Zantac causes cancer says FDA

FDA calls for removal of Zantac from the market

The U.S. Food and Drug Administration announced it is requesting manufacturers withdraw all prescription and over-the-counter ranitidine drugs from the market immediately.

This is the latest step in an ongoing investigation of a contaminant known as N-Nitrosodimethylamine, or NDMA, in ranitidine medications, commonly known by the brand name Zantac.

FDA says Zantac causes cancer; orders product removal

The agency has determined that the impurity in some ranitidine products increases over time and when stored at higher than room temperatures and may result in consumer exposure to unacceptable levels of this impurity.

As a result of this immediate market withdrawal request, ranitidine products will not be available for new or existing prescriptions or OTC use in the U.S. NDMA is a probable human carcinogen.

In the summer of 2019, the FDA became aware of independent laboratory testing that found NDMA in ranitidine.

Low levels of NDMA are commonly ingested in the diet, for example NDMA is present in foods and in water. These low levels would not be expected to lead to an increase in the risk of cancer.

However, sustained higher levels of exposure may increase the risk of cancer in humans.

The FDA conducted thorough laboratory tests and found NDMA in ranitidine at low levels.

Ranitidine causes cancer, Stockwinners

At the time, the agency did not have enough scientific evidence to recommend whether individuals should continue or stop taking ranitidine medicines, and continued its investigation and warned the public in September 2019 of the potential risks and to consider alternative OTC and prescription treatments.

New FDA testing and evaluation prompted by information from third-party laboratories confirmed that NDMA levels increase in ranitidine even under normal storage conditions, and NDMA has been found to increase significantly in samples stored at higher temperatures, including temperatures the product may be exposed to during distribution and handling by consumers.

The testing also showed that the older a ranitidine product is, or the longer the length of time since it was manufactured, the greater the level of NDMA.

These conditions may raise the level of NDMA in the ranitidine product above the acceptable daily intake limit.

With today’s announcement, the FDA is sending letters to all manufacturers of ranitidine requesting they withdraw their products from the market.

The FDA is also advising consumers taking OTC ranitidine to stop taking any tablets or liquid they currently have, dispose of them properly and not buy more; for those who wish to continue treating their condition, they should consider using other approved OTC products.

FDA orders removal of Zantac, Stockwinners

Patients taking prescription ranitidine should speak with their health care professional about other treatment options before stopping the medicine, as there are multiple drugs approved for the same or similar uses as ranitidine that do not carry the same risks from NDMA.

To date, the FDA’s testing has not found NDMA in famotidine (Pepcid), cimetidine (Tagamet), esomeprazole (Nexium), lansoprazole (Prevacid) or omeprazole (Prilosec). Zantac is marketed and sold by Sanofi (SNY).

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COVID-19 vaccine is coming

Johnson & Johnson announces lead vaccine candidate for COVID-19

Johnson & Johnson (JNJ) announced the selection of a lead COVID-19 vaccine candidate from constructs it has been working on since January 2020.

JNJ’s Janssen Pharmaceutical promises a Covid-19 Vaccine, Stockwinners

The significant expansion of the existing partnership between the Janssen Pharmaceutical Companies of Johnson & Johnson and the Biomedical Advanced Research and Development Authority (BARDA); and the rapid scaling of the company’s manufacturing capacity with the goal of providing global supply of more than one billion doses of a vaccine.

Janssen expects a Covid-19 vaccines by 2021, Stockwinners

The company expects to initiate human clinical studies of its lead vaccine candidate at the latest by September and anticipates the first batches of a COVID-19 vaccine could be available for emergency use authorization in early 2021, a substantially accelerated time frame in comparison to the typical vaccine development process.

Through a landmark new partnership, BARDA, which is part of the Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services, and Johnson & Johnson together have committed more than $1B of investment to co-fund vaccine research, development, and clinical testing. Johnson & Johnson will use its validated vaccine platform and is allocating resources, including personnel and infrastructure globally, as needed, to focus on these efforts.

