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 biopharmaceutical company Theravance (NASDAQ: THRX ) climbed as high as 13% today after announcing plans to split into two companies, separating its drugs under development with GlaxoSmithKline from its other operations.
So what: The stock has been stagnant over the past couple of years on sluggish sales and royalties, but the separation should unlock some hidden value from two very different sets of assets. The move also increases the likelihood that Glaxo will eventually buy out Theravance's franchise lung disease drugs Breo and Anoro.
Now what: Theravance expects that the separation will be completed by late 2013 or early 2014. "After the separation, Theravance Biopharma will focus on Theravance's multivalent discovery capabilities and pipeline of programs," wrote the company in a statement.�"Royalty Management Co will continue to focus on managing the rights to the significant potential royalty streams from certain products developed under the LABA collaboration with GSK." So while the stock is still too speculative for average Fools, Theravance might be a special situation for biotech-savvy investors to consider.
10 Best Gas Utility Stocks To Own Right Now: TESARO Inc (TSRO)
TESARO, Inc. (TESARO), incorporated in March 2010, is a development-stage, oncology-focused biopharmaceutical company for cancer patients. The Company focuses on rolapitant and TSR-011 product. The Company�� marketed products and product candidates in development treat cancer through non-specific damage to cellular components or alter cell metabolism or internal repair mechanisms to the demise of cancer cells.
Rolapitant
Rolapitant is a potent and long-acting neurokinin-1, or NK-1, receptor antagonist is in Phase III clinical trials for the prevention of chemotherapy induced nausea and vomiting (CINV). It is in Phase III clinical trials. CINV, if not prevented by prophylaxis, has the potential to afflict up to 90% or more of cancer patients undergoing chemotherapy, depending upon the type of chemotherapy administered the dosing schedule of the chemotherapy, and the patients' age and gender, among other predisposing factors. Prolonged nausea and vomiting may result in unwanted weight loss, dehydration and malnutrition, as well as hospitalization. The Company has in-licensed the rights to rolapitant from OPKO Health, Inc.
TSR-011
TSR-011 is an orally available ALK inhibitor in preclinical development. ALK is known to be involved in certain types of cancers, including subsets of NSCLC, neuroblastoma and lymphoma. For patients in these subsets, the ALK gene is fused to an activating partner or contains point mutations, resulting in constitutive activation of ALK and the growth of cancer cells and tumor development. Inhibition of ALK in these cancer cells results in cell death and tumor growth inhibition or regression. In August 2011, the United States Food and Drug Administration approved the first ALK inhibitor, developed by Pfizer Inc., Xalkori (crizotinib), which was approved for the treatment of patients with locally advanced or metastatic NSCLC that are ALK positive.
The Company competes with GlaxoSmithKline plc, Roche Holding Ltd! . and Sanofi S.A.
Advisors' Opinion:- [By Jake L'Ecuyer]
Equities Trading UP
Tesaro (NASDAQ: TSRO) shares shot up 20.78 percent to $29.00 after the company reported successful primary and secondary endpoints in final Phase 3 trial for rolapitant. - [By Ben Levisohn]
Werber and Eckhard’s favorites include Gilead (GILD) and Celgene (CELG), and they find the “risk/reward…compelling” in Medivation (MDVN) and Tesaro (TSRO).
- [By Brian Orelli]
Tesaro (NASDAQ: TSRO ) is also up today after announcing that it established a partnership with clinicians to run the phase 3 development of its PARP inhibitor, niraparib. The trial will enroll about 300 breast cancer patients with BRCA mutations, comparing niraparib to investigators' choice of other breast cancer treatments.
- [By Brian Pacampara]
Based on the aggregated intelligence of 180,000-plus investors participating in Motley Fool CAPS, the Fool's free investing community, biopharmaceutical company TESARO (NASDAQ: TSRO ) has received the dreaded one-star ranking.
Top 10 Biotech Companies To Watch 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 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.�
Top 10 Biotech Companies To Watch For 2014: Dendreon Corporation(DNDN)
Dendreon Corporation, a biotechnology company, engages in the discovery, development, and commercialization of therapeutics to enhance cancer treatment options for patients. The company offers active cellular immunotherapy and small molecule product candidates to treat various cancers. Its product candidates comprise Provenge (sipuleucel-T), an active cellular immunotherapy for the treatment of metastatic, castrate-resistant prostate cancer; DN24-02, an investigational active immunotherapy for the treatment of patients with bladder, breast, ovarian, and other solid tumors expressing HER2/neu; and TRPM8, a small molecule agonist to transient receptor potential ion channel, for multiple cancers. The company also has a range of products in preclinical studies, which include Carcinoembryonic antigen for the treatment of lung, colon, and breast cancer; and Carbonic AnhydraseIX for the treatment of kidney cancer. Dendreon Corporation was founded in 1992 and is headquartered in S eattle, Washington.
