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 Medical Stocks To Own For 2015: Bio-Matrix Scientific Group Inc (BMSN)
Bio-Matrix Scientific Group, Inc., incorporated on October 6, 1998, is a development stage company. The Company, through its wholly-owned subsidiary Regen BioPharma ,Inc., is engaged in the development of regenerative medical applications which it focuses to license from other entities up to the point of completion of Phase I and or Phase II clinical trials after which it would either attempt to sell or license those developed applications or, alternatively, advance the application further to Phase III clinical trials.
The Company has begun development of HemaXellerate, a cellular drug designed to heal damaged bone marrow. HemaXellerate I (TM) is a patient-specific composition of cells that have been demonstrated to repair damaged bone marrow and stimulate production of blood cells based on previous animal studies.
- [By Bryan Murphy]
If you’re a small cap enthusiast looking for some budding ideas, you may not need to look any further than China GengSheng Minerals, Inc. (NYSEMKT:CHGS), Bio Matrix Scientific Group Inc. (OTCMKTS:BMSN), and MER Telemanagement Solutions Ltd. (NASDAQ:MTSL). All three have either pushed themselves to the brink of a breakout, if they haven’t started one already. Here’s a closer technical look at MTSL, BMSN, and CHGS, and what it’s going to take to get them going if they’re not going already.
Best Medical Stocks To Own For 2015: Cell Therapeutics Inc (CTIC)
Cell Therapeutics, Inc. (CTI), incorporated in 1991, develops, acquires and commercializes treatments for cancer. The Company’s 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 acquisitio n gaining worldwide rights to S*BIO Pte Ltd.’s (S*BIO) pacritinib.
As of December 31, 2011, the Company developed Pixuvri, an aza-anthracenedione derivative, for the treatment of non-Hodgkin’s lymphoma (NHL), and various other hematologic malignancies, and solid tumors. Pixuvri was studied in the Company’s 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 compl ete 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 is the Company’s biologically-enhanced chemotherapeutic agent that links paclitax el 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 responsive ness 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.
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’s 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 syndrom e (MDS), a precursor of AML.
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.
- [By MONEYMORNING.COM]
Cell Therapeutics Inc. (Nasdaq: CTIC), based in Seattle, Wash., acquires, develops, and commercializes treatments for cancers, including non-Hodgkin’s leukemia and ovarian, neck, and brain cancers. The company just announced it has completed patient enrollment in clinical trials for an investigational agent to be used as a maintenance therapy in ovarian cancer patients. The trial is being conducted by the Gynecologic Oncology Group, one of the National Cancer Institute’s funded research groups. Roth Capital recently reiterated a “Buy” rating on the stock and raised its price target from $6 to $7. Roth believes the company’s treatment for leukemia, Pacritinib, is effectively evolving. Additionally, the investment firm sees potential in CTIC’s Tosedostat, which deprives tumor cells of the amino acid building blocks needed to make proteins necessary for tumor cell survival. Shares rose 2% Tuesday to $3.52 on volume of 6 million shares.
- [By John Udovich]
The start of 2014 shows that biotech is still a hot area with the sector along with small cap biotech stocks like AMAG Pharmaceuticals, Inc (NASDAQ: AMAG), Mast Therapeutics Inc (NYSEMKT: MSTX), Cell Therapeutics Inc (NASDAQ: CTIC), Imprimis Pharmaceuticals Inc (NASDAQ: IMMY) and TNI BioTech (OTCMKTS: TNIB) producing news or returns plus Auspex Pharmaceuticals (NASDAQ: ASPX), Cara Therapeutics (NASDAQ: CARA), Egalet (NASDAQ: EGLT), Flexion Therapeutics (NASDAQ: FLXN) and Ultragenyx Pharmaceutical (NASDAQ: RARE) are among the (many…) planned biotech IPOs that have recently been announced publicly:
Best Medical Stocks To Own For 2015: Pharmacyclics Inc (PCYC)
Pharmacyclics, Inc., incorporated on April 19, 1991, is a clinical-stage biopharmaceutical company focused on developing and commercializing small-molecule drugs for the treatment of cancer and immune mediated diseases. The Company’s clinical development and product candidates are small-molecule enzyme inhibitors designed to target biochemical pathways involved in human diseases. As of June 30, 2011, it had three drug candidates under clinical development and a number of preclinical lead molecules. This includes an inhibitor of Bruton’s tyrosine kinase (Btk) (PCI-32765) in Phase II studies in hematologic malignancies; a Btk inhibitor lead optimization program targeting autoimmune indications, an inhibitor of Factor VIIa (PCI-27483) in a Phase II clinical trial in pancreatic cancer, and a histone deacetylase (HDAC) inhibitor (PCI-24781) in Phase I and II clinical trials in solid tumors and hematological malignancies as of June 30, 2012.
As of June 30, 2012, t he Company developed ibrutinib, which has demonstrated clinical activity and tolerability in Phase I and Phase II clinical trials in a variety of B-cell malignancies, including chronic lymphocytic leukemia (CLL) and a number of non-Hodgkin’s lymphoma (NHL) subtypes. CLL, mantle cell lymphoma (MCL), follicular lymphoma (FL), diffuse B-cell lymphoma (DLBCL) and multiple myeloma (MM) are specific indications of its current or planned Phase Ib/II and Phase III development program. had development programs for B-cell malignancies and autoimmune diseases. For malignant indications it has developed PCI-32765, which has demonstrated clinical activity and tolerability in Phase I and Phase II clinical trials in a range of B-cell malignancies, including chronic lymphocytic leukemia (CLL) and a number of non-Hodgkin’s lymphoma (NHL) subtypes. CLL, mantle cell lymphoma (MCL), follicular lymphoma (FL), diffuse large B cell lymphoma (DLBCL) and multiple myeloma (MM) are specific indica tions of its Phase II development. It has developed an assay! to measure occupancy of Btk in PBMCs using a cell-permeable fluorescently-labeled derivative of PCI-32765.
