In this video, Fool health-care analyst David Williamson discusses Discovery Labs (NASDAQ: DSCO ) , as it struggles with yet another delay to its drug Surfaxin. Shares are down 15% on news that the FDA has requested Surfaxin product specifications and a new analytical chemistry method. It took the company an unbelievable five attempts to finally get this drug approved a year ago. David tells investors when they might expect the delays to end, and what the key things to watch with Discovery Labs will be in the meantime, as the company continues to lose out on sales and burn cash.
While you can certainly make huge gains in biotech and pharmaceuticals, the best investing approach is to choose great companies and stick with them for the long term. The Motley Fool's free report "3 Stocks That Will Help You Retire Rich" names stocks that could help you build long-term wealth and retire well, along with some winning wealth-building strategies that every investor should be aware of.�Click here now�to keep reading.
Top 5 Machinery Companies To Own For 2015: BIND Therapeutics Inc (BIND)
BIND Therapeutics, Inc., incorporated on May 19, 2006, is a clinical-stage nanomedicine platform company developing Accurins, its targeted and programmable therapeutics. Accurins are designed with specified physical and chemical characteristics to target specific cells or tissues and concentrate a therapeutic payload at the site of disease to enhance efficacy while minimizing adverse effects on healthy tissues. Its drug candidate, BIND-014, is in Phase II clinical trials for non-small cell lung cancer, or NSCLC, and metastatic castrate-resistant prostate cancer (mCRPC).
Accurins represent the evolution of targeted therapies and nanomedicine. Accurins are polymeric nanoparticles that incorporate a therapeutic payload and are designed to have prolonged circulation within the bloodstream, enable targeting of the diseased tissue or cells, and provide for the controlled and timely release of the therapeutic payload. The four components include Targeting ligands, Stealth and protective layer, Controlled-release polymer matrix and Therapeutic payload. The Company focuses to use its medicinal nanoengineering platform to develop Accurins in several therapeutic areas, with an initial focus on the treatment of various types of cancer. In addition, the Company entered into collaboration agreements with several biopharmaceutical companies to develop and commercialize Accurins that are based on its collaborators��therapeutic payloads. The Company�� programs include BIND-014, solid tumor accurin and hematologic cancer accurin.
Advisors' Opinion:- [By John Udovich]
If you have not been watching the biotech sector lately, you should start paying attention as the sector along with small cap biotech stocks like Cell Therapeutics Inc (NASDAQ: CTIC), BIND Therapeutics Inc (NASDAQ: BIND) and TNI BioTech (OTCMKTS: TNIB) continue to produce a steady stream of good news for investors thanks to positive industry trends. Moreover, Ophthotech Corp (NASDAQ: OPHT), Foundation Medicine Inc (NASDAQ: FMI), Evoke Pharma and Fate Therapeutics Inc (NASDAQ: FATE) are this week's biotech IPOs that will no doubt be watched closely by Wall Street and industry observers in general. With that in mind, consider the following biotech news or recent articles about the industry and the small cap players in it:
- [By Anna Prior]
Bind Therapeutics sa(BIND)id a collaboration with Amgen Inc.(AMGN) has been ended after both companies agreed not to pursue an option to jointly develop a molecularly targeted cancer therapy. Bind Therapeutics shares fell 11% to $11.50 premarket.
Best Biotech Stocks To Buy 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 Garrett Cook]
Receptos (NASDAQ: RCPT) shares shot up 46.35 percent to $99.14 after the company announced positive Phase 2 results for TOUCHSTONE Trial of RPC1063 in Ulcerative Colitis.
- [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.
- [By Jayson Derrick]
Receptos (NASDAQ: RCPT) announced that its lead product candidate RPC1063 successfully achieved its primary endpoint in a Phase 2 clinical study, which evaluated safety and efficacy for the treatment of ulcerative colitis with a 1 mg dose. Shares surged to new 52-week highs of $102.60 before closing the day at $95.75, up 41.35 percent.
Best Biotech Stocks To Buy Right Now: Protalix Biotherapeutics Inc (PLX)
Protalix BioTherapeutics, Inc. is a biopharmaceutical company focused on the development and commercialization of recombinant therapeutic proteins based on its ProCellEx protein expression system, ProCellEx. Using its ProCellEx system, the Company is developing a pipeline of biosimilar or generic versions of recombinant therapeutic proteins based on its plant cell-based expression technology, which focuses pharmaceutical markets and that rely upon known biological mechanisms of action. ProCellEx protein expression system consists of a set of technologies and capabilities for the development of recombinant proteins, including advanced genetic engineering technology and plant cell-based protein expression methods. Its ProCellEx protein expression system is built on flexible custom-designed bioreactors made of polyethylene and optimized for the development of complex proteins in plant cell cultures. In June 2010, it had completed the preliminary phase I clinical trial of PRX-105.
Taliglucerase Alfa
Taliglucerase alfa is a plant cell expressed recombinant glucocerebrosidase enzyme (GCD) for the treatment of Gaucher disease. The Company has commenced pre-clinical studies of an oral form of taliglucerase alfa. Its oral taliglucerase alfa is a plant cell expressed form of GCD that is naturally encapsulated within carrot cells genetically engineered to express the GCD enzyme. Pre-clinical studies of oral taliglucerase alfa demonstrate the stability of the enzyme in the cell and the capacity of the cell�� cellulose wall to protect the enzyme against degradation in the digestive tract in an in-vitro model of the stomach and intestines. Additionally, rats fed with lyophilized carrot cells expressing GCD have accumulated the active enzyme in the target organs; the spleen and liver. As of December 31, 2010, the Company had completed Phase III Clinical Trial.
