Apple announces new U.S. investments

Apple announces new U.S. investments, sees $38B of repatriation taxes

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Apple has too much cash

Apple (AAPL) announced a new set of investments “to build on its commitment to support the American economy and its workforce,” concentrated in three areas: direct employment by Apple, spending and investment with Apple’s domestic suppliers and manufacturers, and fueling the app economy.

Apple said in a statement that it is already responsible for creating and supporting over 2M jobs across the United States.

It expects “to generate even more jobs as a result of the initiatives being announced today.”

Combining new investments and Apple’s current pace of spending with domestic suppliers and manufacturers, an estimated $55B for 2018, Apple’s direct contribution to the U.S. economy will be more than $350B over the next five years, not including Apple’s ongoing tax payments, the tax revenues generated from employees’ wages and the sale of Apple products.

Planned capital expenditures in the U.S., investments in American manufacturing over five years and a record tax payment upon repatriation of overseas profits will account for approximately $75B of Apple’s direct contribution, the iPhone maker said.

Apple anticipates repatriation tax payments of approximately $38B as required by recent changes to the tax law.

The company expects to invest over $30B in capital expenditures in the U.S. over the next five years and create over 20,000 new jobs through hiring at existing campuses and opening a new one. Apple already employs 84,000 people in all 50 states.

The company plans to establish an Apple campus in a new location, which will initially house technical support for customers. The location of this new facility will be announced later in the year.

Today, Apple is breaking ground on a new facility in downtown Reno, which will support its existing Nevada facilities.

AAPL is up $2.79 to $179.05.


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Android spyware Skygofree called very dangerous

Kapersky Lab says finds Android spying app called ‘Skygofree’

Android spying app called 'Skygofree' is widely distributed. Stockwinners.com
Android spying app called ‘Skygofree’ is widely distributed 

According to Kapersky Lab, “At the beginning of October 2017, we discovered new Android spyware with several features previously unseen in the wild.

In the course of further research, we found a number of related samples that point to a long-term development process. We believe the initial versions of this malware were created at least three years ago – at the end of 2014.

Since then, the implant’s functionality has been improving and remarkable new features implemented, such as the ability to record audio surroundings via the microphone when an infected device is in a specified location; the stealing of WhatsApp messages via Accessibility Services; and the ability to connect an infected device to Wi-Fi networks controlled by cybercriminals.

We observed many web landing pages that mimic the sites of mobile operators and which are used to spread the Android implants. These domains have been registered by the attackers since 2015.

According to our telemetry, that was the year the distribution campaign was at its most active.

The activities continue: the most recently observed domain was registered on October 31, 2017.

Based on our KSN statistics, there are several infected individuals, exclusively in Italy.

Moreover, as we dived deeper into the investigation, we discovered several spyware tools for Windows that form an implant for exfiltrating sensitive data on a targeted machine.

The version we found was built at the beginning of 2017, and at the moment we are not sure whether this implant has been used in the wild.

We named the malware Skygofree, because we found the word in one of the domains.”

According to researchers, the Skygofree Android implant is ” one of the most powerful spyware tools that we have ever seen for this platform.

As a result of the long-term development process, there are multiple, exceptional capabilities: usage of multiple exploits for gaining root privileges, a complex payload structure, never-before-seen surveillance features such as recording surrounding audio in specified locations.

Given the many artifacts we discovered in the malware code, as well as infrastructure analysis, we are pretty confident that the developer of the Skygofree implants is an Italian IT company that works on surveillance solutions, just like HackingTeam.”

GOOG closed at $1121.76.


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Watch these bank earnings

What to watch in bank space earnings reports

What to watch in bank earnings. Stockwinners.com
What to watch in bank earnings.

Bank of America (BAC) and Goldman Sachs (GS) are scheduled to report quarterly results on January 17, while Morgan Stanley (MS) is expected to report on January 18.

What to watch for:

1. TAX REFORM:

Goldman Sachs estimates that the enactment of the new tax legislation will result in a reduction of approximately $5B in the firm’s earnings for Q4 and year ending December 31, 2017, approximately two-thirds of which is due to the repatriation tax.

The remainder includes the effects of the implementation of the territorial tax system and the re-measurement of U.S. deferred tax assets at lower enacted corporate tax rates.