Factor VII is an enzyme that becomes activated (FVIIa) by binding to the cell surface protein tissue factor (TF), a protein found in the body that helps to trigger the process of blood clotting in response to injury. TF is over expressed in many cancers including gastric, breast, colon, lung, prostate, ovarian and pancreatic cancers. In these tumors, the FVIIa/TF complex induces intracellular signaling pathways by activating protease activated receptor 2 (PAR-2), another cell-surface protein. This in turn increases the expression of interleukin-8 (IL-8), a protein produced by white blood cells and other immune cells in response to pathogenic stimulation, and vascular endothelial growth factor (VEGF), a signal protein produced by cells that stimulate the growth of blood vessels. Both proteins play an important role in tumor growth and metastases as well as angiogenesis (growth of new blood vessels). FVIIa/TF complex also initiates the coagulation (a process by which blood forms clots) processes implicated in the high incidence of thromboembolic (the process by which the blood clots within a blood vessel) complications seen in patients with TF-expressing cancers. Thromboembolic events are a cause of death in patients with cancer and anticoagulant treatment has been shown to improve survival in a variety of cancers (Klerk et al. JCO. 2005).
PCI-27483 Factor VIIa Inhibitor
The Company’s Factor VIIa inhibitor PCI-27483 is a first-in-human small molecule inhibitor that selectively targets FVIIa. As an inhibitor of FVIIa, PCI-27483 has two potential mechanisms of action: inhibition of intracellular signaling involved in tumor growth and metastases and inhibition of early coagulation processes associated with thromboembolism.
Factor VIIa PCI-27483 Clinical Development Update
A mu lticenter Phase I/II of PCI-27483 in patients with locally a! dvanced o! r metastatic pancreatic cancer that are either receiving or are planned to receive gemcitabine therapy has completed enrollment. The Phase II portion of the study randomized patients to receive either gemcitabine alone or gemcitabine plus PCI-27483 (1.2 mg/kg twice daily). The objectives are to assess the safety of FVIIa Inhibitor PCI-27483 at pharmacologically active dose levels, to assess potential inhibition of tumor progression and to obtain initial information of the effects on the incidence of thromboembolic events. Due to a paradigm shift away from the use of gemcitabine alone for the treatment of pancreatic cancer, enrolling patients in this randomized study has been challenging. PCYC is evaluating other alternatives for development of this agent.
A multicenter Phase I/II of PCI-27483 in patients with locally advanced or metastatic pancreatic cancer that are either receiving or are planned to receive gemcitabine therapy has completed enrollment. The Phas e II portion of the study randomized patients to receive either gemcitabine alone or gemcitabine plus PCI-27483 (1.2 mg/kg twice daily). PCI-27483 is covered by United States patents and patent applications and counterpart patents and patent applications in fourteen ex-United States territories, including Europe, Canada, Mexico, Japan, China, India, South Korea, Australia and Brazil.
- [By MONEYMORNING.COM]
We saw this last year with such Private Briefing recommendations as The Boeing Co. (NYSE: BA) and Pharmacyclics Inc. (Nasdaq: PCYC), which rose more than 100% and 400%, respectively, following our recommendation.
- [By Ben Levisohn]
Somaiya and team named Gilead and Neurocrine Biosciences (NBIX) their top picks, hile putting Buy ratings on Celgene, Biogen Idec, Alexion (ALXN), Incyte (INCY), Pharmacyclics (PCYC) and Synageva (GEVA). BioMarin (BMRN), Infinity Pharmaceuticals (INFI) and Amgen (AMGN) earned Neutral ratings.
- [By John McCamant]
The company—which we consider conservative among biotech stocks—is Pharmacyclics (PCYC). Its pill is also expected to be approved for a much larger B-cell cancer market, chronic lymphocytic leukemia (CLL), by the end of February.
Best Medical Stocks To Own For 2015: Hemispherx Biopharma Inc (HEB)
Hemispherx Biopharma, Inc. (Hemispherx) is a specialty pharmaceutical company engaged in the clinical development of new drugs therapies based on natural immune system enhancing technologies for the treatment of viral and immune based chronic disorders. Hemispherx focuses on two core pharmaceutical technology platforms Ampligen and Alferon N Injection.The commercial focus for Ampligen includes application as a treatment for Chronic Fatigue Syndrome (CFS) and as an influenza vaccine enhancer (adjuvant) for both therapeutic and preventative vaccine development. Alferon N Injection is a United States Food and Drug Administration (FDA) approved product with an indication for refractory or recurring genital warts. Alferon LDO (Low Dose Oral) is a formulation under development targeting influenza. It has three subsidiaries BioPro Corp., BioAegean Corp., and Core BioTech Corp. The Company’s foreign subsidiary is Hemispherx Biopharma Europe N.V./S.A.
Ampligen is an experimental drug, which is undergoing clinical development for the treatment of Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS). Over 1,000 patients have participated in the Ampligen clinical trials representing the administration of more than 90,000 doses of this drug. The Company is also engaged in ongoing, experimental studies assessing the efficacy of Ampligen against influenza viruses.
Alferon N Injection
Alferon N Injection is the registered trademark for the Company’s injectable formulation of natural alpha interferon. Interferons are a group of proteins produced and secreted by cells to combat diseases. The Company’s natural alpha interferon is produced from human white blood cells. Alferon N Injection [Interferon alfa-n3 (human leukocyte derived)] is a highly purified, natural-source, glycosylated, multi-species alpha interferon product.
