With the�SPDR S&P Biotech Index�up 35% over the trailing-12-month period, it's evident that investment dollars are willingly flowing into the biotech sector. Keeping that in mind, let's have a look at some of the rulings, studies, and companies that made waves in the sector last week.
There weren't many well-known names making big moves this week, but we were privy to a good variety of stories including FDA designations and new drug filings, plenty of analyst action, and a late-week, rally-killing share offering.
The best-known, and potentially most exciting, story of the week was the Food and Drug Administration's classification of Pfizer's (NYSE: PFE ) Palbociclib as a "breakthrough therapy." Palbociclib is an oral treatment for ER+, HER2-positive metastatic breast cancer that, in trials, when combined with Novartis'�Femara, crushed the control arm made up of Femara alone in terms of progression-free survival (26.1 months versus 7.5 months). Those amazing results earned Palbociclib this extremely rare designation from the FDA, which should help expedite its development and hopeful approval of the drug.�
Top 5 Biotech Companies To Own For 2016: Gilead Sciences Inc.(GILD)
Gilead Sciences, Inc., a biopharmaceutical company, engages in the discovery, development, and commercialization of therapeutics for the treatment of life threatening diseases worldwide. Its products include Atripla, Truvada, Viread, Emtriva for the treatment of human immunodeficiency virus infection in adults; Hepsera, an oral formulation for the treatment of chronic hepatitis B; AmBisome, a amphotericin B liposome injection to treat invasive fungal infections; Letairis, an endothelin receptor antagonist for the treatment of pulmonary arterial hypertension; Ranexa for the treatment of chronic angina; Vistide, an antiviral medication for the treatment of cytomegalovirus retinitis in patients with AIDS; and Cayston, an inhaled antibiotic used as a treatment to enhance respiratory systems. The company?s products also comprise Tamiflu, an oral antiviral for the treatment and prevention of influenza A and B; Macugen, an intravitreal injection for the treatment of neovascular a ge-related macular degeneration; and Lexiscan/Rapiscan, an injection used as a pharmacologic stress agent in radionuclide myocardial perfusion imaging. Its products under the Phase III clinical trials consist of Cobicistat, a pharmacoenhancer that is under evaluation as a boosting agent for HIV medicines; Elvitegravir, an oral integrase inhibitor being evaluated as part of combination therapy for HIV; Integrase Single-Tablet, a ?Quad? regimen of elvitegravir, cobicistat, tenofovir disoproxil fumarate, and emtricitabine for the treatment of HIV/AIDS in treatment-naive patients; and Aztreonam for inhalation solution for the treatment of cystic fibrosis patients with Pseudomonas aeruginosa. The company?s Phase II clinical trials products comprise Cicletanine, Ranolazine, and Aztreonam, as well as GS 9190, GS 9256, and GS 9451. Its Phase I clinical trial products include GS 7340, GS 5885, GS 6620, GS 9620, and GS 6624. The company was founded in 1987 and is headquartered in Fost er City, California.
Advisors' Opinion:- [By Selena Maranjian]
More than a handful of rapidly growing companies had strong performances over the past year. Gilead Sciences (NASDAQ: GILD ) surged 131%, for example, with investors hopeful about its oral hepatitis C drug, sofosbuvir, which has cleared four phase 3 trials and received priority-review designation from the FDA. The company has also been doing well with its HIV drugs in recent years, though sales of some have been flagging and competition looms. The stock may not look like a bargain with a P/E ratio in the 30s, but its five-year projected earnings growth rate is around 26%.
- [By David Williamson]
In this video, David Williamson reviews some of his favorite biotech firms. Many analysts have thrown their weight behind Biogen� (NASDAQ: BIIB ) and its new BG12 drug for multiple sclerosis. However, David favors Gilead� (NASDAQ: GILD ) over Biogen since Gilead�has a�larger, more diverse product pipeline. Celgene� (NASDAQ: CELG ) is the No. 1 biotech in David's opinion since it also has blockbuster drugs but a PEG of less than 1.0. Amgen� (NASDAQ: AMGN ) is�a big company with more products in development than most people realize. Overall, for value and future earnings potential, David likes Celgene the best.