Earlier this month, Morgan Stanley (MS) said it also estimates the net income for the quarter ending December 31, 2017 will include an aggregate net discrete tax provision of approximately $1.25B, comprised of an approximate $1.4B net discrete tax provision as a result of the enactment of the Tax Cuts and Jobs Act, primarily from the re-measurement of certain net deferred tax assets using the lower enacted corporate tax rate, partially offset by an approximate $160M net discrete tax benefit, primarily associated with the re-measurement of reserves and related interest relating to the status of multi-year Internal Revenue Service tax examinations.

2. CRYPTOCURRENCY:

On December 14, Bloomberg reported that Goldman Sachs is seeking a 100% margin on some bitcoin future trades deterring some customers from looking to clear their trades through the bank and resulting in some taking their business elsewhere.

A week later, the publication said the bank was establishing a trading desk to make markets in digital currencies such as bitcoin. The company intends to get the business running by the end of June, if not earlier, the report added.

Also last month, Morgan Stanley said in a regulatory filing that it had purchased an 11.4% stake in Overstock (OSTK), which launched cryptocurrency trading with its tZERO subsidiary.

3. FAVORABLE OUTLOOK:

On November 29, JPMorgan analyst Kian Abouhossein raised his price target for Goldman Sachs to $270 from $263 and called it his top investment banking pick for 2018.

The analyst said he is more positive around the strength of the franchise and believes its fixed income, currencies and commodities business revenue growth opportunity of $1B-plus is more likely to be achieved. Goldman has shown “excellent progress” when it comes to delivering shareholder value, #Abouhossein contended.

Last month, BofA/Merrill analyst Michael #Carrier added Goldman Sachs to the U.S. 1 List, citing an increasing favorable outlook with rising GDP growth, favorable risk/reward, low expectations, and potential catalysts from de-regulation, tax reform, and increased volatility.

Carrier reiterated a Buy rating on the stock and raised his price target on the shares to $300 from $290.

4. BREXIT

On November 20, Goldman Sachs CEO Lloyd Blankfein said the bank will have two EU hubs, in Frankfurt and Paris, post-Brexit, according to Reuters. “We will have more employees on the continent. Some, if they want to, would come from London, we will hire others,” Blankfein said.

“Brexit pushes us to decentralize our activities. In the end, it’s the people who will largely decide where they prefer to live.”


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Blackhawk Network sold for $3.5 billion

Blackhawk to be acquired by Silver Lake, P2 Capital Partners for $45.25 a share

 

Blackhawk Network sold for $3.5 billion. Stockwinners.com
Blackhawk Network sold for $3.5 billion

Blackhawk Network (HAWK) announced that Silver Lake, the global leader in technology investing, and P2 Capital Partners have agreed to acquire Blackhawk in an all-cash transaction for a total consideration of approximately $3.5 billion, which includes Blackhawk’s debt.

Under the terms of the agreement, Blackhawk stockholders will receive $45.25 per share in cash upon closing of the transaction, representing a premium of 24.0% over Blackhawk’s closing share price of $36.50 on January 12, 2018 and a premium of 29.3% over the average closing share price during the 90 calendar days ended January 12, 2018.

Blackhawk operates a leading physical and digital gift card and prepaid payments network with global scale, connecting more than 1,000 brands to over 244,000 retail distribution locations and online channels.

Upon completion of the transaction Blackhawk will operate as a private company under the leadership of the current management team.

Blackhawk’s Board of Directors has unanimously approved the definitive merger agreement and recommends that stockholders vote in favor of the transaction.

The definitive agreement has fully committed debt and equity financing, including an approximately $1.7 billion equity commitment from Silver Lake.

P2 Capital Partners, which beneficially owns approximately 5.4% of Blackhawk’s outstanding common stock, has committed to vote in favor of the proposed transaction.


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Worldwide IT spending to reach $3.7T in 2018

Gartner says worldwide IT spending to reach $3.7T in 2018 

worldwide IT spending to reach $3.7T in 2018. Stockwinners.com
Worldwide IT spending to reach $3.7T in 2018

Worldwide IT spending is projected to total $3.7 trillion in 2018, an increase of 4.5 percent from 2017, according to the latest forecast by Gartner, Inc.  (IT)

“Global IT spending growth began to turn around in 2017, with continued growth expected over the next few years. However, uncertainty looms as organizations consider the potential impacts of Brexit, currency fluctuations, and a possible global recession,” said John-David Lovelock, research vice president at Gartner.

