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Archive for the ‘Biotechnology’ Category

Is Puma Biotechnology, Inc. (PBYI) a good buy? – TopChronicle

Friday, May 26th, 2017

Share Price and 1 Year Extreme Prices Analysis

The share of Puma Biotechnology, Inc. (PBYI) currently has a value of $78.05 while the companys 52 week low is at $27.64, the shares dropped to the 52 week low on 06/27/16. While the companys share hit the 52 week high on 05/25/17 stationing the value of $75.10.

The difference of 52 week low value as well as 52 week high value and the current price of the stock suggests the next move of the shares. If the share price is currently hovering near the 52 week low and the value is achieved in the current past then it can suggest that the price of the shares is likely to go up.

Share Volume Analysis

The volume of the particular stock is the shares bought and sold in a single trading day. The average volume of a stock suggests the liquidity of a particular company. If the average volume is low then the liquidity is low which means it is hard to buy or sell the stock as there are fewer buyers or sellers of the stock.

Currently the shares of Puma Biotechnology, Inc. (PBYI) has the trading volume of 5.7 Million shares with the average trading volume of 5180 shares.

Price to Earnings Ratio

P/E of the company is not reported.

Earnings per Share EPS

Yet another important factor while evaluating a good buy/sell decision for Puma Biotechnology, Inc. (PBYI) is its Earnings per Share or EPS. EPS breaks down the profitability of the company on a single share basis.

Currently, EPS of Puma Biotechnology, Inc. (PBYI) is -1.97 while the analysts predicted the EPS of the stock to be -1.98 suggesting the company fell short of the analysts expectations.

Market Capitalization Analysis

Market Capitalization can be thought of as the overall price to buy the company. Market Capitalization if basically the market value of the companys shares outstanding. Market Cap is also the figure use to determine companys size, as opposed to using sales or total asset figures.

Puma Biotechnology, Inc. (PBYI) has a market capitalization of 2.89 Billion which suggests the company is a huge company further suggesting that the shares of Puma Biotechnology, Inc. (PBYI) are stable and safe compared to the lower market capitalization companies.

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The Bears And Bulls Square Off On Puma Biotechnology, Inc. (PBYI) – NY Stock News

Friday, May 26th, 2017

NY Stock News
The Bears And Bulls Square Off On Puma Biotechnology, Inc. (PBYI)
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Puma Biotechnology, Inc. (PBYI) has presented a rich pool of technical data in recent sessions. These are the trends we've been tracking and how we feel they should be played in the current environment. Successful trading professionals know that in ...

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Lakeland Community College biotechnology sciences students getting boost from grant – News-Herald.com

Thursday, May 25th, 2017

Thanks to a $40,320 grant from the Ohio Department of Higher Education, some hard-working Lakeland Community College biotechnology students will be eligible for scholarships to cover their tuition and fees.

The program is called Choose Ohio First and is aimed at helping students pursuing degrees in science, technology, engineering, mathematics and medicine or STEMM, its associated web page shows.

In Lakelands case, the grant applies to biotechnology science students who meet certain criteria, a media release from the school confirms.

Students who receive this scholarship will have their tuition fully covered at Lakeland, said Joe Deak, chairman of the schools biotechnology science program.

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He added that two Lakeland Community College students are now using this funding.

The scholarship covers up to $4,000 in tuition and fees for biotechnology students who dont receive PELL grants, according to Lakelands release.

It goes on to explain that high school graduates who passed chemistry with a C or better are encouraged to apply if they fit the following criteria:

Have an interest in a career in the laboratory biological sciences or data/analysis management as it pertains to biological data

Have a 3.0 overall GPA

Place into college algebra

Reside in Ohio.

Lakelands recent investments in its science and health technology programs and facilities have been making headlines in recent years, especially with the 2015 passage of its capital improvement bond issue, which is being used to fund a $40 million renovation and expansion of the colleges 20-year-old Health Technologies Building, bring the science hallway renovation to completion and help with other infrastructure improvements.

This is the stuff of the future, confirmed Arts & Sciences Division Dean Steven Oluic, who was on hand at a Sept. 1 open house for the renovated, third-floor science wing, when students, teachers, staff and anyone interested could see it, tour the classrooms and labs and learn about all the new, cutting-edge technology there.

I will submit to you that our biology, chemistry and physical science labs are among the best in the area, Oluic said. Really, youd be hard-pressed to find better labs.

College President Morris W. Beverage agreed.

When I went to Lakeland in 1972 and 1973, in the original labs up there, they were new, he said. This is the sort of thing you do every 40 or 50 years and you do it right. And, to do it right, you make sure the equipment and technology the students will be using are the standard of what theyll be using when they leave here. We want our students to experience what theyre going to experience in the world when they move on from here.

For Deak, theres no question thats exactly what Lakelands students are getting.

Deak said that, in his 20 years with the schools program, hes always been able to find grant money to keep it at the cutting edge and, thanks to this latest round of funding, the department is able to offer an unprecedented level of training to students who will likely go on to hit the ground running in roles which may not even exist yet.