Alferon LDO (Low Dose Oral)
Alferon LDO [Low Dose Oral Interferon Alfa-n3 (Human Leukocyte Derived)]! is an experimental low-dose, oral liquid formulation of Natural Alpha Interferon and like Alferon N Injection should not cause antibody formation, which is a problem with recombinant interferon. It is an experimental immunotherapeutic that works by stimulating an immune cascade response in the cells of the mouth and throat, enabling it to bolster systemic immune response through the entire body by absorption through the oral mucosa.
The Company competes with Pfizer, GlaxoSmithKline, Merck, AstraZeneca, Baxter International, Fletcher/CSI, AVANT Immunotherapeutics, AVI BioPharma and Genta.
- [By MONEYMORNING.COM]
Hemispherix Biopharma Inc. (NYSE: HEB) is a specialty pharmaceutical company. It engages in the clinical development of new drug therapies based on natural immune system enhancing technologies and targets the treatment of viral and immune-based clinical disorders. The Philadelphia, Pa.-headquartered company gained widespread attention over the last several months for its work on flu research. Its flagship products include Alferon N Injection, approved by the FDA for a category of sexually transmitted disease infection. Experimental treatments include Ampligen and Oragens, in development stages for the potential treatment of global viral diseases and disorders of the immune system including human papilloma virus, human immunodeficiency virus, chronic fatigue syndrome, hepatitis, and influenza. Shares have traded as low as $0.18 and as high as $0.55 over the last year. At last check, shares were changing hands around $0.50 on volume of 2 million shares.
Best Medical Stocks To Own For 2015: Universal Biosensors Inc (UBI)
Universal Biosensors, Inc. (Universal Biosensors) is an early-stage specialist medical diagnostics company focused on the research, development and manufacture of in vitro diagnostic test devices for consumer and professional point-of-care use. The Company uses its electrochemical cell technology platform to develop tests for a number of different markets. The Company’s principal activities are research and development, commercial manufacture of approved medical or testing devices and the provision of services including contract research work. The Company operates primarily in Australia. The Company uses its electrochemical cell technology platform to develop tests for a number of different markets. The Company has rights to a portfolio comprising patent applications owned by its wholly owned subsidiary, Universal Biosensors Pty Ltd, and a number of patents and patent applications licensed to the Company by LifeScan, Inc., an affiliate of Johnson & Johnson Company. Advisors’ Opinion:
- [By Namitha Jagadeesh]
Banco Popolare SC (BP) declined 3.5 percent to 1.29 euros and Unione di Banche Italiane SCPA (UBI) slid 2.3 percent to 4.93 euros after Societe Generale SA reduced its 12-month price forecast on the shares.
Best Medical Stocks To Own For 2015: 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’s 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.
- [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 “life 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.
- [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
Best Medical Stocks To Own For 2015: Curis Inc.(CRIS)
Curis, Inc., a drug discovery and development company, focuses on the research and development of cancer therapeutics. The company, under collaboration with Genentech, Inc., is conducting a pivotal Phase II clinical trial on its lead molecule, GDC-0449 in advanced basal cell carcinoma patients, as well as various Phase II clinical trials in first-line metastatic colorectal cancer and advanced ovarian cancer patients. It is also evaluating CUDC-101, a small molecule that is in a Phase I clinical testing and is designed to target histone deacetylase, epidermal growth factor receptor, and epidermal growth factor receptor 2. In addition, Curis has a development candidate, Debio 0932, which is a Heat Shock Protein 90 or Hsp90 inhibitor. The company holds a license agreement with Debiopharm related to its Hsp90 technologies. Further, it involves in preclinical testing for the development of candidates from its targeted cancer programs. The company was founded in 2000 and is base d in Lexington, Massachusetts.
- [By Monica Gerson]
Curis (NASDAQ: CRIS) dipped 18.97% to $3.16 in the pre-market session after the company reported Q3 financial results and provided CUDC-427 development update.
Best Medical Stocks To Own For 2015: Organovo Holdings Inc (ONVO)
Organovo Holdings, Inc. (Organovo), formerly Real Estate Restoration & Rental, Inc., incorporated in 2007, is a development-stage company. The Company has developed and is commercializing a platform technology for the generation of three-dimensional (3D) human tissues that can be employed in drug discovery and development, biological research, and as therapeutic implants for the treatment of damaged or degenerating tissues and organs. On December 28, 2011, Real Estate Restoration and Rental, Inc.’s (RERR) entered into an Agreement and Plan of Merger, pursuant to which RERR merged with its, wholly owned subsidiary, Organovo (Merger Sub). On February 8, 2012, the Company merged with and into Organovo Acquisition Corp. (Acquisition Corp.), a wholly owned subsidiary of Organovo, with the Company surviving the merger as a wholly owned subsidiary of Organovo Holdings (the Merger). As a result of the Merger, Organovo acquired the business of Organovo, Inc.
The Comp any has collaborative research agreements with Pfizer, Inc. (Pfizer) and United Therapeutic Corporation (Unither). As of March 31, 2012, it has five federal grants, including Small Business Innovation Research grants and developed the NovoGen MMX Bioprinter (its first-generation 3D bioprinter). The Company is engaged in the development of specific 3D human tissues to aid Pfizer in discovery of therapies in two areas of interest. In addition, in October 2011, it entered into a research agreement with Unither to establish and conduct a research program to discover treatments for pulmonary hypertension using its NovoGen MMX Bioprinter technology. Additionally, under the research agreement with Unither, the Company granted Unither an option to acquire from the Company a worldwide, royalty-bearing license in certain intellectual property created under the research agreement solely for use in the treatment or prevention of pulmonary hypertension and all other lung diseases.
