Shares of Hologic (HOLX) have plunged today after the maker of medical devices for women reported results that left investors searching for a diagnosis.
The Associated Press has the details:
Hologic said late Monday that it expects lower sales of ThinPrep pap tests, NovaSure endometrial ablations systems, and blood screening tests. Hologic also said sales of its older 2-dimensional Selenia digital mammography system will decline as it begins selling its newer Dimensions systems. The company expects to report adjusted net income of $1.32 to $1.38 per share in its new fiscal year, which started Sept. 29. It forecast $2.43 billion to $2.48 billion in total revenue, down from $2.49 billion in fiscal 2013.
Analysts had predicted much higher net income of $1.63 per share and $2.59 billion in revenue, according to FactSet.
Citigroup’s Amit Bhalla summarizes the good and the bad:
While HOLX beat the Street by $0.02 on the bottom-line, revenues came in light and F2014 guidance was below Street expectations. 3D mammo remains a positive (+50% Y/Y) and GPRO was up +11%, but ThinPrep (-13% Y/Y) and NovaSure weakness remain a headwind. Initial F14 guidance includes revs down -1-3% (Street expected +3%) and during this “transition” year, HOLX expects to complete more asset reviews/sales, further streamline the business, and begin a new $250M share buyback. While we believe these efforts are a positive, a $1.1B write-down on diagnostics (GPRO & ThirdWave) indicates that some businesses may need more time to recover ��we remain Neutral-rated.
Best Biotech Companies To Buy For 2015: ZELTIQ Aesthetics Inc (ZLTQ)
ZELTIQ Aesthetics, Inc. (ZELTIQ), incorporated on March 22, 2005, is a medical technology company. The Company is focused on developing and commercializing products utilizing its controlled-cooling technology platform. Its commercial product is the CoolSculpting System that reduces stubborn fat bulges. The Company generates revenues from capital sales of its CoolSculpting System and from procedure fees its physician customers pay for each CoolSculpting procedure they perform. As of March 31, 2011, it had an installed base of 346 and 475 CoolSculpting Systems worldwide and over 88,000 CoolSculpting procedures had been sold to its physician customers. The Company markets CoolSculpting to the dermatologists, plastic surgeons, and aesthetic specialists. As of March 31, 2011, ZELTIQ�� North American direct sales force consisted of 23 professionals, and over 88,000 CoolSculpting procedures were sold to ZELTIQ�� physician customers.
CoolSculpting System
ZELTIQ generates revenues from capital sales of its CoolSculpting System and from procedure fees its physician customers pay for each CoolSculpting procedure they perform. Capital sales of ZELTIQ�� CoolSculpting System include the CoolSculpting control unit and its CoolSculpting vacuum applicators. ZELTIQ generates procedure fees through sales of CoolSculpting procedure packs, which include its consumable gelpads and liners and a disposable computer cartridge that it markets as the CoolCard. The CoolCard contains enabling software that permits its physician customer to perform a fixed number of CoolSculpting procedures.
The CoolSculpting control unit is the base of the CoolSculpting System. ZELTIQ�� CoolSculpting control unit also contains software that tracks and collects data about each procedure performed and any error messages that may be generated during the procedure. CoolSculpting System includes three CoolSculpting vacuum applicators. ZELTIQ�� CoolSculpting procedure packs facilitate the pay-per-procedu! re feature of its CoolSculpting System. Its CoolSculpting procedure packs include CoolCard and its consumable gelpads and liners.
Advisors' Opinion:- [By Garrett Cook]
Wednesday morning, the healthcare sector proved to be a source of strength for the market. Leading the sector was strength from ZELTIQ Aesthetics (NASDAQ: ZLTQ) and Aegerion Pharmaceuticals (NASDAQ: AEGR).
- [By Garrett Cook]
Wednesday morning, the healthcare sector proved to be a source of strength for the market. Leading the sector was strength from ZELTIQ Aesthetics (NASDAQ: ZLTQ) and Aegerion Pharmaceuticals (NASDAQ: AEGR).