Our folks wind up in research and development, quality control and medical lab technology, he said, just naming a few, and he added that the lab in which he answered these questions would pretty much be the envy of anyone at Case Western Reserve or Cleveland State University.

There are numbers to prove it, too.

According to Lakelands statement about the Choose Ohio First grant, Lakelands biotechnology science program has more than a 95 percent placement rate into jobs or transfer to a four-year school.

Institutions where graduates matriculate include Case Western Reserve University, Cleveland State University, Indiana Wesleyan University, John Carroll University, Lake Erie College and Youngstown State University, the statement reads. Lakeland also has a 2+2 articulation with Ursuline College, which allows students to transfer all of their credits and graduate with a bachelors degree in two additional years or less.

Deak said some students are even fortunate enough to land jobs with employers who actually pay their tuition for them.

After graduating from Lakeland, many students are then able to receive tuition waivers or reimbursements from their employers to reduce, or eliminate, the cost of the bachelors degree, he said.

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Why Abercrombie & Fitch, Triumph Group, and Puma Biotechnology Jumped Today – Madison.com

Thursday, May 25th, 2017

Wednesday was a good day for stocks, and the Dow Jones Industrials and S&P 500 both climbed through milestone levels. Most market participants attributed the positive sentiment to the Federal Reserve, which released the minutes of its latest monetary policy meeting during the afternoon. The central bank revealed plans to clamp down on the size of its balance sheet, which it initially expanded in the aftermath of the financial crisis to provide liquidity to the bond market and additional stimulus to the U.S. economy. Investors were pleased that the Fed believes that it's no longer necessary to extend that level of monetary accommodation to the economy. In addition, some individual companies had extremely good news, and Abercrombie & Fitch (NYSE: ANF), Triumph Group (NYSE: TGI), and Puma Biotechnology (NASDAQ: PBYI) 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.

Shares of Abercrombie & Fitch climbed 6% in the wake of reports that the teen retailer might receive an acquisition bid from a consortium of investors. According to The Wall Street Journal(subscription required), industry peer American Eagle Outfitters (NYSE: AEO) and private equity company Cerberus Capital Management are looking at putting together a potential buyout offer for Abercrombie & Fitch, following speculation that other players in the industry might also be interested in consolidation. A&F has been dealing with takeover speculation for a while, and it has typically noted that any discussions wouldn't necessary translate into actual offers. Yet with Abercrombie set to release its first-quarter financial results Thursday, investors will want to see signs that the company can take care of its challenges on its own -- or else they'll start clamoring more loudly for a buyout to take place.

Image source: Getty Images.

Triumph Group stock soared over 30% after the company announced its fiscal fourth-quarter financial results and resolved a dispute with aircraft manufacturer Bombardier. The aerospace components and systems specialist said that sales fell 13% from year-ago levels, and it posted a GAAP loss of $126.8 million. With challenges in its aerospace structures business, Triumph has focused on amending contracts and addressing operational and financial challenges, and the company's transformation plan has led to improving free cash flow and cost savings. Investors were also happy that Triumph reached a settlement of all of its disputes with Bombardier. Triumph said that the agreement "resets the commercial relationship between [Triumph] and Bombardier and allows each of them to better achieve their business objectives going forward."

Finally, shares of Puma Biotechnology jumped 30%. The biopharmaceutical company earned a hoped-for approval from the U.S. Food and Drug Administration advisory panel looking at its neratinib candidate treatment for breast cancer. The panel voted 12 to 4 in favor of recommending the drug to the FDA, and although panelists expressed some thoughts about potentially limiting the size of the group of women eligible to use the drug, investors nevertheless took the news as a positive. The FDA still needs to make its own decision about Puma's drug, and it isn't bound by the opinion of the advisory panel. Nevertheless, today's recommendation moves Puma one step further to getting a big win under its belt, and shareholders recognized that fact with the second big move in the stock this week.

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Amicus Therapeutics: A Rare Find In Biotechnology – Seeking Alpha

Wednesday, May 24th, 2017

Amicus Therapeutics (NASDAQ:FOLD) is a global biotherapeutics company focused on rare genetic devastating diseases. The company has advanced its precision medicine, Galafold (migalastat), in treating patients in Europe with Fabry disease (alpha galactosidase A deficiency), a rare X-linked genetic lysosomal disorder in which sphingolipids are not metabolized properly. Galafold, an orally administered drug, is the first medicine approved (EMA but not yet FDA) for treatment of Fabry disease. Other goals for 2017 include submitting a J-NDA (Japan) for migalastat, establishing a clinical plan for ATB200/AT2221 in Pompe disease, completion of phase 3 clinical trial in epidermolysis bullosa.

FOLD announced its regulatory plan with FDA for U.S. treatment with Galafold in advancing it's Fabry disease program including two phase 3 trials in late 2016. As previously mentioned, the EMA approved use of Galafold for treatment of Fabry disease. The company published data from its pivotal trial in the New England Journal of Medicine. A statistically significant benefit was conferred by Galafold in 50 patients with treatable mutant galactosidase alleles. However, a closer look at the trial endpoints reveals that the study failed to reach its primary endpoints including greater than 50% reduction in GL-3 inclusions per kidney, and if all 67 patients were included in the study (including mutant alleles that are not expected to benefit by Galafold). More studies are needed for FDA going forward. It could be well worth the company's investment, as the market for Fabry's disease is estimated to be in excess of $1.2 billion by 2024.

