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.
Top 5 Medical Companies To Own For 2014: Oncolytics Biotech Inc (ONCY)
Oncolytics Biotech Inc. (Oncolytics), incorporated on April 2, 1998, is a development-stage company. The Company is focused on its research and development of REOLYSIN, which is its cancer therapeutic. REOLYSIN is developed from the reovirus. This virus has been demonstrated in tumour cells bearing an activated Ras pathway. Oncolytics is directing a clinical trial program with the focus of developing REOLYSIN as a human cancer therapeutic. The clinical program includes clinical trials, which it sponsors directly along with Third Party Clinical Trials. Third Party Clinical Trials are clinical trials that are being sponsored by other institutions. As of December 31, 2011, the United States National Cancer Institute (NCI), the University of Leeds and the Cancer Therapy & Research Center at the University of Texas Health Center in San Antonio (CTRC) were sponsoring part of its clinical trial program.
The Company�� clinical trial program has included human trials using REOLYSIN alone, and in combination with radiation and chemotherapy, and delivered via local administration and/or intravenous administration. Oncolytics uses contract toll manufacturers to produce REOLYSIN. On December 31, 2011, the Company had two wholly owned subsidiaries, Oncolytics Biotech (Barbados) Inc. (OBB) and Valens Pharma Ltd. Oncolytics Biotech (US) Inc. and Oncolytics Biotech (U.K.) are wholly owned subsidiaries of OBB.
Advisors' Opinion: - [By Sean Williams]
With this in mind, I feel it'd be prudent of biotech-savvy investors to give Oncolytics Biotech (NASDAQ: ONCY ) a closer look.
The big risks
I'm quite aware that there are a lot factors that'd raise a red flag with Oncolytics. Similar to Affymax, you could say that Oncolytics has put all of its eggs in one basket with its lead experimental drug, reolysin. According to Oncolytics' website, including its U.K., Canadian, and U.S. studies, reolysin as either a monotherapy or combination therapy is the basis for all 31 clinical trials! Obviously, if reolysin proves ineffective or unsafe, Oncolytics is going to be a world of hurt.
- [By John Udovich]
The biotech sector along with small cap biotech stocks Cardiome Pharma Corp (NASDAQ: CRME), Oncolytics Biotech, Inc (NASDAQ: ONCY), Vital Therapies Inc (NASDAQ: VTL) and TNI BioTech (OTCMKTS: TNIB) have all been producing their share of news this week for investors and traders alike to trade on. Moreover and while some 42 ��ife sciences��companies have gone public raising about $3 billion from investors so far this year, there are a growing number of biotechs pulling the plug on upcoming IPOs who are citing market conditions. With that in mind, here is a look at important news from the biotech sector and small cap biotech stocks this week:
- [By Maxx Chatsko]
T-VEC is not your traditional biologic drug. It is actually a bioengineered form of the herpes virus that, once injected into cancerous tumors, replicates, and produces an immune-stimulating protein that puts a bulls eye on cancer cells throughout the body. Despite its promise and intriguing mechanism of action, T-VEC is not in further development at Amgen. However, Oncolytics (NASDAQ: ONCY ) has shown promising results for its bioengineered form of reovirus called Reolysin. Initial phase 3 results showed that 86% of patients taking the drug had reduced tumor mass or growth after six weeks of treatment. �
Top 5 Medical Companies To Own For 2014: Cell Therapeutics Inc (CTIC)
Cell Therapeutics, Inc. (CTI), incorporated in 1991, develops, acquires and commercializes treatments for cancer. The Company�� research, development, acquisition and in-licensing activities concentrate on identifying and developing new ways to treat cancer. As of December 31, 2011, CTI focused its efforts on Pixuvri (pixantrone dimaleate) (Pixuvri), OPAXIO (paclitaxel poliglumex) (OPAXIO), tosedostat, brostallicin and bisplatinates. As of December 31, 2011, it developed Pixuvri, an anthracycline derivative for the treatment of hematologic malignancies and solid tumors. Another late-stage drug candidate of the Company, OPAXIO, is being studied as a potential maintenance therapy for women with advanced stage ovarian cancer, who achieve a complete remission following first-line therapy with paclitaxel and carboplatin. As of December 31, 2011, it also developed tosedostat in collaboration with Chroma Therapeutics, Ltd. (Chroma). On May 31, 2012, CTI completed its acquisition gaining worldwide rights to S*BIO Pte Ltd.'s (S*BIO) pacritinib.