The Company’s NovoGen MMX Bioprinter is an automate! d device that enables the fabrication of three-dimensional (3D) living tissues comprised of mammalian cells. A custom graphic user interface (GUI) facilitates the 3D design and execution of scripts that direct precision movement of the dispensing heads to deposit cellular building blocks (bio-ink) or supporting hydrogel. The Company is using a third party manufacturer, Invetech Pty., of Melbourne, Australia, to manufacture its NovoGen MMX Bioprinter. Its bioprinting technology and surrounding intellectual property and commercial rights serve as a platform for product generation across multiple markets that employ cell- and tissue-based products and services.
The Company competes with Organogenesis, Advanced BioHealing, Tengion, Genzyme, HumaCyte and Cytograft Tissue Engineering.
- [By Paul Ausick]
A unique 3D printing stock is Organovo Holdings Inc. (NYSEMKT: ONVO). Shares are down more than 15% in 2014 after rising about 325% in 2013. The company is developing a 3D bioprinting technology that can create functional human tissues on demand for research and medical use. Organovo announced a first delivery of liver tissue in late January, well ahead of schedule, and the stock gained back some of its year-to-date losses. The company has been publicly traded for about a year and a half, and the stock hit a post-IPO high of $13.65 in November. It closed on Friday at $9.35. There is no price target on the stock, and the company is not expected to post positive earnings at least through 2015. In terms of market cap, though, Organovo ranks fourth among the publicly traded 3D printing companies with a market value of nearly $728 million.
- [By MONEYMORNING.COM]
During my July interview, Michael enthusiastically recommended 3D Systems Corp. (NYSE: DDD) and Organovo Holdings Inc. (NYSEMKT: ONVO). But he urged readers to take a wait-and-see approach with ExOne, saying the stock had just corrected.
- [By Jake L’Ecuyer]
Organovo Holdings (NYSE: ONVO) was also up, gaining 2.54 percent to $9.28. The rise in the shares may be attributed to Thursday’s Computerworld Article on 3D printed liver coming in 2014.
- [By Jake L’Ecuyer]
Organovo Holdings (NYSE: ONVO) was also up, gaining 2.98 percent to $9.32. The rise in the shares may be attributed to Thursday’s Computerworld Article on 3D printed liver coming in 2014.
Best Medical Stocks To Own For 2015: Medtronic Inc (MDT)
Medtronic, Inc. (Medtronic), incorporated on April 23, 1957, is engaged in medical technology – alleviating pain, restoring health, and extending life for millions of people worldwide. As of April, 27, 2012, the Company functions in two operating segments that manufacture and sells device-based medical therapies. The Company’s operating segments include Cardiac and Vascular Group, which consists of Cardiac Rhythm Disease Management (CRDM) and CardioVascular, and Restorative Therapies Group, which consists of Spinal, Neuromodulation, Diabetes and Surgical Technologies. Medtronic serves hospitals, physicians, clinicians, and patients in more than 120 countries worldwide. The Company’s primary customers include hospitals, clinics, third-party health care providers, distributors, and other institutions, including governmental health care programs and group purchasing organizations. In August 2013, Medtronic, Inc. announced the closing of the acquisition of Cardiocom. Effective September 3, 2013, Medtronic Inc acquired a 30% stake in NGC Medical SpA.
Cardiac Rhythm Disease Management
CRDM develops, manufactures, and markets products for the diagnosis, treatment, and management of heart rhythm disorders and heart failure, including implantable devices, leads and delivery systems, products for the treatment of atrial fibrillation (AF), and information systems for the management of patients with CRDM devices. The Company’s principal products offered by CRDM business include Implantable Cardiac Pacemakers (Pacemakers), Implantable Cardioverter Defibrillators (ICDs), Implantable Cardiac Resynchronization Therapy Devices (CRT-Ds and CRT-Ps), AF Products, Diagnostics and Monitoring Devices and Patient Management Tools. The Company’s pacemaker systems are compatible with certain magnetic resonance imaging (MRI) machines. This includes the Revo MRI SureScan with United States Food and Drug Administration approval and the Advisa a nd Ensura MRI SureScan models with Conformite Europeene (CE)! Mark approval. Medtronic also continues to market the Adapta product family, which includes the Adapta, Versa, Sensia, and Relia models.
The Medtronic ICDs is the Protecta family with SmartShock technology, including the Lead Integrity Alert, a technology designed to improve the detection of lead fractures. Devices in the ICD family are the Protecta XT, Protecta, Cardia, and Egida models. Medtronic also continues to market the Secura and Maximo II devices. The Medtronic CRT-Ds is the Protecta family with SmartShock technology, including Protecta XT and Protecta, and the CRT-P devices are Consulta and Syncra. Medtronic also continues to market the Consulta, Cardia, Egida, and Maximo II CRT-D devices. In addition to these devices, Medtronic has an offering of left heart leads and delivery catheters with its Attain family of products. The Company’s portfolio of AF products includes the Arctic Front Cardiac CryoAblation Catheter designed to treat paroxysmal AF by performing pulmonary vein isolation. The Company also offers the Reveal XT Insertable Cardiac Monitor, which is designed to identify and quantify episodes of AF. The Reveal DX and Reveal XT Insertable Cardiac Monitors devices are used to record the heart’s electrical activity before, during, and after transient symptoms such as syncope and palpitations to help provide a diagnosis. It has a number of patient management tools, such as CareLink, Paceart, and CardioSight Service. CareLink enables patients to transmit data from their pacemaker, ICD, CRT-D, or Insertable Cardiac Monitors using a portable monitor that is connected to a standard telephone line or cellular network using the Medtronic M-Link accessory.
