A weekly Saturday night show that attempts to predict market direction for the week ahead by looking at a variety of technical and fundamental indicators. This week’s show features commentary on President Trump’s executive orders signed last week, Orexigen Therapeutics and Laboratorios Farmaceuticos Rovi has launched Mysimba In Spain, Granite Construction a border wall and infrastructure play, KapStone Paper and Packaging as a play on paper and packaging stocks moving higher on stronger-than-expected prices of containerboard and pulp, AECOM as a play on the $1 trillion Infrastructure spending bill, Vertex beats on earnings and revenue, Endologix and data From the Ovation European Post Market Registry and reinstatement of the CE Mark for AFX and AFX2 Endovascular AAA Systems, Tetra Tech’s horizontal channel breakout on border wall speculation, Jefferies reiterates TherapeuticsMD As their top small-cap pick for 2017, and more.
I wasn’t the only one moved to tears after hearing Trump’s inauguration speech.
President Trump’s Inauguration Speech Transcript
Chief Justice Roberts, President Carter, President Obama, fellow Americans and people of the world, thank you. We the citizens of America are now joined in a great national effort to rebuild our country and restore its promise for all of our people. Together we will determine the course of America, and the world, for many, many years to come. We will face challenges, we will confront hardships, but we will get the job done.
Every four years we gather on these steps to carry out the orderly and peaceful transfer of power. We are grateful to President Obama and Michelle Obama. They have been magnificent.
Today’s ceremony however has very special meaning, because today we are not merely transferring power from one administration to the other, but from Washington, D.C. and giving it back to you, the people.
For too long, a small group in our nation’s Capitol has reaped the rewards of government while the people have born the cost. Washington has flourished, but the people did not share in its wealth. The establishment protected itself, but not the citizens of our country. Their victories have not been your victories. Their triumphs have not been your triumphs. There was little to celebrate for struggling families all across our land. That all changes starting right here and right now. This moment is your moment, it belongs to you. It belongs to everyone gathered here today and everyone watching all across America.
This is your country.
What truly matters is not which party controls our government, but whether out government is controlled by the people. January 20th, 2017 will be remembered as the day the people became the rulers of this nation again.
The forgotten men and women of our country will be forgotten no longer. Everyone is listening to you now. You came by the tens of millions to become part of a historic movement. The likes of what this country has never seen before. At the center of this movement is a crucial conviction — that the nation exists to serve its people. These are just and reasonable demands of righteous people in a righteous public. But, for too many of our citizens, a different reality exist.
This American carnage stops right here and stops right now. We are one nation, and their pain is our pain. Their dreams are our dreams. Their success will be our success. We share one heart, one home, and one glorious destiny. The oath of office I take today is an oath of allegiance to all Americans.
The wealth of our middle class has been ripped from their homes and then redistributed all across the world. But that is the past. And now we are looking only to the future. We, assembled here today, are issuing a new decree to be heard in every city: from this day forward, a new vision will govern our land. From this day forward, it’s going to be only America first. America first. Every decision on trade, on taxes, immigration, foreign affairs, will be made to benefit American workers and American families. We must protect our borders.
Protection will lead to great prosperity and strength. I will never, ever let you down. America will start winning again — winning like never before. We will bring back our jobs, our borders, our wealth, our dreams. We will build new roads, bridges, airports and highways all across the nation. We will get people off of welfare. We will follow two simple rules: buy American and hire American. We will seek friendship and goodwill with the nations of the world, but we do so with the understanding that is the right of all nations to put their own notions first.
At the bedrock of our politics will be a total allegiance to the United States of America. Through our loyalty to our country, we will rediscover our loyalty to each other. When you open your heart to patriotism, there is no room for prejudice.
The Bible tells us how good and pleasant it is when God’s people live together in unity. We must speak our minds openly, debate our minds honestly, but always pursue solidarity. When America is united, America is totally unstoppable. There should be no fear. We are protected, and we will always be protected.
Most importantly, we will be protected by God.
Finally, we must think big and dream even bigger. In America, we understand that a nation is only living as long as it is striving. We will no longer accept politicians who are all talk and no action. The time for empty talk is over. Now arrives the hour of action. No challenge can match the heart and fight of America. We will not fail. Our country will thrive and prosper again.
No matter if we are black, brown or white, we all bleed the red blood of patriots. We all enjoy the same freedoms and we all salute the same great American flag.
