Last year, Pharmacyclics (NASDAQ: PCYC ) shares gained a whopping 280%. That was enough to land the biotech a spot on The Motley Fool's list of top health-care stocks in 2012. How is 2013 looking so far? Shares have gained more than 30% year to date but have been anemic since early March.
Pharmacyclics announced its first-quarter results after the market closed. Will those results possibly help the stock to soar once again? Let's take a look.
Results
The biotech reported a non-GAAP net loss during the first quarter of $28.3 million, or $0.40 per share. That compares to a non-GAAP net loss of $9.3 million, or $0.14 per share, in the same quarter of 2012. The average analysts' estimate called for a loss of $0.17 per share, so this was a miss for Pharmacyclics.
On a GAAP basis, the company announced a net loss for the quarter of $51.9 million, or $0.73 per share. This reflects a decline from a net loss of $12.8 million, or $0.19 per share, reported for the first quarter last year.
10 Best Wireless Telecom Stocks To Own Right Now: Receptos Inc (RCPT)
Receptos, Inc. (Receptos), incorporated on June 9, 2008, is a biopharmaceutical company. The Company is focused on discovering, developing and commercializing therapeutics for immune disorders. The Company�� product candidates span three specialty disease areas. The Company�� lead asset, RPC1063, is being developed as an oral therapy for the treatment of relapsing multiple sclerosis (RMS) and inflammatory bowel disease (IBD). Its second asset, RPC4046, is being developed for the treatment of an allergic/immune-mediated disorder, eosinophilic esophagitis (EoE), which is an orphan disease. RPC1063 is an oral, once daily, selective and potent sphingosine 1-phosphate 1 receptor (S1P1R) modulator. RPC4046 is a monoclonal antibody selective to interleukin-13 (IL-13) and produced by recombinant deoxyribonucleic acid (DNA) technology.
As of December 31, 2012, RPC1063 was being tested in the Phase II portion of an accelerated design, randomized Phase II/III study for the treatment of RMS. In addition, Receptos has obtained special protocol assessment (SPA) agreement from the United States food and drug administration (FDA) on its clinical trial design for the planned Phase III portion of the Phase II/III study, as well as a second planned RMS Phase III study. RPC1063 is also being tested in a randomized Phase II study for the treatment of ulcerative colitis (UC), a gastrointestinal (GI) disea se.
As of December 31, 2012, the Company was enrolling a randomized Phase II study evaluating the ability of RPC1063 to induce clinical remission in patients with moderately-to-severely active UC called TOUCHSTONE. The Company�� second asset, RPC4046 for the treatment of EoE, builds upon its competencies in immunology and GI diseases. In-licensed from AbbVie Bahamas Ltd. and AbbVie Inc. (AbbVie) RPC4046 is a monoclonal antibody directed against the IL-13 target, which has been validated in Asthma, a predominantly allergic/immune-mediated disorder.
Advisors' Opinion:- [By RichardCox]
For those willing to take on some added volatility (and potential for increased risk based on less diversification), investors can look at Receptos Inc. (RCPT), to play this year's momentum in IPO entries. Enhanced expectations for the company's IPO drove the company to raise its initial share offering to 5.2 million shares. Receptos has reached late-stage development for its oral treatment for multiple sclerosis (MS). MS treatments are dominated by industry heavyweights but MS pills are expected to surge in the next few years because oral treatments are becoming more efficient than injected therapies, and can cater to a broader consumer base. Being a new company, the Receptos chart only offers limited incite, and will not be included here.
- [By Roberto Pedone]
Receptos (RCPT) is a biopharmaceutical company engaged in discovering, developing and commercializing therapeutics for immune disorders. This stock closed up 5% at $23.19 in Monday's trading session.
Monday's Volume: 69,000
Three-Month Average Volume: 55,356
Volume % Change: 50%From a technical perspective, RCPT ripped higher here right above some key near-term support at $21 with decent upside volume. This move is quickly pushing shares of RCPT within range of triggering a major breakout trade. That trade will hit if RCPT manages to take out its all-time high at $25 with high volume.