Hot Medical Stocks To Buy For 2014: Conatus Pharmaceuticals Inc (CNAT)
Conatus Pharmaceuticals Inc., incorporated on July 13, 2005, is a biotechnology company focused on the development and commercialization of medicines to treat liver disease. The Company is developing its lead compound, emricasan, for the treatment of patients in orphan populations with chronic liver disease and acute exacerbations of chronic liver disease. The Company has designed a clinical program to demonstrate the therapeutic benefit of emricasan across the spectrum of fibrotic liver disease. The Company�� initial development strategy targets indications for emricasan with high unmet clinical need in orphan patient populations, such as patients with acute-on-chronic liver failure (ACLF), chronic liver failure (CLF), and patients who have developed liver fibrosis post-orthotopic liver transplant due to Hepatitis C virus infection (HCV-POLT).
The Company has completed two placebo-controlled Phase II trials in patients with liver disease showing reductions in ALT levels that occur rapidly, within as little as one day after initiation of therapy, and are maintained throughout the treatment period. In the Company�� 204-patient Phase 2b trial, it also measured cCK18, an important biomarker of apoptosis and disease severity. Emricasan has been generally well-tolerated in all of the clinical studies. As of July 23, 2013, the Company had not generated any revenue.
Advisors' Opinion:- [By John Udovich]
While Intercept Pharmaceuticals Inc (NASDAQ: ICPT) surged earlier this year and Achillion Pharmaceuticals, Inc (NASDAQ: ACHN) has surged this week after Merck & Co. Inc (NYSE: MRK) agreed to purchase hepatitis stock�Idenix Pharmaceuticals Inc (NASDAQ: IDIX) at a 239% premium, it seems the herd has realized that small cap Conatus Pharmaceuticals Inc (NASDAQ: CNAT) is also a liver disease stock as shares suddenly surged 56.69% on no apparent company news. But just what is�Conatus Pharmaceuticals and is it worth taking a chance on?
- [By Lauren Pollock]
Conatus Pharmaceuticals Inc.'s(CNAT) shares jumped 26% to $7.75 premarket after the biotechnology firm said its treatment for chronic liver disease has been granted a status that could mean quicker approval.
Hot Medical Stocks To Buy For 2014: ImmunoCellular Therapeutics Ltd (IMUC)
ImmunoCellular Therapeutics, Ltd., incorporated on March 20, 1987, is a clinical-stage biotechnology company. The Company is engaged in developing immune-based therapies for the treatment of cancers, such as brain, ovarian and other solid tumors. Immunotherapy is an approach to treat cancer in which a patient�� own immune system is stimulated to target tumor antigens, which are molecular signals that the immune system uses to identify foreign bodies. The Company�� products include ICT-107, ICT-140, ICT-120, ICT-109 and DIAAD. ICT-107, the pipeline product, is a Phase II therapeutic dendritic cell (DC) vaccine for the treatment of glioblastoma multiforme (GBM), the common and lethal type of brain cancer. ICT-107 is designed to activate a patient�� immune system to target six different tumor-associated antigens. In February 2012, it acquired a world-wide license from the University of Pennsylvania and The John Hopkins University (JHU).
The Company in addition to ICT-107, is also developing other therapeutic DC vaccines: ICT-140 for ovarian cancer and ICT-121 for recurrent GBM. ICT-140 targets seven tumor-associated antigens expressed on ovarian cancer cells. ICT-107 is a DC vaccine that targets six different tumor-associated antigens that are found on patients��tumor cells; four of the six antigens are expressed on CSCs. The therapeutic vaccine is used subsequent to conventional therapy or concomitantly with chemotherapy in patients with newly diagnosed GBM. ICT-140 is a DC vaccine that targets seven different ovarian cancer antigens. ICT-121 is a DC vaccine that targets CD133 antigens; it has the potential to be a universal cancer vaccine because CD133 is widely expressed on CSCs from a majority of cancers. Data from this small study demonstrated that ICT-109 had a statistically ability to discriminate between cancerous and non-cancerous samples, suggesting the potential to detect pancreatic and lung cancer in plasma and serum study sets. The DIAAD (differential immunization for an! tigen and antibody discovery) platform it acquired from Molecular Discoveries utilizes immunological tolerization to accelerate the discovery of the molecular differences between diseased cells and their normal counterparts. The monoclonal antibodies produced by DIAAD provide the basis for the discovery and development of its potential diagnostic and therapeutic products.
