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Category Archives: Biotechnology

Planda Biotechnology Changing the Future of Green Tea with Technology Used in Origine 8 Capsules – Markets Insider

Posted: May 11, 2017 at 12:42 pm

NEW YORK, NY--(Marketwired - May 10, 2017) - Planda Biotechnology's (OTCQB: PLPL) Origine 8 capsules could be the future of green tea. Drinking a cup of green tea tastes great, but unless the eight catechins from the green tea plant are getting into your blood stream and staying there long enough to offer a therapeutic dose, it's really just a tasty cup of green tea and nothing more. Planda has already proven in clinical studies that its green tea extract, Phytofare Catechin Complex, is highly bioavailable, which in Planda's case means that all eight catechins of the green tea extract are getting into the blood stream and staying there for 24 hours.

Planda isn't satisfied with just delivering a potent green tea extract; instead, it has taken the delivery of Phytofare deep into the body a step further. Basically, Origine 8 capsules use an advanced liposome technology to move Phytofare around inside the human body in a protective bubble. Liposomes are tiny nano-sized bubbles with an outer shell made up of healthy lipids and a hollow aqueous center that Planda fills with Phytofare. The outer layer of the liposome protects the green tea extract from gastric juices and liver enzymes, and clinical studies are showing that liposomes support the absorption of nutrition and have excellent efficacy.

The company starts with its high-quality extract Phytofare, and then further enhances the product by using this technology for improved delivery on the cellular level.

Liposomes work by initially protecting the payload (Phytofare) from the harsh acidic environment of the stomach. Once past the stomach, Phytofare is delivered where needed by absorption through one of the many mechanisms available to liposomes. This higher absorption of nutrition allows its full benefit to be realized. An added advantage of liposomes is increased circulation time of Phytofare, which allows for a longer active life and benefit inside the body.

According to Planda, Origine 8 uses the only known Good Manufacturing Practices (GMP) and registered liposome-manufacturing facility in the world. In the case of the liposome used in the production of Origine 8, phosphatidylcholine is used and extracted from Non-GMO sunflower, the liposome itself has the added benefit of becoming nutrition for the liver, brain, mitochondria, eyes, and the most essential cells in the human body.

Planda calls it a "complete green tea extract" and they state that it's the first and only green tea extract to offer complete catechin absorption. Planda offers all of this in the convenience of a single capsule per day. And, if one capsule per day can deliver a highly bioavailable and protected green tea extract throughout the body, then the days of countless cups of green tea, which may offer no effect at all, may be over. After all, we know today that it's not what you consume but what you absorb that is the most important factor when choosing a product to improve your health.

About Stock Market Media Group

Stock Market Media Group is a Content Development IR firm offering a platform for corporate stories to unfold in the media with research reports, corporate videos, CEO interviews and feature news articles.

We may from time to time include our own opinions about our featured companies, their businesses, markets and opportunities. Any opinions we may offer are solely our own, and are made in reliance upon our rights under the First Amendment to the U.S. Constitution, and are provided solely for the general opinionated discussion of our readers and viewers. Our opinions should not be considered to be complete, precise, accurate, or current investment advice, or construed or interpreted as research. Any investment decisions you may make concerning any company are solely your responsibility based on your own due diligence. Our publications are provided only as an informational aid. We encourage you to invest carefully and read the investor information available at the web site of the U.S. Securities and Exchange Commission at: http://www.sec.gov. We also recommend as a general rule, that before investing in any securities you consult with a professional financial planner or advisor, and you should conduct a complete and independent investigation before investing in any security after prudent consideration of all pertinent risks.

We are not a registered broker, dealer, analyst, or adviser. We hold no investment licenses and may not sell, offer to sell or offer to buy any security. Our publications are not a recommendation to buy or sell a security.