Traders should now look for long-biased trades in RCPT as long as it's trending above support at $21 and then once it sustains a move or close above its all-time high at $25 with volume that's near or above 55,356 shares. If that breakout hits soon, then RCPT will set up to enter new all-time-high territory, which is bullish technical price action. Some possible upside targets off that breakout are $30 to $35.
Top 10 Biotech Companies To Own For 2014: CEL-SCI Corp (CVM)
CEL-SCI Corporation (CEL-SCI), incorporated on March 22, 1983, is engaged in the business of Multikine cancer therapy; New cold fill manufacturing service to the pharmaceutical industry, and ligand epitope antigen presentation System (LEAPS) technology, with two products, hemagglutinin type 1 and neuraminidase type 1 (H1N1) swine flu treatment for H1N1 hospitalized patients and CEL-2000, a rheumatoid arthritis treatment vaccine.
Multikine
CEL-SCI's Multikine, is being developed for the treatment of cancer. It is a cancer immunotherapy drugs called Combination Immunotherapy because it combines active and passive immunity in one product. It is the only cancer immunotherapy that both kills cancer cells and activates the general immune system to destroy the cancer. Multikine target the tumor micro-metastases for treatment failure. Multikine is also applicable in many other solid tumors.
New Manufacturing Facility
CEL-SCI's facility manufactures Multikine for CEL-SCI's Phase III clinical trial. CEL-SCI offers the use of the facility as a service to pharmaceutical companies and others, particularly those that need to fill and finish their drugs in a cold environment. Fill and finish is the process of filling injectable drugs in a sterile manner.
LEAPS
CEL-SCI's patented T-cell Modulation Process uses heteroconjugates to direct the body to choose a specific immune response. The heteroconjugate technology, referred to as LEAPS, is intended to stimulate the human immune system to fight bacterial, viral and parasitic infections, as well as autoimmune, allergies, transplantation rejection and cancer. Administered like vaccines, LEAPS combines T-cell binding ligands with small, disease associated and peptide antigens.
Using the LEAPS technology, CEL-SCI has created a peptide treatment for H1N1 (swine flu) hospitalized patients. This LEAPS flu treatment is designed to focus on the conserved, non-changing epitopes of the di! fferent strains of Type A Influenza viruses, including swine, avian or bird, and Spanish Influenza. CEL-SCI's LEAPS flu treatment contains epitopes.
Advisors' Opinion:- [By Bryan Murphy]
It may not have blazed a trail into the young, immunology segment of the biotech industry the way Dendreon Corporation (NASDAQ:DNDN) did back in 2010 with the debut of Provenge. It may not have the same immunology pipeline (and company size) that ImmunoGen, Inc. (NASDAQ:IMGN) boasts. One thing is pretty certain about cancer-immunotherapy developer CEL-SCI Corporation (NYSEMKT:CVM) right now, however - its stock may be poised to dole out a much bigger foreseeable-future reward than DNDN or IMGN are.
- [By Bryan Murphy]
To say that 2014 has been a good year so far for CEL-SCI Corporation (NYSEMKT:CVM) would be an understatement. It's been a great year for the company, and more specifically, its shareholders. CVM is up 96% year-to-date, cutting into a big chunk of the loss that was suffered in 2013. And, though a near-doubling in less than a month would normally be an invitation to a painful wave of profit-taking, in the case of CEL-SCI, the situation says this is one of those rallies that could get hotter the hotter it gets.
