Bulls vs Bears on Principal Financial

Wells Fargo cautious on Principal Financial as Goldman says buy

Bulls vs Bears on Principal Financial. Stockwinners.com
Bulls vs Bears on Principal Financial

 

This morning, Goldman Sachs analyst Alex Scott upgraded Principal Financial (PFG) to Buy on his view that the company has potentially positive earnings growth drivers and the stock has limited downside risk.

 

Meanwhile, his peer at Wells Fargo downgraded the stock to Market Perform, arguing that its current valuation already reflects the relative growth in earnings derived from the company’s niche of fee-based businesses, aided by healthy equity market performance.

 

BUY PRINCIPAL FINANCIAL

 

In a research note to investors this morning, Goldman Sachs‘ Scott upgraded Principal Financial to Buy from Neutral after his work suggested a number of potentially positive earnings growth drivers.

 

The analyst noted that he sees organic growth in the Spread and International segments, upside to estimates driven by margins, potential for inorganic growth through deploying excess capital, and a possibility that the pension partnership with the China Construction Bank will be finalized in 2018.

 

Nonetheless, Scott pointed out that he believes the company could experience some pricing pressure within the Specialty Benefits segment during the year, but the improved growth related to tax reform and scale positions the segment well. The analyst also raised his price target on the shares to $80 from $71.

 

MOVING TO THE SIDELINES

Conversely, Wells Fargo analyst Sean Dargan downgraded Principal Financial to Market Perform from Outperform, with a $79 price target, saying the stock’s valuation already reflects the relative growth in earnings.

 

While the analyst acknowledged that Principal’s earnings per share will benefit from tax reform, like all companies under his coverage, #Dargan noted that its push to show growth in spread earnings via pension risk transfer exposes the company to “greater longevity risk,” which deserves a lower multiple than “pure” spread earnings.

 

The analyst told investors that he now prefers Voya Financial (VOYA), pointing out that the company should look more like Principal over time after shedding its capital-intensive annuity business. Furthermore, Dargan argued that he sees more upside in Voya at current valuation levels.

 

Principal Financial (PFG) is  up 1% to $73.12.


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Apple to address child addiction concerns

Apple plans new features following concerns over child phone addiction

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Apple plans new features following concerns over child phone addiction

Apple is planning to launch new features and tools for its products after Jana Partners and the California State Teachers’ Retirement System, which hold a combined $2B stake in the tech giant, called on the company to address child phone addiction, Business Insider reports, citing an Apple representative.

The company said, “Apple has always looked out for kids, and we work hard to create powerful products that inspire, entertain, and educate children while also helping parents protect them online. We lead the industry by offering intuitive parental controls built right into the operating system…

We have new features and enhancements planned for the future, to add functionality and make these tools even more robust…We take this responsibility very seriously and we are committed to meeting and exceeding our customers’ expectations, especially when it comes to protecting kids.”

AAPL closed at $174.35.


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Alliance Data to launch credit cards for IKEA Group 

Alliance Data to launch co-brand, private label credit cards for IKEA Group 

Alliance Data to launch credit cards for IKEA. Stockwinners
Alliance Data to launch credit cards for IKEA

Alliance Data Systems  (ADS) announced its Columbus, Ohio-based card services business, a premier provider of branded private label, co-brand and business credit card programs, has signed a new agreement to provide branded credit card services in the United States for IKEA Group, the world’s largest furniture retailer.

The IKEA Group operates 47 stores in the U.S. and a total of 362 in 29 countries around the world.

IKEA aims to offer consumers home furnishing solutions of good design and function at affordable prices.

Alliance Data will create a loyalty-driven credit card program that combines customer insights and industry benchmarking to develop a customized rewards and benefits package tailored for the unique IKEA customer base.

The co-branded rewards card can be used for both IKEA purchases and for everyday spending needs such as gas, groceries and utilities. The card will incorporate custom program perks designed to recognize customers for their loyalty.

In order to make the card as affordable and rewarding as possible, IKEA Group in the U.S. has designed the card without an annual fee, and will reinvest resources from the card to offer customers more generous rewards.

Alliance Data will leverage its digital and mobile expertise throughout the customer’s shopping journey, including its Frictionless Mobile CreditSM, which provides a seamless application experience-throughout the store or online-and puts customers in control of how and where they want to initiate the experience.


