Category Archives: Biotechnology

Tenax Therapeutics, Inc. (TENX) ended last trading session with a change of 1.3 percent. It trades at an average volume of 1.1M shares versus 3.36M shares recorded at the end of last trading session. The share price of $0.72 is at a distance of 73.16 percent from its 52-week low and down -75.56 percent versus its peak. The company has a market cap of $22.8M and currently has 31.73M shares outstanding. The share price is currently -61.84 percent versus its SMA20, -62.99 percent versus its SMA50, and -68.05 percent versus its SMA200. The stock has a weekly performance of -63.15 percent and is -63.15 percent year-to-date as of the recent close.

On January 31, 2017 Tenax Therapeutics, Inc. (TENX) announced top-line results from its Phase 3 LEVO-CTS trial. The study did not achieve statistically significant reductions in the dual endpoint of death or use of a mechanical assist device at 30 days, nor in the quad endpoint of death, myocardial infarction, need for dialysis, or use of a mechanical assist device at 30 days. However, the study demonstrated statistically significant reductions in two of three secondary endpoints including reduction in low cardiac output syndrome (LCOS) and a reduction in postoperative use of secondary inotropes. Patient visits for data on death through day 90 have not yet been completed. The Company has a meeting scheduled with the U.S. Food and Drug Administration (FDA) to review the preliminary trial data and discuss a path forward to bring this potentially lifesaving treatment to the benefit of patients undergoing serious cardiac surgery.

Intrexon Corporation (XON) recently recorded -2.77 percent change and currently at $21.43 is 5.1 percent away from its 52-week low and down -46.74 percent versus its peak. It has a past 5-day performance of 2.05 percent and trades at an average volume of 1.34M shares. The stock has a 1-month performance of -17.03 percent and is -11.81 percent year-to-date as of the recent close. There were about 118.35M shares outstanding which made its market cap $2.54B. The share price is currently -7.68 percent versus its SMA20, -17.93 percent versus its SMA50, and -19.97 percent versus its SMA200.

On Jan. 24, 2017 Intrexon Corporation (XON) announced that it has entered into a definitive agreement to acquire GenVec, Inc. (GNVC), a clinical-stage company and pioneer in the development of AdenoVerse gene delivery technology.

Intrexon intends to integrate and expand upon GenVecs expertise in adenoviral vectors and cGMP drug product manufacturing to enhance its broad gene transfer capabilities that encompass multiple viral and non-viral platforms. Notably, the combined technologies have the potential to yield the next generation of adenoviral (AdV) delivery through the creation of a scalable manufacturing platform utilizing helper-dependent adenovirus with significantly higher payload capacity of >30kb, as compared to current viral delivery methods ranging from 4.5kb 9kb.

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Top Biotechnology Stock Picking: Tenax Therapeutics, Inc. (TENX), Intrexon Corporation (XON) - The Independent Republic

Forbes

Biotechnology Executives Oppose Trump Immigration Policy Forbes Nearly 100 founders and leaders of biotechnology companies have signed a letter rebuking President Donald Trump for the immigration restrictions he put in place through an executive order on January 27. The letter is being published by Nature Biotech, ... Leaders of biotech company oppose travel ban, say scientists fear traveling to USCortez Journal all 6 news articles »

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Biotechnology Executives Oppose Trump Immigration Policy - Forbes

Merrimack Pharmaceuticals, Inc. (MACK) ended last trading session with a change of 0.96 percent. It trades at an average volume of 4.05M shares versus 1.35M shares recorded at the end of last trading session. The share price of $3.17 is at a distance of 12.01 percent from its 52-week low and down -64.86 percent versus its peak. The company has a market cap of $399.07M and currently has 125.89M shares outstanding. The share price is currently 0.08 percent versus its SMA20, -26.55 percent versus its SMA50, and -41.42 percent versus its SMA200. The stock has a weekly performance of 3.59 percent and is -22.3 percent year-to-date as of the recent close.

