Category Archives: Biotechnology

What happened

Puma Biotechnology (NASDAQ:PBYI) ended the day down 13.8% after Roche (NASDAQOTH:RHHBY) reported that its rival breast cancer drug, Perjeta, had passed its phase 3 trial, dubbed "Aphinity."

Image source: Getty Images.

In Roche's trial, patients either took Perjeta and Herceptin with chemotherapy or just Herceptin with chemotherapy, and then took Perjeta and Herceptin, or just Herceptin, for an additional year. Roche didn't release the full data from the clinical trial, but it did say the triple combination reduced the risk of recurrence of invasive disease or death compared to Herceptin and chemotherapy alone.

The potential to establish a new standard of care where patients take Herceptin and Perjeta for a year could be problematic for Puma Biotechnology because its drug candidate, neratinib, was tested after just Herceptin use, the current standard of care.

Without any data, doctors will likely wonder whether neratinib helps patients that have received Herceptin and Perjeta. And the relapse rate for patients on the current standard of care is already quite low; if adding Perjeta decreases it further, doctors and their patients may decide taking another drug after that isn't worth it, especially given neratinib's side-effect profile.

Investors will have to wait for the full data from Aphinity -- perhaps at the American Society of Clinical Oncology meeting in June -- to know how much better Herceptin plus Perjeta is than Herceptin alone, and how that might affect neratinib's sales, assuming it's approved later this year.

Brian Orelliand The Motley Fool have no positions in any of the stocks mentioned. The Motley Fool has adisclosure policy.

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Why Puma Biotechnology Inc. Got Hammered Today - Motley Fool

Puma Biotechnology, Inc. (PBYI - Free Report) is expected to report fourth-quarter 2016 results next month. The company has a mixed earnings history. It missed estimates in two of the trailing four quarters, met expectations in one and surpassed the same in the other. The company had an average negative surprise of 2.98% in the last four quarters.

Pumas shares have outperformed the Zacks classified Medical-Biomedical and Genetics industry, year to date. Shares of the company gained 17.9% so far this year, while the industry recorded an increase of 6%.

Lets see how things are shaping up for this announcement.

Factors at Play

Being a development-stage company, Puma Biotech does not have any approved product in its portfolio. Thus, investor focus should remain on updates pertaining to the development of neratinib.

Puma Biotech has made significant progress with its lead candidate, neratinib. The candidate is currently under review in both the U.S. and the EU for the extended adjuvant treatment of HER2-positive early-stage breast cancer that has previously been treated with Herceptin-based adjuvant therapy.

We note that several phase II combination studies on neratinib for the treatment of breast cancer are currently underway.

In Dec 2016, Puma presented encouraging additional data from breast cancer studies at the San Antonio Breast Cancer Symposium (SABCS). These include data from HER2-positive early-stage breast cancer using loperamide and budesonide prophylaxis study; the FB-7 neoadjuvant HER2-positive breast cancer study in the subgroup of patients who are MammaPrint High; and data from neratinib plus AstraZenecas (AZN - Free Report) Faslodex in patients with HER2 non-amplified breast cancer with a HER2 mutation.

Earnings Whispers

Our proven model does not conclusively show that Puma Biotech is likely to beat estimates this quarter. That is because a stock needs to have both a positive Earnings ESP and a Zacks Rank #1 (Strong Buy), 2 (Buy) or 3 (Hold) for this to happen. That is not the case here, as you will see below.

Zacks ESP: The Earnings ESP, which represents the difference between the Most Accurate Estimate and the Zacks Consensus Estimate, is pegged at 0.00%. This is because both the Most Accurate Estimate and the Zacks Consensus Estimate stand at a loss of $2.02. You can uncover the best stocks to buy or sell before theyre reported with our Earnings ESP Filter.

Zacks Rank: Puma Biotechs carries a Zacks Rank #3. Though a favorable Zacks Rank increases the predictive power of ESP, the companys 0.00% Earnings ESP makes surprise prediction difficult.

Note that we caution against stocks with a Zacks Rank #4 or 5 (Sell-rated) going into the earnings announcement, especially when the company is seeing negative estimate revisions.

Stocks That Warrant a Look

Here are a couple of health care stocks that you may want to consider, as our model shows that this have the right combination of elements to post an earnings beat this quarter.

Pacira Pharmaceuticals, Inc. (PCRX - Free Report) is scheduled to release fourth-quarter results on Mar 1. The company has an Earnings ESP of +20% and a Zacks Rank #2. You can seethe complete list of todays Zacks #1 Rank stocks here.

Syndax Pharmaceuticals, Inc. (SNDX - Free Report) has an Earnings ESP of +18.18% and a Zacks Rank #3. The company is scheduled to release fourth-quarter results on Mar 2.