“Despite this uncertainty, businesses will continue to invest in IT as they anticipate revenue growth, but their spending patterns will shift.

Projects in digital business, blockchain, Internet of Things, and progression from big data to algorithms to machine learning to artificial intelligence (AI) will continue to be main drivers of growth.”

The devices segment is expected to grow 5.6 percent in 2018. In 2017, the devices segment experienced growth for the first time in two years with an increase of 5.7 percent.

End-user spending on mobile phones is expected to increase marginally as average selling prices continue to creep upward even as unit sales are forecast to be lower.

PC growth is expected to be flat in 2018 even as continued Windows 10 migration is expected to drive positive growth in the business market in China, Latin America and Eastern Europe.

The impact of the iPhone 8 and iPhone X was minimal in 2017, as expected. However, iOS shipments are expected to grow 9.1 percent in 2018.


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MGM Growth offers to buy VICI Properties for $19.50 per share

MGM Growth offers to buy VICI Properties for $19.50 per share

MGM Growth offers to buy VICI Properties for $19.50 per share. Stockwinners.com
MGM Growth offers to buy VICI Properties for $19.50 per share

MGM Growth Properties (MGM) announced that it sent a letter to the CEO and the Chairman of the Board of Directors of VICI Properties (VICI) proposing to acquire 100% of VICI’s outstanding common stock for $19.50 per share, and to date, VICI has elected not to engage in meaningful discussions.

MGP believes that a proposed combination is extremely attractive strategically and financially for both VICI and MGP. MGP is making its proposal public in an effort to engage and move forward quickly to consummate a transaction.

Under the terms of the proposal, the consideration would be in the form of MGP shares, with the exchange ratio fixed at signing of a definitive agreement.

If desired by VICI shareholders, MGP would be willing to offer a portion of the consideration in the form of cash. Upon completion of the proposed transaction, VICI shareholders would own approximately 43% of the combined company assuming an all-stock transaction and based on MGP’s current share price.

MGM Growth Properties has substantial financial resources to complete the transaction and its offer is not contingent on any financing condition.

Any transaction would be subject to regulatory and shareholder approvals and other customary closing conditions.

MGM Growth Properties believes that a combination with VICI would be accretive to AFFO and represents a compelling opportunity to create significant value for both companies’ respective shareholders.

The combination of the Company and VICI would create the largest triple-net lease REIT and a Top 15 public REIT in the RMZ by enterprise value.

The combined company will have a leading portfolio of premier large scale destination leisure, entertainment and hospitality assets with even greater geographic, asset and tenant diversity.

The combination would also establish a larger combined company with greater efficiencies and an enhanced financial profile that in our view will provide a better path toward maximizing the value of future growth opportunities.

In addition, the ownership in the combined company would enable VICI shareholders to participate meaningfully in the benefits of the transaction, including synergies, a potential trading multiple expansion, more efficient cost of capital and additional liquidity in a significantly larger company.

Furthermore, MGM Growth Properties strongly believes that its proposal provides VICI shareholders with clear value without the execution risk associated with VICI’s proposed public offering, particularly given the fees, discounts, dilution, lock-ups, risks and uncertainties associated with such an offering.


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Barron’s is bullish on Pfizer, Amgen and FAANG stocks

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:

FAANG stocks still have room to run – The FAANGs – Facebook (FB), Amazon (AMZN), Apple (AAPL), Netflix (NFLX) and Google’s parent Alphabet (GOOG; GOOGL) – “took it on the chin” from critics and investors this past week but despite any woes, it is not time to dump them just yet, Ben Levisohn writes in this week’s edition of Barron’s. While concerns could limit gains in the short term, other factors suggest they have more room to run, he adds.

 Franklin may be ‘a bargain’ given potential return of cash – With the new tax law, Franklin Resources is likely to repatriate a significant amount of that cash and may distribute a chunk of it to shareholders, Andrew Bary writes in this week’s edition of Barron’s. Cash represents some 42% of Franklin’s current share price of $44, and its real estate could be worth another $2-$3 a share, he adds.