To Americans: You will never be ignored again. Your voice, your hopes and your dreams will define our American destiny. Your courage and goodness and love will forever guide us along the way. Together we will make America strong again. We will make America wealthy again. We will make America proud again. We will make America safe again. And yes, together, we will make America great again.
A weekly Saturday night show that attempts to predict market direction for the week ahead by looking at a variety of technical and fundamental indicators.
This week’s show includes commentary on Yellen’s comments at the Commonwealth Club on Wednesday, January 18, 2017, and why President Trump needs to get rid of her as quickly as possible, consumer confidence, and the rising U.S. dollar.
The top catalysts focused on this week are Sanchez Energy’s Eagleford acquisition that doubled their drilling inventory, EPAM Systems contract win worth more than $300 Million, Tutor Perini Building $1.37 Billion contract win from Los Angeles County, how CEMEX is well positioned on both sides of the border between the US and Mexico to supply concrete for the US/Mexico border wall, Iridium Communications successful satellite launch for its next generation space-based ADS-B network, and Applied Optoelectronics as an excellent play on the switch from copper to optical interconnect inside datacenters.
January 19, 2017: Hearing takeover rumors circulating again about 3D Systems. The rumor is that GE might be interested in acquiring the company. The rumors appear to come from this article: http://www.bizjournals.com/charlotte/news/2017/01/17/3d-systems-stock-shoots-up-on-rumor-of-buyout.html
January 9, 2017: Hearing vague takeover rumors circulating about 3D Systems. Can not confirm the source of the rumors.
3D Systems provides the most advanced and comprehensive 3D digital design and fabrication solutions available today, including 3D printers, print materials and cloud-sourced custom parts. Its powerful ecosystem transforms entire industries by empowering professionals and consumers everywhere to bring their ideas to life using our vast material selection, including plastics, metals, ceramics and edibles.
January 17, 2017: UBS signs multi-year agreement valued at over $300 million with EPAM. UBS AG, the world’s largest wealth manager, has signed a multi-year strategic framework agreement. For the past nine years, UBS and EPAM have collaborated to stay at the forefront of technology, positioning UBS as a global leader in innovative financial products and services. The agreement, which is valued at over $300 million, supports the bank’s strategic cost reduction program. This commitment to efficiency allows EPAM to continue to focus on innovative, end-to-end solutions, reducing time-to-market and improving ROI on technology investments.
The partnership between UBS and EPAM spans almost nine years, ten countries and three continents. In addition to the many business solutions that EPAM has provided during this relationship, innovation will be a large focus throughout this multi-year deal.
Established in 1993, EPAM Systems, Inc. is recognized as a leader in software product development by independent research agencies. Headquartered in the United States, EPAM serves clients worldwide utilizing its award-winning global delivery platform and its locations in 19 countries across North America, Europe, Asia, and Australia. EPAM was ranked #6 in 2013 America’s 25 Fastest-Growing Tech Companies, and #3 in 2014 America’s Best Small Companies lists by Forbes Magazine.
A weekly Saturday night show that attempts to predict market direction for the week ahead by looking at a variety of fundamental and technical indicators. This week’s show includes commentary on Trump’s weak press conference on January 11, 2017 where he called drug makers murders for charging high prices. The show also includes Exact Sciences guiding revenue up +142% YOY, Illumina amazing announcement that Novaseq DNA Sequencer will be able to sequence a human genome In one hour, Amgen’s Phase 3 study results published In JAMA for Parsabiv (Etelcalcetide) which could be approved by the FDA in February 2017, and more.
January 9, 2017: Keefe Bruyette initiates coverage of First Internet Bancorp with an Outperform rating and a price target of $36.
First Internet Bancorp Stock Chart
The Finviz screener settings used to find First Internet Bancorp are: Sector Financial, P/E Low (<15), Forward P/E Low (<15), EPS growth this year 100% – 105%, Sales growth qtr over qtr High (>25%)
First Internet Bancorp is the parent company of First Internet Bank, which opened for business in 1999 as the nation’s first state-chartered, FDIC-insured institution to operate solely via the Internet. With customers in all 50 states, First Internet Bank offers consumers services including checking, savings, money market, certificates of deposit and IRA accounts as well as consumer loans, residential mortgages, residential construction loans and home equity products.
January 9, 2017: Sell ARIAD Pharmaceuticals on the news that it will be acquired by Takeda for $24 per share. This was a monster 86.7% win for us. Congratulations if you were able to make money on the trade.