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Volkswagen to use NVIDIA AI into new electric microbus

VW taps Nvidia to build AI into new electric microbus 

Nvidia pullback after Q2 beat a buying opportunity. See Stockwinners.com Market Radar for more
VW taps Nvidia to build AI into new electric microbus

Volkswagen (VLKAY) and NVIDIA (NVDA) shared their vision for how AI and deep learning will shape the development of a new generation of intelligent Volkswagen vehicles using the NVIDIA DRIVE IX platform to create new cockpit experiences and improve safety.

At the kickoff of CES 2018, Volkswagen CEO Herbert Diess and NVIDIA founder and CEO Jensen Huang discussed on stage how AI is transforming the auto industry and highlighted the new I.D. Buzz, Volkswagen’s rebirth of the iconic VW MicroBus, reimagined in electric car form and infused with AI technology for the cockpit and self-driving.

The VW I.D. Buzz will use DRIVE IX technology to create “Intelligent Co-Pilot” applications, which will include convenience and assistance systems based on processing sensor data from both inside and outside of the car.

The I.D. Buzz is part of the I.D. family with which Volkswagen will launch its electric car campaign and gradually introduce autonomous driving starting in 2020. More than 20 fully electric vehicle models are planned by 2025, as the automaker works toward its goal of becoming the world leader in this area.

These new models are based on the completely new MEB car architecture that is consistently geared toward zero-emission, digital mobility and making use of the electric drive’s overall package benefits.

NVDA closed at $215.40. It last traded at $221.04.


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Novo Nordisk offers to acquire Ablynx

Novo Nordisk offers to acquire Ablynx

 

 Novo Nordisk offers to acquire Ablynx. Stockwinners.com
Novo Nordisk offers to acquire Ablynx

Novo Nordisk (NVO) confirms that it made a proposal on December 22, 2017 to acquire Ablynx (ABLX) for EUR 28.00 per share in cash and one CVR with total potential cash payments over time of up to EUR 2.50 per share.

This proposal implies a total equity valuation of approximately EUR 2.6 billion for Ablynx and represents a premium of up to 60% over Ablynx’s share price as of December 6, 2017 of EUR 19.12, which was the day prior to our first proposal, and up to 66% over Ablynx’s 3 month VWAP of EUR 18.39 as of 5 January 2018.

Novo Nordisk has made a concerted and good faith effort to engage in discussions with Ablynx.

This proposal is the second proposal that Novo Nordisk has made to Ablynx’s Board of Directors and represents up to approximately a 14% increase over the first proposal. Novo Nordisk regrets that the Board of Directors of Ablynx has so far declined to engage in any discussions, despite the proposals which have been put forward.

Novo Nordisk has conducted a deep analysis of Ablynx’s business and product portfolio, based on publicly available information, including caplacizumab, ALX-0171, vobarilizumab, its other pipeline products and partnerships.

Following that analysis, Novo Nordisk has concluded that combining Ablynx’s caplacizumab with Novo Nordisk’s strong global haematology franchise and extensive worldwide resources is a compelling opportunity and provides the clearest path to realizing full potential of Ablynx’s portfolio in the best interests of all stakeholders, including patients and physicians.

The proposed transaction would combine Novo Nordisk’s regulatory, scientific and commercial expertise with Ablynx’s strong existing medical teams to optimise the development and global commercialisation of caplacizumab.

ABLX closed at $25.91.


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December international rig counts rise

Baker Hughes reports December international rig count 954

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Baker Hughes (BHGE), a GE company, announced that the Baker Hughes international rig count for December 2017 was 954, up 12 from the 942 counted in November 2017, and up 25 from the 929 counted in December 2016.

The international offshore rig count for December 2017 was 191, up 8 from the 183 counted in November 2017, and down 19 from the 210 counted in December 2016.

The average US rig count for December 2017 was 930, up 19 from the 911 counted in November 2017, and up 296 from the 634 counted in December 2016.

The average Canadian rig count for December 2017 was 205, up 1 from the 204 counted in November 2017, and down 4 from the 209 counted in December 2016.

The worldwide rig count for December 2017 was 2,089, up 32 from the 2,057 counted in November 2017, and up 317 from the 1,772 counted in December 2016.