A Full-Blown Technological Breakthrough in the Making

Zacks Aggressive Growth Strategist Brian Bolan explores autonomous cars in our latest Special Report, Driverless Cars: Your Roadmap to Mega-Profits Today. In addition to who will be selling them and how the auto industry will be impacted, Brian reveals 8 stocks with tremendous gain potential to feed off this phenomenon. Click to see the stocks right now >>

See the article here:
Puma Biotechnology (PBYI) Q4 Earnings: What's in the Cards? - Zacks.com

March 3, 2017 6:13am NASDAQ:IBB

From Taki Tsaklanos: Biotechnology stocks are breaking out. They have been consolidating for nearly 20 months. Investors lost interestand that is exactly what smart investors, in general, want to see in order to buy a market.

That is also how bull markets start: when nobody talks about it and only a minority of investors is buying it.

Now here it becomes interesting. InvestingHavens research team has closely followed biotechnology, and has written extensively about it last year. The red line throughout all articles was that smart investors are not in a hurry to buy biotech, but prefer to see which direction biotech would go. This is what was published on InvestingHaven until fall of last year:

Biotechnology Close To A Major Breakdown Level

Health Sector Testing All-Time Highs In 2016, Biotech A Buy After Breaking Out

Alert: Biotechnology and Health Sector Testing Long Time Support

Biotechnology Stocks Have News For Investors: It is Now or Never

In other words, on several occasions last year biotechnology stocks were ready to break down, but eventually they did not. The market refused to go lower, and that was a very important observation, which was shared with our readers: Biotechnology Stocks Refusing To Break Down

Then, something very interesting happened in January: Biotech And Health Care Stock Market Sector Showing Signs Of Life. That was the first sign that biotechnology stocks could go higher.

Today, they are attempting to break out.

The most interesting part was what InvestingHavens team wrote last year in April: Biotechnology Sentiment At Multi-Year Extremes. What Should Investors Do? Right at a time when a major breakout attempt in biotechnology stocks was at play, at a time when sentiment was extremely bullish, we wrote this:

What does all this mean to investors? Combining chart patterns with sentiment data is very useful for investors. We believe that a short term top has developed. Biotechnology needs to cool off a bit, which means a retracement is the most likely outcome for the coming weeks. The key is to watch how far the retracement will go: if prices remain within the existing pattern, above support, there is an opportunity for investors to buy the dips. As long as prices remain within the current chart pattern, it is not a good idea to short this market, unless you are a very short term oriented trader.

As a reminder, it was when IBB was trading at 280 points, in April last year, right before it fell 15 percent. Astute readers were very happy, and they keep on thanking us for our wise words.

Right now, biotechnology stocks are going through a serious attempt to break out from their 20-month consolidation period. If the 300 level in IBB holds for at least 5 consecutive days, biotech will go higher in the coming weeks and months.

The iShares NASDAQ Biotechnology Index ETF (NASDAQ:IBB) was unchanged in premarket trading Friday. Year-to-date, IBB has gained 12.97%, versus a 6.59% rise in the benchmark S&P 500 index during the same period.

IBB currently has an ETF Daily News SMART Grade of A (Strong Buy), and is ranked #2 of 36 ETFs in the Health & Biotech ETFs category.

This article is brought to you courtesy of Investing Haven.

Tags: biotech Health Care NASDAQ:IBB Taki Tsaklanos

Categories: NASDAQ:IBB

Excerpt from:
iShares NASDAQ Biotechnology Index (ETF)(NASDAQ:IBB ... - ETF Daily News (blog)

What happened

Puma Biotechnology (NASDAQ: PBYI) ended the day down 13.8% after Roche (NASDAQOTH: RHHBY) reported that its rival breast cancer drug, Perjeta, had passed its phase 3 trial, dubbed "Aphinity."

Image source: Getty Images.

In Roche's trial, patients either took Perjeta and Herceptin with chemotherapy or just Herceptin with chemotherapy, and then took Perjeta and Herceptin, or just Herceptin, for an additional year. Roche didn't release the full data from the clinical trial, but it did say the triple combination reduced the risk of recurrence of invasive disease or death compared to Herceptin and chemotherapy alone.

The potential to establish a new standard of care where patients take Herceptin and Perjeta for a year could be problematic for Puma Biotechnology because its drug candidate, neratinib, was tested after just Herceptin use, the current standard of care.

Without any data, doctors will likely wonder whether neratinib helps patients that have received Herceptin and Perjeta. And the relapse rate for patients on the current standard of care is already quite low; if adding Perjeta decreases it further, doctors and their patients may decide taking another drug after that isn't worth it, especially given neratinib's side-effect profile.

Investors will have to wait for the full data from Aphinity -- perhaps at the American Society of Clinical Oncology meeting in June -- to know how much better Herceptin plus Perjeta is than Herceptin alone, and how that might affect neratinib's sales, assuming it's approved later this year.