Advisors' Opinion:- [By Rick Munarriz]
Briefly in the news
Just in case you weren't armed with enough anecdotal evidence that the housing industry is back, revenue at leading real estate website Zillow (NASDAQ: Z ) climbed 71% in its latest quarter. Zillow became the first company to take questions on Twitter during its earnings call, though most of those were from Wall Street analysts. Shares of Dendreon (NASDAQ: DNDN ) tumbled 15% on Thursday after the company posted an unexpected drop in sales of its flagship prostate cancer treatment. A couple of analysts moved to downgrade Dendreon on the report. Heckmann (NYSE: NES ) was downgraded by Global Hunter Securities after posting a wider quarterly loss than Wall Street was expecting. Revenue also came in a bit light. On the beat side, Tesla Motors (NASDAQ: TSLA ) posted a quarterly profit that was four times larger than analysts were projecting. Tesla CEO Elon Musk also conceded that the company is exploring technology for self-driving cars.
And now let's take a quick look at some of the other stories that shaped our week. - [By Brian Orelli]
The most famous example of these reversals comes from Provenge, the first time that�Dendreon (NASDAQ: DNDN ) applied for approval. The FDA went against the positive committee recommendation and sent Dendreon back to the drawing board. Investors who read the briefing documents weren't all that surprised.
- [By Sean Williams]
Finally, even with the precipitous decline in Dendreon (NASDAQ: DNDN ) shares, all eyes would be wise to keep an eye on the company with the American Society of Clinical Oncology meeting this weekend. ASCO, for short, is the single most-important event for cancer drug developers and it could give Dendreon a chance to show off its experimental immunotherapy line of products and impress analysts. If anything is said with regard to Provenge and its current status in Europe, you'll be sure to know by next week if not sooner!
Top 10 Biotech Companies To Watch For 2014: Lpath Inc (LPTN)
Lpath, Inc. (Lpath), incorporated on September 18, 2002, is a biotechnology company focused on the discovery and development of bio-active lipid-targeted monoclonal antibody (mAb) therapeutics. The Company has three product candidates, iSONEP, ASONEP and Lpathomab. The Company's program, iSONEP, is a mAb against Sphingosine-1-Phosphate (S1P). As of December 31, 2012, it was in phase-II clinical trials for wet Age-Related Macular Degeneration. The Company is also advancing ASONEP, the systemic formulation of the mAb to S1P. ASONEP has completed a phase-I clinical trial and is entering phase-II clinical trials in Renal Cell Carcinoma.
Lpath's third product candidate, Lpathomab, is a mAb to the bioactive lipid, Lysophosphatidic Acid (LPA). The Company also applies its technology platform, ImmuneY2, to discovering mAbs to new bioactive lipid targets.
Advisors' Opinion:- [By Lauren Pollock]
Biotechnology company Lpath Inc.(LPTN) warned Pfizer Inc.(PFE) may divest itself of its exclusive option to co-develop the smaller firm’s leading product candidate. Lpath’s stock fell.
- [By Lauren Pollock]
Lpath Inc.(LPTN) said it is no longer actively seeking to reacquire exclusive rights to its leading product candidate from Pfizer Inc.(PFE), saying the pharmaceutical giant informed the company that its offers weren’t competitive. The biotechnology company in October had warned that Pfizer might may divest itself of its exclusive option to co-develop the smaller firm’s leading product candidate–known as iSONEP.
Top 10 Biotech Companies To Watch For 2014: Sucampo Pharmaceuticals Inc (SCMP)
Sucampo Pharmaceuticals, Inc., incorporated on December 9, 2008, is a global biopharmaceutical company focused on research, discovery, development and commercialization of drugs based on ion channel activators known as prostones. The Company�� prostone-based compounds target the ClC-2 and big potassium (BK), ion channels. It is focused on developing prostones to treat gastrointestinal, ophthalmic, neurologic, and oncology-based inflammatory disorders, and is also considering other therapeutic applications of its drug technology. The Company�� products include AMITIZA (lubiprostone) and RESCULA (unoprostone isopropyl).