Top 10 Biotech Companies To Own For 2014: Vertex Pharmaceuticals Incorporated(VRTX)
Vertex Pharmaceuticals Incorporated engages in discovering, developing, manufacturing, and commercializing small molecule drugs for the treatment of serious diseases worldwide. Its products include telaprevir, a prescription medicine used for the treatment of patients with genotype 1 hepatitis C virus (HCV) infection; and Ivacaftor, a prescription medicine used for the treatment of cystic fibrosis. The company markets its products under the INCIVEK brand name in the United States and Canada; INCIVO brand in the United Kingdom, Germany, France, Sweden, Austria, Finland, Denmark, Switzerland, and Norway; KALYDECO brand in the United States; and TELAVIC brand in Japan. Its drug candidates comprise VX-222, a Phase II clinical trial drug candidate, and ALS-2200 and ALS-2158, a Phase I clinical trial drug candidates that are designed to inhibit the replication of HCV; VX-809 and VX-661, a Phase II clinical trial drug candidates that improve the function of defective cystic fibro sis; VX-509, a Phase II clinical trial drug candidate for the treatment of patients with rheumatoid arthritis and other immune-mediated inflammatory diseases; VX-765, a Phase II clinical trial drug for the treatment of epilepsy; and VX-787, an investigational drug candidate for the treatment of influenza A. The company was founded in 1989 and is headquartered in Cambridge, Massachusetts.
Advisors' Opinion:- [By Selena Maranjian]
Vertex Pharmaceuticals (NASDAQ: VRTX ) jumped 48%, as it looks to expand the application of its promising cystic fibrosis drug, Kalydeco. Vertex recently entered into a deal�with Bristol-Myers Squibb�to pursue a treatment for Hepatitis C.�
Top 10 Biotech Companies To Own For 2014: Intellicell Biosciences Inc (SVFC)
Intellicell Biosciences, Inc., formerly Media Exchange Group, Inc., incorporated on March 8, 1999, is engaged in regenerative medicine company focused on the expanding regenerative medical markets using a process to separate adult autologous vascular cells (AAVC's) from blood vessels in adult adipose (fat) tissue. The Company is also exploring and undertaking, either on its own or in collaboration with a third party, providing a service for the collection, processing and storage of autologous cells for future use. As of December 31, 2011, the Company has developed technologies that allow reproducible separation of stromal vascular fraction (IntelliCell) containing adipose stem cells that can be performed in tissue processing centers and in doctors��offices. On June 3, 2011, the Company completed the acquisition of Intellicell Biosciences, Inc. The Company formed a wholly-owned subsidiary, ICBS Research, Inc.
The Company's process involves the application of ultrasonic cavitation (sound waves) to the extracted adipose tissue, which results in the separation AAVC's from the blood vessels in adult adipose (fat) tissue. This AAVC, or stromal vascular fraction (IntelliCells), are removed from the patient at the point of care, and separated at the point of care under the supervision of its certified technicians following current good manufacturing practices (cGMPs) and current good tissue practices (cGTPs), and the cells are then returned to the medical professionals at the point of care for use a patient's own body (autologous treatment), by way of a same-day clinical procedure for homologous use of these cells.
Intellicell Biosciences, Inc., formerly Media Exchange Group, Inc., incorporated on March 8, 1999, is engaged in regenerative medicine company focused on the expanding regenerative medical markets using a process to separate adult autologous vascular cells (AAVC's) from blood vessels in adult adipose (fat) tissue. The Company is also exploring and undertaking, either on ! its own or in collaboration with a third party, providing a service for the collection, processing and storage of autologous cells for future use. As of December 31, 2011, the Company has developed technologies that allow reproducible separation of stromal vascular fraction (IntelliCell) containing adipose stem cells that can be performed in tissue processing centers and in doctors��offices. On June 3, 2011, the Company completed the acquisition of Intellicell Biosciences, Inc. The Company formed a wholly-owned subsidiary, ICBS Research, Inc.
The Company's process involves the application of ultrasonic cavitation (sound waves) to the extracted adipose tissue, which results in the separation AAVC's from the blood vessels in adult adipose (fat) tissue. This AAVC, or stromal vascular fraction (IntelliCells), are removed from the patient at the point of care, and separated at the point of care under the supervision of its certified technicians following current good manufacturing practices (cGMPs) and current good tissue practices (cGTPs), and the cells are then returned to the medical professionals at the point of care for use a patient's own body (autologous treatment), by way of a same-day clinical procedure for homologous use of these cells.
The Company competes with Cytori Therapeutics, Stem Cell Assurance, Inc., Osiris, Aastrom Biosciences, Aldagen, BioTime, Baxter International, Celgene, Geron, Harvest Technologies, Mesoblast, Regenexx, NeoStem, X-Cell Center, Stem Cells, Athersys, and Tissue Genesis, Life Technologies, Asterand, pacific biosciences of california inc. and AllCells, LLC.