10 stocks we like better than Puma Biotechnology

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David and Tom just revealed what they believe are the 10 best stocks for investors to buy right now... and Puma Biotechnology wasn't one of them! That's right -- they think these 10 stocks are even better buys.

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Read the rest here:
Why Puma Biotechnology Inc. Got Hammered Today - Madison.com

Julie Kelly, cooking instructor, food writer, blogger and a Mom who lives in the Chicago area. In 2015, she got passionate about GMOs. Kelly is a contributing writer to the Wall Street Journal, National Review, Huffington Post, The Hill and other media outlets.| March 2, 2017

HIGHLIGHTS:

Hollywood is in our homes daily,often spreading misconceptions about science, and GE crops in particular Gary Hirshberg, founder of Stonyfield Organic and Just Label It, is the key celebrity organizer Gwyneth Paltrow has emerged as the face of celebrity moms who question the safety of GE foods Mark Ruffalo questions GE foods but also rejects biotechnological solutions beyond food, such as the gene-edited mosquito that could curtail the Zika virus Celebrity misinformation campaigns have filled a void created by the agricultural and food industries, which have been reticent to defend the science of biotechnology While the Internet and social media are valuable tools for disseminating information about complicated subjects like science and agriculture, it has also given rise to a modern-day monster: the expert celebrity From movie stars to television chefs, a cadre of self-promoting yet often ill-informed celebrities are influencing the public discussion about topics way beyond their expertise, particularly consequential issueslike vaccines and biotechnology

The explosive growth of cable television and more recently of the Internet has led to a celebrication of everyday lifeHollywood has invaded our homes in an oddly intimate way. Celebrities have long weighed in on public issues, which is okay if the issue is what clothes to wear next season, but science is different: it actually can impact peoples lives.

If Big Bang star Mayim Bialik talks about Zikas impact on the brain, we might be interested because she has a PhD in neurosurgeryshe has genuine credentials. But science-educated stars are few and far between. For example, campaigns led by Robert Kennedy, Jr., reality TV star Jenny McCarthy and her former husband Jim Carrey and flip comments by Bill Maher have convinced a lot of credulous fans to forgo getting their kids vaccinated the lowest vaccination rates in the country are in the swanky Hollywood suburban playgrounds. And thats just one of many misguided celebrity-driven campaigns.

Celebrities may have any number of motives for injecting themselves into the middle of debates over controversial, scientific issues. Ego, for example. Its a way to get publicity for themselves (McCarthy is more known now for her anti-vaccine activism than for her acting.) And as we know, stars are eager to follow the cause du jour. It is science-as-fashion.

While some people wisely ignore celebrity advice, their ill-informed and selectively ignorant comments can sway public opinion in destructive ways. Thats whats happening in the ongoing debate over our food and farming systems. In the last few years, movies such as Consumed and GMO OMG have fueled misperceptions about genetic engineering. And celebrity chefs such as Tom Colicchio have joined the fray, partnering with other anti-GMO chefs in a Facebook page, Chefs Against GMOs, and making appeals in Washington and on TV shows. But Hollywood is where anti-GMO groups draw their most visible campaigners.

A slew of Hollywood celebrities, have lent their names to one anti-GMO or pro-labeling campaign or another, among them a fading generation of actors and musicians: Morgan Freeman, Paul McCartney, Dave Mathews, Danny DeVito, Woody Harrelson and Neil Young, to name just a few. But there are some younger faces who have lobbied hard against modern agriculture, mostly B-list actresses, with Gwyneth Paltrow the most prominent. They rail against GMOs in an effort to persuade consumers our food system is hopelessly broken, and that crop biotechnology is scary, unnatural and part of a corporate conspiracy to control the worlds food supply. Its easily dismissible nonsense to those who know the consensus science, but their distortions have consequences outside of clickbait headlines.

Paltrow has emerged as the face of the anti-GMO movement over the last few years. Its unclear exactly how or why she decided to take up this cause except that she has worked closely with one of the most powerful figures in the organic movement, Gary Hirshberg, founder of Stonyfield Organic, who also started Just Label It, which has campaigned for mandatory labels. Just Label it and the organic industry in general have spent hundreds of millions of dollars in recent years to demonize conventional agriculture and mislead consumers into thinking organic food is healthier, safer and more nutritious than conventional food.

Although state-of-the-art meta studies conclude there are no meaningful differences, and some research shows organic farming is more stressful on the environment than farming using advanced technology including genetically engineered crops, organic companies peddle that narrative in hopes of driving consumers toward their pricier products. As the self-appointed priestess of all that is healthy and good in the world, Paltrow promotes organic food, which is by definition non-GMO.