The Company competes with St. Jude Medical, Inc., Boston Scientific Corporation, Biotronik, Inc. and Sorin Group.
CardioVascular is comprised of three businesses: Coronary, Endovascular and Peripheral, and Structur al Heart. The Coronary business includes therapies to treat ! coronary ! artery disease (CAD) and hypertension. The products contained within this business include coronary stents and related delivery systems, along with a broad line of balloon angioplasty catheters, guide catheters, guidewires, diagnostic catheters, and accessories. The products offered by its Coronary business include Percutaneous Coronary Intervention (PCI) and Renal Denervation. The Endovascular and Peripheral business is comprised of a range of products and therapies to treat abdominal and thoracic aortic aneurysms and peripheral vascular disease (PVD). The Company’s products include endovascular stent graft systems, embolic protection systems, and stent systems for the treatment of narrowed iliac arteries. The products offered by the Company’s Endovascular and Peripheral business include Endovascular Stent Grafts and Peripheral Vascular Intervention (PVI). The Structural Heart business offers a range of products and therapies to treat a variety of heart valve disorders. The Company’s products include products for the repair and replacement of heart valves, perfusion systems, positioning and stabilization systems for beating heart revascularization surgery, and surgical ablation products. The Company’s principal products offered by its Structural Heart business include Heart Valves, Transcatheter Heart Valves, Arrested Heart Surgery, Beating Heart Surgery and Surgical Ablation.
The Company competes with Abbott Laboratories, Boston Scientific, and Johnson & Johnson, Cook, Inc., W. L. Gore & Associates, Inc., Endologix, Inc., C.R. Bard, Inc., Edwards LifeSciences Corporation, St. Jude, Terumo Medical Corporation and Sorin Group.
The Company’s Spinal business develops, manufactures, and markets a range of medical devices and implants used in the treatment of the spine and musculoskeletal system. The Company’s products and therapies treat a range of conditions affecting the spine, including degenerativ e disc disease, spinal deformity, spinal tumours, fractures ! of the sp! ine, and stenosis. The Company’s Spinal business also provides biologic solutions for the dental and orthopedic markets. The Company’s Spinal products are used in spinal fusion of both the thoracolumbar region, referring to the mid to lower vertebrae, as well as of the cervical region, or upper spine and neck vertebrae. Products used to treat spinal conditions include rods, pedicle screws, hooks, plates, and interbody devices, as well as biologics products, primarily bone growth substitutes including bone graft extenders and structural allografts such as dowels and wedges. The products offered by the Company’s Spinal business include Thoracolumbar Products, Cervical Products and Biologics Products.
The Company competes with DePuy Spine, Inc., Synthes, Inc., Stryker Corporation, NuVasive, Inc., Globus Medical, Inc., Zimmer, Inc., Alphatec Spine, Inc., Orthofix International N.V., Biomet, Inc. and Johnson & Johnson.
The C ompany’s Neuromodulation business develops, manufactures, and markets medical devices for the treatment of chronic pain, movement disorders, psychological disorders, and urological, fecal, and gastroenterological disorders. The l products offered by the Company’s Neuromodulation business includes Neurostimulators for Chronic Pain, Implantable Drug Delivery Systems, Deep Brain Stimulation (DBS) Systems and Urology, Fecal, & Gastroenterology Devices. The Company’s portfolio of products includes the RestoreSensor (rechargeable), with the Company’s AdaptiveStim technology, as well as the RestoreULTRA (rechargeable), RestoreADVANCED (rechargeable), and PrimeADVANCED (non-rechargeable) neurostimulation systems. The SynchroMed II Programmable Infusion System delivers small quantities of drug directly into the intrathecal space surrounding the spinal cord. These devices are used to treat chronic, intractable pain and severe spasticity associated with cerebral palsy, multiple scleros is, spinal cord and traumatic brain injuries, and stroke.
DBS uses a surgically implanted medical device, similar to a cardiac pacemaker, to deliver carefully controlled electrical stimulation to precisely targeted areas in the brain. The Company’s family of Activa Neurostimulators for DBS includes Activa SC (single-channel primary cell), Activa PC (dual channel primary cell), and Activa RC (dual channel rechargeable). The Company’s therapeutic portfolio for urology and gastroenterology includes the InterStim Therapy System, which treats the symptoms of overactive bladder, urinary retention, and chronic fecal incontinence, and the Enterra Therapy System for the treatment of chronic nausea and vomiting caused by gastroparesis of diabetic or idiopathic origin for drug refractory patients.
The Company’s competes with Boston Scientific, St. Jude., Urologix, Inc. and Allergan.
The Company’s Diabetes business develops, manufactures, and markets advanced, integrated diabetes management s olutions that include insulin pump therapy, continuous glucose monitoring systems, and therapy management software. The products offered by the Company’s Diabetes business includes Integrated Diabetes Management Solutions, Professional CGM and CareLink Therapy Management Software. Outside the United States, the Company offers its Paradigm Veo System, an integrated system that includes a Low Glucose Suspend feature that automatically suspends insulin delivery when glucose levels become too low. In the United States, the Company offers the Paradigm Revel System, which incorporates new CGM features, including predictive alerts that can give early warning to people with diabetes so they can take action to prevent dangerous high or low glucose events. Medtronic offers physicians a Professional CGM product called the iPro CGM and iPro2 Professional CGM. The Company offers Web-based therapy management software solutions, including CareLink Personal software for patients and CareLin k Pro software, to helps patients and their health care prov! iders con! trol their diabetes.
The Company competes with DexCom, Inc., Insulet Corporation, Johnson & Johnson and Roche Ltd.