Section 17(b) of the 1933 Securities and Exchange Act requires publishers who distribute information about publicly traded securities for compensation, to disclose who paid them, the amount, and the type of payment. In order to be in full compliance with the Securities Act of 1933, Section 17(b), we are disclosing that SMMG is compensated $5,000 per month by Plandai Biotechnology for content development. Neither SMMG nor anyone associated with it owns shares in PLPL.

For more information: http://www.stockmarketmediagroup.com.

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Puma Biotechnology Reports First Quarter 2017 Financial Results – Business Wire (press release)

Posted: May 11, 2017 at 12:42 pm

LOS ANGELES--(BUSINESS WIRE)--Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, announced financial results for the first quarter ended March 31, 2017.

Unless otherwise stated, all comparisons are for the first quarter 2017 compared to the first quarter 2016.

Based on accounting principles generally accepted in the United States (GAAP), Puma reported a net loss applicable to common stock of $72.9 million, or $1.97 per share, for the first quarter of 2017, compared to a net loss applicable to common stock of $71.0 million, or $2.19 per share, for the first quarter of 2016.

Non-GAAP adjusted net loss was $43.1 million, or $1.16 per share, for the first quarter of 2017, compared to non-GAAP adjusted net loss of $41.5 million, or $1.28 per share, for the first quarter of 2016. Non-GAAP adjusted net loss excludes stock-based compensation expense, which represents a significant portion of overall expense and has no impact on the cash position of the Company. For a reconciliation of GAAP net loss to non-GAAP adjusted net loss and GAAP net loss per share to non-GAAP adjusted net loss per share, please see the financial tables at the end of this news release.

Net cash used in operating activities for the first quarter of 2017 was $36.0 million. At March 31, 2017, Puma had cash and cash equivalents of $105.1 million and marketable securities of $88.9 million, compared to cash and cash equivalents of $194.5 million and marketable securities of $35.0 million at December 31, 2016.

We made significant progress with our lead investigational drug, neratinib, during the first quarter of 2017, said Alan H. Auerbach, Chairman, Chief Executive Officer and President of Puma. We look forward to continuing to work with the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) as they review our New Drug Application (NDA) and Marketing Authorization Application (MAA)filings, respectively, and we look forward to presenting the data on neratinib at the upcoming FDA Oncologic Drugs Advisory Committee on May 24th.

Data on neratinib was also presented at the 2017 American Association for Cancer Research Annual Meeting in April which included data on the use of antidiarrheal prophylaxis to reduce the diarrhea with neratinib in the extended adjuvant treatment of patients with early stage HER2-overexpressed/amplified breast cancer who have received prior adjuvant trastuzumab-based therapy (CONTROL trial). There was also clinical data presented on neratinib in the treatment of patients who have solid tumors with activating HER2 or HER3 mutations (SUMMIT trial). Additional data was also presented on the combination of T-DM1 and neratinib in patients with HER2 positive metastatic breast cancer (MBC) that has previously been treated with pertuzumab and trastuzumab. We look forward to continuing to achieve our objectives and believe that Puma is very well-positioned to build value for our shareholders.

Mr. Auerbach added, During 2017, we anticipate the following key milestones with neratinib: (i) reporting data from the Phase III trial in third-line HER2-positive MBC patients in the second quarter of 2017; (ii) reporting data in the second quarter of 2017 from the TBCRC-022 Phase II trial of neratinib plus capecitabine in HER2-positive MBC patients with brain metastases; (iii) reporting final 5-year disease free survival (DFS) data during the second quarter of 2017 from the ExteNET Phase III trial of neratinib as an extended adjuvant treatment in HER2-positive early stage breast cancer; and (iv) announcing regulatory decisions in the United States and European Union on neratinib for the extended adjuvant treatment of patients with HER2-positive early stage breast cancer in the third quarter of 2017.

Operating Expenses

Operating expenses were $73.2 million for the first quarter of 2017, compared to $71.2 million for the first quarter of 2016.