Hirshberg has fueled and funded anti-GMO advocacy under the guise of promoting mandatory GMO labels. He has organized several anti-GMO groups, and has used celebrities like Paltrow to push his agenda. At his invitation, Paltrow was featured at a press conference on Capitol Hill in August 2015 to voice her support for mandatory GMO labeling. A bill the organic industry opposed had just passed in the House, and Paltrow wanted to use her powers of persuasion to stop the bill from advancing in the Senate:

Im not here as an expert, Im here as a mom who honestly believes I have the right to know whats in the food I feed my family. And we dont even know, the science is still inconclusive about GMOs, there are arguments they could possibly be harmful and there are arguments that they could be incredibly beneficial. But at this point, we just dont know.

The presser echoed widely on social media, but most disturbingly, her comments were reported uncritically by major media sites, giving her credibility on an issue she did not deserve.

Here is where Paltrow is wrong. We do know that GMOs are safe. They hold tremendous potential and promise to alleviate global hunger now and into the future as food demands are expected to nearly double by 2050.Nearly every major independent scientific organization and governmental agency in the world, including most recently the National Academies of Sciences, Engineering and Medicine (NAS), have affirmed that genetically engineered crops and food are just as healthy and environmentally safe as other conventionally grown foods, including organic. American farmers have been using genetically modified seeds for 20 years and most of the corn, soy, cotton and sugarbeets grown are from those seeds. This has cut down on the use of pesticides (since some of those crops have been developed to include natural pesticides already used by organic farmers), which has reduced crop losses and increased yield, a huge boon to both farmers and consumers.

In its analysis of the GMO controversy, the NAS also noted several problems with mandatory labeling, such as higher costs to consumers and the probability that companies might eliminate genetically engineered ingredients in order to avoid labels. The report also outlined several crops that can only be achieved through genetic engineering that boost nutrients, withstand climate challenges and resist crop diseases. Promising new crops in the pipeline include nutritionally enhanced rice and bananas and disease-resistant cassava, a plant that hundreds of millions depend on every day. So, its galling for an ultra-rich celebrity to spread falsehoods about a technology that can feed and fortify the diets of hundreds of millions of poor people around the world.

That wasnt the last we heard from Paltrow. In April 2016, she made a brief cameo in a video sponsored by Just Label It (with Hirshberg taking a star turn) entitled GMO Transparency in the Real World. A harried mother attempts to use her smart phone to scan a QR code on a can of soup to see if the soup contains GMOs (QR codes are anathema to the pro-GMO labeling crowd). As she stumbles to use her smart phone, and her kids smash a watermelon in the aisle, a fresh-faced Paltrow appears from the dairy aisle, asking the distraught mom if she has a scanner on her smart phone that she could use.

Paltrow isnt the only actress to play the Im not an activist, Im a mom card. Around Mothers Day 2015, several B-list mom-actresses appeared in a Moms Against GMOs video produced by another Hirshberg group to talk about GMOs, including Sarah Michelle Gellar, The Talks Sarah Gilbert, UnREALs Constance Zimmer, Once Upon a Times Ginnifer Goodwin, Furious 7s Jordana Brewster, The Biggest Losers Jillian Michaels, Mariel Hemingway and Sharon Osbourne. They pledged to protect their little ones from the dangers of GMOs: This Mothers Day, give moms the right to know whats in the food we feed our kids. Tell the FDA to require GMO labeling.

These actresses are now part of a coordinated, calculated attack on American agriculture and an attempt to stop millions of farmers from using technological tools necessary for their livelihood and Americas food security. They are part of a destructive campaign to hurt American farmers and our overall agricultural and food system.

Since a bill requiring mandatory GMO labels passed Congress and was signed into law by President Obama in August 2016, the GMO labeling groups have been more forthcoming about their true motives. Anti-GMO activist and Institute for Responsible Technology founder Jeffrey Smith, who makes regular appearances on Dr. Oz and other celebrity-type shows, acknowledged their real agenda:

Labeling GMOs was never the end goal for us. It was a tactic. Labels make it easier for shoppers to make healthier non-GMO choices. When enough people avoid GMOs, food companies rush to eliminate them. Labeling can speed up that tipping pointbut only if consumers are motivated to use labels to avoid GMOs.

Some celebrities brazenly profit by spreading misinformation about biotechnology. Jessica Alba parlayed her fame into selling organic, non-GMO products as part owner of The Honest Company. She boasts about the naturality of her products, from organic baby formulameticulously blended using non-GMO, naturally derived, organicto organic tampons to non-GMO lip balm. Many items brandish a non-GMO label. Alba explains her healthy eating habits as trying to have the least amount of GMOs and pesticides you have energy, arent starving and dont have to count calories.

Actor and progressive environmental activist Mark Ruffalo, who does not have a college education, has embraced any number of controversial causes, from fracking to GMOs, where the science is contested. He became a rock star in the anti-GMO community, even confronting Monsanto CEO Hugh Grant in a CBS green room rant before a joint TV appearance and later bragging about it.