December 2016, FOLD announced positive early phase 1/2 data for Pompe disease, a rare genetic disorder leading to the buildup of glycogen in the body, particularly the muscles, which become impaired in function. The study showed a positive safety profile with no serious adverse events and generally showed musculatoprotection as shown by biomarkers of muscle damage. The study is divided into three cohorts: non-ambulatory ERT-switch, ERT-switch, and ERT-naive. Creatine kinase, alanine aminotransferase, and aspartate aminotransferase levels showed a trend towards improvement in half the patients and were stable in all. ATB200/AT2221 has a unique mechanism of treatment that uses ATB200, a recombinant functional alpha-glucosidase enzyme carrying mannose-6 phosphate moieties designed to increase uptake. AT2221 is a pharmacological chaperone co-treated to stabilize the compound. The company believes that its Pompe program (with market of $1.2 billion) will be a driver in its growth with 12% CAGR as a world's leading rare disease company. Key study readout dates include Q2 and Q3 2017.

SD-101 is currently in phase 3 studies as a topical for Epidermolysis Bullosa, and FOLD believes it will be the first-to-market therapy for the rare indication. The inherited disease is characterized by blistering of keratinized outer skin, wet skin (such as mouth), and internal organs. Serious complications include infection, pain, and even death. The company was granted FDA Breakthrough Therapy Designation in 2013 based on results from its phase 2a study, having demonstrated wound closure in all disease types. Strong Bio has previously written about the impacts of FDA Breakthrough Therapy Designation on biotechnology stocks, and if you are an investor and have not perused the article, now might be a good time, as it is a part of the investment plan for FOLD. Phase 3 top-line data for the 160 patient study in which 95% of the patients elected to continue the open-label extension is due Q3 2017. This statement could be the company's way of saying they find it likely it will have clinical benefit for patients. Since it has been observed that FDA breakthrough therapy status stocks get volatile late in stage 3, any sharp drops may indicate stock manipulation that interested investors might jump on with a small position. Strong Bio regards FOLD as a nice investment prospect for any unexplainable late Q2 early Q3 pullbacks. With significant market potential of $1 billion, severe symptoms, and 30,000 sufferers in the U.S. alone, its worth watching for that pullback. One competitor, RegeneRx (OTCQB:RGRX) has initiated phase 3 trials for RGX-137 (active ingredient thymosin beta 4 wound healing gel) in the condition as well.

Cash burn was $55 million in first quarter 2017. Cash on hand at end Q1 was $280 million. The current runway is expected to last through the second half of 2018. Seven analysts average about $12 per share for FOLD, which is currently trading at about $8, which may be a slight pullback from fair value. Strong Bio will look for dips in price below $6 for no a brainer initial position. If all three drugs get FDA approval, this stock could be off to the races. Strong Bio has learned a lesson from Amicus. Rare diseases may have surprisingly large markets!

Risk factors for FOLD could include dilution (which may be yet another entry opportunity). Risks also include FDA approval and/or regulatory delays for all three major indications. Clinical trial design will be key, because FDA wants a clear metric upon which to agree with FOLD to approve these rare disease therapies. Large scale GMP-compliant manufacturing for U.S. application will also be a significant but manageable obstacle. Because the company has a market cap over $1.1 billion dollars, SD-101 key readout will be very important in terms of valuation for FOLD stock. If approved by FDA, the stock could easily triple in value over the next year. With ATB200/AT2221 being regarded as a key driver in value by the company, 2017 is going to be a pivotal year for FOLD. With three candidates all on the verge of pivotal data, this is a must-watch!

Disclosure: I/we have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours.

I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it (other than from Seeking Alpha). I have no business relationship with any company whose stock is mentioned in this article.

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Amicus Therapeutics: A Rare Find In Biotechnology - Seeking Alpha

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Puma Biotechnology FDA Live Blog – Forbes

Wednesday, May 24th, 2017

Forbes
Puma Biotechnology FDA Live Blog
Forbes
This is a live blog of the meeting of the Food and Drug Administration's meeting regarding neratinib, a breast cancer drug being developed by Puma Biotechnology. The basic questions to be addressed, per my story from Monday. Puma's not applying to sell ...
Why Puma Biotechnology Inc Jumped Higher TodayMotley Fool
Puma Biotechnology Receives FDA Advisory Committee Support for NeratinibBusiness Wire (press release)
Puma Biotechnology (PBYI) PT Raised to $86 at BofA/Merrill LynchStreetInsider.com
ExpertGazette -Equities.com -Finance News Daily -Zacks
all 71 news articles »

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BBP: A Diversified Biotech ETF – Seeking Alpha

Wednesday, May 24th, 2017

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's 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 behind them. They have already successfully completed multiple human clinical trials and have received FDA approval to sell and market a drug." That sounds a lot like IBB so what's the big differentiator between the two funds? It's BBP's focus on small- and micro-cap biotechs. Nearly 60% of fund assets are dedicated to this space whereas IBB has nearly 40% of the portfolio alone invested in the big five of Regeneron (NASDAQ:REGN), Biogen , Celgene (NASDAQ:CELG), Amgen (NASDAQ:AMGN) and Gilead .