 Pfizer, Amgen among ‘good bets’ in pharma/biotech – Pfizer (PFE), Amgen (AMGN), AbbVie (ABBV), Elli Lilly (LLY), Bristol-Myers Squibb (BMY) and Johnson & Johnson (JNJ) have strong prospects, promising product pipelines, and good dividends that should keep growing, Lawrence Strauss writes in this week’s edition of Barron’s.

Under hostile takeover, Qualcomm tries offense – Qualcomm (QCOM), which is under a hostile takeover by Broadcom (AVGO), announced new radio frequency business, signaling a greater will to fight back and even go to the offense, Tiernan Ray writes in this week’s edition of Barron’s. Qualcomm’s new business could put pressure on Broadcom and, at the very least, may suggest the latter will have to raise its bid if it hopes to succeed, he adds.

Vivendi music holdings could be worth over $40B – The music business is headed for a growth spurt, as more listeners sign up subscription services such as Spotify, Jack Hough writes in this weekend’s edition of Barron’s. That is good news for rights owners like Vivendi, he adds. With a hand in music, TV and video games, Vivendi (VIVHY) is valued at $37B, but its music holdings alone could be worth more than $40B, thanks to streaming, the report notes.

BEARISH  MENTIONS

Still a long road ahead for self-driving vehicles – Dozens of companies presented driverless technology at the annual Consumer Electronics Show, Jon Swartz writes in this week’s edition of Barron’s. But while optimism about the growth of the market comes as consumers appear to become more comfortable with self-driving “robo-taxis,” the technology has not quite arrived, he notes, adding that autonomous cars are pricey and with drivers ready to take the wheel as a safety buffer. Among the players of the crowded road to the self-driving future are Alphabet (GOOG; GOOGL), Tesla (TSLA), BMW (BMWYY), Ford (F), Toyota Motor (TM), General Motors (GM), and Volkswagen (VLKAY), the report notes.


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Pluristem Therapeutics says its PLX cells ‘significantly inhibit’ cancer cell growth

Pluristem PLX cells ‘significantly inhibit’ cancer cell growth in new study

Pluristem PLX cells 'significantly inhibit' cancer cell growth in new study. Stockwinners.com
Pluristem PLX cells ‘significantly inhibit’ cancer cell growth in new study

Pluristem Therapeutics (PSTI) announced the publication of a peer-reviewed article in the journal Scientific Reports, from the publisher of Nature, titled, “Human Placental-Derived Adherent Stromal Cells Co-Induced with TNF-alpha and IFN-gamma Inhibit Triple-Negative Breast Cancer in Nude Mouse Xenograft Models.”

The article is based on studies which examined the effect of PLX cells that had been induced with tumor necrosis factor alpha and interferon-gamma, on the proliferation of over 50 lines of human cancerous cells.

The induction of the cells was carried out by adjusting their manufacturing process in order to transiently alter their secretion profile.

Data from the first study showed that the modified PLX cells exhibited an anti-proliferative effect on 45% of the tested cancer cell lines, with a strong inhibitory effect on various lines of breast, colorectal, kidney, liver, lung, muscle and skin cancers.

Comprehensive bioinformatics analysis identified common characteristics of the cancer cell lines inhibited by PLX cells.

This knowledge could potentially be used in the future for screening patients’ tumors to identify those patients most likely to show a positive response to treatment with PLX cells.

Based on these promising results, Pluristem conducted a pre-clinical study of female mice harboring human triple negative breast cancer, or TNBC.

TNBC is an aggressive form of breast cancer that does not respond to standard hormonal therapy due to a lack of estrogen and progesterone receptors. Current treatment for TNBC consists of a combination of surgery, radiation therapy, and chemotherapy, and yet the prognosis remains poor for patients with this type of breast cancer.

In this study, weekly intramuscular (IM) injections of the induced PLX cells produced a statistically significant reduction in mean tumor size in the treated group compared with the untreated group, with 30% of the treated mice exhibiting complete tumor remission.

In addition, a statistically significant reduction was seen in the percentage of proliferating tumor cells as well as in the level of blood vessels within the tumors.

Pluristem has filed patent applications relating to the technology for the induction of PLX cells and the use of these cells for the treatment of cancer.

PSTI  last traded at $1.62.


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AMD gives an update on processor security issues

AMD CTO Mark Papermaster gives update on processor security issues

AMD gives update on processor security issues. Stockwinners.com
AMD gives update on processor security issues.

