylphenidate products which are used in FOCALIN XR and RITALIN LA.
Preclinical and Clinical-Stage Pipeline
The product candidates in the Company�� pipeline are at various stages of preclinical and clinical development. Pomalidomide is a small molecule that is orally available and modulates the immune system and other biologically important targets. Pomalidomide is being evaluated in a phase III clinical trial for the treatment of myelofibrosis and a phase III clinical trial evaluating pomalidomide as a treatment for patients with relapsed/refractory multiple myeloma is accruing patients.
The Company is developing a product, ORAL ANTI-INFLAMMATORY AGENTS, which is orally available small molecules that target PDE4, an intracellular enzyme that modulates the production of multiple pro-inflammatory and anti-inflammatory mediators, including interleukin-2 (IL-2), IL-10, IL-12, IL-23, INF-gamma, TNF-a, leukotrienes,! and nitr! ic oxide synthase. Its investigational drug, apremilast (CC-10004), is used for the treatment of moderate to severe psoriasis and active psoriatic arthritis and is being evaluated in a phase II trial for rheumatoid arthritis and six phase III multi-center international clinical trials. In addition, it is investigating its oral PDE4 inhibitor, CC-11050, which is an anti-inflammatory compound that treat a variety of chronic inflammatory conditions, such as Cutaneous Lupus Erythematosus (CLE).
The Company�� oral kinase inhibitor platform includes inhibitors of the c-Jun N-terminal kinase (JNK) mTOR kinase, spleen tyrosine kinase (Syk) c-fms tyrosine kinase (c-FMS) and DNA-dependent protein kinase (DNAPK). Its oral Syk, c-FMS and DNAPK kinase inhibitors are being investigated in pre-clinical studies. The Company�� new second generation JNK inhibitor, tanzisertib (CC-930), is being evaluated in a phase II trial for the treatment of idiopathic pulmonary fibrosis and a phase II trial for the treatment of discoid lupus is accruing patients. Amrubicin is a third-generation fully synthetic anthracycline molecule with potent topoisomerase II inhibition.
At Celgene Cellular Therapeutics (CCT), it is researching stem cells derived from the human placenta, as well as from the umbilical cord. CCT is the Company�� research and development division. Stem cell based therapies provide disease-modifying outcomes for serious diseases, which lack adequate therapy. It has developed technology for collecting, processing and storing placental stem cells with broad therapeutic applications in cancer, auto-immune diseases, including Crohn's disease, multiple sclerosis, neurological disorders, including stroke and amyotrophic lateral sclerosis (ALS), graft-versus-host disease, and other immunological / anti-inflammatory, rheumatologic and bone disorders.
The Company has collaborated with Acceleron Pharma, Inc. (Acceleron) to develop sotatercept. Two phase I clinical studies have been co! mpleted. ! An additional phase II clinical study has been initiated and is ongoing related to treatments for end-stage renal anemia and to evaluate effects on red blood cell mass and plasma volume.
The Company competes with Abbott Laboratories, Amgen Inc. (Amgen), AstraZeneca PLC., Biogen Idec Inc., Bristol-Myers Squibb Co., Eisai Co., Ltd., F. Hoffmann-LaRoche Ltd., Johnson and Johnson, Merck and Co., Inc., Novartis AG, Pfizer, Sanofi and Takeda Pharmaceutical Co. Ltd. (Takeda).
Advisors' Opinion:- [By Rich Smith]
This series, brought to you by Yahoo! Finance, looks at which upgrades and downgrades make sense, and which ones investors should act on. Today, our headlines feature a pair of biotech upgrades for Gilead Sciences (NASDAQ: GILD ) and Celgene (NASDAQ: CELG ) . But the news isn't all good, so before we get to those, let's find out first why one ...
- [By Ben Levisohn]
J&J’s Velcade sales could be a good sign for Celgene (CELG) shareholders, according to Yee and team:
Velcade ex-US sales were $404M, up +7% Q/Q, likely due to continued growth with new SubQ formulation (much lower neuropathy tox) and EU approval as induction therapy in combination w/ dex or thalomid-dex in “first line” transplant eligible MM patients (EU approved August 2013). We think CELG puts up a solid Q3 too driven by market growth and increasing duration of therapy.
- [By Maxx Chatsko]
Rising biotech stars Celgene (NASDAQ: CELG ) , Biogen Idec (NASDAQ: BIIB ) , and Gilead Sciences (NASDAQ: GILD ) have all crushed the market in the last year. Heck, even Amgen has been rewarded by the market for making biologics and biosimilars a top priority. Shares of each company have shot upwards on earnings acceleration expectations thanks to promising late stage pipelines. Multiple potential megablockbusters in the wings could bring in billions in sales by the end of the decade if approved and launched successfully.
- [By Ben Levisohn]
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.
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