So what did BBP have going for it that IBB didn't over the past year or so? I think it's a combination of portfolio construction and M&A.

BBP has a portfolio that has performed almost as well as can be expected, especially in 2017. Take a look at this chart with the year-to-date performance of the fund's biggest components.

That's exactly what you want to see out of your ETFs - the largest holdings performing the best. Part of that is due to the fact that the fund is equal-weighted and rebalanced semiannually (the last rebalance was done on December 15th). Still, that's a lot of companies whose stocks have risen by 20% or more.

Among the top 10 holdings, all have posted double-digit gains with seven components delivering 25%+ gains.

The other advantage the fund has is that a number of its holdings are in the sweet spot of being developed enough to generate meaningful revenue from their approved product line yet being small enough that they can be potential takeover targets. We've seen that within the fund multiple times recently. Relypsa (RYLP) has a top holding when it got bought out by Galenica (OTC:GNHAY). Not an M&A deal, but the fund's stake in Progenics (NASDAQ:PGNX) spiked when its partnership with Valeant (NYSE:VRX) was announced. Current holdings such as Exelixis (NASDAQ:EXEL) and Acadia (NASDAQ:ACAD) have been rumored as potential takeover targets for a while so further action could be in store for the fund in the near future as well.

Conclusion

Equal weighting the mature biotech players has been a strategy that's paid off for investors in the last year. The relatively limited exposure to the likes of Celgene and Gilead, which are still nearly 50% off of recent highs, has made the fund more attractive than its more well-known counterpart.

This fund will underperform when the mega-cap biotech names begin to rally again, but over the long-term this ETF should hold up well to IBB given its more diversified portfolio.

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Disclosure: I/we have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours.

I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it (other than from Seeking Alpha). I have no business relationship with any company whose stock is mentioned in this article.

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Why Abercrombie & Fitch, Triumph Group, and Puma Biotechnology Jumped Today – Motley Fool

Wednesday, May 24th, 2017

Wednesday was a good day for stocks, and the Dow Jones Industrials and S&P 500 both climbed through milestone levels. Most market participants attributed the positive sentiment to the Federal Reserve, which released the minutes of its latest monetary policy meeting during the afternoon. The central bank revealed plans to clamp down on the size of its balance sheet, which it initially expanded in the aftermath of the financial crisis to provide liquidity to the bond market and additional stimulus to the U.S. economy. Investors were pleased that the Fed believes that it's no longer necessary to extend that level of monetary accommodation to the economy. In addition, some individual companies had extremely good news, and Abercrombie & Fitch (NYSE:ANF), Triumph Group (NYSE:TGI), and Puma Biotechnology (NASDAQ:PBYI) 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.

Shares of Abercrombie & Fitch climbed 6% in the wake of reports that the teen retailer might receive an acquisition bid from a consortium of investors. According to The Wall Street Journal(subscription required), industry peer American Eagle Outfitters (NYSE:AEO) and private equity company Cerberus Capital Management are looking at putting together a potential buyout offer for Abercrombie & Fitch, following speculation that other players in the industry might also be interested in consolidation. A&F has been dealing with takeover speculation for a while, and it has typically noted that any discussions wouldn't necessary translate into actual offers. Yet with Abercrombie set to release its first-quarter financial results Thursday, investors will want to see signs that the company can take care of its challenges on its own -- or else they'll start clamoring more loudly for a buyout to take place.

Image source: Getty Images.

Triumph Group stock soared over 30% after the company announced its fiscal fourth-quarter financial results and resolved a dispute with aircraft manufacturer Bombardier. The aerospace components and systems specialist said that sales fell 13% from year-ago levels, and it posted a GAAP loss of $126.8 million. With challenges in its aerospace structures business, Triumph has focused on amending contracts and addressing operational and financial challenges, and the company's transformation plan has led to improving free cash flow and cost savings. Investors were also happy that Triumph reached a settlement of all of its disputes with Bombardier. Triumph said that the agreement "resets the commercial relationship between [Triumph] and Bombardier and allows each of them to better achieve their business objectives going forward."

Finally, shares of Puma Biotechnology jumped 30%. The biopharmaceutical company earned a hoped-for approval from the U.S. Food and Drug Administration advisory panel looking at its neratinib candidate treatment for breast cancer. The panel voted 12 to 4 in favor of recommending the drug to the FDA, and although panelists expressed some thoughts about potentially limiting the size of the group of women eligible to use the drug, investors nevertheless took the news as a positive. The FDA still needs to make its own decision about Puma's drug, and it isn't bound by the opinion of the advisory panel. Nevertheless, today's recommendation moves Puma one step further to getting a big win under its belt, and shareholders recognized that fact with the second big move in the stock this week.