- [By Ben Levisohn]
Shares of Celgene gained 0.6% to $142.06 today, even as Amgen (AMGN) dropped 2% to 111.41, Biogen (BIIB) fell 3.1% to $285.81 and the SPDR S&P Biotech ETF (XBI) declined 3.9% to $124.37, extending its losing streak to three days. Gilead Sciences (GILD) dipped 0.2% to $73.90, ending a nine-day winning streak
Top 5 Biotech Companies To Own For 2016: 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.
10 Best Promising Stocks To Own Right Now: ARIAD Pharmaceuticals Inc.(ARIA)
ARIAD Pharmaceuticals, Inc., a biopharmaceutical company, focuses on the discovery, development, and commercialization of small-molecule drugs for the treatment of cancer. The company?s lead cancer product, ridaforolimus is being studied in multiple clinical trials in patients with various types of cancers, including metastatic sarcomas, breast cancer, endometrial cancer, prostate cancer, and non-small cell lung cancer. Its product pipeline also includes ponatinib, a pan BCR-ABL inhibitor in phase 2 clinical trial for applications in various hematological cancers and solid tumors; and AP26113, an anaplastic lymphoma kinase inhibitor in preclinical studies for the treatment of various cancers, including non-small cell lung cancer, lymphoma, and neuroblastoma. In addition, the company focuses on a drug discovery program centered on small-molecule therapies that are molecularly targeted to cell-signaling pathways implicated in cancer. Further, it licenses its ARGENT cell-sign aling regulation technologies to pharmaceutical and biotechnology companies to develop and commercialize therapeutic products, and to conduct drug discovery research. The company has collaboration and license agreements with Merck & Co., Inc. for the development, manufacture, and commercialization of ridaforolimus; and license agreements with Medinol Ltd. and ICON Medical Corp. to develop and commercialize stents and other medical devices to deliver ridaforolimus to prevent restenosis of injured vessels. ARIAD Pharmaceuticals, Inc. was founded in 1991 and is based in Cambridge, Massachusetts.
Advisors' Opinion:- [By David Williamson]
In the following video, Motley Fool health-care analyst David Williamson discusses Ariad Pharmaceuticals (NASDAQ: ARIA ) , as the company's stock reverses direction today, up 3% following yesterday's tumble. He notes the results of a boutique institutional research survey that found Ariad's new drug Iclusig to have toxicity concerns, and even more negative information coming from the FDA, citing blood clots and liver toxicity. David tells investors what the potential for this drug is, and whether it has a shot at success on the market despite these safety concerns.
Top 5 Biotech Companies To Own For 2016: Cubist Pharmaceuticals Inc.(CBST)
Cubist Pharmaceuticals, Inc., a biopharmaceutical company, focuses on the research, development, and commercialization of pharmaceutical products that address unmet medical needs in the acute care environment. The company markets CUBICIN (daptomycin for injection), a once-daily, bactericidal, intravenous, antibiotic with activity against gram-positive organisms, including methicillin-resistant staphylococcus aureus. Its clinical development product pipeline consists of CXA-201, which is in the phase III clinical trial for patients with complicated urinary tract infections; and in phase II clinical trial for patients with complicated abdominal infections. The company is also developing CXA-201 for the treatment of hospital acquired pneumonia. In addition, its product under development comprises CB-183,315, an oral, bactericidal lipopeptide with in vitro bactericidal activity against C. difficile, for the treatment of clostridium difficile-associated diarrhea (CDAD). Further , the company?s pre-clinical programs include therapies to treat various bacterial infections and agents to treat acute pain. Additionally, it promotes MERREM I.V. (meropenem for injection), a carbapenem class intravenous antibiotic, in the United States under a commercial services agreement with AstraZeneca Pharmaceuticals, LP; and DIFICID as the treatment for CDAD in adults under the co-promotion agreement with Optimer Pharmaceuticals, Inc. The company also has collaborations with Forma Therapeutics, Inc. to discover and develop antibacterial compounds; an agreement with the Broad Institute to transform natural products discovery; a collaboration with Hydra Biosciences, Inc., to develop ion channel drugs; and a collaboration agreement with Alnylam Pharmaceuticals, Inc., for the development and commercialization of Alnylam's RNAi therapeutics as a therapy for the treatment of respiratory syncytial virus. The company was founded in 1992 and is headquartered in Lexington, Mas sachusetts.
