Category Archives: Biotechnology

By Robert Martin, InvestorPlace Writer|May 22, 2017, 11:12 am EDT Puma Biotechnology Inc (NASDAQ:PBYI) jolted as much as 80% higher on Monday morning on news that theU.S. Food & Drug Administration posted a seemingly positive review of Pumas breast cancer drug, neratinib, ahead of an official vote Wednesday. PBYI then settled back to just 60% gains a few hours into the trading day. The FDA asked a few questions and raised a few concerns, notably, tolerability of neratinib in this patient population is a concern given the frequent dose interruptions, reductions, and discontinuations observed, mostly due to diarrhea. Specifically, 95% of patients in clinical trials suffered from diarrhea, with 40% of those suffering the grade 3 form of the side effect. However, on the whole, PBYI investors seemed pleased with what the FDA did (and didnt) ask, taking the review as an encouraging sign ahead of the companys Oncologic Drugs Advisory Committee meeting, scheduled for Wednesday. Neratinib (PB272) is being tested for the extended adjuvant treatment of HER2-positive early stage breast cancer. The drug is meant for patients who have already received Herceptin. The FDA preview said that the primary analysis showed an improvement with neratinib, and that despite changes … Continue reading →

While 2017 has been a pretty good year overall for biotechs, the two largest ETFs in the space - the iShares Nasdaq Biotechnology ETF (NASDAQ:IBB) and the SPDR S&P Biotech ETF (NYSEARCA:XBI) - are up 10% and 17%, respectively. It's tough to forget that both of these funds are still about 25% off of their 2015 highs. IBB, which is heavily influenced by the largest biotech names, has been impacted by 50% drops in Gilead (NASDAQ:GILD) and Biogen (NASDAQ:BIIB). XBI has a much more diversified all-cap mix but has experienced similar results. But not all news coming out of the sector is bad. In fact, one biotech ETF has been downright ripping it since its launch at the end of 2014. The BioShares Biotechnology Products ETF (NASDAQ:BBP), which invests in companies that have at least one primary product that has received FDA approval, is up roughly 42% since its inception at the end of 2014 compared to a loss of 4% for IBB during the same time frame. IBB Total Return Price data by YCharts As fund advisor Virtus says on its website, companies that the fund invests in are "typically more established companies with much clinical trial failure risk … Continue reading →

BioTime to Present at 16 thNational Life Sciences and Biotechnology Week (MIXiii BIOMED) BioTime, Inc.(NYSE MKT: BTX and TASE: BTX), a clinical-stage biotechnology company developing and commercializing products addressing degenerative diseases, today announced that BioTime, and its subsidiary Cell Cure Neurosciences Ltd., will be featured in two presentations at the 16th National Life Sciences and Biotechnology Week (MIXiii BIOMED) on Wednesday, May 24, 2017 as part of the Regenerative and Cell Therapies track. The conference is being held at the David InterContinental in Tel Aviv, Israel, May 23-25, 2017. Presentations will be held at 12:15 p.m. and 3:45 p.m. IDT in Hall B of the InterContinental, and will highlight both the companys technology and business model. Jim Knight, BioTime, Inc. Senior Vice President and Head of Corporate Development, will discuss the evolution of the BioTime group of companies during one of the presentations. A second presentation will focus on cell-based transplantation therapy in AMD patients. Each presentation will be followed by a panel discussion. More information about the conference program and presentations can be found here. About BioTime BioTime, Inc. is a clinical-stage biotechnology company focused on developing and commercializing novel therapies developed from what the company believes to be … Continue reading →

WALTHAM, Mass.--(BUSINESS WIRE)--Bioverativ Inc. (NASDAQ: BIVV), a global biotechnology company focused on the discovery, development and commercialization of innovative therapies for hemophilia and other rare blood disorders, today announced that it has entered into a definitive agreement to acquire South San Francisco-based True North Therapeutics, a privately-held, clinical-stage rare disease biotechnology company, for an upfront payment of $400 million plus assumed cash. True North investors are also eligible to receive additional payments of up to $425 million contingent on the achievement of future development, regulatory and sales milestones. As part of the acquisition, Bioverativ will obtain worldwide rights to True Norths lead candidate, TNT009, a first-in-class monoclonal antibody in development to treat cold agglutinin disease (CAD). CAD is a rare and chronic hemolytic condition that often leads to severe anemia, requiring numerous transfusions, and can result in life-threatening thrombotic events. There are no approved therapies for CAD, which occurs in approximately 16 people per million globally, including an estimated 5,000 people in the United States. In May 2017, the U.S. Food and Drug Administration (FDA) granted TNT009 breakthrough therapy designation for the treatment of hemolysis in patients with primary CAD, and plans for the full clinical development program, including a … Continue reading →

DUBLIN--(BUSINESS WIRE)--Research and Markets has announced the addition of the "Global Biotechnology Congress 2017 - (5th in the Series) Academic" conference to their offering. The 'Global Biotechnology Congress 2017' would provide eminent scientists the opportunity to present their cutting edge researches in the field of biotechnology and its applications in medicine. A number of Nobel Laureates and leading researchers are expected to participate in this important conference. This unique international conference provides a platform for researchers and decision makers in biotechnology to present their latest findings and learn about all the important developments in biotechnology. Many Nobel Laureates and world's renowned experts will participate in the conference. The conference will cover the translational nature of biotechnological research, with emphasis on both the basic science as well as its applications in industry and academia. Presentations will include major research advances in biotechnology, business development, strategic alliances, partnering trends, product opportunities, growth business models and strategies, licensing and pharmaceutical biotechnology (e.g. vaccines, CNS, cancer, antibodies), medical biotechnology, industrial biotechnology, bioprocess engineering, protein engineering, plant and environmental technologies, transgenic plant and crops, bioremediation, and microbial diversity research. Throughout the course of the four day conference, you will have the opportunity to both network … Continue reading →