WTI crude last traded at $61.65 per barrel, up 21 cents.  Brent crude is up 16 cents to $67.78 per barrel.


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Celgene is acquiring Impact Biomedicines for $7B

Celgene to acquire Impact Biomedicines, adds Fedratinib to pipeline

Celgene tumbles
Celgene to acquire Impact Biomedicines, adds Fedratinib to pipeline

Celgene (CELG) and privately held Impact Biomedicines announced the signing of a definitive agreement in which Celgene will acquire Impact Biomedicines, which is developing fedratinib for myelofibrosis and polycythemia vera.

Under the terms of the agreement, Celgene will pay approximately $1.1B upfront and up to $1.25B in contingent payments based on regulatory approval milestones for myelofibrosis.

Additional future payments for regulatory approvals in additional indications and sales-based milestones are also possible.

#Fedratinib, a highly selective JAK2 kinase inhibitor, was evaluated in 877 patients across 18 clinical trials.

Celgene to acquire Impact Biomedicines, adds Fedratinib to pipeline, Stockwinners.com
Celgene to acquire Impact Biomedicines, adds Fedratinib to pipeline

In a randomized, placebo-controlled, phase III pivotal trial for patients with treatment-naive myelofibrosis, fedratinib demonstrated statistically significant improvements in the primary and secondary endpoints of splenic response and total symptom score, respectively.

In an exploratory subgroup analysis, these improvements were observed regardless of a patient’s baseline platelet count. A multi-center, single-arm phase II trial evaluated fedratinib in myelofibrosis patients who were found to be resistant or intolerant to ruxolitinib, a JAK1/JAK2 inhibitor. In this second-line setting, fedratinib demonstrated clinically meaningful improvements in splenic response and total symptom score.

#JAKARTA-2 was stopped prematurely due to a clinical hold placed on the fedratinib program by the U.S. Food and Drug Administration after potential cases of Wernicke’s encephalopathy were reported in eight out of 877 patients receiving one or more doses. The FDA removed the clinical hold in August 2017.

Based on the reported benefit risk profile of fedratinib from the JAKARTA-1 and JAKARTA-2 clinical trials, regulatory applications in #myelofibrosis are planned beginning in the middle of 2018.

Myelofibrosis is a serious bone marrow disorder that disrupts body’s normal production of blood cells. The result is extensive scarring in one’s bone marrow, leading to severe anemia, weakness, fatigue and often an enlarged spleen.

Myelofibrosis is an uncommon type of chronic #leukemia — a cancer that affects the blood-forming tissues in the body. Myelofibrosis belongs to a group of diseases called myeloproliferative disorders.

 Many people with myelofibrosis get progressively worse, and some may eventually develop a more serious form of leukemia. Yet it’s also possible to have myelofibrosis and live symptom-free for years.
CELG closed at $104.99.


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Barron’s is bullish on Gold and FedEx, bearish on Caterpillar

Barron’s, the weekly publication owned by the Wall Street Journal, in its latest issue mentions several names: 

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Stockwinners offers Barron’s review of stocks to buy, stocks to watch

BULLISH  MENTIONS:

FedEx EPS (FDX) growth should more than triple next year – U.S. postal rates look likely to rise, pinching Amazon (AMZN) and benefiting FedEx and UPS (UPS), Jack Hough writes in this week’s edition of Barron’s. While for now UPS enjoys higher profit margins, investors should favor FedEx as years-long investment in automating and expanding its hubs has given the company a speed and efficiency advantage over the former, he adds. Earnings per share growth for FedEx should more than triple next year as tax cuts kick in, the report notes.

Deal makers now ‘on the clock.’  – Deal makers may be on the clock, especially if one believes that the bull market is in its waning stages and the Federal Reserve is serious about interest rate hikes, Alex Eule writes in this week’s edition of Barron’s. 2018 merger speculation already kicked off in a big way, with headlines that Amazon (AMZN) could buy Target (TGT) and Apple could acquire Netflix (NFLX), he notes, adding that M&A may be necessary to grow and even to survive.

Valero, Home Depot among companies expected to raise dividend – Charles Schwab (SCHW), Home Depot (HD), Valero Energy (VLO), NextEra Energy (NEE), Allstate (ALL) and Cisco Systems (CSCO) are among the large companies expected to announce healthy dividend increases soon, Lawrence Strauss writes in this week’s edition of Barron’s. These projected boosts come amid a solid outlook for dividend growth in the U.S. and globally, he adds.