Covid-19 has shut down most of the world, Stockwinners.com

Separately, BARDA and the company have provided additional funding that will enable expansion of their ongoing work to identify potential antiviral treatments against the novel coronavirus.

As part of its commitment, Johnson & Johnson is also expanding the company’s global manufacturing capacity, including through the establishment of new U.S. vaccine manufacturing capabilities and scaling up capacity in other countries.

The additional capacity will assist in the rapid production of a vaccine and will enable the supply of more than one billion doses of a safe and effective vaccine globally.

The company plans to begin production at risk imminently and is committed to bringing an affordable vaccine to the public on a not-for-profit basis for emergency pandemic use.

JNJ closed at $123.16, last traded at $128.85.

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Microsoft acknowledges security flaw in its new Windows operating system

Microsoft says aware of new security flaw found in Microsoft Windows

Microsoft (MSFT) said it is aware of limited targeted attacks that could leverage un-patched vulnerabilities in the Adobe Type Manager Library, and is providing the following guidance to help reduce customer risk until the security update is released.

A security flaw is discovered in Windows, Stockwinners

Two remote code execution vulnerabilities exist in Microsoft Windows when the Windows Adobe Type Manager Library improperly handles a specially-crafted multi-master font – Adobe Type 1 PostScript format.

There are multiple ways an attacker could exploit the vulnerability, such as convincing a user to open a specially crafted document or viewing it in the Windows Preview pane.

Vulnerability exists on Adobe Type Manager, Stockwinners

Microsoft is aware of this vulnerability and working on a fix.

Updates that address security vulnerabilities in Microsoft software are typically released on Update Tuesday, the second Tuesday of each month.

This predictable schedule allows for partner quality assurance and IT planning, which helps maintain the Windows ecosystem as a reliable, secure choice for our customers.

The operating system versions that are affected by this vulnerability are listed below. Please see the mitigation and workarounds for guidance on how to reduce the risk.

Software patch is coming, Stockwinners

The security flaw, which Microsoft deems “critical” — its highest severity rating — is found in how Windows handles and renders fonts, according to the advisory posted.

Although Windows 7 is also affected, only enterprise users with extended security support will receive patches. In the meantime, the advisory offered a temporary workaround for affected Windows users to mitigate the flaw until a fix is available.

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Willis Towers Watson sold for $30B in stock

Aon plc to combine with Willis Towers Watson in all-stock transaction

Aon plc (AON) and Willis Towers Watson (WLTW) announced a definitive agreement to combine in an all-stock transaction with an implied combined equity value of approximately $80B.

The combined company, to be named Aon, will be “the premier, technology-enabled global professional services firm focused on the areas of risk, retirement and health,” the companies stated.

Willis Tower Watson merges with AON, Stockwinners

Aon will maintain operating headquarters in London, United Kingdom. John Haley will take on the role of Executive Chairman with a focus on growth and innovation strategy.

The combined firm will be led by Greg Case and Aon Chief Financial Officer Christa Davies.

AON merges with Willis Tower Watson

Under the terms of the agreement unanimously approved by the Boards of Directors of both companies, each Willis Towers Watson shareholder will receive 1.08 Aon ordinary shares for each Willis Towers Watson ordinary share, and Aon shareholders will continue to own the same number of ordinary shares in the combined company as they do immediately prior to the closing.

Upon completion of the combination, existing Aon shareholders will own approximately 63% and existing Willis Towers Watson shareholders will own approximately 37% of the combined company on a fully diluted basis.

Aon anticipates that the transaction will provide annual pre-tax synergies and other cost reductions of $800M by the third full year of combination, thereby allowing the firm to continue significant investment in innovation and growth. Potential revenue synergies due to complementary capabilities are expected but not included in the synergy estimates.

The transaction is expected to be accretive to Aon adjusted EPS in the first full year of the combination with peak adjusted EPS accretion in the high teens after full realization of $800M of pre-tax synergies.

Willis Towers Watson and Aon anticipate savings of $267M in the first full year of the combination, reaching $600M in the second full year, with the full $800M achieved in the third full year.