General and Administrative Expenses:

General and administrative expenses were $18.4 million for the first quarter of 2017, compared to $11.0 million for the first quarter of 2016. The approximately $7.4 million increase resulted primarily from increases of approximately $1.4 million for stock-based compensation, $3.9 million for professional fees, $1.3 million for payroll and related costs, and $0.5 million for facility and equipment costs. These increases reflect overall corporate growth.

Research and Development Expenses:

Research and development (R&D) expenses were $54.8 million for the first quarter of 2017, compared to $60.2 million for the first quarter of 2016. The approximately $5.4 million decrease resulted primarily from decreases of approximately $1.1 million for stock-based compensation and $5.0 million for clinical trial expenses, partially offset by an increase of $0.6 million for consultants and contractors. For our existing clinical trials, we expect R&D expenses to decrease in subsequent quarters as clinical trials wind down.

About Puma Biotechnology

Puma Biotechnology, Inc. is a biopharmaceutical company with a focus on the development and commercialization of innovative products to enhance cancer care. The Company in-licenses the global development and commercialization rights to three drug candidatesPB272 (neratinib (oral)), PB272 (neratinib (intravenous)) and PB357. Neratinib is a potent irreversible tyrosine kinase inhibitor that blocks signal transduction through the epidermal growth factor receptors, HER1, HER2 and HER4. Currently, the Company is primarily focused on the development of the oral version of neratinib, and its most advanced drug candidates are directed at the treatment of HER2-positive breast cancer. The Company believes that neratinib has clinical application in the treatment of several other cancers as well, including non-small cell lung cancer and other tumor types that over-express or have a mutation in HER2.

Further information about Puma Biotechnology can be found at http://www.pumabiotechnology.com.

Forward-Looking Statements

This press release contains forward-looking statements, including statements regarding the potential announcement of regulatory decisions in the United States and European Union on neratinib for the extended adjuvant treatment of patients with HER2-positive early stage breast cancer and the Companys clinical trials and the announcement of data relative to these trials. All forward-looking statements included in this press release involve risks and uncertainties that could cause the Company's actual results to differ materially from the anticipated results and expectations expressed in these forward-looking statements. These statements are based on current expectations, forecasts and assumptions, and actual outcomes and results could differ materially from these statements due to a number of factors, which include, but are not limited to, the fact that the Company has no product revenue and no products approved for marketing, the Company's dependence on PB272, which is still under development and may never receive regulatory approval, the challenges associated with conducting and enrolling clinical trials, the risk that the results of clinical trials may not support the Company's drug candidate claims, even if approved, the risk that physicians and patients may not accept or use the Company's products, the Company's reliance on third parties to conduct its clinical trials and to formulate and manufacture its drug candidates, the Company's dependence on licensed intellectual property, and the other risk factors disclosed in the periodic and current reports filed by the Company with the Securities and Exchange Commission from time to time, including the Company's Annual Report on Form 10-K for the year ended December 31, 2016. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. The Company assumes no obligation to update these forward-looking statements, except as required by law.

Non-GAAP Financial Measures

In addition to operating results as calculated in accordance with generally accepted accounting principles, or GAAP, the Company uses certain non-GAAP financial measures when planning, monitoring, and evaluating operational performance. The following table presents the Companys net loss and net loss per share calculated in accordance with GAAP and as adjusted to remove the impact of employee stock-based compensation. For the three months ended March 31, 2017, stock-based compensation represented approximately 40.9% of net loss. Although net loss is important to measure financial performance, the Company currently places an emphasis on cash burn and, more specifically, cash used in operations. Stock-based compensation appears in GAAP net loss but is removed from net loss to arrive at cash used in operations on the statement of cash flows. Due to its noncash nature, the Company believes these non-GAAP measures enhance understanding of financial performance, are more indicative of operational performance and facilitate a better comparison among fiscal periods. These non-GAAP financial measures are not, and should not be viewed as, substitutes for GAAP reporting measures.

(1)

To reflect a non-cash charge to operating expense for General and Administrative stock-based compensation.

(2)

To reflect a non-cash charge to operating expense for Research and Development stock-based compensation.