Intel not to be blamed for failures of computer security – Intel (INTC) came under fire for the revelation that its chips were vulnerable, but the nature of technology and how the industry approaches computer security are the real problem, not Intel chips, Tiernan Ray writes in this week’s edition of Barron’s. There may be things Intel can do, and in fact AMD (AMD), whose chips run the same software, said its products are less vulnerable than Intel’s, he notes, but difference here are just relative as hackers’ inventiveness will continue.

Kohl’s making right moves to grow earnings. – Until recently, Kohl’s (KSS) was largely written off as a casualty of Amazon’s (AMZN) domination of the retail sector, but the stock has become one of the hottest plays in retail as investors increasingly believe that the e-Commerce giant could acquire the company, Steven Sears writes in this week’s edition of Barron’s. Even without Amazon, Kohl’s seems to be making the right moves to grow earnings, he adds.

Gold rally may be ‘just the start.’  – Gold’s recent rally could be just the start, and investors betting on a new bull market in gold can buy physical gold, mining stocks or funds that track the metal and mining shares, with junior miners typically outperforming big-caps in a gold bull market, John Kimelman writes in this week’s edition of Barron’s. Publicly traded companies in the sector include Newmont Mining (NEM), Barrick Gold (ABX), Goldcorp (GG) and Agnico Eagle (AEM).

BEARISH  MENTIONS:

Bank earnings could ‘be messy.’ – The backdrop for banks could not be much better but earnings season is about to begin – with JPMorgan (JPM), Wells Fargo (WFC) and PNC Financial (PNC) expected to report on Friday – and it could “be messy,” Ben Levisohn writes in this week’s edition of Barron’s. While tax reform should be a boon for banks, it will also produce one-time charges and gains that will need to be accounted for, he adds.

Time to sell Caterpillar – In a follow-up story, Barron’s says that with Caterpillar (CAT) soaring, it is time to sell. Investors should not expect the stock to move quickly from here, as cyclical companies like Caterpillar tend to trade at high multiples of earnings at the bottom of the cycle and low multiples at the top, it adds.


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The U.S. trade deficit in November at six year high

The U.S. trade deficit rises to a 6 year high

U.S. trade deficit rose to a 6-year high. Stockwinners
U.S. trade deficit rose to a 6-year high.

The U.S. trade deficit rose to a larger than expected $50.5 B, a 6-year high in November, after gaps of $48.9 (was $48.7) B in October and $44.9 B in September, versus a prior 5-year high of $48.8 B last January.

The November gap was $0.5 B wider than indicated by the “advance” trade report thanks to a larger upside import surprise than export surprise.

Exports of goods and services have returned to the cycle-high from October of 2014, while imports are now 4.1% above their level in October of 2014.

Analysts trimmed the Q4 GDP growth estimate to 2.5% from 2.6%, after a 3.2% Q3 rate, with a $38 (was $34) B net export subtraction, following a $16.2 B addition in Q3.

Analysts project a 5% growth rate in real exports in Q4 after a 2.1% rate in Q3, and a 9% growth rate for real imports in Q4 after a 0.7% Q3 contraction rate.

Analysts expect a current account deficit widening to $119.7 B in Q4 from just $100.6 B in Q3.

Analysts expect an annual current account gap of $458 B that will mark a new expansion-high in 2017, following the $452 B prior expansion-high in 2016.


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Kala Pharmaceuticals falls following its dry eye drug failure

Kala Pharmaceuticals announces topline results for clinical trials of KPI-121

Kala Pharmaceuticals announces topline results for clinical trials of KPI-121. Stockwinners
Kala Pharmaceuticals announces topline results for clinical trials of KPI-121

Kala Pharmaceuticals (KALA) announced topline results from its two Phase 3 clinical trials, STRIDE 1 and STRIDE 2, evaluating the safety and efficacy of KPI-121 0.25% versus placebo in patients with dry eye disease.

In the STRIDE 1 trial, statistical significance was achieved for the primary sign endpoint of conjunctival hyperemia change from baseline to day 15 in the ITT population and the primary symptom endpoint of ocular discomfort severity change from baseline to day 15 in the ITT population.