AMITIZA
The Company�� AMITIZA is being marketed in the United States for three gastrointestinal indications under a license agreement, or the Takeda Agreement, with Takeda Pharmaceutical Company Limited, or Takeda. The three gastrointestinal indications include chronic idiopathic constipation (CIC), in adults, irritable bowel syndrome with constipation (IBS-C), in adult women, and opioid-induced constipation (OIC), in adult patients with chronic, non-cancer pain. AMITIZA for OIC received approval from the United States Food and Drug Administration (FDA), in April 2013. In Japan, AMITIZA is marketed under a license, commercialization and supply agreement, or the Abbott Agreement, with Abbott Japan Co. Ltd. (Abbott), for the gastrointestinal indication of chronic constipation (CC), excluding constipation caused by organic diseases. In Switzerland, the Company is marketing AMITIZA.
RESCULA
The Company holds license agreements for RESCULA in the United States and Canada and the rest of the world, with the exception of Japan, Korea, Taiwan and the People�� Republic of China. The Company is commercializing RESCULA (unoprostone isopropyl ophthalmic solution) 0.15% for the lowering of intraocular pressure (IOP), in patients with open-angle glaucoma or ocular hypertension in the United States. RESCULA may be used as an agent or concomit! antly with other topical ophthalmic drug products to lower intraocular pressure. RESCULA is a BK channel activator and has a different mechanism of action than other IOP lowering agents on the market.
Advisors' Opinion:- [By James Brumley]
Still, for the nimble who know when to get out, OREX is one of the few cheap stocks worth a closer look.
Sucampo Pharmaceuticals (SCMP)Finally, though the price of $7.60 clearly qualifies it as one pf the cheapest of the cheap stocks out there in the pharmaceutical world, that’s not the reason Sucampo Pharmaceuticals (SCMP) may be worth a look here. It’s the 30% slide we’ve seen SCMP stock suffer since peaking in mid-January. It’s not a pullback that’s bound to go unchallenged by the bulls.
- [By Roberto Pedone]
Another under-$10 stock that's starting to trend within range of triggering a major breakout trade is Sucampo Pharmaceuticals (SCMP), which is engaged in the discovery, development and commercialization of proprietary drugs based on prostones, and other novel drug technologies. This stock is off to a decent start in 2013, with shares up by 26%.
If you take a look at the chart for Sucampo Pharmaceuticals, you'll notice that this stock has been downtrending badly for the last four months, with shares dumping hard from its high of $10.48 to its recent low of $5.40 a share. During that downtrend, shares of SCMP have been consistently making lower highs and lower lows, which is bearish technical price action. That said, the downside volatility for SCMP looks to be over in the short-term since the stock has started to reverse its downtrend and enter an uptrend. That reverse is quickly pushing shares of SCMP within range of triggering a major breakout trade above a key downtrend line.
Traders should now look for long-biased trades in SCMP if it manages to break out above some near-term overhead resistance levels at $6.33 to $6.66 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 115,383 shares. If that breakout triggers soon, then SCMP will set up to re-test or possibly take out its next major overhead resistance levels at $7.09 to $7.67 a share. Any high-volume move above those levels will then give SCMP a chance to tag $8 to $9 a share.
Traders can look to buy SCMP off weakness to anticipate that breakout and simply use a stop that sits right below some key near-term support levels at $5.58 to $5.40 a share. One can also buy SCMP off strength once it clears those breakout levels with volume and then simply use a stop that sits a comfortable percentage from your entry point.
Top 10 Biotech Companies To Watch For 2014: Synergy Pharmaceuticals Inc (SGYP)
Synergy Pharmaceuticals, Inc., incorporated on February 11, 1992, is a biopharmaceutical company focused primarily on the development of drugs to treat gastrointestinal (GI), disorders and diseases. The Company�� lead product candidate is plecanatide, a guanylyl cyclase C (GC-C), receptor agonist, to treat GI disorders, primarily chronic constipation (CC), and constipation-predominant-irritable bowel syndrome (IBS-C). It is also developing SP-333, the second generation GC-C receptor agonist for the treatment of gastrointestinal inflammatory diseases, such as ulcerative colitis (UC). The Company�� active pharmaceutical ingredients (APIs) and the final formulated drug products are manufactured for it by third party contractors.