The Company’s Surgical Technologies business develops, manufactures, and markets products and therapies to treat diseases and conditions of the ear, nose, and throat (ENT) and certain neurological disorders. In addition, the business develops, manufactures, and markets image-guided surgery and intra-operative imaging systems that facilitate surgical planning during precision cranial, spinal, sinus, and orthopedic surgeries. The products offered by the Company’s Surgical Technologies business includes ENT, Neurological Technologies, Navigation and Advanced Energy. The ENT products treat diseases and conditions, such as NIM Nerve Monitoring Systems, Fusion ENT Navigation System, Hydrodebrider Endoscopic Sinus Irrigation System, Meniett Device for Meniere’s Disease, Pillar Procedure for Snoring and Sleep Apnea, and Repose System for Obstructive Sleep Apnea. The Neurological Technologies products treat certain neurological disorders and conditions, such as Midas Rex Spine Shaver, the Midas Rex MR7 Pneumatic Platform, the Midas Rex Legend EHS High Speed Surgical Drill, the Strata Family of Adjustable Valves for the treatment of Hydrocephalus, Duet External Drainage & Monitoring System, the IPC System, and the Subdural Evacuating Port System.
The Navigation products are used in cranial, spinal, sinus, and orthopedic surgeries, such as the StealthStation S7 Navigation and i7 Integrated Navigation Systems, the O-Arm 2D/3D Surgical Imaging System, and the PoleStar Surgical MRI System. The products make up the Advanced Energy business: PEAK Surgery System, a tissue dissection system that consists of the PEAK PlasmaBlade and the PULSAR Generator and is cleared for use in a variety of settings, including ENT, plastic reconstructive and general surgery; and the Aquamant ys System, which uses patented Transcollation technology to ! provide h! aemostatic sealing of soft tissue and bone and is cleared for use in a range of surgical procedures, including orthopedic surgery, spine, solid organ resection and thoracic procedures.
The Company competes with Gyrus ACMI, Stryker Corporation, Johnson & Johnson, Integra LifeSciences Holdings Corporation, BrainLAB, Inc., GE Healthcare, Siemens Medical Solutions USA, Inc., Philips Medical Systems, Covidien and ArthroCare Corporation.
- [By Eric Volkman]
After receiving the necessary regulatory approval, Medtronic (NYSE: MDT ) is launching its latest product on the global market. The medical devices company announced on Wednesday that it has received clearance from the U.S. Food and Drug Administration and the European Union for its Reveal LINQ Insertable Cardiac Monitor System, which is now available for purchase.
- [By Lauren Pollock]
Medtronic Inc.(MDT) said its fiscal third-quarter earnings fell 23% on a big write-down related to the medical-device maker’s renal denervation program that masked revenue growth. The company narrowed its earnings forecast for the year.
Best Medical Stocks To Own For 2015: Galena Biopharma Inc (GALE)
Galena Biopharma, Inc. (Galena), formerly RXi Pharmaceuticals Corporation, incorporated on April 3, 2006, is a biotechnology company focused on discovering, developing and commercializing therapies addressing unmet medical needs using targeted biotherapeutics. The Company is pursuing the development of cancer therapeutics using peptide-based immunotherapy products, including its main product candidate, NeuVaxTM (E75), for the treatment of breast cancer and other tumors. NeuVax is a peptide-based immunotherapy intended to reduce the recurrence of breast cancer in low-to-intermediate HER2-positive breast cancer patients not eligible for trastuzumab (Herceptin; Genentech/Roche). On January 19, 2012, the Company initiated enrollment in its Phase 3 PRESENT clinical trial for NeuVax (E75 peptide plus GM-CSF) vaccine in low-to-intermediate HER2 1+ and 2+ breast cancer patients in the adjuvant setting to prevent recurrence (Clinicaltrials.gov identifier NCT01479244). The Preventio n of Recurrence in Early-Stage, Node-Positive Breast Cancer with Low to Intermediate HER2 Expression with NeuVax Treatment study is a randomized, multicenter, multinational clinical trial that will enroll approximately 700 breast cancer patients. The Company’s Phase 2 trial of NeuVax achieved its primary endpoint of disease-free survival (DFS). On April 13, 2011, the Company completed its acquisition of Apthera, Inc.,(Apthera).
The Company focuses to start a Phase 2 trial comparing NeuVax in combination with trastuzumab (Herceptin) versus trastuzumab, alone, in a 300-patient, randomized study in the adjuvant breast cancer setting. The Company’s second product candidate, Folate Binding Protein-E39 (FBP), is a vaccine, consisting of the peptides E39 and J65, aimed at preventing the recurrence of ovarian, endometrial, and breast cancers. On February 14, 2012, the Company announced the initiation of a Phase 1/2 clinical trial in two gynecological cancers: ovarian and endometrial adenocarcinomas. Folate binding protein has ! very limited tissue distribution and expression in non-malignant tissue and is over-expressed in more than 90% of ovarian and endometrial cancers, as well as in 20% to 50% of breast, lung, colorectal and renal cell carcinomas.
In April 2011, the Company acquired Apthera Inc and its NeuVax product candidate. The Company focuses on developing a pipeline of immunotherapy product candidates for the treatment of various cancers based on the E75 peptide, the advanced of which is NeuVax, which is targeted at preventing the recurrence of breast cancer. NeuVax has had positive Phase 1/2 clinical trial results for the prevention of breast cancer recurrence in patients who have had breast cancer and received the standard of care treatment (surgery, chemotherapy, radiotherapy and hormonal therapy as indicated). The Company had also initiated its Phase 3 PRESENT clinical trial of NeuVax for the prevention of breast cancer recurrence in early-stage low-to-intermediate HER2 br east cancer patients. NeuVax directs killer T-cells to target and destroy cancer cells that express HER2/neu, a protein associated with epithelial tumors in breast, ovarian, pancreatic, colon, bladder and prostate cancers. NeuVax is comprised of a HER2/neu-derived peptide called E75. E75 is a nine-amino acid sequence that is immunogenic (produces an immune response) and GM-CSF is a commercially available protein that acts to stimulate and activate components of the immune system such as macrophages and dendritic cells.