January 4, 2017: Seeing heavy weekly call activity in Ariad Pharmaceuticals: 1,684 Jan 13 $13 calls trade at $0.40
December 7, 2016: ARIAD Pharmaceuticals announced that the investigational medicine brigatinib demonstrated 15.6 month systemic median progression-free survival in ALTA Study. The clinical data on brigatinib, its investigational anaplastic lymphoma kinase (ALK) inhibitor, from the pivotal ALTA trial in ALK-positive (ALK+) non-small cell lung cancer (NSCLC) patients who had experienced disease progression on crizotinib therapy. As of May 31, 2016, the data show that of patients on the 180-mg regimen with a median follow-up of 11 months, 55% achieved confirmed objective response as assessed by the investigator. In this arm, the median progression-free survival (PFS) was 15.6 months in this post-crizotinib setting, by both investigator and independent review committee (IRC) assessment. Additionally, in this arm, 67 percent of patients with measurable brain metastases achieved a confirmed intracranial objective response, and intracranial PFS was 18.4 months among patients with any brain metastases at baseline. These data will be presented today at the International Association for the Study of Lung Cancer (IASLC) 17th World Conference on Lung Cancer (WCLC) being held in Vienna.
The ALTA Trial
The ALTA (ALK in Lung Cancer Trial of AP26113) trial enrolled 222 patients with ALK+ NSCLC who had been treated with and experienced disease progression on their most recent crizotinib therapy. Patients were randomized one-to-one to receive either 90 mg of brigatinib once per day (QD) (Arm A), or 180 mg QD, preceded by a lead-in dose of 90 mg QD for seven days (Arm B). Also, patients were stratified by presence of brain metastases at baseline and best response to prior crizotinib therapy.
The primary endpoint of the ALTA trial is investigator-assessed confirmed objective response rate (ORR) as measured by the Response Evaluation Criteria in Solid Tumors (RECIST). Key secondary endpoints include PFS, confirmed ORR assessed by an IRC, overall survival (OS), CNS response and PFS, duration of response, safety and tolerability.
Key Data from the ALTA Trial UpdateBrigatinib Efficacy and Safety in ALK+ NSCLC Patients:
A total of 222 patients with ALK+ NSCLC treated with prior crizotinib therapy were randomized in the study (110 patients in Arm B at the 180-mg dose level with a seven-day lead-in at 90 mg and 112 patients in Arm A at the 90-mg dose level). The last patient was enrolled in the study in September 2015.
The median follow-up was 11 months in Arm B and 10.2 months in Arm A. ALTA trial data presented at the 2016 American Society of Clinical Oncology (ASCO) meeting, as of February 29, 2016, had median follow-up of 8.3 months in Arm B and 7.8 months in Arm A.Investigator-assessed confirmed ORR in Arm B was 55 percent. IRC-assessed confirmed ORR in Arm B was 54 percent. Investigator-assessed confirmed ORR in Arm A was 45 percent. IRC-assessed confirmed ORR in Arm A was 49 percent.
In a subgroup analysis of confirmed ORR by baseline characteristics, there was no difference in confirmed ORR based on prior chemotherapy versus no prior chemotherapy.
The subgroup analysis by best response to prior crizotinib (partial or complete response versus other) suggests that patients who had achieved partial or complete responses to prior crizotinib treatment had a significantly higher confirmed ORR, compared with patients who did not reach these reactions.
Responses in Arm B included a confirmed partial response in a patient with the ALK kinase domain G1202R mutation at baseline, which is associated with resistance to all approved tyrosine kinase inhibitors (TKIs).
Median PFS was 15.6 months by both investigator assessment and IRC assessment in Arm B. Median PFS was 8.8 months by investigator assessment and 9.2 months by IRC assessment in Arm A.
The probability of OS at one year was 82 percent and 71 percent in Arm B and Arm A, respectively. The median OS had not been reached in either arm.Of the 44 patients with measurable intracranial brain metastases at baseline, the IRC-assessed intracranial ORR was 67 percent (12/18) in Arm B and 46 percent (12/26) in Arm A.
