This week, these five stocks have the worst ratings in Earnings Growth, one of the eight Fundamental Categories on Portfolio Grader.
BlackBerry Limited () engages in the design, manufacture and marketing of wireless solutions worldwide. BBRY also gets F’s in Earnings Momentum, Analyst Earnings Revisions, Equity, Cash Flow and Sales Growth. .
Top 5 Small Cap Stocks To Watch Right Now: Puma Biotechnology Inc (PBYI)
Puma Biotechnology, Inc., incorporated in April 2007, is a development-stage biopharmaceutical company that acquires and develops products for the treatment of various forms of cancer. The Company focuses on in-licensing drug candidates that are undergoing or have already completed initial clinical testing for the treatment of cancer and then seeks to further develop those drug candidates for commercial use. As of December 31, 2011, the Company licensed three drug candidates: PB272 (neratinib (oral)), which the Company is developing for the treatment of advanced breasts cancer patients and gastric cancer patients; PB272 (neratinib (intravenous)), which the Company is developing for the treatment of advanced cancer patients, and PB357.
PB272 (neratinib (oral))-Breast Cancer
Neratinib is a potent irreversible tyrosine kinase inhibitor, or TKI, that blocks signal transduction through the epidermal growth factor receptors (EGFRs), HER1, HER2 and HER4. The Company's initial focus is on the development of neratinib as an oral treatment of patients with HER2 positive metastatic breast cancer.
PB272 (neratinib (intravenous))
The Company develops neratinib as an intravenously administered agent. In pre-clinical studies the intravenous version of neratinib resulted in higher exposure levels of neratinib in pre-clinical models.
PB357
PB357 is an orally administered agent that is an irreversible TKI that blocks signal transduction through the epidermal growth factor receptors, HER1, HER2, and HER4. PB357 is structurally similar to PB272. Pfizer completed single dose Phase I trials of PB357. The Company is evaluating PB357.
The Company competes with Genentech, GlaxoSmithKline, Roche, Boehringer Ingelheim, Takeda, Array Biopharma and Ambit Biosciences.
Advisors' Opinion:- [By Anna Prior]
Puma Biotechnology Inc.(PBYI) reported positive top-line data from the Phase II clinical trial of the biopharmaceutical company’s investigational drug PB272 for the neoadjuvant treatment of breast cancer.
- [By Ben Levisohn]
The Dow Jones Industrial Average and S&P 500 squeaked out new highs today, while the Nasdaq Composite and small caps dropped, following stronger-than-forecast manufacturing data out of China and a U.S. manufacturing survey that had to be corrected twice. Caterpillar (CAT) and Broadcom�(BRCM) gained, while Express Scripts (ESRX) and Puma Biotechnology (PBYI) tumbled.
- [By Lee Jackson]
Puma Biotechnology Inc. (NYSE: PBYI) is a stock that UBS views as having multiple catalysts. The analysts are positive on the potential for their cancer drug neratinib to demonstrate positive data in neoadjuvant breast, as well as specific genetic mutations for other cancers. Success in either area may lead to strong upside for the stock. The UBS price target is $61, while consensus is at $62.50.
Top 10 Biotech Stocks To Watch For 2014: Intrexon Corp (XON)
Intrexon Corporation, incorporated on April 19, 2004, is engaged in the business of synthetic biology. Using the Company�� suite of complementary technologies, it design, build and regulate gene programs, or sequences of deoxyribonucleic acid (DNA) that control cellular function, and cellular systems, or activities that take place within a cell and the interaction of those systems in the greater cellular environment, to enable the development of new and improved products and manufacturing processes across a variety of end markets, including healthcare, food, energy and environmental sciences. Its technologies include the UltraVector gene design and fabrication platform; Cell Systems Informatics; LEAP-cell identification and selection, and mAbLogix-antibody discovery.
The Company�� LEAP technology facilitates the automated identification of an individual cell with the highest levels of expression, quality and potency from a population of over 100,000 cells. Its mAbLogix platform complements UltraVector with a library of human antibodies that exceeds 500 million. By immortalizing human tonsils, which consists of lymphatic tissue containing B-cells, its mAbLogix platform creates a B-cell library that can generate antibodies against an almost infinite number of new antigens.