As of December 31, 2011, the Company was developing plecanatide, a synthetic hexadecapeptide designed to mimic the actions of the GI hormone uroguanylin, for the treatment of CC and IBS-C. Plecanatide is an agonist of GC-C receptor. As of December 31, 2011, the Company was dosing patients in an 800-patient Phase II/III clinical trial of plecanatide to treat. It is also developing a second generation GC-C receptor analog, SP-333, which is in pre-clinical development for the treatment of gastrointestinal inflammatory diseases. SP-333 is a synthetic analog of uroguanylin, a natriuretic hormone.
The Company competes with Ironwood Pharmaceuticals, Inc., Forest Laboratories, Inc., Takeda Pharmaceuticals America, Inc., Sucampo Pharmaceuticals, Inc., Salix Pharmaceuticals, Inc. and Shire Plc.
Advisors' Opinion:- [By Sean Williams]
Finally, Synergy Pharmaceuticals (NASDAQ: SGYP ) may have had the wildest week of them all. Synergy's share price spiked 16% on Tuesday as an analyst at Cantor Fitzgerald raised her peak sales estimate for plecanatide, the company's midstage drug for chronic idiopathic constipation and irritable bowel syndrome with constipation, to $1.58 billion from $1.05 billion, as clinical data has been stronger than expected. However, the company didn't return the favor to shareholders by -- the very next day, mind you ��announcing a secondary offering of 16.375 million shares. The downside of clinical-stage companies is the always apparent risk of dilution. Shares have lost 25% since their Tuesday close.
Top 10 Biotech Companies To Watch For 2014: KYTHERA Biopharmaceuticals Inc (KYTH)
KYTHERA Biopharmaceuticals, Inc., incorporated in June 2004, is a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of prescription products for the aesthetic medicine market. The Company�� initial focus is on the facial aesthetics market. The Company�� product candidate, ATX-101, is a injectable drug in Phase III clinical development for the reduction of submental fat, which commonly presents as an undesirable double chin. Based on clinical trials conducted, ATX-101 has exhibited results in the reduction of submental fat. ATX-101 contains a synthetic form of sodium deoxycholate. In the United States and Canada, the Company is conducting two pivotal Phase III trials of ATX-101 for the reduction of submental fat. The Company initiated this pivotal Phase III clinical program, with planned enrollment of 1,000 patients, in March 2012.
In Europe, Bayer, its collaborator outside the United States and Canada, recently completed two pivotal Phase III trials of ATX-101 for the reduction of submental fat. In these multi-center, randomized, double-blind, placebo-controlled pivotal trials involving 723 patients, ATX-101 resulted in a reduction in submental fat, as assessed by a validated clinician scale and a patient satisfaction scale.
ATX-101 contains a synthetic form of sodium deoxycholate. ATX-101 is designed to be a locally-injected drug that causes proximal, preferential destruction of adipocytes, or fat cells, with minimal effect on surrounding tissue. Upon subcutaneous injection under the skin, ATX-101 disrupts cell membranes in protein-poor tissues, such as fat, while being attenuated by interactions with protein-rich tissue, such as skin, muscle and blood vessels. This attenuation by protein-rich tissue results in the preferential destruction of adipocytes by ATX-101. The destruction of adipocytes, or adipocytolysis, elicits a natural response, in which macrophages are attracted to remove cellular debris and fat particles t! hrough the lymphatic system. The macrophages also emit low levels of chemical messengers, known as cytokines, which attract fibroblasts, another cell type, to the area. Fibroblasts produce collagen, and it is believed that new collagen production, or neocollagenesis, promotes retraction of the skin in the areas of fat reduction. The fat removal process with ATX-101 is incremental with each treatment, thereby allowing for control of the aesthetic outcome.
Advisors' Opinion:- [By Lisa Levin]
Kythera Biopharmaceuticals (NASDAQ: KYTH) shares moved up 24.01% to $41.58. The volume of Kythera Biopharmaceuticals shares traded was 6431% higher than normal. Kythera reported positive ATX-101 top line phase III trial results for the reduction of submental fat.
- [By Lisa Levin]
Kythera Biopharmaceuticals (NASDAQ: KYTH) shares surged 24.40% to touch a new 52-week high of $41.71 after the company reported positive ATX-101 top line phase III trial results for the reduction of submental fat.
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