You are wrong, he lectured Grant. You are engaged in monopolizing food. You are poisoning people. You are killing small farms. You are killing bees. What you are doing is dead wrong. Its the horrible stuff you guys do that makes you and your company horrible. People like you and your company are horrible because you are horrible.

He has more than 2 million followers on Twitterthats scary. His obsession to demonize genetic engineering took a bizarre turn earlier this year when he started tweeting that the Zika virus was caused by a chemical manufactured by an obscure Japanese company that has a research pact with Monsanto, the bete noire of anti-GMO activists. By doing so, he deflects attention from what experts now say is the only feasible solution to containing Zikathe release of genetically engineered sterile mosquitoes to drive out the poison-carrying ones.

Chef Attack

Many celebrity chefs have taken up the anti-GMO crusade, apparently believing their ability to run a restaurant or cook on television gives them special insight into how food is grown on a farm. Tom Colicchio, the star of Bravos Top Chef program, gathered signatures of more than 4,000 chefs on a petition he delivered to Capitol Hill in March 2016 demanding mandatory GMO labels and rejecting a Senate bill that would have made the labels voluntary.

He claims he only supports the right to know. But his twitter feed is filled with anti-GMO propaganda and like most activists in the GMO labeling movement, he is also broadly against the technology. In a December 2015 op-ed in the New York Times entitled, Are you eating Frankenfish? Colicchio warned readers that the newly approved GE fast-growing salmon could escape enclosed tanks and endanger native speciesclaims multiple US and Canadian regulators have reviewed and rejected as untrue. Colicchio has also come out in opposition to insect-resistant eggplant, grown with government developed seeds distributed free to farmers in Bangladesh, which has reduced the spraying of dangerous chemicals by 85 percent.

Why are celebrities getting so much traction in their campaign against GMOs? They are filling an information void left by the scientific and agricultural communities. Scientists are reluctant to engage the public, either out of trepidation or arrogance, convinced that science will win the day. Infighting has plagued the science communications effort as leaders dispute the best way to fight misinformation from people like Paltrow and Ruffalo.

Some want to take a submissive approach and others want to fight fire with fire. The agricultural community and companies that benefit from genetic engineering arent standing up to defend the technology, either.

While science and farming communicators struggle with how to best educate consumers and the media, organic executives and celebrities are defining the narrative on GMOs. This is not without serious ramifications if we turn away from genetically modified crops. Food prices will rise and farmers will be forced to use more insecticide and more toxic herbicides. Its wonderful to celebrate the performances of TV, movie and music celebrities, but their opinions on science issues are no more relevantnow than they were when they were waiting tables in Hollywood and Nashville looking for a break. Hit the mute button when they start opining on serious policy issues that have considerable consequences for vulnerable people around the world.

Julie Kelly is a cooking instructor, food writer, blogger and mother of two who lives in the Chicago area. In 2015, she got passionate about GMOs. Kelly is a contributing writer to the Wall Street Journal, National Review, Huffington Post and other media outlets.

The Genetic Literacy Project is a 501(c)(3) non profit dedicated to helping the public, journalists, policy makers and scientists better communicate the advances and ethical and technological challenges ushered in by the biotechnology and genetics revolution, addressing both human genetics and food and farming. We are one of two websites overseen by the Science Literacy Project; our sister site, the Epigenetics Literacy Project, addresses the challenges surrounding emerging data-rich technologies.

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When Celebrity And Science Collide: Hollywood And The Anti ... - Genetic Literacy Project

Shares of Puma Biotechnology Inc (NASDAQ: PBYI) plunged more than 25 percent following plans to modify the summary of product characteristics (SmPC) in its European Marketing Authorization Application (MAA) for its breast cancer drug neratinib.

The company now plans to restrict the intended population to patients initiating neratinib treatment within one year after completion of adjuvant trastuzumab therapy.

Earlier, the proposed indication was for the "extended adjuvant treatment of adult patients with early-stage HER2-overexpressed/amplified breast cancer who have received prior adjuvant trastuzumab based therapy."

Puma submitted its neratinib MAA last summer.

During the regulators meeting, the timeline for Neratinib was discussed. Neratinib will likely be sequenced immediately after adjuvant trastuzumab. Furthermore, more benefits were observed in the subgroup of patients who received neratinib within one year from prior trastuzumab completion.

Related Link: Here's What To Expect Following Trump's Drug Pricing 'Robbery' Comments

In addition, data from the pivotal adjuvant trastuzumab trials suggest that patients are at higher risk of recurrence closer to completion of adjuvant trastuzumab, and the risk of recurrence may decrease over time.

Puma also noted that the Committee for Medicinal Products for Human Use (CHMP) is continuing to review Puma's MAA and has not yet made a final decision to recommend approval of the drug for the updated or any other indication and there is no guarantee when, if ever, the MAA will be approved.