(3)

Non-GAAP adjusted net loss per share was calculated based on 36,931,167 and 32,478,408 weighted average common shares outstanding for the three months ended March 31, 2017 and 2016, respectively.

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Puma Biotechnology Stock Slumps as Regulatory VP Departs Before FDA Review – Los Angeles Business Journal

Posted: May 9, 2017 at 4:43 am

Puma Biotechnology Inc.s stock took a dive last week after its regulatory executive resigned less than three weeks before a U.S. Food and Drug Administration panel is scheduled to review the public companys breast cancer drug Neratinib.

The Westwood companys share price dipped 14 percent to $31.38 at the close of business May 5 from $36.45 the day before, when the company notified the Securities and Exchange Commission that Robert Charnas, senior vice president of regulatory affairs and project management, would step down for health reasons effective May 15.

The stock was trading at $29.15 when the markets closed Monday.

The company, which has a market cap of $1.07 billion, hired 63-year-old Charnas last year with a base salary of more than $330,000, stock options, and a more than $378,000 signing bonus, according to the employment offer letter filed with the SEC.

An independent panel of experts is scheduled to review Neratinib for safety and efficacy May 24 before making a recommendation for its use to the FDA.

Caroline Anderson is a staff reporter covering retail, restaurants, and hospitality. She can be reached at canderson@labusinessjournal.com.

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ETF Flopper: Biotechnology and Pharmaceuticals Feel the Pain – Barron’s

Posted: May 9, 2017 at 4:43 am


Barron's
ETF Flopper: Biotechnology and Pharmaceuticals Feel the Pain
Barron's
Meanwhile the SPDR S&P Biotech ETF (XBI), the SPDR S&P Pharmaceuticals ETF (XPH), and the First Trust NYSE Arca Biotechnology Index (FBT) fell about 2.7% apiece. The AHCA could have both positive and negative impact on pharma and biotech, but ...

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Animal Biotechnology Technologies, Markets and Companies 2016 … – PR Newswire (press release)

Posted: May 9, 2017 at 4:43 am

This report describes and evaluates animal biotechnology and its application in veterinary medicine and pharmaceuticals as well as improvement in food production. Knowledge of animal genetics is important in the application of biotechnology to manage genetic disorders and improve animal breeding. Genomics, proteomics and bioinformatics are also being applied to animal biotechnology.

Transgenic technologies are used for improving milk production and the meat in farm animals as well as for creating models of human diseases. Transgenic animals are used for the production of proteins for human medical use. Biotechnology is applied to facilitate xenotransplantation from animals to humans. Genetic engineering is done in farm animals and nuclear transfer technology has become an important and preferred method for cloning animals.There is discussion of in vitro meat production by culture.

Biotechnology has potential applications in the management of several animal diseases such as foot-and-mouth disease, classical swine fever, avian flu and bovine spongiform encephalopathy. The most important biotechnology-based products consist of vaccines, particularly genetically engineered or DNA vaccines. Gene therapy for diseases of pet animals is a fast developing area because many of the technologies used in clinical trials humans were developed in animals and many of the diseases of cats and dogs are similar to those in humans.RNA interference technology is now being applied for research in veterinary medicine.

Molecular diagnosis is assuming an important place in veterinary practice. Polymerase chain reaction and its modifications are considered to be important. Fluorescent in situ hybridization and enzyme-linked immunosorbent assays are also widely used. Newer biochip-based technologies and biosensors are also finding their way in veterinary diagnostics.

Approximately 124 companies have been identified to be involved in animal biotechnology and are profiled in the report. These are a mix of animal healthcare companies and biotechnology companies. Top companies in this area are identified and ranked. Information is given about the research activities of 11 veterinary and livestock research institutes. Important 108 collaborations in this area are shown.

Share of biotechnology-based products and services in 2016 is analyzed and the market is projected to 2026.

The text is supplemented with 35 tables and 5 figures.Selected 260 references from the literature are appended.