Dan Caplinger has no position in any stocks mentioned. The Motley Fool has no position in any of the stocks mentioned. The Motley Fool has a disclosure policy.

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The Technical Chart For Puma Biotechnology, Inc. (PBYI) Is Very Revealing Today – NY Stock News

Wednesday, May 24th, 2017
The Technical Chart For Puma Biotechnology, Inc. (PBYI) Is Very Revealing Today
NY Stock News
The technicals for Puma Biotechnology, Inc. (PBYI) has spoken via its technical chart and the message is loud and clear. Based on that message, this is the relevant information necessary to make sense of that current setup. Often the difference between ...

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Global Biotechnology Congress 2017: Academic Registration (Boston, United States – July 10-11-12-13, 2017 … – Business Wire (press release)

Tuesday, May 23rd, 2017

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 and hear leaders from the international academic and corporate biotechnology communities.

Benefits of Attending

- Exchange ideas and network with leading biotechnologists and decision makers.

- Bring together top international biotechnology professionals presenting cutting-edge discoveries, research and opportunities for new biotech business practices and partnerships.

- Participants can gain direct access to a core audience of biotechnology professionals and decision makers, and have increased visibility through branding and networking at the conference.

- Obtain a global roundup of Pharmaceutical research capabilities and opportunities.

- The conference will feature a commercial exhibition and poster sessions.

For more information about this conference visit http://www.researchandmarkets.com/research/tw4sc3/global

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Why Puma Biotechnology, Applied Optoelectronics, and Ferroglobe Jumped Today – Motley Fool

Tuesday, May 23rd, 2017

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 the drug is likely to get a favorable review from the advisory panel. That by itself won't mean certain approval for neratinib, as the final decision from the FDA doesn't necessarily hinge on the advisory panel. Nevertheless, positive signs have investors excited about Puma, and there's potential for further gains if the FDA does indeed follow through with approval later this year.

Applied Optoelectronics stock climbed 12% after the supplier of fiber-optic components got a favorable review from Wall Street analysts. Needham & Co. began its coverage of Applied Optoelectronics stock with a strong buy rating, arguing that the company has a lot of growth potential stemming from moves among enterprise data center users to upgrade their performance and incorporate faster transfer speeds. Needham set an $85-per-share price target on the stock, which still gives investors nearly 20% upside from current levels. If Applied Optoelectronics can turn the new upgrade cycle into accelerating growth, then investors could see even greater gains in the long run.

Finally, shares of Ferroglobe rose 9%. The producer of silicon metal and various related alloys released its first-quarter financial results, which included flat revenue compared to the fourth quarter of 2016 and a minimal net loss for the quarter. Shipment volumes were down from year-ago levels, but a rise in prices for manganese alloys was sufficient to keep total average selling prices relatively steady. Yet CEO Pedro Larrea was optimistic about the company's performance, noting that "significant margin improvement reflects solid demand across end markets and a continued improvement in the overall pricing environment." Even with the gains, Ferroglobe shares have lost half their value in the past two years, but investors are optimistic that the company can earn back some of those losses over time.

Dan Caplinger has no position in any stocks mentioned. The Motley Fool has no position in any of the stocks mentioned. The Motley Fool has a disclosure policy.

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BioTime to Present at 16th National Life Sciences and Biotechnology Week (MIXiii BIOMED) – Stockhouse

Tuesday, May 23rd, 2017

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 the worlds premier collection of pluripotent cell assets. The foundation of BioTimes core therapeutic technology platform is pluripotent cells that are capable of becoming any of the cell types in the human body. Pluripotent cells have potential application in many areas of medicine with large unmet patient needs, including various age-related degenerative diseases and degenerative conditions for which there presently are no cures. Unlike pharmaceuticals that require a molecular target, therapeutic strategies based on the use of pluripotent cells are generally aimed at regenerating or replacing affected cells and tissues, and therefore may have broader applicability than pharmaceutical products. BioTime also has significant equity holdings in two publicly traded companies, Asterias Biotherapeutics, Inc. and OncoCyte Corporation, which BioTime founded and which, until recently, were majority-owned consolidated subsidiaries of BioTime.

BioTimecommon stock is traded on the NYSE MKT and TASE under the symbol BTX. For more information, please visitwww.biotimeinc.comor connect with the company on Twitter, LinkedIn, Facebook, YouTube, and Google+.

Investor Contact: EVC Group, Inc. Michael Polyviou/Doug Sherk, 646-445-4800 mpolyviou@evcgroup.com;dsherk@evcgroup.com or Media Contact: JQA Partners, Inc. Jules Abraham, 917-885-7378 jabraham@jqapartners.com

View source version on businesswire.com: http://www.businesswire.com/news/home/20170523005380/en/

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BioTime to Present at 16th National Life Sciences and Biotechnology Week (MIXiii BIOMED) - Stockhouse

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How to Trade these Stock After an unavoidable Selloff: Puma Biotechnology, Inc. (PBYI), BofI Holding, Inc. (BOFI) – StockNewsJournal

Tuesday, May 23rd, 2017
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 ...