The UltraVector gene design and fabrication platform
The Company�� gene program design platform, which it refer to as UltraVector, is an integrated suite of tools comprising advanced DNA construction technology and components, cellular and protein engineering tools, computational models and statistical methods which facilitate the rapid design, build and testing of complex systems. The UltraVector platform allows the Company to translate gene programs into standard components that can be designed, manufactured and tested in an automated format. This technology enables it to engineer at the cellular level from biological sources.
UltraVector DNA design is computer-automated and ! utilizes a set of defined construction rules to assemble components that are stored in its DNA library. In addition to the number of gene components in its UltraVector library, it is designing and creating enzymatic and regulatory components that provide control over genome integration and gene regulation. Its RheoSwitch Therapeutic System is a three-component transcriptional regulator that provides inducible gene expression. The RheoSwitch Therapeutic System provides the ability to not only express proteins/enzymes of interest, but also the ability to control the level and timing of expression to achieve a biological outcome. Other ongoing programs include its Attsite recombinases, which mediate predictable gene exchange into host cells thereby eliminating many of the difficulties seen with traditional gene insertion.
Cell Systems Informatics
The Company�� Cell systems informatics permits design, as well as testing and learning about new gene targets or product pathways. Its bioinformatics software and database systems for mapping cellular pathways when combined with its genome-scale modeling and experimental data, including, gene expression profiling and protein engineering, enable the Company to optimize selection and development of gene programs and cellular systems for its collaborators. Its computational modeling and simulation platform enables the development of predictive computer models of organisms, from microbes to humans. This platform builds virtual cells from their basic molecular components, and can simulate the activity of the cell�� complete reaction network.
The Company is designing proteins with post-translational modifications. It is also working to develop enzyme inhibitors and fusion proteins for a variety of applications in human and animal therapeutics. Its protein engineering may utilize one or more of its technologies to obtain catalysis activitiesits component library, the generation of component variants sequence, evolutionary analy! sis and s! tructure-based sequence alignment, computer-aided drug discovery, de novo, or synthesized or generated, and comparative protein modeling, molecular dynamics simulation and free energy analysis, antibody design and humanization, antigenicity prediction, protein pharmacokinetics optimization, and/or in silico support of enzyme engineeringand quantitative structure-function relationships with machine learning algorithms to optimize, facilitate and prioritize protein variant libraries for the advancement of its collaborators.
LEAP-cell identification and selection
The Company�� Laser-Enabled Analysis and Processing technology (LEAP), is an instrument that merges semiconductor manufacturing technologies for cell processing applications to provide high levels of control and scale to cell purification and stem cell culture management. The LEAP platform can identify and purify cells of interest from large libraries of cells created by its UltraVector and bioinformatics technologies using a laser-based purification process, thereby providing a mechanism of testing the degree of protein expression in genetically modified cells, as well as means to learn from the genetic building process.
mAbLogix- antibody discovery
The Company�� mAbLogix antibody discovery platform, or mAbLogix platform, enables production of B-cell libraries for discovery of antibodies. The mAbLogix platform permits antigen targeting using fully human monoclonal and polyclonal antibodies. Its mAbLogix antibody discovery process consists of two major activities: the build of human B-cell libraries expressing a large number of antibodies, and the testing of these libraries based on an analysis of B-cells that express antibodies in response to a chosen antigen.
The Company competes with AbD SeroTec, Alexion Pharmaceuticals, Inc., XOMA Corporation, Genmab US, Inc., MorphoSys AG, NovImmune SA, Societe Des Systemes Biologiques, Adimab, LLC, ProMab Biotechnologies, Inc., Abpro, Inc.,! AIIM The! rapeutics and Open Monoclonal Technology, Inc.
Advisors' Opinion:- [By John Udovich]
Bubble talk, biotech IPO setbacks plus news�about small cap biotechs like Intrexon Corp (NYSE: XON) and TNI BioTech (OTCMKTS: TNIB) have dominated biotech news this week or in recent weeks. Just consider the following news:
- [By Jon C. Ogg]
Intrexon Corp. (NYSE: XON) was started as Buy at Mizuho Securities, started as Equal Weight at Barclays and started as Overweight at J.P. Morgan.
Nokia Corp. (NYSE: NOK) was raised to Hold from Sell at Deutsche Bank, raised to Neutral from Underperform at Credit Suisse and
Canaccord Genuity raised its price target to $5.50 from $3.30.
