The past four days have brought together pharmaceutical, biotechnology, and medical device makers all under one roof in what is arguably the most important health care conference of the year, the 2014 JPMorgan Healthcare Conference.
Just like the recently concluded Consumer Electronics Show in Las Vegas, this annual event gives health care companies a chance to demonstrate to investors and Wall Street where they've been and where they're headed. Because earnings guidance can be somewhat irrelevant for clinical-stage biotech and medical device companies, consider this event your chance to gain guidance from some 300 top health care companies.
Today, we're going to take a closer look at�Sarepta Therapeutics' (NASDAQ: SRPT ) presentation, which was delivered Wednesday by President and CEO Chris Garabedian.
Sarepta Therapeutics' past year
Like many of the companies we've chronicled this week, Sarepta's had a wild ride over the past year, flying high at one point on continued follow-up data of its relatively small midstage study of eteplirsen for Duchenne muscular dystrophy, or DMD, a disorder that results in muscle degeneration and early death in boys.
Hot US Companies To Invest In 2015: Regulus Therapeutics Inc (RGLS)
Regulus Therapeutics Inc., incorporated on September 5, 2007, is a biopharmaceutical company focused on discovering and developing microRNAs to treat a range of diseases. microRNAs are naturally occurring ribonucleic acid (RNA), molecules that play a critical role in regulating key biological pathways. The Company uses its microRNA product platform to develop chemically modified, single-stranded oligonucleotides that the Company calls anti-miRs. As of December 31, 2012, the Company�� operations included acquiring and in-licensing intellectual property rights, developing its microRNA, undertaking basic research around microRNA targets and conducting preclinical studies for its initial programs.
The Company is developing RG-101 for the treatment of HCV and is advancing other microRNA therapeutics toward clinical development in several areas, including oncology, fibrosis and metabolic diseases. The Company intends to focus its resources on product opportunities in therapeutic areas where development and commercialization activities are appropriate for its size and financial resources, which the Company anticipates will include niche indications and orphan diseases.
The Company competes with Groove Biopharma, Inc., miRagen Therapeutics, Inc., Mirna Therapeutics, Inc., and Santaris Pharma A/S.
Advisors' Opinion:- [By Sean Williams]
What: Shares of Regulus Therapeutics (NASDAQ: RGLS ) , a biopharmaceutical company focused on the development of therapies utilizing its proprietary microRNA product platform, saw its shares skyrocket as much as 127% at one point today after announcing the interim results for its human proof-of-concept trial for its early stage hepatitis C drug RG-101.
- [By Brian Orelli]
Partners like this investment idea
When Regulus Therapeutics (NASDAQ: RGLS ) went public last year, investors weren't the only ones buying the share offering; Regulus' partners and founders clearly thought it was a good investment idea, because they bought more shares. Lots of them. AstraZeneca, Biogen Idec, Sanofi, GlaxoSmithKline�and Isis combined to purchase more than 70% of the shares that raised nearly $81 million for the biotech. - [By Sean Williams]
A blast to the past
It's occasionally very difficult to value biotech stocks, because of the wide range of outcomes possible given their pipelines. Other times, as in the case with Regulus Pharmaceuticals (NASDAQ: RGLS ) , I bang my head against a table and wonder what the heck investors are thinking.
Best Biotech Stocks To Watch 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 18.28 percent to $28.40 after the company reported successful primary and secondary endpoints in final Phase 3 trial for rolapitant. - [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.
Best Biotech Stocks To Watch Right Now: Amgen Inc.(AMGN)
Amgen Inc., a biotechnology medicines company, discovers, develops, manufactures, and markets human therapeutics based on advances in cellular and molecular biology for grievous illnesses primarily in the United States, Europe, and Canada. The company markets recombinant protein therapeutics in supportive cancer care, nephrology, and inflammation. Its principal products include Aranesp and EPOGEN erythropoietic-stimulating agents that stimulate the production of red blood cells; Neulasta and NEUPOGEN to stimulate the production of neutrophils, which is a type of white blood cell that helps the body to fight infections; and Enbrel, an inhibitor of tumor necrosis factor that plays a role in the body?s response to inflammatory diseases. The company also markets other products comprising Sensipar/Mimpara, a small molecule calcimimetic that lowers serum calcium levels; Vectibix, a monoclonal antibody that binds specifically to the epidermal growth factor receptor; and Nplate, a thrombopoietin (TPO) receptor agonist that mimics endogenous TPO, the primary driver of platelet production. In addition, it provides Denosumab, a human monoclonal antibody that targets RANKL, an essential regulator of osteoclasts. Further, the company offers product candidates in mid-to-late stage development in a variety of therapeutic areas, including oncology, hematology, inflammation, bone, nephrology, cardiovascular, and general medicine consisting of neurology. It markets its products to healthcare providers, including physicians or their clinics, dialysis centers, hospitals, and pharmacies; consumers; and wholesale distributors of pharmaceutical products. The company has various collaborative arrangements with Pfizer Inc.; GlaxoSmithKline plc; Takeda Pharmaceutical Company Limited; Daiichi Sankyo Company, Limited; Array BioPharma Inc.; Kyowa Hakko Kirin Co. Ltd.; and Cytokinetics, Inc. Amgen Inc. was founded in 1980 and is headquartered in Thousand Oaks, California.