Advisors' Opinion:- [By Bryan Murphy]
To say that shares of IntelliCell BioSciences, Inc. (OTCMKTS:SVFC) has been disappointing since 2011 would be an understatement. SVFC has been an outright disaster since 2011, falling from a peak of $19.00 to a low of, well, just a few pennies as of late last year. In fact, there are those who are understandably wondering how the company is still alive, only producing about a half a million dollars in revenue in 2012, and then dialing that figure back down to nothing for the last few quarters. Yet, there's just something about a company that refuses to go away.... something compelling now.
- [By Bryan Murphy]
Well, though I give myself a C for timing, it looks like I'm going to be able to give myself an A for stock-picking. Back on January 27th I deemed IntelliCell BioSciences, Inc. (OTCMKTS:SVFC) was a compelling buy, and though SVFC was stagnant for a month after that, it looks like the stock's finally getting on its horse. If you didn't get it then, you may want to get in now.
Top 10 Biotech Companies To Own For 2014: Senesco Technologies Inc (SNTI)
Senesco Technologies, Inc., incorporated on September 30. 1999, is engaged in utilize its eukaryotic translation initiation Factor 5A, or Factor 5A, and deoxyhypusine synthase (DHS), and related technologies for human therapeutic applications to develop approaches to treat cancer and inflammatory diseases. In agricultural applications, the Company has licensed applications of the Factor 5A, DHS and Lipase platforms to develop the productivity of fruits, flowers, vegetables, agronomic and biofuel feedstock crops through the control of cell death and growth in plants.
Human Therapeutic Applications
The Company has developed a therapeutic candidate, SNS01-T, an improved formulation of SNS01, for the potential treatment of multiple myeloma and non-Hodgkin B-cell lymplomas. SNS01-T utilizes the Company's Factor 5A technology and consists of two components, which include a DNA plasmid (pDNA), expressing human eIF5A containing a lysine to arginine substitution at amino acid position 50, (eIF5AK50R), and a small inhibitory RNA (siRNA). These two components are combined in a fixed ratio with a polymer, polyethyleneimine (PEI), which enables self-assembly of the DNA and RNA into nanoparticles with demonstrated enhanced delivery to tissues and protection from degradation in the blood stream. The Company has also demonstrated that the combination of lenalidomide and SNS 01-T performs better than either treatment alone in mouses xenograft models of human mantle cell lymphoma. The Company's human therapeutic research program, which consists of pre-clinical in-vitro and in-vivo experiments designed to assess the role and mode of action of Factor 5A in human diseases and a phase 1a/2b clinical trial.
The Company competes with Celgene, Inc., Takeda/Millennium, ONYX Pharmaceuticals, Inc., Amgen Inc., Janssen Biotech, Inc., Novartis AG, and Pharmacyclics, Inc.
Agricultural Applications
The Company's agricultural research focuses on the discovery and develo! pment of certain gene technologies, which are designed to confer positive traits on fruits, flowers, vegetables, forestry species and agronomic crops. The Company's research and development initiatives for agriculture include develop and implement the DHS and Factor 5A gene technology in banana, canola, cotton, turfgrass, rice, alfalfa, corn, soybean and trees; and test the resultant crops for new beneficial traits such as increased yield, increased tolerance to environmental stress, disease resistance and more efficient use of fertilizer.
The Company competes with Mendel Biotechnology, Renessen LLC, Exelixis Plant Sciences, Inc., and Syngenta International AG.
Advisors' Opinion:- [By CRWE]
Today, SNTI has shed (-2.44%) down -0.0010 at $.0400 with�723,673 shares in play thus far (ref. google finance Delayed: 2:58PM EDT October 7, 2013).
Senesco Technologies, Inc. previously reported it has entered into a securities purchase agreement with certain investors to raise $1.725 million in gross proceeds through the sale of 69,000,000 shares of its common stock. The common stock was priced at $0.025 per share.