Key Topics Covered:

Executive Summary

1. Introduction to Animal Biotechnology

2. Application of Biotechnology in Animals

3. A Biotechnology Perspective of Animals Diseases

4. Molecular Diagnostics in Animals

5. Biotechnology-based Veterinary Medicine

6. Research in Animal Biotechnology

7. Animal Biotechnology Markets

8. Regulatory issues

9. Companies Involved in Animal Biotechnology

10. References

For more information about this report visit http://www.researchandmarkets.com/research/mdr33b/animal

About Research and Markets

Research and Markets is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends.

Media Contact:

Laura Wood, Senior Manager press@researchandmarkets.com

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To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/animal-biotechnology-technologies-markets-and-companies-2016-2026-with-profiles-of-the-top-companies---research-and-markets-300452977.html

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Biotechnology sachet solution launched – Cleaning & Maintenance

Posted: May 9, 2017 at 4:43 am

London-based Cleanology is launching what it claims to be the worlds first biotech wipe for tablets and mobile phones, and pre-portioned cleaning fluids and floor cleaners in sachets.

Biotechnology uses enzymes to eat dirt and bacteria. The tiny molecules access even the hardest to reach areas and carry on working for days after application. Enzyme-based solutions are gaining traction in the industry, but to date no firm has focused on mobile device screens, which are often taken out of the office at night, when cleaning takes place.

Cleanology has created a multi-purpose biotech tech wipe which cleans and sanitises mobile phones, tablets and laptops with a moist tissue impregnated with a biotechnology cleaning solution. It has also addressed portioning, with the development of handy-sized sachets which hold a pre-dosed amount of solution. When added to water, this creates a biotechnology cleaning agent.

CEO Dominic Ponniah said: Biotechnology is a fantastic advance which has rightly been embraced by the industry. However, as with all cleaning products that require dilution, people often use too much product - they think that the more they slosh into a bucket, the more effective they will be. Using too much product - especially biotechnology products which are pH-neutral and completely safe - does not cause any harm, but it is wasting valuable resources. An extra cupful of solution every couple of days might not seem disastrous, but multiply that over a year and across the 450,000 people working in the industry, and the impact becomes significant. The cleaning firm ends up buying larger quantities of product and paying more to transport it, not to mention the environmental impact of extra journeys, waste generation and the unnecessary manufacture of products.

To counteract this excess, Cleanology has introduced its own range of pre-portioned biotechnology solutions and wipes. Each sachet of multi-purpose or floor cleaner is sufficient to fill one bucket or spray can, with a pack of 50 sachets able to last a month. The sachets fit easily into the pocket, so a cleaning operative can carry supplies with them from job to job. The wipes are impregnated with biotechnology solution and pre-diluted with water.

Cleanology was one of the first cleaning firms to embrace biotechnology. It has partnered with InnuScience, a leader in the development and manufacture of biotechnology cleaning products. Ponniah continued: InnuScience are experts in their field, supplying all the major FM companies and retail brands. We are experts in cleaning, while InnuScience provides the cutting-edge technology thats inside our Bioclean sachets.

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Puma Biotechnology Inc (PBYI) Plunges 5.54% on May 08 – Equities.com

Posted: May 9, 2017 at 4:43 am

Market Summary Follow

Puma Biotechnology Inc is a A biopharmaceutical company

PBYI - Market Data & News

PBYI - Stock Valuation Report

Puma Biotechnology Inc (PBYI) had a rough trading day for Monday May 08 as shares tumbled 5.54%, or a loss of $-1.7 per share, to close at $29.00. After opening the day at $30.45, shares of Puma Biotechnology Inc traded as high as $31.20 and as low as $28.50. Volume was 1.11 million shares over 8,212 trades, against an average daily volume of 941,762 shares and a total float of 36.97 million.