Advisors' Opinion:- [By Sheila Dang]
Halozyme�� return on equity and assets are consistently in the red, ending at about -109% in return on equity in 2012, and -82% in return on assets in 2013. The company�� competitors in biotechnology, such as Novo Nordisk (NVO) and Amgen Inc. (AMGN), post much more favorable return percentages. Yet, Halozyme�� revenue, EBITDA and EPS growth percentages are much higher than the industry median, with Halozyme�� revenue growth being higher than 97% of the global biotechnology industry.
Best Biotech Stocks To Watch Right Now: Gentium SpA(GENT)
Gentium S.p.A., a biopharmaceutical company, focuses on the development and manufacture of its primary product candidate, defibrotide, an investigational drug based on a mixture of single-stranded and double-stranded DNA extracted from pig intestines. It develops defibrotide for the treatment and prevention of hepatic veno-occlusive disease (VOD), a condition that occurs when veins in the liver are blocked as a result of cancer treatments, such as chemotherapy or radiation, that are administered prior to stem cell transplantation. The company has completed a Phase III clinical trial of defibrotide for the treatment of severe VOD in the United States, Canada, and Israel; and a Phase II/III pediatric trial in Europe for the prevention of VOD. It also offers sulglicotide that is developed from swine duodenum, and has ulcer healing and gastrointestinal protective properties in South Korea; and urokinase, which is made from human urine to treat various vascular disorders, such as deep vein thrombosis and pulmonary embolisms. The company was formerly known as Pharma Research S.r.L. and changed its name to Gentium S.p.A. in July 2001. Gentium S.p.A. was founded in 1993 and is headquartered in Villa Guardia, Italy.
Advisors' Opinion:- [By Sean Williams]
A parabolic problem
It has also been a year to remember for shareholders of biopharmaceutical company Gentium (NASDAQ: GENT ) whose share price has catapulted approximately 600% off its lows thanks to growth in its lead drug Defibrotide (known as Defitelio in the European Union).
Best Biotech Stocks To Watch Right Now: Actelion Ltd (ATLN.VX)
Actelion Ltd is a Swiss biopharmaceutical holding company that focuses on the discovery, development and commercialization of small molecule drugs. The Company has four approved drugs on the market: Tracleer, an oral dual endothelin receptor antagonist; Veletri, a prostanoid vasodilator; Ventavis, an inhaled formulation of iloprost, and Zavesca, an oral treatment for type 1 Gaucher disease. Furthermore, the Company has a number of compounds various stages of development. The Company operates through a number of worldwide subsidiaries, including Actelion Registration Ltd, which holds marketing authorizations for products marketed in the European Union; Actelion Clinical Research, Inc, engaged in clinical development on behalf of the Company's group; Actelion Re SA, providing insurance solutions for the Company's group and Actelion US Holding Company, engaged in the holding activities of the Company's United States-based units. In September 2013, it acquired Ceptaris Therapeutics, Inc. Advisors' Opinion:- [By Victor Selva]
Forest Laboratories has a current ratio of 2.69% which is higher than the ones registered by Endo International Plc (ENDP), Valeant Pharmaceuticals International (VRX) and Cubist Pharmaceuticals Inc. (CBST). For investors looking for a higher ROE, Allergan Inc. (AGN) and Actelion Ltd. (ATLN.VX) are good options.
Best Biotech Stocks To Watch Right Now: Taro Pharmaceutical Industries Ltd (TARO)
Taro Pharmaceutical Industries Ltd., incorporated in 1959, is a science-based pharmaceutical company. The Company develops manufactures, and markets prescription and over-the-counter (OTC) pharmaceutical products, primarily in the United States, Canada and Israel. The Company also develops and manufactures active pharmaceutical ingredients (APIs), primarily for use in its finished dosage form products. The Company�� primary areas of focus include pediatric creams and ointments, liquids, capsules and tablets, mainly in the dermatological and topical, cardiovascular, neuropsychiatric and anti-inflammatory therapeutic categories. The Company operates through three companies: Taro Pharmaceutical Industries Ltd. (Taro Israel), and two of its subsidiaries (including indirect), Taro Pharmaceuticals Inc. (Taro Canada) and Taro U.S.A. The Company markets more than 180 pharmaceutical products in over 25 countries.