On Jan. 18, 2017 Merrimack Pharmaceuticals, Inc. (MACK) announced that Richard Peters, M.D., Ph.D., has been appointed as the Companys President and Chief Executive Officer, effective February 6, 2017, at which time he will also be appointed to the Merrimack Board of Directors. Dr. Peters will join Merrimack from his current role at Sanofi Genzyme, where he serves as Senior Vice President and Head of Global Rare Diseases. He replaces Gary Crocker, Chairman and Interim President and CEO, who guided the Company during the recent restructuring process and search for a permanent CEO and will remain Chairman of the Board.

MannKind Corporation (MNKD) recently recorded -4.25 percent change and currently at $0.54 is 31.98 percent away from its 52-week low and down -75.84 percent versus its peak. It has a past 5-day performance of -15.76 percent and trades at an average volume of 5.54M shares. The stock has a 1-month performance of -17.78 percent and is -15.01 percent year-to-date as of the recent close. There were about 498.94M shares outstanding which made its market cap $269.98M. The share price is currently -17.65 percent versus its SMA20, -15.12 percent versus its SMA50, and -34.44 percent versus its SMA200.

Feb. 01, 2017 MannKind Corporation (MNKD), a fully integrated biopharmaceutical company focusing on the discovery and development of therapeutic products for patients with diseases such as diabetes, announced the launch of a new Titration Pack containing 60 4 unit cartridges, 60 8 unit cartridges and 60 12 unit cartridges of Afrezza (insulin human) Inhalation Powder.

This new package is intended to simplify physician prescribing of Afrezza and allow patients greater dose flexibility in managing their diabetes, while potentially reducing the cost burden of multiple copays.

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Two Biotechnology Names Are Hot: Merrimack Pharmaceuticals, Inc. (MACK), MannKind Corporation (MNKD) - The Independent Republic

Forbes

Beyond Bricks And Mortar: Reimagining Infrastructure Investment To Spur Biotechnology Innovation Forbes Biotechnology (including not only biopharmaceuticals, but also bioengineered food products, biofuels and biodefense mechanisms) is ripe for an infusion of infrastructure investment. By supplementing existing tools with robotics, advanced computing and ...

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Beyond Bricks And Mortar: Reimagining Infrastructure Investment To Spur Biotechnology Innovation - Forbes

Artizan is a newly created biotechnology company headquartered in Durham, North Carolina, with labs in New Haven, Connecticut, that was founded to address diseases involving the human intestinal microbiota.

Irish based life sciences company Malin said on Monday that it has acquired a 32 per cent shareholding of US biotechnology company Artizan Biosciences.

Dublin-based Malin, which has invested more than 300 million in life sciences companies since it was established in early 2015, invested in Artizan via a founding equity round alongside Hatteras Venture Partners, a venture capital firm with which Malin has a strategic partnership.

Artizan is a newly created biotechnology company headquartered in Durham, North Carolina, with labs in New Haven, Connecticut, that was founded to address diseases involving the human intestinal microbiota. It was spun out of Yale University and established as a standalone business in 2016 and its founders include Prof. Richard Flavell, Noah Palm, PhD, and Marcel de Zoete, PhD, from Yale University. Artizan, which aims to be a leader in the microbiota-driven inflammatory diseases space, has developed a capability of distinguishing certain pathogenic bacteria from the remainder of the intestinal microbiota. The ability to target these specific bacteria could lead to treatment options for any number of digestive disorders as well as other diseases including obesity, autoimmune disease and a wide variety of skin, lung and central nervous system (CNS) diseases.

Artizans proposed approach is disruptive to current treatment and would offer new and novel therapeutic options for patients suffering from a broad array of inflammatory disorders, Adrian Howd, chief investment officer of Malin, said.

Last month Malin acquired a 33 per cent shareholding of Wren Therapeutics, a newly created biopharmaceutical company based in Cambridge, UK. It was set up by a number of former Elan executives in 2015.

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Malin stakes 32% take in US biotechnology company Artizan - Irish Times

President Trump pressed Big Pharma executives to increase U.S. production and lower drug prices.

As biotechnology stocks have been showing momentum following a meeting between President Trump and pharmaceutical executives Tuesday, our two long investments to watch are in that sector. There are also several shorts among our charts to watch to play the potential downside in this near-term, toppy-looking stock market.