Statistical significance was also achieved for a second pre-specified primary symptom endpoint of ocular discomfort severity change from baseline to day 15 in patients with more severe baseline ocular discomfort.

Statistical significance was not achieved for a second pre-specified primary sign endpoint, inferior corneal staining change from baseline to day 15.

A positive treatment effect for ocular discomfort was also observed in the ITT population at day 8. KPI-121 was well tolerated in this trial with the most common adverse event in STRIDE 1 being instillation site pain, which was observed in 6.1% of patients in both the KPI-121 treatment group and the placebo group.

The only other adverse event reported by greater than 1% of patients was eye irritation, which was reported in 1.1% of patients on KPI-121 vs. 1.5% of patients on placebo.

Elevations in IOP, a known side effect with topical corticosteroid administration, were similar between the two groups with 0.4% in the KPI-121 group experiencing an increase in IOP of 5 mm of mercury or greater resulting in an IOP of 21 mmHg or greater compared to 0.4% in the placebo group.

In the STRIDE 2 trial, statistical significance was achieved for the primary sign endpoint of conjunctival hyperemia change from baseline to day 15 in the ITT population.

Statistical significance was not achieved for the primary symptom endpoint of ocular discomfort severity change from baseline to day 15 in the ITT population, although a positive treatment effect was observed at day 8, a key secondary endpoint.

A trend towards a positive treatment effect was observed for ocular discomfort severity change from baseline to day 15 in the patients with more severe baseline ocular discomfort, which was a key secondary endpoint in this trial.

KPI-121 was well tolerated in this trial with instillation pain being the most common adverse event In STRIDE 2 as reported by 5.7% of patients in the KPI-121 treatment group vs. 4.4% in the placebo group.

The only other adverse event reported by greater than 1% of patients was blurred vision, which was reported in 0.2% of patients on KPI-121 vs. 1.3% of patients on placebo.

Elevations in IOP were similar between the two groups with 1.1% in the KPI-121 group experiencing an increase in IOP of 5 mmHg or greater resulting in an IOP of 21 mmHg or greater compared to none in the placebo group.

Mark Iwicki, CEO of Kala Pharmaceuticals, said that “We will continue to analyze the results of both Phase 3 trials and the totality of the data from all 3 trials conducted to date and expect to discuss our clinical program with the FDA.

We believe that our preliminary, unaudited December 31, 2017 cash balance of approximately $114M puts us in a strong position as we maintain our focus on moving this program forward to serve patients with dry eye disease.”

KALA closed at $17.33, it last traded at $16.50 in pre-market trading.


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Dexcom tumbles after Abbott receives Medicare approval for Libre

Dexcom falls after Abbott receives Medicare approval for Libre

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Dexcom falls after Abbott receives Medicare approval for Libre

Shares of Dexcom (DXCM) are sinking after Abbott (ABT) announced that FreeStyle Libre, its new continuous glucose monitoring system, is now available to Medicare patients.

ABBOTT ANNOUNCES MEDICARE COVERAGE

This morning, Abbott announced that the FreeStyle Libre System, the company’s new continuous glucose monitoring system, is now available to Medicare patients, having met the codes for therapeutic CGM systems used for coverage by the U.S. Centers for Medicare & Medicaid Services.

Coverage includes all Medicare patients with diabetes who use insulin and who meet the eligibility criteria.

Abbott said that the factory-calibrated FreeStyle Libre system is the only CGM system recognized by Medicare that requires no user calibration whatsoever and also does not require the need for routine fingersticks.

BUYING OPPORTUNITY

Following Abbott’s announcement, Piper Jaffray analyst JP #McKim said he believes Abbott’s Medicare approval for #Libre is “more market-expanding than share-taking” for Dexcom, and maintained an Overweight rating on Dexcom shares, seeing the pullback as a buying opportunity for longer-term investors.

The analyst believes the sooner-than-expected Medicare coverage minimizes upside potential for Medicare revenue in 2018, but added that CGM adoption is expected to accelerate and he thinks “the superior product” of Dexcom will win more Medicare patients.

NORTHLAND DOWNGRADES

Northland analyst Suraj #Kalia downgraded Dexcom to Underperform from Market Perform after Abbott announced Medicare coverage for the Libre FGM.

The analyst believes it undercuts Dexcom’s competitive advantages, and contends that there is additional headline risk vis-a-vis Medtronic’s (MDT) Guardian Connect CGM approval in the pipeline.