Top 10 Biotech Stocks To Watch For 2014: OncoMed Pharmaceuticals Inc (OMED)
OncoMed Pharmaceuticals, Inc. (OncoMed) incorporated on July 19, 2004, is a clinical development-stage biopharmaceutical company. The Company focuses on discovering and developing monoclonal antibody therapeutics targeting cancer stem cells (CSCs). It utilizes its technologies to identify, isolate and evaluate CSCs; identify and/or validate multiple potential targets and pathways critical to CSC self-renewal and differentiation; and develop targeted antibody and other protein-based therapeutics that are designed to modulate these CSC targets and inhibit the growth of CSCs. The Company's anti-cancer therapeutics include anti-DLL4 (demcizumab, OMP-21M18), Anti-DLL4/Anti-VEGF Bispecific, and Anti-Notch2/3 (OMP-59R5), Anti-Notch1 (OMP-52M51, Anti-Fzd7, Fzd8-Fc, RSPO-LGR.
Anti-DLL4 (demcizumab, OMP-21M18) is a humanized monoclonal antibody that inhibits Delta Like Ligand 4 (DLL4) in the Notch signaling pathway. The Company has completed a single-agent Phase Ia trial in advanced solid tumor patients. The Company focuses on conducting two Phase Ib combination trials of demcizumab. Anti-DLL4/anti-VEGF bispecific is a monoclonal antibody that targets and inhibits both DLL4 and vascular endothelial growth factor ( VEGF). VEGF is the target of Avastin. Anti-Notch2/3 (OMP-59R5) is a human monoclonal antibody that targets the Notch2 and Notch3 receptors.
Anti-Notch1 OMP-52M51 is a humanized monoclonal antibody targeted to the Notch1 receptor. Anti-Fzd7 OMP-18R5 is a human monoclonal antibody identified by screening against the Frizzled7 receptor (Fzd7) that binds a conserved epitope on five Frizzled receptors and inhibits Wnt signaling. OMP-18R5 is in a Phase I single-agent trial in advanced solid tumor patients. Fzd8-Fc OMP-54F28 is a fusion protein based on a truncated form of the Frizzled8 receptor ( Fzd8). RSPO-LGR ligands signal through the LGR receptor family.
The Company utilizes several robust technologies for the discovery and optimization of its antibody and protein-bas! ed therapeutics, including multiple proprietary technologies. Its antibody technologies include Mammalian Display Technology, Bispecific Antibody Technology, Hybridoma Technology. Mammalian Display Technology utilizes flow cytometry to isolate mammalian cells expressing antibodies on the cell surface with desired characteristics from large libraries of candidate antibodies. Bispecific Antibody Technology is used to generate its anti-DLL4/anti-VEGF antibody. Hybridoma Technology is used for isolating antibodies from mice, including multiplex single-cell screening techniques.
Advisors' Opinion:- [By Stephen Quickel]
Recently, too, Celgene has formed a strategic partnership with OncoMed (OMED) to develop up to six anti-cancer stem-cell antibodies.
Celgene itself has posted four successive quarters of revenue growth, which is expected to lift annual sales from $5.5 to $6.4 billion for calendar 2013, and to $7.5 billion in 2014. Despite its expanding size, earnings per share are projected to grow by 23.2% a year, by 28 Street analysts following its stock.
- [By Roberto Pedone]
OncoMed Pharmaceuticals (OMED), a clinical development-stage biotechnology company, focuses on discovering and developing monoclonal antibody therapeutics targeting cancer stem cells. This stock closed up 5.3% at $18.08 in Monday's trading session.
Monday's Volume: 446,000
Three-Month Average Volume: 178,792
Volume % Change: 155%From a technical perspective, OMED ripped higher here right above previous support at $16.57 with above-average volume. This stock has been downtrending badly for the last four months and change, with shares moving lower from its high of $28.43 to its recent low of $16.57. During that move, shares of OMED have been making mostly lower highs and lower lows, which is bearish technical price action. That said, shares of OMED have now starting to rebound off some previous support and it's quickly moving within range of triggering a near-term breakout trade. That trade will hit if OMED manages to clear some near-term overhead resistance levels at $19.17 to its 50-day at $19.92 and then above more resistance at $20 with high volume.