As a result of the decline, Puma Biotechnology Inc now has a market cap of $1.07 billion. In the last year, shares of Puma Biotechnology Inc have traded between a range of $73.27 and $19.74, and its 50-day SMA is currently $38.11 and 200-day SMA is $43.37.

For a complete fundamental analysis of Puma Biotechnology Inc, check out Equities.coms Stock Valuation Analysis report for PBYI.

Want to invest with the experts? Subscribe to Equities Premium newsletters today! Visit http://www.equitiespremium.com/ to learn more about Guild Investments Market Commentary and Adam Sarhans Find Leading Stocks today.

Puma Biotechnology Inc is a biopharmaceutical company. It is engaged in the acquisition, development and commercialization of products to enhance cancer care.

Puma Biotechnology Inc is based out of Los Angeles, CA and has some 160 employees. Its CEO is Alan H. Auerbach.

Puma Biotechnology Inc is a component of the Russell 2000. The Russell 2000 is one of the leading indices tracking small-cap companies in the United States. It's maintained by Russell Investments, an industry leader in creating and maintaining indices, and consists of the smallest 2000 stocks from the broader Russell 3000 index.

Russell's indices differ from traditional indices like the Dow Jones Industrial Average (DJIA) or S&P 500, whose members are selected by committee, because they base membership entirely on an objective, rules based methodology. The 3,000 largest companies by market cap make up the Russell 3000, with the 2,000 smaller companies making up the Russell 2000. It's a simple approach that gives a broad, unbiased look at the small-cap market as a whole.

To get more information on Puma Biotechnology Inc and to follow the companys latest updates, you can visit the companys profile page here: PBYIs Profile. For more news on the financial markets and emerging growth companies, be sure to visit Equities.coms Newsdesk. Also, dont forget to sign-up for our daily email newsletter to ensure you dont miss out on any of our best stories.

All data provided by QuoteMedia and was accurate as of 4:30PM ET.

DISCLOSURE: The views and opinions expressed in this article are those of the authors, and do not represent the views of equities.com. Readers should not consider statements made by the author as formal recommendations and should consult their financial advisor before making any investment decisions. To read our full disclosure, please go to: http://www.equities.com/disclaimer

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Why Puma Biotechnology, Trex, and National CineMedia Slumped Today – Motley Fool

Posted: May 5, 2017 at 11:44 pm

The stock market performed reasonably well on Friday, sending major benchmarks to gains of 0.25% to 0.5% on the day. Favorable news from the U.S. economy outweighed any concerns about geopolitical events occurring this weekend, including the much-awaited final phase of the French elections. The Dow regained the 21,000 level, and the S&P 500 finished just below the 2,400 mark. But some stocks missed out on the rally, and Puma Biotechnology (NASDAQ:PBYI), Trex (NYSE:TREX), and National CineMedia (NASDAQ:NCMI) were among the worst performers on the day. Below, we'll look more closely at these stocks to tell you why they did so poorly.

Shares of Puma Biotechnology fell 16% after the biotech company said in an SEC filing that an executive in charge of regulatory affairs and project management would resign from the company effective May 15. The filing said that Dr. Robert Charnas had told Puma last week about his departure, with the filing citing health reasons for the move. Yet investors seem to be nervous about the timing, coming immediately before a key advisory panel meeting for its neratinib treatment for breast cancer. Given that neratinib has seen patients in trials report negative side effects, some investors believe that Puma might have trouble getting a positive recommendation from the panel when it meets later this month. The stock's decline might prove to be an overreaction, but the company's decision to put the information in a filing rather than doing a full press release might have contributed to investors' skepticism about the move.

Image source: Trex.

Trex stock declined 9% in the wake of the company releasing its first-quarter financial results. The home deck and railing specialist said that sales climbed 10% from year-ago figures, with increasing margins helping to produce an 18% rise in net income. Trex has gotten a lot of accolades from its industry, including kudos for its environmentally friendly practices and its leadership role in promoting alternatives to traditional wood decking and railing materials. Yet guidance for sales of $160 million in the second quarter only matched investor expectations, and despite calls for improving market share and margin figures, Trex investors seemed to want more from the decking specialist as the high spring season for home improvement begins.