Further, #Kalia believes Dexcom’s stock is bound to be under pressure over the next 12-18 months. The analyst added that Dexcom does have the best in class sensor and the company has an “excellent” pipeline but argued that the Libre FGM may be “good enough” for a large chunk of patients, especially as its about one-tenth the cost of Dexcom’s upfront price.

OTHER ANALYST COMMENTARY

Cowen analyst Doug Schenkel believes shares of Dexcom are down too much following Abbott’s announcement and that a 10% sellof “appears disproportionate” on a three month timing swing on an expected event. Baird analyst Jeff Johnson said he believes today’s news may not be create as much near-term risk to Dexcom numbers as investors believe.

PRICE ACTION

In Thursday’s trading, Dexcom is down 10.8%, or $6.29, to $51.79.


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Overstock rises on plans for new blockchain venture

Overstock rises after reporting plans for new blockchain venture 

Overstock rises on plans for new blockchain venture. Stockwinners.com
Overstock rises on plans for new blockchain venture

In a regulatory filing last night, Overstock.com (OSTK) disclosed that on December 27 the company, its wholly owned subsidiary Medici Ventures, Patrick Byrne and Hernando de Soto entered into a Memorandum of Understanding that provides that the parties will form a company, “Desoto,” that will be owned 50% by Medici, 33% by Hernando de Soto and 17% by Patrick Byrne, who is the CEO and a member of the Board of Directors of Overstock, and also serves on the board of directors of Medici.

The goal of the new company is to develop a blockchain-based system to develop a global property registry system focused on the property rights of people in the developing world.

Overstock and/or Medici will pay or contribute $14M to help launch the project, $8M of which will be used to fund DeSoto, and Medici will receive a 50% ownership interest in DeSoto.

Patrick Byrne personally will contribute $14M to help launch the project, and will receive a 17% ownership interest in DeSoto.

Hernando de Soto will serve as Chairman of DeSoto and as a director of Medici. Patrick Byrne will serve as Co-Chairman and CEO of DeSoto, in addition to his positions with Overstock and Medici.

“The MOU contemplates a more detailed future agreement, and provides that the parties will cooperate in good faith to reach more detailed agreements in the future,” the filing added.

In pre-market trading, Overstock has risen $1.95, or 2.7%, to $73.50 per share.


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Cellect Biotechnology reports stem cell breakthrough

Cellect Biotechnology announces successful transplant using ApoGraft

Cellect Biotechnology announces successful transplant using ApoGraft. Stockwinners.com
Cellect Biotechnology announces successful transplant using ApoGraft

Cellect Biotechnology (APOP) announced that it has successfully completed transplantation of the first group of three patients using Cellect’s ApoGraft technology in the company’s Phase I/II clinical trial and that after one month follow-up, all three patients have demonstrated complete acceptance of the stem cell transplant with no adverse events related to the study treatment, as determined by the clinical investigator, and no reported serious adverse events or suspected unexpected serious adverse reactions.

The Phase I/II, dose escalating, 4-cohort, open label clinical trial of up to twelve patients is designed to evaluate the safety, tolerability and efficacy of functionally selected donor derived mobilized peripheral blood cells that underwent the company’s ApoGraft process and were transplanted into patients with hematological malignancies in an allogeneic hematopoietic stem cell transplantation.

The primary endpoint of the study is overall incidence, frequency and severity of adverse events potentially related to ApoGraft at 180 days from transplantation. The company plans on recruiting a further three patients for the second cohort of patients following review of the independent data and safety monitoring board.

The company believes that these interim results of ApoGraft present the first signs of a breakthrough in stem cell transplantation.

The product is transplantable within less than 12 hours from donation through a simple process performed on the bedside after selective physiological elimination of immune reaction-causing cells.

The ApoGraft transplantation is intended to result in complete recovery of the patient’s immune system with no related safety concerns in contrast to the significant morbidity or even death causing standard medical procedure.

APOP closed at $7.12. It traded at $9.69 in pre-market trading.