Traders should now look for long-biased trades in OMED as long as it's trending above some key near-term support at $16.57 and then once it sustains a move or close above those breakout levels with volume that hits near or above 178,792 shares. If that breakout kicks off soon, then OMED will set up to re-test or possibly take out its next major overhead resistance levels at $21.80 to $22.43, or even $24 to $24.48.
- [By WWW.DAILYFINANCE.COM] Stocks ended a mini-losing streak on Friday, led by upbeat news from Intel (INTC). The Dow Jones industrial average (^DJI) rose 41 points, after sliding more than 200 over the previous two days. The Nasdaq composite (^IXIC) gained 13 and the Standard & Poor's 500 index (^GPSC) added 6 points. Those modest gains did little to trim the loss for the week. The major averages posted their biggest weekly declines in more than two months. Intel is a component of all three big indexes, and it jumped 7 percent after raising its revenue guidance for the current quarter. The company sees stronger business demand for PCs than it previously expected. Intel shares are up 23 percent over the past six months. The Intel news had a ripple effect. Computer maker Hewlett-Packard (HPQ) rose more than 5 percent and Microsoft (MSFT) gained 1½ percent. Part of the increased demand Intel points to is tied to corporate buyers who need to replace their Windows XP machines, because Microsoft has stopped providing technical support for that platform. But Apple (AAPL) lost more than 1 percent. The stock is down since its 7-for-1 stock split took effect on Monday. There were two other big stories that had some legs beyond the companies directly involved. Open Table (OPEN) agreed to be acquired by Priceline (PCLN) for $2.6 billion. Open Table, which provides restaurant reservations, jumped 48 percent. Other online service providers rode the coattails of that deal. Yelp (YELP) gained 14 percent and Groupon (GRPN) gained 4 percent. In the retail arena, Express (EXPR) jumped 21 percent after a private equity firm took a 9.9 percent stake in the teen retailer and indicated it may make a buyout offer. That gave a boost to Aeropostale (ARO) and American Eagle (AEO), which both rose more than 2 percent. Abercrombie & Fitch (ANF) gained 1½. Elsewhere, International Game Technology (IGT) gained 10½ percent on a Reuters report that a bidding war could erupt for
- [By Jake L'Ecuyer]
Equities Trading UP
OncoMed Pharmaceuticals (NASDAQ: OMED) shot up 8.62 percent to $30.09 after the company initiated Phase 1B trial of WNT-parthway-target antibody. Jefferies lifted the price target on the stock from $27 to $46.
Top 10 Biotech Stocks To Watch For 2014: 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�� 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.
Advisors' Opinion:- [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. �
Top 10 Biotech Stocks To Watch For 2014: Cytomedix Inc (CMXI)
Cytomedix, Inc. (Cytomedix), incorporated in April 29, 1998, is a regenerative therapies company marketing and developing products within the United States and internationally .The Company commercializes cell-based technologies that harness the regenerative capacity of the human body to trigger natural healing. The Company is a commercial operation, and a robust clinical pipeline representing a logical extension of its commercial technologies in the evolving field of regenerative medicine. Cytomedix primarily operates in the United States. Its commercial offerings are centered on its point of care platform technologies for the safe and efficient separation of blood and bone marrow to produce platelet based therapies or cell concentrates.
The Company markets and selsl two distinct platelet rich plasma (PRP) technologies, the AutoloGel System for wound care and the Angel concentrated Platelet Rich Plasma (cPRP) Sytem in orthopedic and cardiovascular markets. Its clinical pipeline includes the ALDH, which are cell-based therapies (Bright Cells). In February 2012, the Company acquired Aldagen, Inc.
The AutoloGel System
The AutoloGel System is a point of care device for the production of a platelet based bioactive therapy derived from a small sample of the patient�� own blood. Using the patient�� own platelets as a therapeutic agent, AutoloGel harnesses the body�� natural healing processes to deliver growth factors, chemokines and cytokines known to promote angiogenesis and to regulate cell growth and the formation of new tissue.
Angel Product Line
The Angel concentrated Platelet Rich Plasma (cPRP) System is a multi-functional cell separation device which produces concentrated platelet rich plasma for use in the operating room and clinic and is used in a range of orthopedic and cardiovascular indications. Similar to the AutoloGel System, the Angel System is a point of care device for the production of a concentrated, aseptic platelet! -based bioactive therapy derived from a small sample of the patient�� own blood. The resulting cPRP is applied at the site of injury to promote healing. The Angel product line also includes ancillary products such as phlebotomy and applicator supplies and activAT. activAT is designed to produce autologous thrombin serum from platelet poor plasma and is sold exclusively in Europe and Canada, where it provides a safe alternative to bovine-derived products.