Pixuvri
As of December 31, 2011, the Company developed Pixuvri, an aza-anthracenedione derivative, for the treatment of non-Hodgkin�� lymphoma (NHL), and various other hematologic malignancies, and solid tumors. Pixuvri was studied in the Company�� EXTEND, or PIX301, clinical trial, which was a phase III single-agent trial of Pixuvri for patients with relapsed, refractory aggressive NHL who received two or more prior therapies and who were sensitive to treatment with anthracyclines. On September 28, 2011, CTI announced that a second independent radiology assessment of response and progression endpoint data from its PIX301 clinical trial of Pixuvri was achieved with statistical significance. The results of the EXTEND trial met its primary endpoint and showed that patients randomized to treatment with Pixuvri achieved a significantly higher rate of confirmed and unconfirmed complete response compared to patients treated with standard chem! otherapy had a significantly increased overall response rate and experienced a statistically significant improvement in median progression free survival. Pixuvri had predictable and manageable toxicities when administered at the proposed dose and schedule in the EXTEND clinical trial in heavily pre-treated patients. In March 2011, the Company initiated the PIX-R trial to study Pixuvri in combination with rituximab in patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL). Pixuvri has also been studied in patients with HER2-negative metastatic breast cancer who have tumor progression after at least two, but not more than three, prior chemotherapy regimens. In the second quarter of 2010, the NCCTG opened this phase II study for enrollment. The study is closed to accrual and results are expected to be reported by the NCCTG later in 2012.
OPAXIO
OPAXIO is the Company�� biologically-enhanced chemotherapeutic agent that links paclitaxel to a biodegradable polyglutamate polymer, resulting in a new chemical entity. As of December 31, 2011, the Company focused its development of OPAXIO on ovarian, brain, esophageal, head and neck cancer. OPAXIO was designed to improve the delivery of paclitaxel to tumor tissue while protecting normal tissue from toxic side effects. In November 2010, results were presented by the Brown University Oncology Group from a phase II trial of OPAXIO combined with temozolomide (TMZ), and radiotherapy in patients with newly-diagnosed, high-grade gliomas, a type of brain cancer. The trial demonstrated a high rate of complete and partial responses and a high rate of six month progression free survival (PFS). Based on these results, the Brown University Oncology Group has initiated a randomized, multicenter, phase II study of OPAXIO and standard radiotherapy versus TMZ and radiotherapy for newly diagnosed patients with glioblastoma with an active gene termed MGMT that reduces responsiveness to TMZ. A phase I/II study of OPAXIO combined with radi! otherapy ! and cisplatin was initiated by SUNY Upstate Medical University, in patients with locally advanced head and neck cancer.
Tosedostat
In March 2011, the Company entered into a co-development and license agreement with Chroma Therapeutics, Ltd. (Chroma), providing the Company with marketing and co-development rights to Chroma�� drug candidate, tosedostat, in North, Central and South America. Tosedostat is an oral, aminopeptidase inhibitor that has demonstrated anti-tumor responses in blood related cancers and solid tumors in phase I-II clinical trials. Interim results from the phase II OPAL study of tosedostat in elderly patients with relapsed or refractory acute myeloid leukemia (AML) showed that once-daily, oral doses of tosedostat had predictable and manageable toxicities and results demonstrated response rates, including a high-response rate among patients who received prior hypomethylating agents, which are used to treat myelodysplastic syndrome (MDS), a precursor of AML.
Brostallicin
As of December 31, 2011, the Company developed brostallicin through its wholly owned subsidiary, Systems Medicine LLC, which holds rights to use, develop, import and export brostallicin. Brostallicin is a synthetic deoxyribonucleic acid (DNA) minor groove binding agent that has demonstrated anti-tumor activity and a favorable safety profile in clinical trials, in which more than 230 patients have been treated as of December 31, 2011. The Company uses a genomic-based platform to guide the development of brostallicin. A phase II study of brostallicin in relapsed, refractory soft tissue sarcoma met its predefined activity and safety hurdles and resulted in a first-line phase II clinical trial study that was conducted by the European Organization for Research and Treatment of Cancer (EORTC).
The Company competes with Bristol-Myers Squibb Company, Sanofi-Aventis, Pfizer, Roche Group, Genentech, Inc., Astellas Pharma, Eli Lilly and Company, Celgene, Telik, I! nc., TEVA! Pharmaceuticals Industries Ltd. and PharmaMar.