Finally, shares of National CineMedia lost more than a quarter of their value. The in-theater media company said that revenue was down 6% from the year-ago quarter, leading to a drop in operating income and a wider net loss compared to the first quarter of 2016. Despite gains in sales from its local and regional segment as well as its digital and beverage businesses, softness in national advertising revenue weighed on the company's overall results. CEO Andy England reiterated that he sees 2017 as "a transitional year for NCM as we evolve from being the largest cinema network into a truly progressive, integrated digital media company." That means investors have to expect tough results this year, and National CineMedia's guidance called for revenue to fall 1% to 6% and produce a 6% to 12% drop in adjusted operating income. As movie theaters struggle to get people to leave their homes for entertainment, National CineMedia will have to work harder to find new avenues for growth.

Dan Caplinger has no position in any stocks mentioned. The Motley Fool owns shares of and recommends Trex. The Motley Fool has a disclosure policy.

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Why Puma Biotechnology, Trex, and National CineMedia Slumped Today - Motley Fool

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Why Puma Biotechnology Shares Are Crashing 18.2% Today – Motley Fool

Posted: May 5, 2017 at 11:44 pm

What happened

Puma Biotechnology(NASDAQ:PBYI) stock has plummeted 18.2% as of 12:53 p.m. EDT following news that Dr. Robert Charnas, its head of regulatory affairs and project management, is hitting the exits ahead of a scheduled Food and Drug Administration (FDA) advisory panel meeting on May 24.

Puma Biotechnology has only one product in its clinical-stage drug pipeline, and that drug, neratinib, has been the subject of a lot of scrutiny after trials showed that a large number of patients taking it suffered from high-grade diarrhea.

Image source: Getty Images.

Puma Biotech's CEO Alan Auerbach hired Charnaslast year to help get neratinib across the regulatory finish line. Previously,Charnas worked at Johnson & Johnson in its research and development department. He was responsible for ongoing development of Zytiga, a prostate cancer drug that J&J acquired in 2009 when it bought Auerbach's previous company, Couger Biotech. Charnas joined Cougar in 2008.

Yesterday, Puma Biotech said Charnas is leaving because of health reasons. However, there's some conflicting information circulating that there may have been some disagreements between him and his co-workers. If so, no one is saying for sure what those disagreements were about.

News of his departure so close to the FDA advisory committee meeting is disconcerting, regardless of Charnas' reasons for leaving.

After all, neratinib is far from a lock to win the committee's recommendation for approval. It's being considered as an extended maintenance therapy to help delay disease recurrence in breast cancer patients who have previously been treated for one year with Herceptin. In trials, neratinib hit its mark in terms of efficacy, but many of its patients reported severe diarrhea.

In hopes of overcoming a rejection because of this safety risk, Puma Biotech has been studying the use of the anti-diarrhea drug loperamide and steroids alongside neratinib. Ideally, a diarrhea incidence rate below 20% would be desirable, but interim trial results showed a 27% rate of grade 3 or higher diarrhea when using loperamide. Steroids may lower that rate further, but their use can cause other unwanted side effects.

It's anyone's guess what will happen at the advisory committee meeting, or what the FDA will ultimately decide to do with neratinib's application. Nevertheless, I think the risk of failure is too high to recommend buying shares ahead of a decision.

Todd Campbell has no position in any stocks mentioned.His clients may have positions in the companies mentioned. The Motley Fool owns shares of and recommends Johnson & Johnson. The Motley Fool has a disclosure policy.

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iShares NASDAQ Biotechnology Index (IBB) Position Maintained by Ausdal Financial Partners Inc. – The Cerbat Gem

Posted: May 5, 2017 at 11:44 pm


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iShares NASDAQ Biotechnology Index (IBB) Position Maintained by Ausdal Financial Partners Inc. - The Cerbat Gem

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