ALDHbr Cell Technology and Development Pipeline
The ALDHbr (Bright Cell) technology is an approach to cell-based regenerative medicine and a logical extension of its commercial technologies in the evolving regenerative medicine market, with potential clinical indications in markets with unmet medical needs such as peripheral arterial disease and ischemic stroke. The Bright Cell technology is in that it utilizes an intracellular enzyme marker to facilitate fractionation of essential regenerative cells from a patient�� bone marrow. The bone marrow fractionation process identifies and isolates active stem and progenitor cells expressing high levels of the enzyme aldehyde dehydrogenase, or ALDH, which is a key enzyme involved in the regulation of gene activities associated with cell proliferation and differentiation.
The Company�� lead product candidate, ALD-401, is an autologous preparation of Bright Cells for the post-acute treatment of ischemic stroke. ALD-401 is being evaluated in the RECOVER-Stroke clinical study, an ongoing 100-patient, double-blind, placebo-controlled Phase 2 study in patients with unilateral, cerebral ischemic stroke with an NIH stroke scale score of less than 22. An additional product candidate, ALD-301, is in clinical development for peripheral arterial disease (PAD), a condition causing reduced flow of blood and oxygen to muscles in the leg. It has completed a Phase 1/2 study of autologous ALD-301 in critical limb ischemia (CLI), a late stage condition caused by PAD. The Phase 2 PACE! (Patient! s with Intermittent Claudication Injected with ALDH Bright Cells) study is an 80 patient, double-blind, placebo-controlled clinical trial intended to demonstrate the safety and efficacy of ALD-301 (Bright Cells) in patients diagnosed with IC.
The Company competes with Harvest Technologies (a subsidiary of Terumo), Biomet, Arteriocyte, and Arthrex.
Advisors' Opinion:- [By Bryan Murphy]
When traders think of post-surgical wound management stocks, they may first think of names like Cytomedix, Inc. (OTCBB:CMXI) or Alliqua Inc. (OTCMKTS:ALQA). And well they should. Both companies have something of a history in the arena. ALQA is the purveyor of SilverSeal and Hydress antibiotic bandages, while CMXI is the developer of the AutoloGel system, which induces an affected patient's on body to do what it's supposed to do if there's a wound that won't heal. Cytomedix also makes the Angel platelet-rich plasma (PRP) delivery system. There's a relatively new name to add to the list of game-changing stocks in wound-management industry, however.... Arch Therapeutics Inc. (OTCBB:ARTH). The company is developing - well, has developed - a product called AC5 that nips post-surgical bleeding in the bud, largely negating the need for other post-surgical bleeding-control measures.
Top 10 Biotech Stocks To Watch For 2014: Alcobra Ltd (ADHD)
Alcobra Ltd is an Israel-based Biopharmaceutical company. It focuses on the development and commercialization of a proprietary drug, MG01CI, to treat Attention Deficit Hyperactivity Disorder (ADHD), a common and morbid neuropsychiatric condition in children and adults. Adult ADHD is associated with increased health risks and healthcare costs, higher divorce rates, lower levels of socioeconomic attainment, lower academic achievement, unemployment and work place deficits, increased risks for motor vehicle accidents, greater likelihood of additional psychiatric disorders, increased criminal activity and incarceration, and higher rates of substance use and abuse. MG01CI product has completed phase two studies. Advisors' Opinion:- [By Roberto Pedone]
A biopharmaceutical stock that's starting to trend within range of triggering a big breakout trade is Alcobra (ADHD), which is engaged in the development and commercialization of its proprietary drug, MG01CI, to treat attention deficit hyperactivity disorder. This stock has been on fire so far in 2013, with shares up huge by 126%.
If you take a look at the chart for Alcobra, you'll notice that this stock has been trending sideways and consolidating over the last month and change, with shares moving between $14.78 on the downside and $18.75 on the upside. Shares of ADHD have now started to uptrend a bit over the last few weeks, with shares moving higher from its low of $15.05 to its recent high of $18.45 share. That move has started to push shares of ADHD within range of triggering a big breakout trade above the upper-end of its recent sideways trading chart pattern.