The Company competes with Dendreon, Oncothyreon, Galena, Bavarian Nordic and Immunovaccine, Northwest Biotherapeutics, Prima Biomed, DCPrime, Roche/Genentech, Seattle Genetics, Bristol-Myers Squibb and Immunogen.
Advisors' Opinion:- [By Smith On Stocks]
Using my assumptions, the common of Agenus might be worth about $7.00 per share in early 2014 based on the royalties from the Glaxo vaccines and the net operating loss carry forward even if every other asset in the company were valued at zero. However, there may be substantial value in Agenus' internal vaccine programs in recurrent and newly diagnosed glioblastoma and the genital herpes vaccine. Based on a comparison to peer companies like Northwest Biotherapeutics (NWBO) and ImmunoCellular Therapeutics (IMUC), I believe that the internal programs at Agenus currently may be worth $150 million or $4.45 per share. Adding this to the value of the MAGE A-3 vaccine could produce a stock price of $11.00 in early 2014.
Hot Medical Stocks To Buy For 2014: Enanta Pharmaceuticals Inc (ENTA)
Enanta Pharmaceuticals, Inc., incorporated on July 25, 1995, is a research and development-focused biotechnology company. The Company uses its chemistry-driven approach and drug discovery capabilities to create small molecule drugs in the infectious disease field. The Company is discovering and developing novel inhibitors designed for use against the hepatitis C virus (HCV). These inhibitors include members of the direct acting antiviral (DAA) inhibitor classes-protease (partnered with AbbVie, the former research-based pharmaceutical business of Abbott Laboratories), NS5A (partnered with Novartis) and nucleotide polymerase, as well as a host targeted antiviral (HTA) inhibitor class targeted against cyclophilin. ABT-450, discovered through its collaboration with AbbVie, is a protease inhibitor that has demonstrated in vitro potency against known resistant HCV mutants.
In Phase I studies, ABT-450 co-administered with ritonavir, a commonly used boosting agent to increase the blood concentrations of many protease inhibitors, was shown to be safe and well tolerated. Co-administration of ABT-450 with ritonavir, which it refers to together as ABT-450/r, has enabled once-daily dosing of ABT-450. Phase II studies have demonstrated the efficacy of ABT-450/r in patients with chronic HCV, and other interferon-free Phase II studies of ABT-450-containing regimens continue. AbbVie is developing a next-generation protease inhibitor discovered within the Enanta-AbbVie collaboration. EDP-239 is the NS5A inhibitor discovered by the Company. The Company also has a program to develop nucleotide inhibitors to HCV NS5B polymerase, which is another DAA mechanism considered to have a barrier to resistance. The Company�� Bicyclolide antibiotic product candidate is EDP-788, which it is developing for use as an intravenous drug in the hospital setting and for oral dosing in the home setting. EDP-788 is a prodrug, which means that it is inactive until it is converted in the body into an active compound. EDP-788 is! a water-soluble molecule which, when administered in preclinical models, is cleanly and rapidly converted into the active compound.
Advisors' Opinion:- [By James Fink]
And lastly I'll go into healthcare, which is kind of a growth cyclical type name. It's partially defensive, partially growth. I think the more growth-oriented section of healthcare would be biotech, and right now, a very promising biotech stock is Enanta Pharmaceuticals. That's a NASDAQ stock; ticker symbol (ENTA).
- [By George Budwell]
Normally, such strong efficacy results would be hailed as a major achievement. However, these results are actually less impressive than those by competing drug's developed by AbbVie (NYSE: ABBV ) , Enanta Pharmaceuticals (NASDAQ: ENTA ) and Gilead. Bristol-Myers' therapy also has a treatment duration double that of Gilead's drug Sovaldi for genotype 1 patients. So, while these results are impressive in their own right, the therapy's commercial prospects may be limited due to the presence of superior competitors in the market.�
- [By Sean Williams]
The next big thing in treating hepatitis-C
The other currently experimental therapy very likely to make it onto the FDA's desk before the midpoint of 2014 is AbbVie's (NYSE: ABBV ) direct-acting antiviral combo drug. In similar fashion to Sovaldi, this DAA-combo therapy, which includes ABT-450 from Enanta Pharmaceuticals (NASDAQ: ENTA ) , is running six confirmatory late-stage trials on various genotypes. There are, however, two primary differences between AbbVie's DAA-combo therapy and Sovaldi.