Advisors' Opinion: - [By John Udovich]
Large and small cap cancer stocks Gilead Sciences, Inc (NASDAQ: GILD), Celgene Corporation (NASDAQ: CELG), Veracyte (NASDAQ: VCYT), Genomic Health, Inc (NASDAQ: GHDX), Cell Therapeutics Inc (NASDAQ: CTIC) and MetaStat Inc (OTCMKTS: MTST) have all been producing a steady stream of news lately for biotech investors looking for a way to cash in on the growth in development of�cancer treatments. Just consider the following news:
Antares Pharma, Inc. (Antares) is a pharma company that focuses on self-injection pharmaceutical products and technologies and topical gel-based products. The Company�� subcutaneous and intramuscular injection technology platforms include Vibex disposable pressure-assisted auto injectors, Vision reusable needle-free injectors, and disposable multi-use pen injectors. In the injector area, it has licensed its reusable needle-free injection device for use with human growth hormone (hGH) to Teva, Ferring Pharmaceuticals BV (Ferring) and JCR Pharmaceuticals Co., Ltd. (JCR), with Teva and Ferring being its two primary customers. The Company has also licensed both disposable auto and pen injection devices to Teva for use in certain fields and territories and is engaged in product development activities for Teva utilizing these devices.
In the gel-based area, it received Food and Drug Administration (FDA) approval in December 2011 for its oxybutynin gel 3% product, Anturol, for the treatment of overactive bladder. Antares also has a licensing agreement with Watson Watson Pharmaceuticals, Inc. (Watson) under which Watson will commercialize its topical oxybutynin gel 3% product in the United States and Canada. Its gel portfolio also includes Elestrin (estradiol gel) in the United States for the treatment of moderate-to-severe vasomotor symptoms associated with menopause. Antares has designed disposable, pressure assisted auto injector devices to address acute medical needs, such as allergic reactions, migraine headaches, acute pain, emesis and other daily therapies.
Pressure Assisted Injection Devices
The Company�� Pressure Assisted Injection Devices consists of three products: reusable needle-free injectors, disposable pressure assisted auto injectors and disposable pen injectors. Reusable needle-free injectors deliver precise medication doses through high-speed, pressurized liquid penetration of the skin without a needle. The injector employs a disposable pl! astic needle-free syringe, which offers liquid medication delivery through an opening that is approximately half the diameter of a standard, 30-gauge needle.
Disposable pressure assisted auto injectors is a technology of controlled pressure delivery of drugs into the body utilizing a spring power source. The Vibex is designed to provide fast subcutaneous or intramuscular injections of up to 0.5ml with minimal discomfort and improved convenience in conjunction with the enhanced safety of a shielded needle. Disposable pen injectors are needle-based devices designed to deliver multiple injections from multi-dose drug cartridges. The devices contain mechanisms that specify the dose to be delivered by defining the amount of movement by the stopper in the cartridge with each device actuation.
The Vision/Tjet has been sold for use in more than 30 countries to deliver either insulin or hGH. The product features a reusable, spring-based power source and disposable needle-free syringe, which acts as the pathway for the injectable drug through the skin and allows for viewing of the medication dose prior to injection. The product is also reusable, with each device designed to last for approximately 3,000 injections (or approximately two years) while the needle-free syringe, when used with insulin or hGH, is disposable after approximately one week when used by a single patient for injecting from multi-dose vials. The Vision/Tjet administers injectables by using a spring to push the active ingredient in solution or suspension through a micro-fine opening in the needle-free syringe. The opening is approximately half the diameter of a 30-gauge needle. The Vision/Tjet is primarily used in the United States, Europe, Asia and Japan.
Antares has designed disposable, pressure assisted auto injector devices to address acute medical needs, such as allergic reactions, migraine headaches, acute pain, emesis and other daily therapies. Its Vibex disposable product combines a low-energy, spr! ing-based! power source with a hidden needle, which delivers up to 0.5ml of the needed drug solution subcutaneously or intramuscularly. Antares is also developing a Vibex MTX auto injector for delivery of methotrexate for treatment of rheumatoid arthritis. The Company�� multi use, disposable pen injector complements its portfolio of single-use pressure assisted auto injector devices. The disposable pen injector device is designed to deliver drugs by injection through needles from multi- dose cartridges. The disposable pen is in the stage of development where devices are being used in clinical evaluations.
Transdermal Products
The Company�� ATD system penetrates the skin to deliver a variety of treatments. The gels consist of a hydro-alcoholic base, including a combination of permeation enhancers. Products being developed/ commercialized include Anturol, Elestrin and Nestragel. Elestrin is a transdermal estradiol gel for the treatment of moderate-to-severe vasomotor symptoms associated with menopause. Its other injectable drugs that are presently self-administered and may be suitable for injection with its systems include therapies for the prevention of blood clots and treatments for multiple sclerosis, migraine headaches, inflammatory diseases, impotence, infertility, acquired immune deficiency symdrome (AIDS) and hepatitis.