By Nicolas Chahine, InvestorPlace Contributor|May 23, 2017, 1:28 pm EDT The iShares Nasdaq Biotechnology Index (ETF) (NASDAQ:IBB) is technically tight and a move is coming. While the direction of which is uncertain I am willing to cautiously bet that it will be upwards. After all, this is an uber-bullish equity market and it will take a really negative headline to cause a selloff, so betting long is easier than shorting. Even when we do sell off, buyers are buying every dip. Originally I was looking to trade several biotech tickers, but the list got so long that I decided to cast a net over the sector rather than fish with a hook. This will also make managing the risk more streamlined. It came down to a toss-up between IBB and theSPDR S&P Biotech (ETF) (NYSEARCA:XBI). Click to Enlarge I chose the IBB because it offers me bigger absolute returns with clear levels. Other names I considered included large components of the ETF so the logic is the same but the vessel has a different ticker. Besides, selling risk on an ETF reduces the chances of a single stock headline which is common among biotech companies. Fundamentally, the IBB carries a … Continue reading →

Allied Academies cordially invites all the participants across the globe from leading universities, clinical research institutions, diagnostic companies and all interested to share their research experiences in the Annual Biotechnology Congress during August 17-18, 2017 at Toronto, Canada with the theme of New Scientific Developments in Biotechnology of Modern Era. Track 1:Biochemistry Biochemistry is the study of the chemical substances and vital processes occurring in live organisms. Biochemists focus heavily on the role, function, and structure of biomolecules. The study of the chemistry behind biological processes and the synthesis of biologically active molecules are examples of biochemistry. The key drivers for molecular biology enzymes, kits and reagents market are the rising R&D expenditure by the pharmaceutical and biotech companies, and increasing public funding for life science research. The World Health Organization estimates that the total aged population may rise from 605 million in 2000 (11% of the global population) to 2 billion by 2050, accounting for 22% of the global population. Track 2:Molecular Biology Molecular biology is the study of molecular underpinnings of the processes of replication, transcription, translation, and cell function. The central dogma of molecular biology where genetic material is transcribed into RNA and then translated into protein, … Continue reading →

Monday was a good start to the week for stocks, with major benchmarks climbing around half a percent on the day. Most market participants pointed to a lack of bad news over the weekend and anticipation about expected favorable economic data in the coming days as drivers of the generally positive attitude among investors. But there are still plenty of factors that are preventing stocks overall from mounting stronger gains, including nervousness about geopolitical issues as well as weaker parts of the global economy. Nevertheless, some stocks posted strong gains, and Puma Biotechnology (NASDAQ:PBYI), Applied Optoelectronics (NASDAQ:AAOI), and Ferroglobe (NASDAQ:GSM) were among the best performers on the day. Below, we'll look more closely at these stocks to tell you why they did so well. Image source: Getty Images. Shares of Puma Biotechnology soared 39% as investors anticipated that the biotech company will get approval of its neratinib breast cancer drug from the U.S. Food and Drug Administration. An FDA advisory committee is scheduled to meet later this week, and documents supporting that meeting were released today. In those documents, investors found fewer critical views of neratinib than some had expected, and that led those following the stock to conclude that … Continue reading →

BUZZ-Puma Biotechnology: Shares on the prowl:BUZZ-Puma Biotechnology: Shares on the prowl ** Puma Biotechnology shares soar 50.3 pct to $56.80 in heavy Monday morning trading; shares rise as high as $69.35, halted multiple times for volatility ** U.S. Food and Drug Administration posts documents reviewing Puma's neratinib for treating breast cancer ahead of FDA advisory committee meeting on the product on Weds ** Based on sensitivity analyses conducted, results appear to be generally similar to the primary analysis results, supporting an effect of neratinib, FDA staffers say in review documents ** Options market has been pricing in a move about 63 pct, positive or negative, in PBYI shares in reaction to neratinib review, JPMorgan analyst Cory Kasimov said in research note last week ** Short interest in PBYI shares stood at 21.5 pct of shares outstanding as of Apr 27, according to Thomson Reuters data ** Five analysts rate PBYI shares a "buy" or "strong buy", two rate "hold", according to TR data; median price target is $80 ** PBYI shares have nearly doubled in 2017, against 9.7 pct rise for Nasdaq Biotechnology index (This story has not been edited by timesofindia.com and is autogenerated from a syndicated feed we … Continue reading →

How to Trade these Stock After an unavoidable Selloff: Puma Biotechnology, Inc. (PBYI), BofI Holding, Inc. (BOFI) StockNewsJournal Puma Biotechnology, Inc. (NASDAQ:PBYI) market capitalization at present is $1.42B at the rate of $37.80 a share. The firm's price-to-sales ratio was noted 0.00 in contrast with an overall industry average of 100.20. Most of the active traders and ... and more » Go here to see the original: How to Trade these Stock After an unavoidable Selloff: Puma Biotechnology, Inc. (PBYI), BofI Holding, Inc. (BOFI) - StockNewsJournal … Continue reading →