Gene-therapy company bluebird bio Inc. BLUE, -2.42% has a strong-looking chart. The stock recently broke out of a wedge pattern, in which its price range had narrowed for two months in essentially a sideways direction. The stock continued the upmove on Tuesday when it popped $5.90, or over 8%, to $74.50, and followed through for another $1.10 on Wednesday to $75.60. The stock is now positioned to challenge its recent high at $79.70 from early December. A break through there could lead to a move into the mid-$80s, followed by a next target in the mid-$90s. With short interest of 9.2 its average volume, the price advance could be further fueled by short covering.

Cara Therapeutics Inc. CARA, +0.18% a cannabis-based biotech, has been steadily climbing since the start of the year. On Wednesday, the stock popped $1.17, or 7.6%, to $16.49 on 4.7 million shares, which is huge volume for this stock, the biggest since mid-November. The stock got as high as $17.20 intraday before pulling back into the close. It is a bit extended near the top of its channel and could pull back and consolidate before its next move, but momentum could carry it a bit further toward $18.

On the short side, Carters Inc. CRI, +0.09% continues lower since its July 2016 top above $112. On Wednesday, shares in the childrens wear retailer were down another $1.05, or 1.3%, to $82.70, on 690,100 shares traded. The stock appears headed toward the bottom of its declining channel in the $73-$74 range.

Signet Jewelers Ltd. SIG, -1.70% is also continuing lower. The stock rallied from the bottom of its declining price channel to the top in the last quarter of 2016, but has since broken down. Shares fell another 66 cents to $77.01 on 1.5 million shares traded on Wednesday. Watch for a test of the late-September low in the $72-$73 range. A takeout of that could drop the stock near its channel bottom in the low- to mid-$60s.

See Harrys video chart analysis on these and other stocks.

The writer has no holdings in any securities mention in this article.

Harry Boxer is the founder of TheTechTrader.com, a live trading room featuring his stock picks, technical market analysis and live chart presentations.

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Opinion: Harry Boxer: Watch these two biotechnology stocks - MarketWatch

Commentary | Feb. 3, 2017

Immoral Uses of Biotechnology Even With Good Intentions Are Nevertheless Evil

Should Christians face unethical uses of biotechnology with despair and resignation or with hope and determination?

Ive spent the last decade writing and speaking about the remarkable and terrifying world of biotechnology from a Catholic perspective. Many times Ive felt like Frodo Baggins at the gates of Mordor, looking upon Mt. Doom with despair and dread.

Ive never felt this more acutely than in the past few months. A series of recent headlines have renewed my sense of hopelessness in the face of the never-ending assault on the dignity of human life by modern biotechnology.

The gloom began to settle when it was revealed that a Swedish scientist is editing the DNA of healthy human embryos.Fredrik Lanner,a developmental biologist, is using a new gene-editing technique called CRISPR to disable some genes in healthy human embryos to see how those genes affect development. He and his team are intentionally modifyingotherwise healthy IVFembryos so they cannot develop properly.

Anin-depth story byNPRreveals that while the reporter was observing thegeneticmanipulation of five donated IVF embryos, one didnt survive the thawing process and one perished after being injected with the experimental gene-editing tool. Of the three who survived, one continued to divide, but not for long.All of the embryos were to be destroyedbefore they are 15 days old,as the law in Sweden dictates. Lanner insists that his research is critical to understanding human development, which, in turn, will shed light on infertility and disease.

Lanners work makes many ethicists and scientists extremely nervous. Jennifer Doudna, the co-inventor of CRISPR, along with other heavy-hitting scientists,havecalled for a voluntary moratorium on any editing of human embryosfor fear that it will lead to the creation of genetically modified children. Marcy Darnovsky, of the left-leaning Center for Genetics and Society, explains why she and her group havebeen so vocal in their opposition to the modification of human embryos. She told NPR: The production of genetically modified human embryos is actually quite dangerous. ... When youre editing the genes of human embryos, that means youre changing the genes of every cell in the bodies of every offspring, every future generation of that human being. So these are permanent and probably irreversible changes that we just dont know what they would mean.