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How to Trade these Stock After an unavoidable Selloff: Puma Biotechnology, Inc. (PBYI), BofI Holding, Inc. (BOFI) - StockNewsJournal

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Puma Biotechnology: Shares on the prowl – Times of India

Tuesday, May 23rd, 2017

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 subscribe to.)

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Bioverativ to Acquire Clinical-Stage Rare Disease Biotechnology Company, True North Therapeutics – Business Wire (press release)

Tuesday, May 23rd, 2017

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 registrational program, are underway. Breakthrough therapy designation was created by the FDA to expedite the development and review of medicines that target serious or life-threatening conditions and have shown preliminary evidence of potential clinical benefit.

One of our strategic priorities is to invest thoughtfully in business development with a focus on building our pipeline in areas where we believe we can make a real difference for patients, said John Cox, Chief Executive Officer of Bioverativ. This acquisition of True North is aligned with those goals and with our vision to become the leading rare disease company focused on blood disorders. It strengthens our pipeline with a potential first-in-class therapy to treat CAD, a rare blood disorder with a high unmet patient need.

People living with CAD currently have no approved treatment options and suffer with a significant disease burden including crippling fatigue, frequent transfusions and an increased risk of life-threatening thrombotic events such as pulmonary embolism and stroke, Mr. Cox continued. By combining True Norths industry-leading science in complement biology with Bioverativs expertise in hematology and robust clinical and commercial capabilities, we believe we can bring meaningful progress to CAD patients. In addition, this transaction is consistent with our capital allocation philosophy, and we expect it to create significant value for our shareholders over the long term."

Todays announcement and TNT009s breakthrough therapy designation are testaments to the innovative science underpinning our lead candidate and the strength of the True North team. We are delighted to have progressed our pipeline to this stage, said Nancy Stagliano, PhD, Chief Executive Officer of True North. Bioverativ is well positioned to advance the development and commercialization of TNT009 on behalf of CAD patients who are greatly in need of safe and effective treatments.

The FDA granted TNT009 breakthrough therapy designation based on data from a Phase 1b trial, which showed that TNT009 normalized hemoglobin levels in six of six study participants with primary CAD, increasing hemoglobin by an average of 4g/dL and resolving their anemia. All participants were transfusion free while on treatment. TNT009 was generally well tolerated. As of December 21, 2016, five of six participants (83.3%) with primary CAD experienced at least one adverse event; all were mild to moderate in severity and no adverse event was assessed as related to TNT009 by the investigator.

TNT009 is designed to selectively inhibit the classical complement pathway by targeting C1s and directly impacting the central mechanism of CAD. The only therapy in development that targets C1s, TNT009 has received orphan drug designation from the FDA and the European Medicines Agency. A number of other rare, complement-mediated diseases share the basic underlying pathological mechanism involving C1s that could potentially be addressed by TNT009.

True Norths second molecule, TNT020, is a discovery-stage, follow-on monoclonal antibody that targets activated C1s with the potential for less-frequent dosing and subcutaneous administration.

The acquisition will be financed through a combination of cash on hand and debt. It is subject to customary closing conditions, including the expiration of the applicable waiting period under the Hart-Scott-Rodino Antitrust Act of 1976 in the United States, and is expected to close in mid-2017.

Conference Call and Webcast Bioverativ will hold a brief conference call and webcast today at 8:30 a.m. ET to discuss the transaction. The conference call can be accessed through the Investors section of Bioverativs homepage, investors.bioverativ.com, and an audio replay will subsequently be available on the website for at least one month.

About Cold Agglutinin Disease (CAD) CAD is a debilitating autoimmune hemolytic anemia in which autoantibodies target red blood cells, leading to red blood cell destruction via complement activation initiated by the C1 complex, causing chronic anemia, severe fatigue and potentially fatal thrombotic events. CAD occurs in approximately 16 people per million, affecting an estimated 5,000 people in the United States. Typically, symptom onset begins around age 60. There are currently no approved therapies for CAD. Treatment is aimed at normalizing hemoglobin levels through blood transfusions, steroids or off-label immunotoxic therapy; however, current treatment options are often intensive, incomplete or nondurable, leaving patients dependent upon frequent transfusions, which can lead to chronic iron overload.

About TNT009 TNT009 is a first-in-class, humanized, monoclonal antibody that is designed to selectively inhibit the classical complement pathway by targeting C1s, a serine protease within the C1-complex in the complement pathway of the immune system. With a unique mechanism of action and high target specificity, TNT009 is designed to selectively inhibit disease processes in the classical complement pathway while maintaining activity of the alternative complement pathway and lectin complement pathway, which are important for immune surveillance and other functions.

About True North Therapeutics True North Therapeutics is a clinical stage biopharmaceutical company focused on the discovery, development and commercialization of first-in-class product candidates for complement-mediated diseases. The companys lead product candidate, TNT009, is designed to selectively inhibit a target in the classical complement pathway. True Norths antibody drug development is focused on the treatment of certain rare diseases mediated by the complement system. True North Therapeutics is located in South San Francisco, California. For more information, please visit http://www.truenorthrx.com.