Traders should now look for long-biased trades in ADHD if it manages to break out above its 50-day moving average of $17.79 a share, and then once it takes out some more key overhead resistance levels at $18.45 to $18.75 a share with high volume. Look for a sustained move or close above those levels with volume that hits near or above its three-month average action of 74,869 shares. If that breakout triggers soon, then ADHD will set up to re-test or possibly take out its next major overhead resistance levels at $22 to $24 a share. Any high-volume move above those levels will then give ADHD a chance to re-test or possibly take out its all-time high at $26.96 a share.
Traders can look to buy ADHD off any weakness to anticipate that breakout and simply use a stop that sits right below some near-term support levels at $16.17 to $15.05 a share, or around $14.78 a share. One could also buy ADHD off strength once it starts to clear those breakout levels with volume and then simply use a stop that sits a comfortable percentage from your entry point.
- [By MONEYMORNING.COM]
For example, a phase 3 clinical trial on metadoxine extended release as a treatment for adult attention deficit hyperactivity disorder (ADHD) will be finishing up at the end of this year. Positive data could give the stock a huge boost.
Top 10 Biotech Stocks To Watch For 2014: Cell Therapeutics Inc (CTIC)
Cell Therapeutics, Inc. (CTI), incorporated in 1991, develops, acquires and commercializes treatments for cancer. The Company�� research, development, acquisition and in-licensing activities concentrate on identifying and developing new ways to treat cancer. As of December 31, 2011, CTI focused its efforts on Pixuvri (pixantrone dimaleate) (Pixuvri), OPAXIO (paclitaxel poliglumex) (OPAXIO), tosedostat, brostallicin and bisplatinates. As of December 31, 2011, it developed Pixuvri, an anthracycline derivative for the treatment of hematologic malignancies and solid tumors. Another late-stage drug candidate of the Company, OPAXIO, is being studied as a potential maintenance therapy for women with advanced stage ovarian cancer, who achieve a complete remission following first-line therapy with paclitaxel and carboplatin. As of December 31, 2011, it also developed tosedostat in collaboration with Chroma Therapeutics, Ltd. (Chroma). On May 31, 2012, CTI completed its acquisition gaining worldwide rights to S*BIO Pte Ltd.'s (S*BIO) pacritinib.
Pixuvri
As of December 31, 2011, the Company developed Pixuvri, an aza-anthracenedione derivative, for the treatment of non-Hodgkin�� lymphoma (NHL), and various other hematologic malignancies, and solid tumors. Pixuvri was studied in the Company�� EXTEND, or PIX301, clinical trial, which was a phase III single-agent trial of Pixuvri for patients with relapsed, refractory aggressive NHL who received two or more prior therapies and who were sensitive to treatment with anthracyclines. On September 28, 2011, CTI announced that a second independent radiology assessment of response and progression endpoint data from its PIX301 clinical trial of Pixuvri was achieved with statistical significance. The results of the EXTEND trial met its primary endpoint and showed that patients randomized to treatment with Pixuvri achieved a significantly higher rate of confirmed and unconfirmed complete response compared to patients treated with standard chem! otherapy had a significantly increased overall response rate and experienced a statistically significant improvement in median progression free survival. Pixuvri had predictable and manageable toxicities when administered at the proposed dose and schedule in the EXTEND clinical trial in heavily pre-treated patients. In March 2011, the Company initiated the PIX-R trial to study Pixuvri in combination with rituximab in patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL). Pixuvri has also been studied in patients with HER2-negative metastatic breast cancer who have tumor progression after at least two, but not more than three, prior chemotherapy regimens. In the second quarter of 2010, the NCCTG opened this phase II study for enrollment. The study is closed to accrual and results are expected to be reported by the NCCTG later in 2012.