Then came the revelation that a U.S. doctor traveled to Mexico to create the first baby intentionally engineered to have three genetic parents. This technique, misnamed mitochondrial replacement or MR, seeks to eliminate the transmission of genetic disease through the mitochondria.Mitochondria are small but abundant organellesoutside the nucleusinthe cytoplasmof our cells that make energy. They have their own DNA called mtDNA. We inherit our mtDNA solely from our mothers. A woman who carries a deleterious mutation in her mtDNA cannot help but pass that on to her offspring.

There are various MR techniques that replace the mitochondria of a woman with mitochondrial disease with the mitochondria of a donor femalein the IVF process.Essentially, MR creates a genetically alteredembryo with the genetic material from three people, one man and two women.

MR had only undergone limited study in primates before getting approval in the United Kingdom for use in fertility clinics to make babies. Little is known about the complexcommunication between the DNA in the nucleus and the DNA in the mitochondria,and so there is little data on the effects ofa mismatch between the nuclear DNA and mtDNA.

Alsoin all MR, its the nucleus thats being moved from cell to cell, not the mitochondria which is why mitochondrial replacement is such a misnomer.This makes MR acousin to cloning, which also transplants the nucleus of one cell into anotherto make a new organism. MR brings with it many of the same risks.Scientists are concerned about the health of the resulting children.

In anopen letterto the U.K. Parliament, Dr. Paul Knoepfler, a vocal American stem-cell researcher, warned: Even if, hypothetically, this technology might help avoid some people from having mitochondrial disorders (and thats a big if), the bottom line is that there is an equal or arguably greater chance that it will tragically produce very ill or deceased babies.

MRis also a germ-line genetic modification, which means that any girl born with this technique will pass her genetic modification on to her children.

A recent review in Nature reveals that MR leaves a tiny percentage of mutant mitochondria behind, and sometimes the mutant mitochondria rapidly divide and overtake the healthy mitochondria. Shoukhrat Mitalipov, head of the Center for Embryonic Cell and Gene Therapy at the Oregon Health and Science University, reported a 15% failure rate where mitochondrial defects returned. Mitalipov told NPR, That original, maternal mitochondrial DNA took over, and it was pretty drastic. There was less than 1% of the original maternal mitochondrial DNA present after replacement with donor DNA and before fertilization, and yet it took over the whole cell later. University of California San Francisco professor Patrick OFarrell suggests that mutant mitochondria can resurge at any time in a developing three-parent child or even resurface in future generations.

For all these reasons, MR is not yet approved by the FDA in the United States,and may never be.So, when a Jordanian woman with mitochondrial disease wanted to have a child using MR, John Zhang, from the New Hope Fertility Center in New York City, had to perform the procedure in Mexico. He created five embryos,and, according toNewScientist.com,only one developed normally. That child is now 9 months old.

Zhang went to Mexico because, he said, there are no rules, and yet he insists he did the safe and ethical thingin the absence of any medical or ethical oversight. In an ironic twist, the couple is Muslim and so chose the MR technique that wouldnt destroy existing embryos.But it was clear that only male embryos would be transferred for gestation, because boys cant pass on the genetic modification. What happened to the other four embryos, however? Were they destroyed,discarded or frozen? If they were females, would they have been destroyed anyway to make sure they couldnt pass on any ill effects?

Darnovskycalledthis rogue experimentationand added, No researcher or doctor has the right to flout agreed-upon rules and make up their own. This is an irresponsible and unethical act.

Knoepflerrespondedto the news by remindingus that this is a living human experiment that is going to unfold over years and decades. It is also worth noting that this child is a genetically modified human being as a result of this technique.

Of course, these are happenings to despair of not only because of the sheer disregard for the sanctity of individual human lives, but because of the breakneck speed at which scientists are kicking ethical lines farther and farther down the road like a tin can. All the while, they insist that its for the good of humanity. I wonder: How can wetreatindividual members of the human species so callously and then, at the same time, say its for the good of the whole human race?

I fear there is no line we wont cross;no ethical boundary wewonttear down in the name of science.

On a daily basis, Im surrounded by science and scientists. Often, their response to this madness is that its going to happen anyway, and theres no way to stop it, which implies we must go along to get along all in the name of progress.