About Bioverativ Bioverativ is a global biotechnology company dedicated to transforming the lives of people with hemophilia and other rare blood disorders through world-class research, development and commercialization of innovative therapies. Launched in 2017 following separation from Biogen Inc., Bioverativ builds upon a strong heritage of scientific innovation and is committed to actively working with the blood disorders community. The companys mission is to create progress for patients where they need it most and its hemophilia therapies when launched represented the first major advancements in hemophilia treatment in more than two decades. For more information, visit http://www.bioverativ.comor follow@bioverativ on Twitter.

Safe Harbor This press release contains forward-looking statements, including statements relating to: the completion of the transaction with True North and timing thereof; the expected benefits of the transaction, including the potential to bring meaningful progress to CAD patients and create shareholder value; and anticipated clinical trials and the timing thereof. These forward-looking statements may be accompanied by such words as anticipate, believe, could, estimate, expect, forecast, intend, may, plan, potential, project, target, will and other words and terms of similar meaning. You should not place undue reliance on these statements.

These forward-looking statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements, including: risks that the transaction will be completed in a timely manner or at all; risks of failure to satisfy the conditions precedent to completion of the transaction, including the ability to secure regulatory approvals in a timely manner or at all; uncertainty of whether Bioverativ can achieve the expected benefits from the transaction and successfully integrate the operations of True North; risks of unexpected costs, liabilities or delays; integration difficulties, including the ability to retain key personnel; risks that Bioverativ will be able to obtain financing on satisfactory terms, if at all; risks relating to the protection of intellectual property; risks and uncertainties relating to product development, clinical trials, regulatory process and approvals, and commercialization that may impact or alter Bioverativs anticipated business plans, strategies and objectives; and other risks and uncertainties described in the Risk Factors section of Bioverativ's quarterly and annual filings with the Securities and Exchange Commission.

These statements are based on our current beliefs and expectations and speak only as of the date of this press release. We do not undertake any obligation to publicly update any forward-looking statements, whether as a result of new information, future developments or otherwise.

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Bioverativ to Acquire Clinical-Stage Rare Disease Biotechnology Company, True North Therapeutics - Business Wire (press release)

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Looking For a Catalyst: Update on Prana Biotechnology Limited (NASDAQ:PRAN) – Morgan Research

Sunday, May 21st, 2017

As of late, the Street has taken a bit closer look at shares of Prana Biotechnology Limited (NASDAQ:PRAN). In the latest session the stock moved-6.63%, putting the stock value at$2.24.

Most investors are likely looking for that next stock that is ready to take off running. Maybe the focus is on finding a stock that has recently taken a turn for the worse for no real apparent reason. As we all know, as quickly as a stock can drop in price, it can bounce back just as fast.

Although the popular stocks that receive a high level of media coverage tend to recover quicker after a sell-off, there may be plenty of under the radar stocks that are ripe for buying. Scoping out these potential market gems may help repair a portfolio that has taken a hit for any number of reasons.

Is Prana Biotechnology Limited Ready to Move higher? Sign Up For Breaking Alerts on this Stock Before the Crowd.

The average investor might not have the time to monitor every single tick of a given stock, but taking a look at historical performance may help provide some valuable insight on where the stock may be trending in the future. Over the past week, Prana Biotechnology Limited (NASDAQ:PRAN) has performed 0.90%. For the past month, shares are -20.85%. Over the last quarter, shares have performed -3.03%. Looking back further, Prana Biotechnology Limited stock has been -23.29% over the last six months, and 37.42% since the start of the calendar year. For the past full year, shares are -38.63%.

There is rarely any substitute for diligent research, especially when it pertains to the equity markets. No matter what strategy an investor employs, keeping abreast of current market happenings is of the utmost importance. Everyone wants to see their stock picks soar, but the stark reality is that during a market wide sell-off, this may not be the case. Recently, shares of Prana Biotechnology Limited (NASDAQ:PRAN)have been seen trading -27.98% away from the 200-day moving average and -14.63% off the 50-day moving average. The stock is currently trading -66.52% away from the 52-week high and separated 47.37% from the 52-week low. Prana Biotechnology Limiteds RSI is presently sitting at 40.44.

New investors may sometimes be working with limited capital. Choosing which stocks to own can be a tough decision. Individuals may be deciding on whether to buy 10 shares of a stock trading at $100 as opposed to purchasing 100 shares of a stock trading at $10. We have recently been focusing on stocks that are trading under the $10 price level. We are constantly monitoring technical and fundamental factors that may lead to breakouts for these relatively cheap (in terms of price) stocks.