OPAXIO
OPAXIO is the Company�� biologically-enhanced chemotherapeutic agent that links paclitaxel to a biodegradable polyglutamate polymer, resulting in a new chemical entity. As of December 31, 2011, the Company focused its development of OPAXIO on ovarian, brain, esophageal, head and neck cancer. OPAXIO was designed to improve the delivery of paclitaxel to tumor tissue while protecting normal tissue from toxic side effects. In November 2010, results were presented by the Brown University Oncology Group from a phase II trial of OPAXIO combined with temozolomide (TMZ), and radiotherapy in patients with newly-diagnosed, high-grade gliomas, a type of brain cancer. The trial demonstrated a high rate of complete and partial responses and a high rate of six month progression free survival (PFS). Based on these results, the Brown University Oncology Group has initiated a randomized, multicenter, phase II study of OPAXIO and standard radiotherapy versus TMZ and radiotherapy for newly diagnosed patients with glioblastoma with an active gene termed MGMT that reduces responsiveness to TMZ. A phase I/II study of OPAXIO combined with radi! otherapy ! and cisplatin was initiated by SUNY Upstate Medical University, in patients with locally advanced head and neck cancer.
Tosedostat
In March 2011, the Company entered into a co-development and license agreement with Chroma Therapeutics, Ltd. (Chroma), providing the Company with marketing and co-development rights to Chroma�� drug candidate, tosedostat, in North, Central and South America. Tosedostat is an oral, aminopeptidase inhibitor that has demonstrated anti-tumor responses in blood related cancers and solid tumors in phase I-II clinical trials. Interim results from the phase II OPAL study of tosedostat in elderly patients with relapsed or refractory acute myeloid leukemia (AML) showed that once-daily, oral doses of tosedostat had predictable and manageable toxicities and results demonstrated response rates, including a high-response rate among patients who received prior hypomethylating agents, which are used to treat myelodysplastic syndrome (MDS), a precursor of AML.
Brostallicin
As of December 31, 2011, the Company developed brostallicin through its wholly owned subsidiary, Systems Medicine LLC, which holds rights to use, develop, import and export brostallicin. Brostallicin is a synthetic deoxyribonucleic acid (DNA) minor groove binding agent that has demonstrated anti-tumor activity and a favorable safety profile in clinical trials, in which more than 230 patients have been treated as of December 31, 2011. The Company uses a genomic-based platform to guide the development of brostallicin. A phase II study of brostallicin in relapsed, refractory soft tissue sarcoma met its predefined activity and safety hurdles and resulted in a first-line phase II clinical trial study that was conducted by the European Organization for Research and Treatment of Cancer (EORTC).
The Company competes with Bristol-Myers Squibb Company, Sanofi-Aventis, Pfizer, Roche Group, Genentech, Inc., Astellas Pharma, Eli Lilly and Company, Celgene, Telik, I! nc., TEVA! Pharmaceuticals Industries Ltd. and PharmaMar.
Advisors' Opinion:- [By John Udovich]
The start of 2014 shows that biotech is still a hot area with the sector along with small cap biotech stocks like AMAG Pharmaceuticals, Inc (NASDAQ: AMAG), Mast Therapeutics Inc (NYSEMKT: MSTX), Cell Therapeutics Inc (NASDAQ: CTIC), Imprimis Pharmaceuticals Inc (NASDAQ: IMMY) and TNI BioTech (OTCMKTS: TNIB) producing news or returns�plus Auspex Pharmaceuticals (NASDAQ: ASPX), Cara Therapeutics (NASDAQ: CARA), Egalet (NASDAQ: EGLT), Flexion Therapeutics (NASDAQ: FLXN) and Ultragenyx Pharmaceutical (NASDAQ: RARE) are among the (many�� planned biotech IPOs that have recently been announced publicly:
- [By Sean Williams]
Cell Therapeutics (NASDAQ: CTIC )
Certainly no discussion of companies with large accumulated deficits would be complete without discussing a biotechnology company. It's perfectly understandable to see a biotech, especially a clinical-stage one, run with an accumulated deficit, as it takes time and money to build up a drug pipeline. However, after multiple complete response letters (the equivalent of a rejection) by the Food and Drug Administration and years without an approved drug, Cell Therapeutics racked up an astounding $1.83 billion in accumulated deficits through the end of fiscal 2012. By comparison, that's nearly 56 times larger than its shareholder equity.� - [By Bryan Murphy]
Like it or not, all good things must come to an end.... even for a red hot stock like Cell Therapeutics Inc. (NASDAQ:CTIC). Yes, CTIC is up 111% since the end of 2013, up 14% today alone, and it doesn't look like the bulls have any reason to slow down now. That's exactly why now's the time for current shareholders to be afraid, however - expect it when you least expect it.
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