Category Archives: Biotechnology

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

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

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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BBP: A Diversified Biotech ETF - Seeking Alpha

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

Link:
Global Biotechnology Congress 2017: Academic Registration ... - Business Wire (press release)

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

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

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 »

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

Bioverativ (NASDAQ:BIVV) announces 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 $400M plus assumed cash.

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).

In May 2017, the FDA granted TNT009 breakthrough therapy designation for the treatment of hemolysis in patients with primary CAD, and plans for the full clinical development program.

The acquisition of True North advances the Company's vision of becoming the leading rare disease company focused on blood disorders.

TNT009 has also received orphan drug designation from the FDA and the European Medicines Agency.

Bioverativ will hold a conference call at 8:30 a.m. ET to discuss the transaction.

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Bioverativ to acquire clinical-stage rare disease biotechnology company, True North Therapeutics - Seeking Alpha

Puma Biotechnology, Inc. (PBYI) Has Finally Shown Its Full Hand Via The Chart Setup NY Stock News Puma Biotechnology, Inc. (PBYI) has been having a set of eventful trading activity and it is clear from an examination of the charts that traders are now fully aware of the company's key metrics. A deeper exploration of the setup is sure to yield a ... and more »

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Puma Biotechnology, Inc. (PBYI) Has Finally Shown Its Full Hand Via The Chart Setup - NY Stock News

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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Puma Biotechnology: Shares on the prowl - Times of India