Separately, Puma reported a wider loss for its fourth quarter. On a GAAP basis, Puma reported a net loss applicable to common stock of $72.7 million, or $2.04 per share, versus a net loss of $61.7 million, or $1.90 per share, a year ago.

Excluding items, the loss came in at $1.22 a share versus loss of $1.23 a share, last year. However, the loss was better than consensus loss estimate of $1.92 a share.

On December 31, 2016, Puma had cash and cash equivalents of $194.5 million and marketable securities of $35.0 million.

Shares of Puma closed Wednesdays trading at $38.05. In the pre-market hours Thursday, the stock plunged 26.41 percent to $28.

According to the verified Twitter account of TheStreet's senior columnist Adam Feuerstein, "Hedge funds that own $PBYI are screaming at sell side analysts to defend the stock."

TheStreet also published on its website a possible connection between Puma's movements and those of Roche Holding Ltd. (ADR) (OTC: RHHBY). Feuerstein and Martin Baccardax wrote: "The Roche AG (RHHBY) breast cancer drug Perjeta notched an important win in the closely followed 'Aphinity' clinical trial, promising to add billions of dollars in sales to the Swiss drugmaker's top line. Perjeta's success spells big trouble for Puma Biotechnology (PBYI), which could see its competeing, but still approved, breast cancer drug neratinib without any patients to treat."

At last check in Thursday's pre-market session, shares of Puma were down 26.54 percent at $27.95. ADR shares of Roche were up 5.75 percent at $32.30.

Posted-In: Biotech Earnings News Health Care FDA Movers Media Trading Ideas Best of Benzinga

2017 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.

Continued here:
Puma Biotechnology Shares Plunge On Plans To Modify Neratinib European MAA, Competitor Roche's Perjeta Win - Benzinga

LOS ANGELES--(BUSINESS WIRE)--Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, announced publication of abstracts on neratinib for the American Association for Cancer Research (AACR) Annual Meeting 2017. The AACR Annual Meeting will be held at the Walter E. Washington Convention Center in Washington, D.C. from April 1 to April 5.

Full abstracts of the following presentations are available online at http://www.aacr.org:

Apr. 4, 2017, 1:00 - 5:00 p.m. EDT Abstract 4818 (Poster): Neratinib/fulvestrant but not fulvestrant alone maintain complete tumor responses after treatment with trastuzumab + paclitaxel of mice bearing ER+/HER2+ xenografts. L.J. Schwarz et al, Vanderbilt University Medical Center.

April 4, 2017, 1:00 - 5:00 p.m. EDT Abstract 4157 (Poster): Co-blockade of mTORC1, ERBB and estrogen receptor signaling pathways in endocrine resistant breast cancer: combating tumour plasticity. R. Ribas et al, Institute of Cancer Research.

April 4, 2017, 1:00 - 5:00 p.m. EDT Abstract 4038 (Poster): Exploring optimal targeted combination therapies with neratinib for HER2+ breast cancer. M. Zhao et al, MD Anderson Cancer Center.

April 5, 2017, 8:00 - 12:00 p.m. EDT Abstract 5167 (Poster): Stem-like colorectal cancer cell lines show response to the ERK1/2 inhibitor, SCH772984, alone and in combination with neratinib while the combination of MEK-162 and neratinib work to decrease tumor growth in inflammatory colorectal cancer subtypes. R. Pal et al, NSABP.

April 5, 2017, 8:00 - 12:00 p.m. EDT Abstract 5684 (Poster): NSABP FC-7 Correlative Study: HER2 amplification in circulating cell-free DNA (cfDNA) in metastatic colorectal cancer (mCRC) resistant to anti-EGFR therapy. S. Rim Kim et al, NSABP.

Full abstracts of the following presentations are expected to be available online March 31, 2017, after 4:00 p.m. EDT:

April 2, 2017, 12:45 - 3:00 p.m. EDT Abstract CT001 (Oral, Clinical Trials Plenary Session): Neratinib in HER2 or HER3 mutant solid tumors: SUMMIT, a global, multi-histology, open-label, phase 2 basket study. D. Hyman et al, Memorial Sloan Kettering Cancer Center.

April 2, 2017, 3:00 - 5:00 p.m. EDT Abstract CT011 (Oral, Minisymposium): Circulating tumor DNA (ctDNA) sequencing for HER2 mutation (HER2mut) screening and response monitoring to neratinib in metastatic breast cancer (MBC). C. Ma et al, Washington University School of Medicine.

April 2, 2017, 3:00 - 5:00 p.m. EDT Abstract CT013 (Oral, Minisymposium): NSABP FB-10: Phase Ib dose-escalation trial evaluating trastuzumab emtansine (T-DM1) with neratinib (N) in women with metastatic HER2+ breast cancer (MBC). J. Abraham et al, NSABP.