AMD (AMD) CTO Mark Papermaster said:

“The public disclosure on January 3rd that multiple research teams had discovered security issues related to how modern microprocessors handle speculative execution has brought to the forefront the constant vigilance needed to protect and secure data.

These threats seek to circumvent the microprocessor architecture controls that preserve secure data.

At AMD, security is our top priority and we are continually working to ensure the safety of our users as new risks arise. As a part of that vigilance, I wanted to update the community on our actions to address the situation.

Google (GOOG, GOOGL) Project Zero Variant 1, Bounds Check Bypass or Spectre,is applicable to AMD processors. We believe this threat can be contained with an operating system patch and we have been working with OS providers to address this issue.

Microsoft (MSFT) is distributing patches for the majority of AMD systems now. We are working closely with them to correct an issue that paused the distribution of patches for some older AMD processors, AMD Opteron, Athlon and AMD Turion X2 Ultra families, earlier this week.

We expect this issue to be corrected shortly and Microsoft should resume updates for these older processors by next week. For the latest details, please see Microsoft’s website.

Linux vendors are also rolling out patches across AMD products now. GPZ Variant 2, Branch Target Injection or Spectre, is applicable to AMD processors. While we believe that AMD’s processor architectures make it difficult to exploit Variant 2, we continue to work closely with the industry on this threat.

We have defined additional steps through a combination of processor microcode updates and OS patches that we will make available to AMD customers and partners to further mitigate the threat.

AMD will make optional microcode updates available to our customers and partners for Ryzen and EPYC processors starting this week. We expect to make updates available for our previous generation products over the coming weeks.

These software updates will be provided by system providers and OS vendors; please check with your supplier for the latest information on the available option for your configuration and requirements. Linux vendors have begun to roll out OS patches for AMD systems, and we are working closely with Microsoft on the timing for distributing their patches.

We are also engaging closely with the Linux community on development of ‘return trampoline,’ Retpoline, software mitigations. GPZ Variant 3, Rogue Data Cache Load or Meltdown, is not applicable to AMD processors. We believe AMD processors are not susceptible due to our use of privilege level protections within paging architecture and no mitigation is required.

There have also been questions about GPU architectures. AMD Radeon GPU architectures do not use speculative execution and thus are not susceptible to these threats. We will provide further updates as appropriate on this site as AMD and the industry continue our collaborative work to develop mitigation solutions to protect users from these latest security threats.”

AMD closed at $12.14.


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FDA votes against Lipocine’s TLANDO

Lipocine announces FDA voted 13-6 against TLANDO

Lipocine announces FDA voted 13-6 against TLANDO. Stockwinners.com
Lipocine announces FDA voted against TLANDO

Lipocine (LPCN) announced that the Bone, Reproductive and Urologic Drugs Advisory Committee of the U.S. Food and Drug Administration voted six in favor and thirteen against the benefit/risk profile of TLANDO, the Company’s oral testosterone product candidate for testosterone replacement therapy in adult males for conditions associated with a deficiency of endogenous testosterone, also known as hypogonadism.

The role of BRUDAC is to provide recommendations to the FDA.

The FDA decision on whether or not to approve the TLANDO New Drug Application is anticipated by the assigned Prescription Drug User Fee Act goal date of May 8, 2018.

CEO Mahesh Patel says: “We continue to believe that efficacy and safety results from numerous clinical studies with TLANDO are consistent with other FDA approved TRT products… We look forward to continuing to work with the FDA through the remainder of the review process.”

LPCN closed at $3.46.


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Novavax higher on its promising vaccine

Analyst quadruples Novavax target after sign that RSV vaccine works

Novavax target quadrupled Novavax  on signs that RSV vaccine works. Stockwinners.com
Novavax target quadrupled Novavax on signs that RSV vaccine works

This morning, B. Riley FBR analyst George Zavoico raised his price target for Novavax (NVAX) nearly five-fold to $10 after the company announced more details about an informational analysis of Prepare, an ongoing Phase 3 trial of an RSV F vaccine for maternal immunization to protect newborn infants.

This target hike comes just five days after #Zavoico started coverage of the stock with a Buy rating and a $2.25 price target.

PREPARE UPDATE

In slides accompanying a presentation by the company at the 36th annual JPMorgan Healthcare conference, Novavax provided an update on the status of its Phase 3 Respiratory Syncytial Virus vaccine for Infants Via Maternal Immunization clinical trial, dubbed the “Prepare” trial.