Advisors' Opinion:- [By Lee Jackson]
Cubist Pharmaceuticals Inc. (NASDAQ: CBST) is another top stock to buy making acquisitions. It recently received antitrust clearance for its�purchase of Trius Pharmaceutical. The acquisition strengthens its already strong antibiotic franchise. UBS has a $70 price target, and the consensus is placed at $65.
Top 5 Biotech Companies To Own For 2016: Intercept Pharmaceuticals Inc (ICPT)
Intercept Pharmaceuticals, Inc., incorporated on September 4, 2002, is a biopharmaceutical company focused on the development and commercialization of therapeutics to treat chronic liver diseases utilizing its bile acid chemistry.The Company�� product candidates treat orphan and more prevalent liver diseases for which there are limited therapeutic solutions. The Company�� product candidate, obeticholic acid, or OCA, is a bile acid analog, a chemical substance that has a structure based on a naturally occurring human bile acid. It is developing OCA initially for primary biliary cirrhosis, or PBC, as a second line treatment for patients who have an inadequate response to or who are unable to tolerate standard of care therapy and therefore need additional treatment. The Company is conducting a Phase 3 clinical trial of OCA in PBC, which it calls the POISE trial, that serves as the basis for seeking regulatory approval in the United States and Europe. As of December 19, 2012, the Company completed enrollment of the POISE trial with 217 patients.
The Company�� clinical focus is on the development of OCA, orally administered, first-in-class FXR agonist that has broad liver-protective properties and may a variety of chronic insults to the liver that cause fibrosis, which can eventually lead to cirrhosis, liver transplant and death. The Company owns worldwide rights to OCA outside of Japan and China, where it has licensed the compound to Dainippon Sumitomo Pharma, or DSP, and granted it an option to license OCA in certain other Asian countries.The Company is sponsoring an independent study involving more than ten leading PBC centers in North America and Europe, or collectively the Global PBC Study Group, that are pooling their long-term patient data to evaluate the relationship between biochemical and clinical endpoints.
The Company competes with Eli Lilly, Exelixis, Inc., Phenex Pharmaceuticals AG, , Johnson & Johnson, NovImmune SA, Dr. Falk Pharma GmbH, Galmed Medical Researc! h Ltd., Immuron Ltd., Mochida Pharmaceutical Co., Ltd., NasVax Ltd. , Raptor Pharmaceutical Corp. Astellas Pharma US, Inc., AstraZeneca, Salix Pharmaceuticals, Inc. and Tioga Pharmaceuticals, Inc.
Advisors' Opinion:- [By John Udovich]
It�� a new year and the first one and a half trading weeks of 2014 has not disappointed biotech investors as the sector and mid cap or small cap biotech or�pharma stocks like Intercept Pharmaceuticals Inc (NASDAQ: ICPT), Epizyme Inc (NASDAQ: EPZM), Tonix Pharmaceuticals Holding Corp (NASDAQ: TNXP) and TNI BioTech Inc (OTCQB: TNIB) either surging or producing some news plus there have been IPO filings for future listings for�Flexion Therapeutics (NASDAQ: FLXN), Aldexa Therapeutics (NASDAQ: ALDX), Retrophin (NASDAQ:�RTRX) and Dicerna Pharmaceuticals (NASDAQ: DRNA). Consider the following news so far this year:
- [By Jake L'Ecuyer]
Equities Trading UP
Shares of Intercept Pharmaceuticals (NASDAQ: ICPT) got a boost, shooting up 62.40 percent to $452.02. Citigroup lifted the price target on the stock from $60.00 to $400.00, while Bank of America raised the price target from $81.00 to $872.00. - [By Jake L'Ecuyer]
Intercept Pharmaceuticals (NASDAQ: ICPT) was also down, falling 26.36 percent to $268.60 after a Wall Street Journal article Friday reported that the NIH had said patient's of the company's drug had more bad cholesterol than when they had started treatment.
- [By Ben Levisohn]
I mean, just look at these returns: Gilead Sciences (GILD) has gained 41% so far this year as investors appear to have put their Sovaldi worries behind them; InterMune (ITMN) has quintupled in 2014 after Roche agreed to purchase it for $8.3 billion; and Intercept Pharmaceuticals (ICPT) has surged 350% as drug trials have been surprisingly good. All told, the iShares Nasdaq Biotechnology ETF (IBB) has risen 21%, more than double the S&P 500′s 8.3% rise.
No comments:
Post a Comment