The offering is expected to close on or about October 2, 2013, subject to customary closing conditions. The net proceeds of the financing will be used primarily for working capital, research and development and general corporate purposes.
- [By Peter Graham]
At the end of last week, small cap stocks Senesco Technologies, Inc (OTCBB: SNTI), VolitionRX Ltd (OTCMKTS: VNRX) and Micromem Technologies Inc (OTCBB: MMTIF) were all trending upwards ��ending up 13.65%, 8.73% and 7.61%, respectively, on Friday. However, it�� a new trading week with the last two trading days for the year. So what direction will these three small caps head in for the end of this year and into next year? Here is a quick look to help you decide on a trading or investment strategy:
Top 10 Biotech Companies To Own For 2014: Osiris Therapeutics Inc.(OSIR)
Osiris Therapeutics, Inc., a stem cell company, focuses on the development and marketing of therapeutic products to treat various medical conditions in the inflammatory, autoimmune, orthopedic, and cardiovascular areas. It operates in two business segments, Therapeutics and Biosurgery. The Therapeutics segment focuses on developing biologic stem cell drug candidates from a readily available and non-controversial source, adult bone marrow. The Biosurgery segment works to harness the ability of cells and novel constructs to promote the body's natural healing. This segment focuses on developing biologic products for use in surgical procedures. The company?s lead biologic drug candidate is Prochymal, which is in phase 2 and 3 clinical trails for various indications, including acute graft versus host disease (GvHD), Crohn's disease, acute myocardial infarction, type 1 diabetes, pulmonary disease, and gastrointestinal injury resulting from radiation exposure. Its biologic drug candidates also include Chondrogen, a preparation of adult mesenchymal stem cells that is in phase 2 clinical trials for osteoarthritis and cartilage protection. The company has collaboration agreements with Genzyme Corporation for the development and commercialization of Prochymal and Chondrogen in various countries except in the United States and Canada. It also has a partnership with Juvenile Diabetes Research Foundation for the development of Prochymal as a treatment for the preservation of insulin production in patients with newly diagnosed type 1 diabetes mellitus. Osiris Therapeutics, Inc. was founded in 1992 and is headquartered in Columbia, Maryland.
Advisors' Opinion:- [By Lauren Pollock]
Osiris Therapeutics Inc.(OSIR) said Friday a proposed ruling from the Centers for Medicare and Medicaid Services won’t immediately affect reimbursements for its Grafix stem-cell product. The regenerative medicine company said Grafix will maintain its current reimbursement status — also called transitional pass-through status — potentially through late 2015.
- [By Alexander Maxwell]
One of the companies attempting to develop a better treatment for chronic diabetic foot ulcers is Osiris Therapeutics� (NASDAQ: OSIR ) . Earlier this month, Osiris shares more than doubled as the company announced positive data for its CDFU drug Grafix. The study results were very impressive to say the least; the study was stopped early due to the overwhelming efficacy exhibited by the treatment. A main highlight is the fact that 62% of Grafix patients had their wound closed at 12 weeks, compared to only 21% of patients using conventional methods. Clearly, the efficacy in this endpoint was overwhelming. Grafix also achieved all of the secondary endpoints for the trial, and more importantly demonstrated a relatively benign safety record.�
- [By Maxx Chatsko]
Additionally, stem cell therapies have remained elusive as the industry's ultimate Holy Grail. Osiris (NASDAQ: OSIR ) received Canadian approval for the world's first stem cell drug, Prochymal, for children battling acute graft-versus-host disease, or GvHD, last year. The approval meant more symbolically than to the bottom line, but it definitely put the potential of stem cells front and center for investors.