April 3, 2017, 10:30 a.m. 12:45 p.m. EDT Abstract LB103 (Oral, Major Symposium): Landscape of Somatic ERBB2 Mutations - Findings from AACR GENIE and Comparison to Ongoing ERBB2 Mutant Basket Study. A. Schram et al, Memorial Sloan Kettering Cancer Center.

April 4, 2017, 1:00 - 5:00 p.m. EDT Abstract CT128 (Poster): Effects of adding budesonide or colestipol to loperamide prophylaxis on neratinib-associated diarrhea in patients (pts) with HER2+ early-stage breast cancer (eBC): the CONTROL trial. E. Ibrahim et al, Beaver Medical Group LP.

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 may be found atwww.pumabiotechnology.com.

Forward-Looking Statements:

This press release contains forward-looking statements that 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 risk factors disclosed in the periodic reports filed by the Company with the Securities and Exchange Commission from time to time. 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.

More here:
Puma Biotechnology Announces Publication of Abstracts on Neratinib for the AACR Annual Meeting 2017 - Business Wire (press release)

March 1 Puma Biotechnology Inc:

* Puma Biotechnology provides update on review of marketing authorisation application for PB272

* Puma Biotechnology Inc - company plans to modify summary of product characteristics in its marketing authorisation application

* Puma Biotechnology-plans to modify summary of product characteristics based on meeting with rapporteur, co-rapporteur, review team members, EMA

* Puma Biotechnology - proposed summary of product characteristics will continue to include both hormone receptor positive, hormone receptor negative patients

* Puma-Will be revising proposed smpc for neratinib to restrict intended population to patients within a year after completion of Adjuvant Trastuzumab Therapy

* Puma-Committee for medicinal products for human use continuing to review co's maa and has not yet made a final decision to recommend approval of drug Source text for Eikon: Further company coverage:

TOKYO, March 2 The dollar hovered near a seven-week high on Thursday on increasing signs given by Federal Reserve officials that the U.S. central bank is seriously considering raising interest rates this month.

* Trump rhetoric deters cenbank from forex intervention -source

RIO DE JANEIRO, March 1 Rio's premier Portela samba school was crowned champion samba school on Wednesday, winning its first Carnival parade in 33 years with a spectacular performance that highlighted the environmental importance of rivers.

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BRIEF-Puma Biotechnology provides update on review of marketing authorisation application for PB272 - Reuters

Posted Feb. 28, 2017 at 3:39 p.m.

Published: 2017-02-28 15:39:55 Updated: 2017-02-28 15:39:55

By JIM SHAMP, NCBiotech Writer

Raleigh, N.C. The North Carolina Biotechnology Center has announced that Pfizer has committed to providing funding in the amount of $4 million which will enable the Center to establish and administer a multi-year academic fellowship program to help advance North Carolinas fast-growing expertise in gene therapy.

The new program, to be managed by NCBiotech, will support distinguished postdoctoral fellowships in North Carolina university research laboratories providing advanced scientific training in gene therapy-related research.

Absent or faulty proteins linked to genetic mutations cause numerous devastating diseases, making gene therapy an increasingly important treatment strategy.

Pfizers portfolio in North Carolina has grown in recent years. The company already operates a pharmaceutical manufacturing facility in the Lee County community of Sanford, and in August 2016, it acquired leading-edge gene therapy company Bamboo Therapeutics, Inc. in Chapel Hill.

With that acquisition, Pfizer gained the expertise of Bamboos world-renowned co-founder, R. Jude Samulski, Ph.D., director of the Gene Therapy Centerat the University of North Carolina at Chapel Hill. The deal also included an 11,000-square-foot facility for the highly specialized manufacturing of recombinant adeno-associated viral vectors.

Pfizer is one of several biopharmaceutical companies that have added high-profile gene therapy acquisitions, and several partnerships with biotechnology companies and leading academic institutions, to its R&D portfolio. Numerous other North Carolina scientists and companies are also making significant inroads into gene therapy, gene editing and related applications, many with NCBiotech support. For example, Samulski was recruited to UNC in 1993 as part of a $430,000 NCBiotech grant. Additionally, Bamboos former parent company received more than $700,000 in Biotech Center grants and loans.

Gene therapy advances require specific skills in addition to deep scientific knowledge. The fellowship program being established with Pfizers funding aims to boost that talent pipeline, with talent that has already proven to be exceptional in North Carolina. Such funding will enable NCBiotech to provide two-year fellowship support to postdoctoral scientists. The funding will afford the Center the ability to cover salaries, benefits, materials, professional development and travel for such postdoctoral scientists. The Center will encourage competitive applications from scientists interested in establishing research careers in gene therapy and related research activities.