Hot Medical Stocks To Buy For 2014: Tonix Pharmaceuticals Holding Corp (TNXP)
Tonix Pharmaceuticals Holding Corp., incorporated on November 16, 2011, is a specialty pharmaceutical company focused on developing novel pharmaceutical products for disorders of the central nervous system (CNS). The Company develops TNX-102 sublingual tablet, or TNX-102 SL. TNX-102 SL is a novel dose and formulation of cyclobenzaprine (CBP), the active pharmaceutical ingredient of two prescribed muscle relaxant products, Flexeril and Amrix. TNX-102 SL is also intended for chronic use. It develops TNX-102 SL for the treatment of FM under a United States Investigational New Drug application (IND), and under three clinical trial applications (CTAs), filed in Canada. It also develops TNX-102 SL for the treatment of post-traumatic stress disorder (PTSD). As of January 25, 2013, the Company focuses on product development, and had not generated any revenues.
The Company searches for potential therapeutic solutions among known pharmaceutical agents that lack regulatory approval for the indications it seeks, but may be approved for use in other indications. It seeks to create new dose and formulation options that are tailored to the therapeutic uses to which it applies these agents. TNX-102 SL is a small, rapidly disintegrating tablet containing CBP for sublingual administration at bedtime. The Company designed TNX-102 SL for delivery of CBP to the systemic circulation through sublingual transmucosal absorption and to avoid first-pass liver metabolism.
CBP is the active pharmaceutical ingredient in its lead product candidate, TNX-102 SL. In addition to CBP, TNX-102 SL contains inactive ingredients, called excipients, which are approved for pharmaceutical use. In addition to TNX-102 SL, it develops other formulations of CBP, including TNX-102 promicellar gelatin capsule, or TNX-102 gelcap. It developed TNX-102 gelcap under an agreement with Lipocine, Inc. (Lipocine), a contract formulation developer and small-scale manufacturer. In addition it has other pipeline of other product cand! idates, including TNX-201 and TNX-301. TNX-201 is based on isometheptene mucate and is under development as a treatment for certain types of headaches.
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:
Hot Medical Stocks To Buy For 2014: Genomic Health Inc (GHDX)
Genomic Health, Inc. (Genomic Health), incorporated in August 2000, is a molecular diagnostics company focused on the global development and commercialization of genomic-based clinical laboratory services that analyze the underlying biology of cancer allowing physicians and patients to make individualized treatment decisions. Its Oncotype DX platform utilizes quantitative genomic analysis known as reverse transcription polymerase chain reaction (RT-PCR), in standard tumor pathology specimens to provide tumor-specific information, or the oncotype of a tumor. As of February 2012, Oncotype DX was evaluated in invasive breast cancer in 13 clinical studies involving more than 4,000 breast cancer patients worldwide. Genomic Health offers its Oncotype DX tests as a clinical service, where it analyzes the expression levels of genes in tumor tissue samples and provide physicians with a quantitative gene expression profile expressed as a single quantitative score, which it calls a Recurrence Score, for invasive breast cancer and colon cancer and a DCIS Score for DCIS. Its Oncotype DX breast cancer test analyzes the expression levels of 21 genes and Oncotype DX colon cancer test analyzes the expression levels of 12 genes. In March 2012, the Company established a wholly owned subsidiary, InVitae Corporation.
Oncotype DX Platform
The Company�� Oncotype DX platform uses its RT-PCR approach to improve cancer treatment decisions. Its diagnostic approach correlates gene expression to clinical outcomes and provides an individualized analysis of each patient's tumor. The Company has built a diagnostic infrastructure that allows it to move from research into development through to processing actual patient samples in its clinical reference laboratory. The Company offers Oncotype DX tests as clinical laboratory services. Its technology allows the Company to analyze tumor tissue samples in its clinical reference laboratory and provide physicians with genomic information specific to the patient'! s tumor. It analyzes tissues that are handled, processed and stored under routine clinical pathology laboratory practices.