Taro Israel manufactures more than 160 finished dosage form pharmaceutical products for sale in Israel and for export. It produces APIs used in the manufacture of finished dosage form pharmaceutical products. It markets and distributes generic products in the local Israeli market. Taro Israel�� primary product lines include dermatology, prescription and OTC semi-solid products (creams, ointments and gels) and liquids; cardiology and neurology, prescription oral dosage products; oral analgesics, both prescription and OTC, and OTC oral and nasal sprays and ophthalmic products.
Taro Canada manufactures more than 70 finished dosage form pharmaceutical products for sale in Canada and for export. It markets and distributes generic products in the local Canadian market. Its product line includes dermatology: prescription and OTC semi-solid products (creams, ointments and gels) and liquids, cardiology, oncology, gastrointestinal and neurology: prescription oral and injects able dosage products, and allergy (antihistamine): OTC oral dosage products.
Taro U.S.A markets! and distributes generic products in the United States market. Its primary product lines include dermatology: prescription and OTC semi-solid products (creams, ointments and gels) and liquids, cardiology and neurology: prescription oral dosage products, and other prescription and OTC products.
The Company competes with Bristol-Myers Squibb, GlaxoSmithKline, Merck, Novartis, Pfizer/Wyeth, Valeant, Galderma, Merck/Schering-Plough, Teva Pharmaceuticals U.S.A., Mylan Laboratories, Perrigo Company, Ranbaxy Pharmaceuticals Inc., Sandoz Pharmaceuticals, Merck Canada Inc., Pfizer Canada Inc., Janssen Inc., Schering-Plough Canada, Novartis Pharmaceuticals Canada Inc., GlaxoSmithKline Inc., Bayer Inc., Bristol-Myers Squibb Canada, Apotex Inc., Teva Canada Limited, Mylan Pharmaceuticals ULC, Sandoz Canada Incorporated, Pharmascience Inc., Teva Pharmaceutical Industries Ltd., Perrigo Israel Pharmaceuticals Ltd., Dexxon Ltd., Rafa Laboratories Ltd., Bayer AG, Eli Lilly and Company, Merck & Co., Inc. and Pfizer Inc.
Advisors' Opinion:- [By Rich Smith]
Israeli drugmaker Taro Pharmaceutical Industries (NYSE: TARO ) has a new CEO -- and a new Chairman of the Board, as well.
On Thursday, Taro announced the imminent retirement of Interim Chief Executive Officer Mr. James Kedrowsk, who will be replaced August 1 by new permanent CEO Mr. Kalyanasundaram Subramanian ("Kal Sundaram"). Additionally, the company said that Dilip Shanghvi�has been appointed Chairman of its Board of Directors.
Best Biotech Stocks To Watch Right Now: Agios Pharmaceuticals Inc (AGIO)
Agios Pharmaceuticals, Inc., incorporated on August 7, 2007, is a biopharmaceutical company. The Company is intend to apply its deep understanding of metabolism, coupled with the Company�� ability to create medicines that can inhibit or activate metabolic enzymes, to fundamentally change the way cancer and inborn errors of metabolism (IEMs) are treated. The Company has identified and validated novel and druggable targets in both cancer and IEMs. The Company�� two advanced cancer programs are targeting mutations in the enzymes isocitrate dehydrogenase 1 and 2, referred to as IDH1 and IDH2. The Company�� drug candidates are selective for the mutated forms of IDH1 and IDH2 found in cancer cells versus the normal forms of IDH1 and IDH2 found in all other cells.
The Company focused on developing medicines to address IEMs, with a novel approach to these orphan diseases for which no effective or disease-modifying therapy is available. The Company has also de-validated and terminated numerous programs, including many that have been reported in scientific journals. In the Company�� IEM portfolio, it uses an equally rigorous set of validation techniques.
Advisors' Opinion:- [By Jake L'Ecuyer]
Shares of Agios Pharmaceuticals (NASDAQ: AGIO) got a boost, shooting up 29.08 percent to $40.84 after the company reported quarterly results.
Stage Stores (NYSE: SSI) was also up, gaining 13.47 percent to $22.41 after the company reported Q4 results and announced the sale of its Steele's off-price division to a new retail unit of Hilco Global.
- [By Ben Levisohn]
3. We see 23+ partnered pipeline assets and are most positive on Phase I/II MOR202 anti-CD38 for myeloma with data in 2015, and others such as Acceleron Pharma (XLRN), Agios Pharmaceuticals (AGIO), Epizyme (EPZM), Concert Pharmaceuticals (CNCE) (just started Phase I for next-gen Revlimid).
- [By Lisa Levin]
Agios Pharmaceuticals (NASDAQ: AGIO) shares touched a new 52-week low of $18.83. Agios Pharmaceuticals' trailing-twelve-month profit margin is -102.87%.
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