The Biotech Center will also create and manage a related gene therapy Exchange Group. It will join some 25 other exchange groups designed to unite North Carolina-based academic and industry scientists with shared professional interests. The Gene Therapy EG will include these new postdoctoral fellows, their mentors, and others interested in the burgeoning gene therapy sector.

The field of gene therapy research has made tremendous strides in recent years, and we are pleased to be able to further enhance our leadership position in this area through this unique fellowship program, said Mikael Dolsten, M.D., Ph.D., president of worldwide research and development at Pfizer. We believe that gene therapy may hold the promise of bringing true disease modification for patients suffering from devastating diseases, and North Carolina is uniquely positioned to help us take advantage of collaborative opportunities that can develop the specialized talent well need.

Doug Edgeton, president and CEO of the Biotech Center, said he was deeply honored that Pfizer targeted North Carolina, and the Center, for the groundbreaking fellowship program.

Pfizer embraced the opportunity to work with us given weve proven for more than 30 years that we have the expertise and success metrics to maximize impact, said Edgeton. We not only have outstanding research institutions across our state, but we also have a well-respected culture of partnering and collaboration that allows us to be nimble and responsive. This is a wonderful example.

(C) N.C. Biotechnology Center

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WASHINGTON, Feb. 23, 2017 Iowa Gov. Terry Branstad, President Trumps choice to be the next U.S. ambassador to China, said today that if confirmed he will make it a priority to get China to lift its ban on U.S. beef and reform its biotechnology approval process.

Branstad spoke at USDAs annual Agricultural Outlook Forum before a scheduled meeting at the Chinese embassy in Washington,

We soon hope to reopen the market for American beef, Branstad said. I want to serve it at the (U.S.) embassy and I certainly want to do what I can to convince the Chinese leadership to do that sooner than later.

It was in September last year that China announced it was going to lift its 14-year-old ban on U.S. beef, but there have been no signs since then that the country was actually following through with that promise.

China was just one of many countries that banned U.S. beef in 2003 after theU.S. discovered its first case of bovine spongiform encephalopathy (BSE).Since then most countries have lifted those bans, and in 2013 the World Organization for Animal Health (OIE) announced that it was placing the U.S. into the negligible, or lowest risk category, for BSE, commonly known as mad cow disease.. Previously the U.S. fell into the higher controlled risk category.

Mad cow disease is long since gone in this country, Branstad said. Theres no reason why the Chinese should continue to restrict American beef. Thats one of the things high on my priority list.

Another thing high on his priority list is persuading China to reform its biotechnology approval process. The Obama administration tried for years to get China to begin the approval process of new seed traits at the same time as regulators in the U.S. or other countries begin. But little progress has been made.

China, to the growing frustration of U.S. farm groups and biotech seed companies, continues to refuse to begin its approval process until new traits have already been approved in another country first. That can add years to the time that it takes for seed companies to get their products on the market.

Furthermore, Branstad said another priority wouldbe to persuadethe Chinese to remove stiff import duties on U.S. distillers dried grains with solubles (DDGS).

It was just last month that Chinas Commerce Ministry slapped new duties and taxes on DDGS that total roughly 90 percent of the price of the commodity, a byproduct of ethanol production and a popular livestock feed ingredient.

U.S. Grains Council President Tom Sleight says the barriers are high enough to virtually halt U.S. exports to China.

China bought 6.3 million tons of DDGS in 2015, valued at about $1.6 billion, according to U.S. Grains Council officials. That was up from 4.3 million tons, valued at $1.25 billion,in 2014.

Branstad told Agri-Pulse that he expects to succeed where others have failed in China because of his strong personal relationships with Chinese President Xi Jinping and other high-ranking officials.

I have the advantage of being an old friend of President Xi, he said.His very first trip to America was to Iowa. He led a corn processing delegation that came to Iowa in 1985.

The two have stayed in contact since then, Branstad said. We have a longstanding personal relationship and thats really important in their culture. I think thats why President Trump chose me.

Branstad also stressed today that the U.S. and China are already major trading partners and he hopes to expand that relationship.

IncreasingChinas demand for U.S. farm commodities took up a significant part of USDA Chief Economist Robert Johansson's presentation today at the Outlook Forum.

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China is the largest destination for U.S. agricultural exports and the country's demand continues togrow for American soybeans, cotton, wheat and other commodities, Johansson said.

In (fiscal year) 2017 U.S. exports to China are projected at $22.3 billion, up more than $3 billion from 2016 and making it the top export market for U.S. agriculture, Johansson said.

The future is especially bright for Chinese imports of soybeans and cotton, he said, predictingthat China will be buying about 14 million bales of cotton from the U.S. annually 10years from now, a 9.6-million-bale increase from present sales.

I look forward to being an advocate for all agricultural exports in this new role. Im humbled by the prospect that a farm kid from Iowa could be chosen to represent our country in China.

#30

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