Novavax pointed out that an informational analysis was performed in the fourth quarter of 2017, and targeted an efficacy threshold against the primary endpoint at day 90 of more than 40%.

In December, the Data Safety Monitoring Board statistician performed an unblinded analysis and communicated that the RSV F vaccine “successfully met” the criteria, the company highlighted in the slides.

Importantly, Novavax stated that the informational analysis indicated that its RSV F Vaccine is efficacious, and that Phase 3 enrollment should yield pivotal efficacy data by the fourth quarter of 2018 and the first quarter of 2019.

The company expects it to be the first licensed RSV vaccine, with an estimated global peak revenue of over $1.5B.

INCREASING CONFIDENCE IN PREPARE TRIAL

Just five days after initiating coverage of the stock, B. Riley FBR analyst George Zavoico raised his price target for Novavax to $10 from $2.25, while reiterating a Buy rating on the shares.

The target increase comes after the company announced more details about the informational analysis of #Prepare.

The analyst noted that he has learned that the objective of the analysis allowed by the FDA was to determine if the trial vaccine efficacy was greater than 45%, a threshold that he thinks will translate into a successful Phase 3 trial and a commercially viable vaccine.

Overall, Zavoico told investors that the results increase his confidence in a successful outcome of the Prepare trial.

WHAT’S NOTABLE

The company’s maternal immunization program is supported by an $89M grant from the Bill and Melinda Gates Foundation and has also been granted Fast Track designation by the U.S. FDA.

PRICE ACTION:

In late Wednesday’s morning trading, shares of Novavax (NVAX) have jumped 53c, or almost 40%, to $1.86.


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Nvidia launches ‘functionally safe’ AI self-driving platform NVIDIA DRIVE 

Nvidia announces ‘functionally safe’ AI self-driving platform NVIDIA DRIVE 

Nvidia pullback after Q2 beat a buying opportunity. See Stockwinners.com Market Radar for more
Nvidia announces ‘functionally safe’ AI self-driving platform NVIDIA DRIVE

NVIDIA (NVDA) unveiled details of its functional safety architecture for NVIDIA DRIVE, its AI autonomous vehicle platform, which uses redundant and diverse functions to enable vehicles to operate safely, even in the event of faults related to the operator, environment or systems.

The NVIDIA DRIVE architecture enables automakers to build and deploy self-driving cars and trucks that are functionally safe and can be certified to international safety standards, such as ISO 26262.

The NVIDIA DRIVE AV autonomous vehicle software stack performs functions like ego-motion, perception, localization and path planning. To realize fail operation capability, each functionality includes a redundancy and diversity strategy.

For example, perception redundancy is achieved by fusing lidar, camera and radar.

Deep learning and computer vision algorithms running on CPU, CUDA GPU, DLA and PVA enhance redundancy and diversity.

The NVIDIA DRIVE AV stack is a full backup system to the self-driving stack developed by the automaker, enabling Level 5 autonomous vehicles to achieve the highest level of functional safety. Included are lockstep processing and error-correcting code on memory and buses, with built-in testing capabilities.

The ASIL-C NVIDIA DRIVE Xavier processor and ASIL-D rated safety microcontroller with appropriate safety logic can achieve the highest system ASIL-D rating.

NVDA closed at $219.59.


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Avadel Pharmaceuticals receives orphan drug designation for its narcolepsy drug

Avadel receives orphan drug designation for FT 218 for narcolepsy 

Avadel receives orphan drug designation for FT 218 for narcolepsy
Avadel receives orphan drug designation for FT 218 for narcolepsy

Avadel Pharmaceuticals (AVDL) announced that FT 218 has been granted Orphan Drug Designation from the U.S. Food and Drug Administration for the treatment of narcolepsy.

FT 218, a once-nightly formulation of sodium oxybate using Avadel’s proprietary Micropump technology, is currently undergoing testing in a Phase III clinical trial for the treatment of excessive daytime sleepiness and cataplexy in patients suffering from narcolepsy.

The designation has been granted on the plausible hypothesis that FT 218 may be clinically superior to the same drug already approved for the same indication because FT 218 may be safer due to ramifications associated with the dosing regimen of the previously-approved product.