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Looking For a Catalyst: Update on Prana Biotechnology Limited (NASDAQ:PRAN) - Morgan Research

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iShares NASDAQ Biotechnology Index (IBB) Upgraded to "Buy" at Vetr Inc. – The Cerbat Gem

Saturday, May 20th, 2017

BBNS
iShares NASDAQ Biotechnology Index (IBB) Upgraded to "Buy" at Vetr Inc.
The Cerbat Gem
iShares NASDAQ Biotechnology Index logo iShares NASDAQ Biotechnology Index (NASDAQ:IBB) was upgraded by research analysts at Vetr from a hold rating to a buy rating in a note issued to investors on Tuesday, April 18th. The firm currently has a ...
11000 Shares in iShares NASDAQ Biotechnology Index (IBB) Acquired by CLS Investments LLCSports Perspectives
The 737 Shares in iShares NASDAQ Biotechnology Index (IBB) Acquired by Sawtooth Solutions LLCBangaloreWeekly
Vetr Inc. Upgrades iShares NASDAQ Biotechnology Index (IBB) to BuyTranscript Daily
Markets Daily -Chaffey Breeze -BBNS
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iShares NASDAQ Biotechnology Index (IBB) Upgraded to "Buy" at Vetr Inc. - The Cerbat Gem

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Harbour Investment Management LLC Invests $4.559 Million in iShares NASDAQ Biotechnology Index (IBB) – The Cerbat Gem

Saturday, May 20th, 2017

Investopedia
Harbour Investment Management LLC Invests $4.559 Million in iShares NASDAQ Biotechnology Index (IBB)
The Cerbat Gem
iShares NASDAQ Biotechnology Index logo Harbour Investment Management LLC bought a new position in iShares NASDAQ Biotechnology Index (NASDAQ:IBB) during the first quarter, according to its most recent filing with the Securities and Exchange ...
Lucas Capital Management Has $2.254 Million Stake in iShares NASDAQ Biotechnology Index (IBB)Sports Perspectives
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Davidson & Garrard Inc. Lowers Stake in iShares NASDAQ Biotechnology Index (IBB)Markets Daily
BBNS -Transcript Daily -Chaffey Breeze
all 31 news articles »

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Harbour Investment Management LLC Invests $4.559 Million in iShares NASDAQ Biotechnology Index (IBB) - The Cerbat Gem

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Harwood Feffer LLP Announces Investigation of Puma Biotechnology, Inc. – PR Newswire (press release)

Saturday, May 20th, 2017

On May 4, 2017, Puma announced the resignation of its Senior Vice President, Regulatory Affairs, effective as of May 15, 2017, less than two weeks before the FDA's scheduled review of neratinib. On May 5, 2017, Fox Business published an article reporting that a large number of patients taking neratinib suffered from severe side effects, posing a safety risk for the drug.

Our investigation concerns whether the Company board of directors has breached its fiduciary duties to shareholders, grossly mismanaged the Company, and/or committed abuses of control in connection with the foregoing.

If you own Puma shares and wish to discuss this matter with us, or have any questions concerning your rights and interests with regard to this matter, please contact:

Robert I. Harwood, Esq. Benjamin I. Sachs-Michaels, Esq. Harwood Feffer LLP 488 Madison Avenue New York, New York 10022 Phone Numbers: (877) 935-7400 (212)935-7400 Email: bsachsmichaels@hfesq.com Website: http://www.hfesq.com Follow us on Twitter: @HarwoodFeffer

Harwood Feffer has been representing individual and institutional investors for many years, serving as lead counsel in numerous cases in federal and state courts. Please visit the Harwood Feffer LLP website (http://www.hfesq.com) for more information about the firm.

Attorney Advertising. The law firm responsible for this advertisement is Harwood Feffer LLP (www.hfesq.com). Prior results do not guarantee or predict a similar outcome with respect to any future matter.

To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/harwood-feffer-llp-announces-investigation-of-puma-biotechnology-inc-300460923.html

SOURCE Harwood Feffer LLP

http://www.hfesq.com

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Harwood Feffer LLP Announces Investigation of Puma Biotechnology, Inc. - PR Newswire (press release)

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China agrees to review US biotechnology applications – Chemical & Engineering News

Friday, May 19th, 2017

China will evaluate eight pending U.S. agricultural biotechnology product applications by the end of May, potentially opening the door for sales by Dow AgroSciences, DuPont Pioneer, Monsanto, and Syngenta.

China agreed to conduct the evaluations as part of an agreement unveiled by the White House on May 12. The two countries reached the trade deal after a meeting in April between U.S. President Donald J. Trump and Chinese President Xi Jinping.

U.S. officials have prodded China for years to speed up its lengthy process for deciding whether to approve the import of new genetically modified (GM) crops. It typically takes six years to win Chinese clearance of a GM variety, twice as long as other major nations take.

Under the new deal, Chinas National Biosafety Committee will meet by the end of May to assess the safety of eight products made by four major U.S. agrochemical companies.

Dow AgroSciences is seeking approval for its corn and soybean seeds, while Syngenta and DuPont Pioneer have each applied to sell a GM corn variety in China. Monsanto makes four of the products pending approval, including herbicide-tolerant corn, soybeans, and two alfalfa varieties that have been under review for nearly six years.

The Biotechnology Innovation Organization (BIO), an industry trade group, wants to make sure China lives up to its commitment.

The ultimate test of success will be for China to follow its process and quickly approve the eight pending biotechnology applications and establish a synchronized, timely, and predictable process going forward, says Joseph Damond, senior vice president for international affairs at BIO.

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China agrees to review US biotechnology applications - Chemical & Engineering News

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