Oncotype DX Breast Cancer Test
To develop its Oncotype DX breast cancer test, the Company evaluated 250 genes in three independent clinical studies, which identified a 21-gene panel whose composite gene expression profile can be represented by a breast cancer Recurrence Score. The Company conducted studies of its Oncotype DX breast cancer test with clinical samples from postmenopausal women with invasive breast cancer who were treated with aromatase inhibitors. In March 2010, the Journal of Clinical Oncology published results from a European study using its test to analyze tumor samples from over 1,200 patients in the ATAC (Arimedix, Tamoxifen, Alone or in Combination) trial, which established the use of aromatase inhibitors for adjuvant treatment of postmenopausal women with hormone receptor-positive breast cancer. The study demonstrated that, along with other standard measures, such as tumor size, its Oncotype DX breast cancer test contributes independently to provide a more complete picture of prognosis for N- and N+ patients treated with aromatase inhibitors.
In December 2011, the Company presented positive results from the ECOG E5194 DCIS clinical validation study at SABCS. The study met its primary endpoint by demonstrating that a pre-specified Oncotype DX DCIS Score can predict the risk of local recurrence, defined as either the development of a new invasive breast cancer or the recurrence of DCIS in the same breast. In December 2011, the Company made Oncotype DX available for patients with ductal carcinoma in situ (DCIS), of the breast, a pre-invasive form of breast cancer. The launch of Oncotype DX for DCIS patients was based on positive results presented from a clinical validation study of Oncotype DX breast cancer test in patients with DCIS, conducted by the Eastern Cooperative Oncology Group (ECOG), a clinical trials cooperative! group su! pported by the National Cancer Institute.
Oncotype DX Colon Cancer Test
The Company developed its gene panel by identifying 761 cancer-related genes through review of existing research literature and computer analysis of genomic databases. The 761 candidate genes were also examined to determine whether they would be useful beyond other key variables including tumor stage, tumor grade, lymph nodes examined and MMR/MSI. It selected a final set of 12 genes, which were then independently evaluated in a validation study of over 1,400 stage II colon cancer patients from the Quick and Simple and Reliable (QUASAR), randomized study of adjuvant chemotherapy in the United Kingdom. This international, multi-center randomized trial examined the recurrence risk and the benefit associated with 5-fluorouracil/leucovorin, or 5FU/LV, adjuvant chemotherapy. Gene expression was quantified by RT-PCR from manually microdissected FPE primary colon cancer tissue, and recurrence-free interval, disease-free survival and overall survival were analyzed. In January 2012, the Company presented positive results of the first clinical decision making study of the Oncotype DX colon cancer test that shows that Recurrence Score result has a significant impact on treatment recommendations for stage II colon cancer patients.
The Company competes with General Electric Company, Hologic, Inc., Novartis AG, Myriad Genetics, Inc., Qiagen N.V., Response Genetics, Inc., Laboratory Corporation of America Holdings, Quest Diagnostics Incorporated, Roche Holding, Ltd, Siemens AG and Johnson & Johnson.
Advisors' Opinion:- [By John Udovich]
Small cap cancer diagnostic stock�Myriad Genetics, Inc (NASDAQ: MYGN) jumped to a five year high on Wednesday�thanks to good�news that the�government will be paying a heftier reimbursement for its main test than previously feared, meaning its worth taking a closer look at the stock along with small cap cancer diagnostic stocks like Rosetta Genomics Ltd (NASDAQ: ROSG) and�Genomic Health, Inc (NASDAQ: GHDX) plus mid cap diagnostic stock Quest Diagnostics Inc (NYSE: DGX). I should also mention that Myriad Genetics has been in our SmallCap Network Elite Opportunity (SCN EO) portfolio since early February and we are now up some 32.5% since then ��thanks in part to the shorts being put in a short squeeze.
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