Top 10 Biotech Companies To Own For 2014: Pain Therapeutics Inc (PTIE)
Pain Therapeutics, Inc., incorporated in May 1998, is a biopharmaceutical company that develops drugs. The Company has four drug candidates in clinical programs, including REMOXY, abuse-resistant hydromorphone, abuse-resistant hydrocodone and a radio-labeled monoclonal antibody to treat metastatic melanoma. It is also working on a new treatment for patients with hemophilia. The Company�� lead drug candidate is REMOXY, which is a painkiller. It has collaboration agreement with King Pharmaceuticals, Inc. (King) develops and commercializes REMOXY and other opioid painkillers. The Company and King jointly managed a Phase III clinical program and New Drug Application (NDA) submission for REMOXY. It is also developing a pipeline of drug candidates in the area of oncology and hematology. It owns all commercial rights to its pipeline of drug candidates in oncology and hematology. As of December 31, 2010, the Company leased approximately 30,700 square feet of space in San Mateo, California and all of its operations are located in San Mateo.
REMOXY
REMOXY is a controlled-release oral capsule form of oxycodone in a highly viscous liquid formulation matrix that includes excipients. It is formulated to help address issues of abuse and misuse of time-release oxycodone tablets. REMOXY�� capsule dosage form provides therapeutic drug levels of oxycodone on a twice-daily dosing schedule, while resisting the rapid increases in plasma levels of oxycodone associated with common methods of abuse and misuse. Its formulation also resists delivery by unapproved routes of administration, such as injection, snorting or inhalation.
Metastatic Melanoma
The Company is developing a drug candidate called PTI-188 to treat metastatic melanoma, a form of skin cancer. PTI-188 is a monoclonal antibody linked to a radioisotope, intended to deliver doses of radiation lethal to melanoma tumors without harming normal tissue. In March 2010, the Company announced data from two open-label! , dose-escalating Phase I studies conducted in Israel to assess the safety, pharmacokinetics, dosimetry and anti-tumor activity of PTI-188. During the year ended December 31, 2010, the second study was completed. The technology used in this program was developed at the Albert Einstein College of Medicine (AECOM). It had licensed worldwide commercial rights to this technology from AECOM.
Hemophilia
The Company has a gene transfer program, initially developed at Stanford University, focused at correcting a genetic disorder in which patients are unable to stop bleeding. During 2010, it conducted a variety of pre-clinical studies with this technology. The Company has licensed worldwide commercial rights to the technology used in this program from Poetic Genetics, LLC (Poetic).
Other product candidates
The Company�� alliance with King includes development of three other abuse-resistant opioid product candidates: hydromorphone, hydrocodone and oxymorphone. Its abuse-resistant formulations of hydromorphone and hydrocodone have completed Phase I clinical trials. In January 2011, the Company announced that the Food and Drug Administration (FDA) had accepted its investigational IND, for abuse-resistant oxymorphone.
The Company competes with Roxane Laboratories, Purdue Pharma, King Pharmaceuticals, Inc., Abbott Laboratories, Cephalon, Endo Pharmaceuticals, Teva Pharmaceuticals, Elkins-Sinn, Watson Laboratories, Ortho-McNeil Pharmaceutical and Forest Pharmaceuticals.
Advisors' Opinion:- [By Jessica Alling]
Elsewhere, Pfizer is evaluating its continued partnership on an experimental oxycodone capsule, Remoxy. The drug is an extended-release formula that is targeted at reducing abuse of the painkiller. After years of setbacks and postponements for FDA approval, Pfizer is weighing its options. Its partners for the drug, Pain Therapeutics (NASDAQ: PTIE ) and Durect, have both fallen heavily due to the news, with Pain Therapeutics falling more than 50% -- its largest decline ever.
- [By Sean Williams]
However, all isn't well when it comes to the future of abuse-resistant painkiller Remoxy, which was developed by Pain Therapeutics (NASDAQ: PTIE ) , using Durect's�special technology-based gel capsule to prevent abuse, and is licensed by Pfizer (NYSE: PFE ) . Remoxy has been rejected twice by the FDA -- the most recent coming in mid-2011 -- and Pfizer commented this morning that if it were to seek reapproval for the drug it wouldn't be for at least two more years. Given Pfizer's extensive product pipeline, losing Remoxy wouldn't be a big deal. For micro-cap clinical-stage companies like Pain Therapeutics and Durect, it'd be a gigantic blow. Fittingly, Pain Therapeutics and Durect shares imploded by 50% and 34%, respectively, on Friday.
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