If I am Frodo, then they and the rest of society are Saruman giving in to the despair and making a deal with Sauron.In the film version of The Lord of the Rings, Saruman says to Gandalf: Against the power of Mordor there can be no victory. We must join with him, Gandalf. We must join with Sauron. It would be wise, my friend.

Gandalf replies, Tell me, friend, when did Saruman the Wise abandon reason for madness?

Indeed. When did science abandon reason for madness, ethics for recklessness?

So what shall we do? If wesuccumb to despair, we become like Saruman.

We always have prayer. Its time toadd human embryonic research and germ-line human genetic engineering to our list of life issues that we pray about.It doesnt matter whether we understand the finer points of the science or not.Praying for an end to abortion andassisted suicide is nolongerenough.

In addition to prayer, there are other things we can do. The first is to vote pro-life at every level of government, from city council to state assemblymen. Being pro-life isnt just about abortion, however. Its about protecting the sanctity of life from the beginning to the end. Pro-life legislators, even if they cannot overturn Roe v. Wade, can effect local and state laws and steer funding away from unethical research.

Secondly, we must fight for conscience rights for medical professionals. I envision a not-so-far-off world wheredoctorsare forced into making genetically engineered embryos and bringing these children to term simply because parents claim its their reproductive right to have the children of their design. Without conscience rights, unethical experimentation on the next generation will be rampant and unchecked.

We must, however, always have hope. Whenstaring downthe juggernaut that is modern biotechnology, I always remember Frodo Baggins.When he was faced with the seemingly impossible task of taking the One Ring to Mordor, instead of shying away because it was too hard, he said: I will take the Ring, though I do not know the way.

Rebecca Tayloris a

clinical laboratory specialist in molecular biology.

She writes about bioethics on her blog,Mary Meets Dolly.

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Immoral Uses of Biotechnology Even With Good Intentions Are Nevertheless Evil - National Catholic Register

Puma Biotechnology Inc (NYSE:PBYI) insider Robert Charnas sold 3,008 shares of Puma Biotechnology stock in a transaction dated Wednesday, February 1st. The stock was sold at an average price of $31.83, for a total transaction of $95,744.64. Following the completion of the sale, the insider now directly owns 28,461 shares in the company, valued at approximately $905,913.63. The sale was disclosed in a legal filing with the Securities & Exchange Commission, which is accessible through the SEC website.

Shares of Puma Biotechnology Inc (NYSE:PBYI) traded up 0.75% during trading on Thursday, reaching $33.45. 527,529 shares of the company traded hands. The companys 50-day moving average price is $33.44 and its 200-day moving average price is $45.94. Puma Biotechnology Inc has a 52 week low of $19.74 and a 52 week high of $73.27. The companys market capitalization is $1.23 billion.

PBYI has been the topic of several research reports. J P Morgan Chase & Co set a $89.00 price objective on shares of Puma Biotechnology and gave the stock a buy rating in a research report on Monday, November 14th. Citigroup Inc. set a $88.00 price objective on shares of Puma Biotechnology and gave the stock a buy rating in a research report on Monday, November 14th. Stifel Nicolaus reaffirmed a buy rating and issued a $88.00 price objective on shares of Puma Biotechnology in a research report on Thursday, November 10th. Zacks Investment Research lowered shares of Puma Biotechnology from a buy rating to a hold rating in a research report on Tuesday, January 10th. Finally, Cowen and Company reaffirmed a market perform rating on shares of Puma Biotechnology in a research report on Tuesday, November 15th. One research analyst has rated the stock with a sell rating, four have given a hold rating and four have issued a buy rating to the companys stock. Puma Biotechnology currently has a consensus rating of Hold and a consensus price target of $68.56.

A number of institutional investors have recently bought and sold shares of PBYI. Redmile Group LLC bought a new position in Puma Biotechnology during the third quarter valued at about $44,406,000. Janus Capital Management LLC boosted its position in Puma Biotechnology by 30.6% in the second quarter. Janus Capital Management LLC now owns 2,540,331 shares of the biopharmaceutical companys stock valued at $75,675,000 after buying an additional 594,821 shares in the last quarter. EverPoint Asset Management LLC bought a new position in Puma Biotechnology during the second quarter valued at about $13,406,000. BlackRock Fund Advisors boosted its position in Puma Biotechnology by 160.7% in the second quarter. BlackRock Fund Advisors now owns 602,071 shares of the biopharmaceutical companys stock valued at $17,936,000 after buying an additional 371,151 shares in the last quarter. Finally, Point72 Asset Management L.P. boosted its position in Puma Biotechnology by 22.3% in the second quarter. Point72 Asset Management L.P. now owns 1,415,800 shares of the biopharmaceutical companys stock valued at $42,177,000 after buying an additional 258,100 shares in the last quarter. Institutional investors and hedge funds own 80.98% of the companys stock.