The Company also develops novel applications for NeuVax based on preclinical studies and phases 2 clinical trials which suggest that combining NeuVax and trastuzumab (Herceptin; Genentech/Roche) can increase antigen presentation by tumor cells by promoting receptor internalization and subsequent proteosomal degradation of the HER2 protein. The Company also is pursuing additional therapeutic indications for NeuVax that are in Phase 1/2 clinical tri als. RXI-109, is a dermal anti-scarring therapy that targets! connecti! ve tissue growth factor (CTGF) and that may inhibit connective tissue formation in human fibrotic disease.
The Company competes with Roche Laboratories, Inc., Pfizer Inc., Bayer HealthCare AG, Sanofi-Aventis, US, LLC, Amgen, Inc., GlaxoSmithKline plc, Renovo Group plc, CoDa Therapeutics, Inc., Sirnaomics, Inc., FirstString Research, Inc., Merz Pharmaceuticals, LLC, Capstone Therapeutics, Halscion, Inc., Garnet Bio Therapeutics, Inc., AkPharma Inc., Promedior, Inc., Kissei Pharmaceutical Co., Ltd., Eyegene, Derma Sciences, Inc., Healthpoint Biotherapeutics, Pharmaxon, Excaliard Pharmaceuticals, Inc., Alnylam Pharmaceuticals, Inc., Marina Biotech, Inc., Tacere Therapeutics, Inc., Benitec Limited, OPKO Health, Inc., Silence Therapeutics plc, Quark Pharmaceuticals, Inc., Rosetta Genomics Ltd., Lorus Therapeutics, Inc., Tekmira Pharmaceuticals Corporation, Arrowhead Research Corporation, Regulus Therapeutics Inc. and Santaris.
- [By James E. Brumley]
The last two weeks have been absolutely fantastic ones for Galena Biopharma Inc. (NASDAQ:GALE). Shares have soared from $2.37 to the current price of $3.32 – a 40% pop – rewarding investors who had been patiently waiting through late October for the runup to take hold. Congratulations if that’s you. But, if that was you, then now might be a great time to take the money and run with the trade, as GALE looks poised to make a sizeable pullback. More on that in a moment.
- [By James E. Brumley]
It may look like little more than a choppy mess with just a quick glance at Galena Biopharma Inc. (NASDAQ:GALE). But, the more you study the chart – and the company – the more you realize there’s enough long-term potential from the company’s pipeline to keep spurring GALE in a generally-upward direction. In fact, the bulls look like they’re on the verge of taking Galena Biopharma out of second gear and putting it into third. As such, it may not be a bad bet at this point.
- [By Sean Williams]
The waiting game
The tables are clearly stacked against small biotech companies developing cancer drugs. History has shown that few (if any) have successfully had the Food and Drug Administration approve a late-stage cancer drug. While mid-stage trials of Galena Biopharma’s (NASDAQ: GALE ) HER2-targeting breast cancer vaccine have been promising thus far, the chances of an approval seem a long way off.
- [By Paul Ausick]
Stocks on the move: Galena Biopharma Inc. (NASDAQ: GALE) is down 15.4% at $1.93 after pricing a secondary offering of 17.5 million units at $2.00. Safeway Inc. (NYSE: SWY) is up 6.1% at $28.21, after an analyst’s upgrade which sent shares to a new 52-week high of $28.88 earlier. Avanir Pharmaceuticals Inc. (NASDAQ: AVNR) is down 18.2% at $4.08.
Best Medical Stocks To Own For 2015: 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’s own immune system is stimulated to target tumor antigens, which are molecular signals that the immune system uses to identify foreign bodies. The Company’s 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’s 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 addit ion 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 s erum 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.
- [By Monica Gerson]
ImmunoCellular Therapeutics (NYSE: IMUC) dropped 11.05% to $1.3699. ImmunoCellular’s trailing-twelve-month ROE is -59.80%.
Posted-In: market losersNews Movers & Shakers Intraday Update Markets
- [By Wallace Witkowski]
Shares of ImmunoCellular (IMUC) jumped after the drug developer said data on a mid-stage brain cancer drug study were looking encouraging.
Best Medical Stocks To Own For 2015: NeoStem Inc (NBS)
NeoStem, Inc., incorporated on September 18, 1980, operates in cellular therapy industry. Cellular therapy addresses the process by which new cells are introduced into a tissue to prevent or treat disease, or regenerate damaged or aged tissue, and consists of a separate therapeutic technology platform in addition to pharmaceuticals, biologics and medical devices. The Company’s business model includes the development of novel cell therapy products, as well as operating a contract development and manufacturing organization (CDMO) providing services to others in the regenerative medicine industry. Progenitor Cell Therapy, LLC, the Company’s wholly owned subsidiary (PCT), is a CDMO in the cellular therapy industry. PCT has provided pre-clinical and clinical current Good Manufacturing Practice (cGMP) development and manufacturing services to over 100 clients advancing regenerative medicine product candidates through rigorous quality standards all the way through to human te sting.
PCT has two cGMP, cell therapy research, development, and manufacturing facilities in New Jersey and California, serving the cell therapy community with integrated and regulatory compliant distribution capabilities. Its core competencies in the cellular therapy industry include manufacturing of cell therapy-based products, product and process development, cell and tissue processing, regulatory support, storage, distribution and delivery and consulting services. The Company’s wholly-owned subsidiary, Amorcyte, LLC (Amorcyte) is developing its own cell therapy, AMR-001, for the treatment of cardiovascular disease. AMR-001 represents its clinically advanced therapeutic product candidate and enrollment for its Phase II PreSERVE clinical trial to investigate AMR-001’s safety and efficacy in preserving heart function after a heart attack in a particular type of post Acute Myocardial Infarction (AMI) patients.