The median IRC-assessed intracranial PFS was 18.4 months in Arm B and 15.6 months in Arm A.The most common treatment-emergent adverse events (TEAEs; = 30% of all patients, [Arm B/A]), regardless of relationship to treatment, were nausea (43%/36%), diarrhea (39%/21%), cough (36%/23%), headache (30%/28%) and increased blood creatine phosphokinase (CPK) (33%/11%).TEAEs, grade =3, occurring in =4 percent of all patients (excluding neoplasm progression; Arm B/A), were increased CPK (10%/3%), hypertension (6%/6%), pneumonia (5%/3%) and increased lipase (3%/5%).
A subset of pulmonary adverse events (AEs) with early onset (median: Day 2; range: Day 1-9) occurred in six percent of all patients (grade =3 in 3% of patients); no such events with early onset occurred after dose escalation to 180 mg QD in Arm B.
Discontinuations and dose reductions due to AEs (Arm B/A) were 10 percent/three percent and 23 percent/eight percent, respectively. Discontinuations due to documented progressive disease (Arm B/A) were 23 percent and 30 percent.
The company said, “We are encouraged by the maturing efficacy and safety profile of brigatinib in this later data cut, which adds three months of follow up compared to the data presented at ASCO. These data are intended to be submitted to the European Medicines Agency in early 2017 for marketing approval. Pending regulatory review, we expect that brigatinib may become an important therapeutic option for the crizotinib-resistant population.”
November 29, 2016: ARIAD Pharmaceuticals announced that the U.S. Food and Drug Administration (FDA) has granted Iclusig (ponatinib) full approval for the treatment of adult patients with chronic phase, accelerated phase, or blast phase chronic myeloid leukemia (CML) or Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) for whom no other tyrosine kinase inhibitor (TKI) therapy is indicated; and for the treatment of adult patients with T315I-positive CML (chronic phase, accelerated phase, or blast phase) or T315I positive Ph+ ALL. Iclusig was initially approved in December 2012 under the FDAs accelerated approval program, which provides patients earlier access to promising new drugs that treat serious conditions based on a surrogate endpoint while the company conducts additional studies to confirm the drugs clinical benefit. The therapy was granted the FDAs orphan drug designation because it is intended to treat a rare disease or condition.
This full approval and label update is based on 48-month follow-up data (as of August 2015) from the pivotal Phase 2 PACE clinical trial of Iclusig in heavily pretreated patients with resistant or intolerant CML or Ph+ ALL. These data were presented at the 2016 meetings of the American Society for Clinical Oncology and the European Hematology Association (EHA).
About Iclusig(ponatinib) Tablets
Iclusig is a kinase inhibitor. The primary target for Iclusig is BCR-ABL, an abnormal tyrosine kinase that is expressed in chronic myeloid leukemia (CML) and Philadelphia-chromosome positive acute lymphoblastic leukemia (Ph+ ALL). Iclusig was designed using ARIAD’s computational and structure-based drug-design platform specifically to inhibit the activity of BCR-ABL. Iclusig targets not only native BCR-ABL but also its isoforms that carry mutations that confer resistance to treatment, including the T315I mutation, which has been associated with resistance to other approved TKIs. Iclusig is approved in the U.S., EU, Australia, Switzerland, Israel, Canada and Japan.
In the U.S., Iclusig is a kinase inhibitor indicated for the treatment of adult patients with chronic phase, accelerated phase, or blast phase chronic myeloid leukemia (CML) or Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) for whom no other tyrosine kinase inhibitor (TKI) therapy is indicated.
Treatment of adult patients with T315I-positive chronic myeloid leukemia (chronic phase, accelerated phase, or blast phase) or T315I-positive Ph+ ALL.
Limitations of use: Iclusig is not indicated and is not recommended for the treatment of patients with newly diagnosed chronic phase CML.
November 7, 2016: ARIAD Pharmaceuticals beat on EPS, reporting Q3 EPS of -$0.12 versus the -$0.19 estimate. Revenue also beat coming in at $46 million versus the $41.9 million estimate.
– Affirming FY16 guidance for global Iclusig net product and royalty revenue of $170 million to $180 million.
– Affirming FY16 guidance for research and development expense of $175 million to $180 million, and sales, general and administration expense of $120 million to $125 million.
– Affirming FY16 guidance for cash, cash equivalents, and marketable securities at December 31, 2016, of $280 million to $290 million.
ARIAD Pharmaceuticals, Inc., headquartered in Cambridge, Massachusetts, and Lausanne, Switzerland, is an integrated global oncology company focused on transforming the lives of cancer patients with breakthrough medicines.