About Puma Biotechnology

Puma Biotechnology, Inc is a biopharmaceutical company that focuses on the development and commercialization of products for the treatment of cancer. The Company focuses on in-licensing the global development and commercialization rights to over three drug candidates, including PB272 (neratinib (oral)), which the Company is developing for the treatment of patients with human epidermal growth factor receptor type 2 (HER2), positive breast cancer, and patients with non-small cell lung cancer, breast cancer and other solid tumors that have a HER2 mutation; PB272 (neratinib (intravenous)), which the Company is developing for the treatment of patients with advanced cancer, and PB357, which is an orally administered agent.

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The Puma Biotechnology Inc (PBYI) Insider Sells $95744.64 in Stock - DailyQuint

More Volatility Ahead for Biotechnology Sector Wall Street Journal (blog) After underperforming the S&P 500 over the past six months, the biotechnology sector is poised for more volatility ahead. The group drew plenty of attention on the campaign trail as both and Democratic candidate criticized the high prices for drugs ...

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More Volatility Ahead for Biotechnology Sector - Wall Street Journal (blog)

Intrexon Corporation (XON) ended last trading session with a change of 5.25 percent. It trades at an average volume of 1.33M shares versus 1.7M shares recorded at the end of last trading session. The share price of $22.04 is at a distance of 8.09 percent from its 52-week low and down -45.23 percent versus its peak. The company has a market cap of $2.61B and currently has 118.35M shares outstanding. The share price is currently -5.82 percent versus its SMA20, -16.17 percent versus its SMA50, and -17.92 percent versus its SMA200. The stock has a weekly performance of 2.04 percent and is -9.3 percent year-to-date as of the recent close.

Jan. 26, 2017 Exemplar Genetics, a wholly owned subsidiary of Intrexon Corporation (XON) committed to enabling the study of life-threatening human diseases, has been awarded a subcontract to create genetically engineered miniswine models of sickle cell disease as part of a national resource that could lead to new treatments for the disorder.

The subcontract is with Leidos Biomedical Research, Inc., prime contractor for the Frederick National Laboratory for Cancer Research, sponsored by the National Cancer Institute, part of the National Institutes of Health (NIH). Work under the subcontract will support the NIHs National Center for Advancing Translational Sciences (NCATS) in creating genetically engineered miniswine models of sickle cell disease. Exemplar Genetics will develop several versions of genetically engineered miniswine models of sickle cell disease that more accurately replicate the human pathology as compared to traditional research models.

Keryx Biopharmaceuticals, Inc. (KERX) recently recorded -0.55 percent change and currently at $5.45 is 75.24 percent away from its 52-week low and down -30.13 percent versus its peak. It has a past 5-day performance of 13.54 percent and trades at an average volume of 1.61M shares. The stock has a 1-month performance of -12.38 percent and is -7 percent year-to-date as of the recent close. There were about 106.55M shares outstanding which made its market cap $580.7M. The share price is currently -1.7 percent versus its SMA20, -5.27 percent versus its SMA50, and -1.49 percent versus its SMA200.

Nov. 18, 2016 Keryx Biopharmaceuticals, Inc. (KERX), a biopharmaceutical company focused on bringing innovative medicines to people with renal disease, announced case study data, which showed that Auryxia (ferric citrate) lowered and maintained serum phosphorus levels in chronic kidney disease (CKD) patients on dialysis. These data were presented in a poster presentation at the American Society of Nephrologys 2016 Kidney Week taking place in Chicago.

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Top Biotechnology Stock Picking: Intrexon Corporation (XON), Keryx Biopharmaceuticals, Inc. (KERX) - The Independent Republic