Through the Company’s subsidiary, A thelos Corporation (Athelos), the Company is collaborating w! ith Becton-Dickinson in early stage clinical development of a therapy utilizing T-cells, collaborating for autoimmune and inflammatory conditions, including but not limited to, graft vs. host disease, type 1 diabetes, steroid resistant asthma, lupus, multiple sclerosis and solid organ transplant rejection. The Company’s pre-clinical assets include its Very Small Embryonic Like (VSEL) Technology platform. The Company has basic research and development capabilities, manufacturing facilities on both the east and west coast of the United States.
- [By Roberto Pedone]
Another under-$10 biopharmaceutical player that’s starting to trend within range of triggering a big breakout trade is Neostem (NBS), engages in the development of proprietary cell therapy products. This stock has been hit hard by the sellers during the last three months, with shares off by 22%.
If you take a look at the chart for Neostem, you’ll notice that this stock has recently spiked higher back above both its 50-day moving average at $6.41 and its 200-day moving average of $6.60 a share. This move has also pushed shares of NBS back above some near-term overhead resistance levels at $6.57 to $6.98 a share. That move is quickly pushing NBS within range of triggering another breakout trade above some key near-term overhead resistance.
Market players should now look for long-biased trades in NBS if it manages to break out above some near-term overhead resistance at $7.22 a share with high volume. Look for a sustained move or close above that level with volume that hits near or above its three-month average action 327,514 shares. If that breakout triggers soon, then NBS will set up to re-fill some of its previous gap down zone from October that started just above $8 a share. If that that gap gets filled with volume, then NBS could easily tag its next major overhead resistance levels at $9 to $9.50 a share, or even its 52-week high at $9.89 a share.
Traders can look to buy NBS off weakness to anticipate that breakout and simply use a stop that sits right below its 50-day moving average of $6.41 a share, or near more support at $6 a share. One can also buy NBS off strength once it takes out $7.22 a share with volume and then simply use a stop that sits a comfortable percentage from your entry point.
- [By Monica Gerson]
NeoStem (NYSE: NBS) priced an underwritten public offering of 5,000,000 shares of common stock at an offering price of $7.00 per share. NeoStem shares dipped 9.44% to $7.10 in after-hours trading.
- [By John Udovich]
Summer and the slow news for the market that usually comes with it is over with and both stem cell researchers or small cap stem cell stocks like Advanced Cell Technology, Inc (OTCBB: ACTC), Neuralstem, Inc (NYSEMKT: CUR), NeoStem Inc (NASDAQ: NBS), International Stem Cell Corp (OTCMKTS: ISCO) and BioRestorative Therapies (OTCBB: BRTX) having news for investors and traders alike. Consider the following:
Best Medical Stocks To Own For 2015: Impax Laboratories Inc.(IPXL)
Impax Laboratories, Inc., a specialty pharmaceutical company, engages in the development, manufacture, and marketing of bioequivalent pharmaceutical products. The company operates in two divisions, Global Pharmaceuticals and Impax Pharmaceuticals. The Global Pharmaceuticals division develops, manufactures, sells, and distributes generic pharmaceutical products. It provides its generic pharmaceutical prescription products directly to wholesalers and retail drug chains; and generic pharmaceutical over-the-counter and prescription products through unrelated third-party pharmaceutical entities. The Impax Pharmaceutical division develops proprietary brand pharmaceutical products that address central nervous system disorders, including Alzheimer?s disease, attention deficit hyperactivity disorder, depression, epilepsy, migraines, multiple sclerosis, Parkinson?s disease, and schizophrenia, as well as promotes third-party branded pharmaceutical products. As of May 2, 2011, the com pany marketed 101 generic pharmaceuticals, which represent dosage variations of 29 different pharmaceutical compounds; and another 16 of its generic pharmaceuticals representing dosage variations of 4 different pharmaceutical compounds. It markets and sells its generic pharmaceutical prescription drug products in the continental United States and the Commonwealth of Puerto Rico. The company has a strategic alliance agreement with Teva Pharmaceuticals Curacao N.V. Impax Laboratories, Inc. was founded in 1993 and is headquartered in Hayward, California.
- [By Eric Ho]
These heavy hitters include Sanofi’s (NYSE: SNY ) Renagel, Fresenius’ Phoslo, and generic calcium acetate versions of Phoslo. Additionally, Impax Laboratories (NASDAQ: IPXL ) intends to market a generic sevelamer product following for Renagel’s 2014 patent expiration.
- [By Eric Volkman]
Impax Laboratories (NASDAQ: IPXL ) will soon hand out a raft of pink slips. As part of a move to slice costs, the company has announced a reduction in its headcount by roughly 110 employees. Most of these cuts will be effected at its manufacturing facility in Hayward, Calif.
- [By Max Macaluso, Ph.D.]
RLS hasn’t been a high-priority target for the pharma industry given the lackluster sales of Requip and Horizant, a third competitor of UCB’s Neupro, and a number of generic alternatives. Impax Laboratories (NASDAQ: IPXL ) was one of the few developing a new therapy, called IPX159, but Impax put the kibosh on the drug after it failed to meet its primary endpoint in a phase 2b study. According to its latest quarterly report, Impax has no other RLS drugs in development and seems to be focusing on getting its rejected Parkinson’s disease drug Rytary back to the FDA for a second chance at approval.