PRX-102
The Company is developing PRX-102, its plant cell expressed modified version of the recombinant ! alpha-GAL-A protein, a therapeutic enzyme for the treatment of Fabry disease. Fabry disease is a rare, hereditary, genetic lysosomal storage disorder in humans caused by an X-lined deficiency of the alpha-GAL-A enzyme. The Company is in the animal evaluation testing phase of the development of PRX-102, which tests are based on a mouse model for Fabry disease.
Acetylcholinesterase
Protalix Ltd. is a wholly owned subsidiary of the Company is licensed the rights to certain technology under a research and license agreement with Yissum Research and Development Company (Yissum) and the Boyce Thompson Institute, Inc. Pursuant to the agreement, the Company is developing PRX-105, a plant cell-based acetylcholinesterase (AChE) and its molecular variants for the use in several therapeutic and prophylactic indications, as well as in a biodefense program and an organophosphate-based pesticide treatment program.
As of December 31, 2010, its in-vitro experiments of PRX-105 have shown that the acetylcholinesterase enzyme in its ProCellEx protein expression system demonstrates biological activity on biochemical and cellular levels. In addition, early animal studies demonstrated that the acetylcholinesterase expressed in its ProCellEx protein expression system was able to treat animals exposed to the nerve gas agent analogues, both when injected with its acetylcholinesterase product candidate immediately before exposure or when injected after exposure. In March 2010, it initiated a preliminary phase I clinical trial of PRX-105, which the Company completed in June 2010.
pr-antiTNF
pr-antiTNF is a candidate for the treatment of certain autoimmune diseases such as rheumatoid arthritis, juvenile idiopathic arthritis, ankylosing, spondylitis, psoriatic arthritis and plaque psoriasis. The Company has designed the antiTNF as pr-antiTNF. pr-antiTNF is a plant cell-expressed recombinant fusion protein made from the soluble form of the human TNF receptor (TNFR), f! used to t! he Fc component of a human antibody domain. pr-antiTNF has an identical amino acid sequence to Enbrel and its in-vitro and preclinical animal studies have demonstrated that pr-antiTNF exhibits similar activity to Enbrel. Specifically, pr-antiTNF binds TNF thereby inhibiting it from binding to cellular surface TNF receptors and protects L929 cells from TNF-induced apoptosis in a dose-dependent manner.
The Company competes with Genzyme, Actelion, Crucell N.V., Biolex, Inc., Chlorogen, Inc., Greenovation Biotech GmbH, Symbiosys, Novartis AG/Sandoz Pharmaceuticals, BioGeneriX AG, Stada Arzneimittel AG, BioPartners GmbH and Teva.
Advisors' Opinion:- [By Maxx Chatsko]
Industrial biotech isn't the only industry headed to Brazil. Protalix (NYSEMKT: PLX ) entered into a technology transfer agreement with Brazil's Ministry of Health last week that will pay the company $280 million. The deal is big news for Protalix's first product, Elelyso/Uplyso, which was developed with partner Pfizer (NYSE: PFE ) . The treatment is approved as an enzyme replacement therapy, or ERT, for adults with type 1 Gaucher disease, and it marks a huge step forward for the future of biomanufacturing. In the following video, Fool contributor Maxx Chatsko explains what this means for the product's commercialization and the adoption of Protalix's novel plant cell-based expression system for therapeutic proteins.
- [By Keith Speights]
Other investors might wish that Pfizer would use some of its cash to acquire a few smaller companies. Protalix BioTherapeutics (NYSEMKT: PLX ) has been mentioned as one possible candidate. The two companies already partner together on Gaucher disease drug Elelyso. In February, Protalix spurred rumors that Pfizer could be interested in buying the company after it announced that it had engaged Citigroup to pursue a "broad array of strategic alternatives."
Best Biotech Stocks To Buy Right Now: OvaScience Inc (OVAS)
OvaScience, Inc., incorporated on April 5, 2011, is a life science company developing products to improve the treatment of female infertility based on recent scientific discoveries about the existence of egg precursor cells. The Company holds license from Massachusetts General Hospital (MGH) to an issued patent and various patent applications directed to methods of identifying and purifying egg precursor cells, compositions comprising egg precursor cells and methods of using egg precursor cells to treat infertility and related disorders. The Company�� product candidates are AUGMENT and OvaTure. The Company�� designs AUGMENT to treat infertility due to poor egg quality.
The Company�� first product candidate is AUGMENT, stands for autologous germline mitochondria energy transfer. It designs AUGMENT to increase the success of in vitro fertilization (IVF) by isolating fresh mitochondria from a woman's own egg precursor cells and then adding the mitochondria into the woman's egg during IVF. Its second product candidate is OvaTure. OvaTure involves the creation of mature fertilizable eggs from a woman's own egg precursor cells. If successful, this would allow women with compromised eggs due to age or other factors to undergo IVF using their own higher quality eggs.
The Company competes with Novocellus Ltd., Auxogyn, Inc, and Ovacyte LLC.
Advisors' Opinion:- [By John Udovich]
On Thursday, small cap infertility stock OvaScience Inc (NASDAQ: OVAS) surged 23.63% plus shares are up 372.9% since the start of the year���meaning its worth taking a closer look at the stock along with the performance of female or reproductive health stocks the Female Health Co (NASDAQ: FHCO) and�Utah Medical Products, Inc (NASDAQ: UTMD)�along with the Vanguard Health Care ETF (NYSEARCA: VHT).
Best Biotech Stocks To Buy Right Now: 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 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.
- [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.
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