Mike Anderson, Avadel’s Chief Executive Officer, said, “Receipt of Orphan Drug Designation for FT 218 is meaningful for both Avadel and patients suffering from Narcolepsy.

Narcolepsy is a debilitating and rare sleep disorder for which limited treatment options exist. We look forward to completing our REST-ON Phase III trial this year and are hopeful that FT 218 can provide meaningful benefit to patients and their quality of life over other standards of care.”

Narcolepsy is a long-term neurological disorder that involves a decreased ability to regulate sleep-wake cycles. Symptoms include periods of excessive daytime sleepiness that usually last from seconds to minutes and may occur at any time. About 70% of those affected also experience episodes of sudden loss of muscle strength, known as cataplexy. These spells can be brought on by strong emotions.  Less commonly there may be inability to move or vivid hallucinations while falling asleep or waking up.[1] People with narcolepsy tend to sleep about the same number of hours per day as people without, but the quality of sleep tends to be worse.

AVDL closed at $9.10, it last traded at $9.86.


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Honda recalls 465,000 vehicles with faulty airbag

Honda to recall additional 465,000 vehicles with faulty airbag inflators

Honda to recall additional 465,000 vehicles with faulty airbag inflators. Stockwinners.com
Honda to recall additional 465,000 vehicles with faulty airbag inflators

In the third phase of planned recalls announced by NHTSA in May 2016 and based on recent Defect Information Reports from the airbag inflator supplier Takata (TKTDY), Honda (HMC) will conduct recalls covering approximately 717,000 Honda and Acura automobiles in the United States to replace, for free, Takata passenger front airbag inflators that do not contain a moisture absorbing desiccant.

Excluding vehicles subject to the earlier Takata airbag inflator recalls, approximately 465,000 additional Honda and Acura vehicles in the U.S. will become subject to recall for the first time as a result of this action.

Including the recall announced today, Honda has adequate replacement part supplies to repair all Honda and Acura models currently included in inflator recalls in the United States.

Owners of affected vehicles can seek repair immediately at authorized Honda and Acura dealers.

No additional driver front airbag inflators in Honda or Acura automobiles will be subject to recall in this action, as all potentially affected driver inflators already are subject to prior recalls.

However, some vehicles previously repaired under earlier driver front inflator recalls will now require replacement of those vehicles’ passenger front inflators under this new action.

In addition, 960 Honda Gold Wing Airbag motorcycles from the 2009-2016 model years will be recalled to replace optional Takata non-desiccated airbag inflator modules installed on those vehicles.

Due to the relatively small vehicle population and an adequate supply of replacement inflators, Honda has elected to pull forward the recall of motorcycles that would have been included in Phase 4 of NHTSA’s recall plan (scheduled for January 2019), placing them under recall earlier than required.

With this action, all Honda motorcycles equipped with defective inflators in the U.S. are now eligible for repair. There have been no Takata airbag inflator ruptures involving Honda motorcycles globally.

With this new action, a total of approximately 11.9 million Honda and Acura automobiles have been or now are subject to recall for replacement of a Takata driver and/or passenger front airbag inflator in the United States, with approximately 4,540 Honda motorcycles subject to recall for the replacement of the Takata airbag inflator module.

HMC closed at $36.00


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Kodak enters cryptocurrency frenzy

Kodak jumps after announcing blockchain initiative and cryptocurrency

Kodak jumps after announcing blockchain initiative and cryptocurrency
Kodak jumps after announcing blockchain initiative and cryptocurrency

Shares of Kodak (KODK) surged after the company and WENN Digital, in a licensing partnership, announced the launch of the KODAKOne image rights management platform and KODAKCoin, a photo-centric cryptocurrency to “empower photographers and agencies to take greater control in image rights management.”

Kodak CEO Jeff Clarke said: “For many in the tech industry, ‘blockchain’ and ‘cryptocurrency’ are hot buzzwords, but for photographers who’ve long struggled to assert control over their work and how it’s used, these buzzwords are the keys to solving what felt like an unsolvable problem.

Kodak has always sought to democratize photography and make licensing fair to artists.

These technologies give the photography community an innovative and easy way to do just that.” The initial coin offering will open on January 31, 2018 and is open to accredited investors from the U.S., UK, Canada and other select countries.

Following the company’s announcement, Kodak shares are up $2.72, or 85%, to $5.85.


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