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Deciphera Pharmaceuticals is in focus

Deciphera initiates Phase 3 clinical study of DCC-2618

Deciphera initiates Phase 3 clinical study of DCC-2618. Stockwinners.com
Deciphera initiates Phase 3 clinical study of DCC-2618

Deciphera Pharmaceuticals (DCPH) announced that it has initiated a Phase 3 clinical study to evaluate the safety and efficacy of DCC-2618, a pan-KIT and PDGFRalpha inhibitor, in patients with advanced gastrointestinal stromal tumors.

Gastrointestinal stromal tumors (GISTs) are the most common mesenchymal neoplasms of the gastrointestinal tract. GISTs arise in the smooth muscle pacemaker interstitial cell of Cajal, or similar cells.

Initiation of the INVICTUS study follows results from the ongoing Phase 1 clinical trial presented at the European Society for Medical Oncology Congress in September 2017, in which durable disease control by DCC-2618 was observed in heavily pretreated patients with GIST.

The INVICTUS Phase 3 clinical study is a randomized, double-blind, placebo-controlled, international, multicenter trial to evaluate the safety, tolerability, and efficacy of DCC-2618 compared to placebo in patients with advanced GIST patients whose previous therapies have included imatinib, sunitinib, and regorafenib.

The trial is expected to enroll approximately 120 patients randomized 2:1 to either 150 mg once daily of DCC-2618 or placebo.

DCC-2618 was specifically designed to improve the treatment of GIST patients by inhibiting the full spectrum of mutations in KIT and PDGFRalpha.

DCC-2618 is a pan-KIT and pan-PDGFRalpha inhibitor that blocks initiating KIT mutations in exons 9, 11, 13, 14, 17, and 18, known to be present in GIST patients and the D816V exon 17 mutation known to be present in ASM patients.

DCC-2618 inhibits PDGFRalpha mutations in exon 18, including the D842V mutation that drives a subset of GIST.

Deciphera Pharmaceuticals is a clinical-stage biopharmaceutical company focused on improving the lives of cancer patients by tackling key mechanisms of drug resistance that limit the rate and/or durability of response to existing cancer therapies.

It’s small molecule drug candidates are directed against an important family of enzymes called #kinases, known to be directly involved in the growth and spread of many cancers.

These investigational therapies comprise tumor-targeted agents designed to address therapeutic resistance causing mutations and immuno-targeted agents designed to control the activation of immunokinases that suppress critical immune system regulators, such as macrophages.

DCPH closed at $26.14.


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Spark Therapeutics to improve patient access to Luxturna

Spark Therapeutics announces programs to improve patient access to Luxturna

Spark Therapeutics announced three new payer programs. Stockwinners.com
Spark Therapeutics announced three new payer programs

Spark Therapeutics (ONCE) announced three new payer programs:

  1. an outcomes-based rebate arrangement with a long-term durability measure,
  2. an innovative contracting model
  3. and a proposal to CMS under which payments for Luxturna would be made over time.

Together, these initiatives aim to help ensure eligible U.S. patients have access to Luxturna, a one-time gene therapy indicated for the treatment of patients with confirmed biallelic RPE65 mutation-associated retinal dystrophy.

Luxturna should only be administered to patients who have viable retinal cells as determined by their treating physicians.

Spark Therapeutics has reached agreement in principle with Harvard Pilgrim to make Luxturna available under the outcomes-based rebate arrangement and the innovative contracting model that aims to reduce risk and financial burden for payers and treatment centers.

Spark Therapeutics also has reached an agreement in principle with affiliates of Express Scripts (ESRX) to enable the innovative contracting model. Luxturna and other potential one-time therapies face unique health insurance challenges given current practices and regulations in the U.S. health care system.

Barriers to offering alternate models include the system’s focus on short-term value, largely because most patients switch health insurance companies on average every three years; government price reporting requirements that are not designed to reflect certain outcomes-based arrangements, therefore limiting a manufacturer’s ability to offer significant performance-based rebates, particularly for diseases with small patient populations; and complicated distribution models, which add costs and financial risk to parties involved in the delivery and reimbursement of specialty drugs and specialized medical care.

“Over these past few months, we have been working with health insurers to create innovative pathways for access to Luxturna that may serve as models for other one-time administered gene therapies in the future,” said Marrazzo.

“Our work is not done, but we believe that the offerings we are announcing today will help ensure that eligible U.S. patients have the coverage and financial support they need to gain access to both Luxturna and the specialized medical care required to deliver the product at treatment centers.”


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