The Company competes with Ypsomed AG, SHL Group AB, OwenMumford Ltd., West Pharmaceuticals, Becton Dickinson, Haselmeir GmbH, Elcam Medical, Vetter Pharma, Bioject Medical Technologies Inc., The Medical House PLC, Watson, Abbott, Eli Lilly, Auxillium, Inc., Endo Pharmaceuticals, Teva, Mylan, Roxane, Bedford Labs, APP Pharmaceuticals, Hospira, Pfizer, GSK/Astellas, Warner Chilcott and Allergan.
Advisors' Opinion: - [By Luke Jacobi]
Antares Pharma (NASDAQ: ATRS) added 6.65 percent to close at $4.33 following the announcement that an FDA decision is expected on its drug on October 14. Equities
- [By Keith Speights]
1. Antares Pharma (NASDAQ: ATRS )
Antares has experienced a roller-coaster ride so far this year. The stock was up more than 10% early in January, then proceeded to fall by more than 20% by late February. Since then, Antares has clawed its way back and now stands up a little over 10% for the year.�
- [By Keith Speights]
Antares Pharma (NASDAQ: ATRS ) announced its first-quarter results �Wednesday morning but failed to impress the market. Shares were down around 3% in midday trading. Here are the highlights from the company's results.
Top 5 Medical Companies To Own For 2014: EntreMed Inc (ENMD.PH)
EntreMed, Inc. (EntreMed), incorporated in 1991, is a clinical-stage pharmaceutical company. EntreMed's drug candidate is ENMD-2076, an Aurora A and angiogenic kinase inhibitor for the treatment of cancer. ENMD-2076 has completed Phase I studies in patients with advanced solid tumors, multiple myeloma and leukemia and is completing data for a multi-center Phase II study in patients with platinum resistant ovarian cancer. The Company�� other product candidates have includes MKC-1, ENMD-1198 and 2-methoxyestrdiol (2ME2, Panzem) for treatment of rheumatoid arthritis.
ENMD-2076 is a novel orally-active, Aurora A/angiogenic kinase inhibitor with potent activity against Aurora A and multiple tyrosine kinases linked to cancer and inflammatory diseases. ENMD-2076 is relatively selective for the Aurora A isoform in comparison to Aurora B. Aurora kinases are key regulators of the process of mitosis, or cell division, and are often over-expressed in human cancers. E NMD-2076 exerts its effects through multiple mechanisms of action, including anti-proliferative activity and the inhibition of angiogenesis. ENMD-2076 has demonstrated significant, dose-dependent preclinical activity as a single agent, including tumor regression, in multiple xenograft models (such as breast, colon, leukemia), as well as activity towards ex vivo-treated human leukemia patient cells.
Top 5 Medical Companies To Own For 2014: Fuse Science Inc (DROP)
Fuse Science, Inc. ( Fuse Science), incorporated on September 21, 1988, is a consumer products holding company. The Company maintains the rights to sublingual and transdermal delivery systems for bioactive agents that can effectively encapsulate and charge many varying molecules in order to produce complete product formulations which can be consumed orally, applied topically or delivered otherwise sublingually or transdermally, thereby bypassing the gastrointestinal tract and entering the blood stream directly. The Fuse Science technology is designed to accelerate conveyance of medicines or nutrients relative to traditional pills and liquids and can enhance how consumers receive these products. In December 2012, the Company launched its initial DROP products, PowerFuse, an energy formulation in a concentrated drop and ElectroFuse, an electrolyte formula in a concentrated drop, online, with the expansion into targeted retail distribution channels.
The Company is developing formulations and devices, which are compatible with alternative delivery systems for energy, medicines, vitamins and minerals, among other bioactives. These alternative systems include, but are not limited to, sublingual, transdermal and buccal drug delivery methods. use Science has developed and continues to advance, in conjunction with its scientific team, sublingual and transdermal delivery systems for bioactives that can effectively encapsulate and charge varying molecules in order to produce product formulations which can be consumed orally, applied topically or otherwise delivered sublingually or transdermally, thereby bypassing the gastrointestinal tract and entering the blood stream directly. The delivery technology is consists of encapsulation vesicles and ion exchange permeation enhancers. This technology utilizes a gradient across the mucosa membrane to help deliver the bioactive more efficiently through the mucosa.
The Company�� products consist of EnerJel, PowerFuse and ElectroFuse. Ene! rJel is a topical product leveraging some of its technology, which is designed to address muscle fatigue and soreness, before, during and after physical activity. The product contains a natural anti-inflammatory and energy source which is directly applied to the problem area. PowerFuse contains natural ingredients, causes no sugar crash with zero calories and less than half the caffeine of an eight ounce cup of premium coffee. It is available in a great tasting Berry Blast Flavor. ElectroFuse contains natural ingredients, causes no sugar crash with zero calories, is easily portable and is available in a great tasting Salty-Sweet flavor.