Free cash flow accretion is expected to breakeven in the second full year of the combination with free cash flow accretion of more than 10% after full realization of synergies.

The transaction is expected to generate over $10B of shareholder value creation from the capitalized value of the expected pre-tax synergies, based on the blended 2020 price to earnings ratio of Willis Towers Watson and Aon UK on 6 March 2020, net of $2.0B in one-time transaction, retention and integration costs.

WTLW last traded at $193.13. AON last traded at $192.15.

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Coronavirus induced slowdown is coming!

U.S. factory orders undershot estimates in January

U.S. factory orders undershot estimates in January, with declines of -0.5% for the headline and -0.1% ex-transportation, alongside a -0.1% factory inventory drop. Note that this report reflects the period prior to the spread of Covid-19 or Coronavirus.

Covid-19 spreads across the World.

The undershoot reflected declines of -0.8% for nondurable shipments and orders, and -0.2% for nondurable inventories, after downward December revisions, with a headwind for both from energy prices.

Factory Orders Slow in January

The equipment data from the durables report were revised modestly lower, alongside slight downward tweaks in the December levels for orders, shipments, and inventories.

The data still show encouraging January gains for most of the equipment data despite downward bumps, but lean shipments and inventory data, with January pull-backs for transportation and defense after December gains.

Analysts still expect a Q4 GDP growth boost to 2.2% from 2.1% but with -$1 B revisions for both factory inventories and equipment spending.

Factory orders fall in January

Analysts expect GDP growth of 2.0% in Q1, with a -5% (was -4%) Q1 contraction rate for real equipment spending after an estimated -4.8% (was -4.4%) Q4 pace. Analysts expect a -$20 B Q1 inventory subtraction that leaves a $9 B liquidation rate, with a big hit to inventories from reduced imports from China.

Analysts assume a -0.1% (was flat) January business inventory drop after a flat (was 0.1%) figure in December.

Earlier, we had a blog regarding slow down in truck sales was flashing an economic slowdown on the horizon. Read the blog here.

Feds Panic

Fed funds futures have continued to rally as the market prices in another 25 bps of easing at the upcoming March 17, 18 FOMC, on top of this week’s 50 bp reduction.

FOMC emergency 50bp rate cut may have hurt the market.

The market is also supported from flight from risk with declines of over 2% on Wall Street in pre-open action.

The futures are now fully priced for a 25 bps easing in two weeks, to be followed by another 25 bps at the April 28, 29 FOMC with about 75% risk, while June is now seeing about a 50-50 bet for yet one more 25 bp cut at the June 9, 10 FOMC.

Jerome Powell gives in to WH pressure and cuts rates.

That would see the policy band at 0% to 0.50%. Analysts continue believe the Fed and the markets are over-reacting and analysts doubt the economic impact of COVID-19 will be as disastrous as the market’s are pricing in.

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AVX sold for about $3.7B

AVX to be acquired by Kyocera for $21.75 per share in cash

AVX Corp. (AVX) announced that Kyocera and AVX have entered into a definitive merger agreement providing for the acquisition by Kyocera of all the outstanding shares of common stock of AVX not owned by Kyocera pursuant to an all-cash tender offer for $21.75 per share, followed by a squeeze-out merger in which all of the outstanding shares of AVX common stock not tendered in the Tender Offer will be converted into the right to receive $21.75 per share of common stock, in cash.

Kyocera currently owns approximately 72% of the outstanding shares of AVX common stock.

Following completion of the Transaction, AVX will become a wholly owned subsidiary of Kyocera.

Kyocera buys the rest of AVX shares that it did not own, Stockwinners

The $21.75 offer price represents a 44.6% premium over AVX’s closing price on November 26, 2019 and a 42.1%, 42.4%, and 34.9% premium over AVX’s 1-, 3- and 12- month average closing share price, respectively.

As previously announced, following receipt of a proposal from Kyocera to acquire all of the outstanding shares of AVX common stock that Kyocera does not own for a price of $19.50 in cash, the AVX board of directors appointed a special committee consisting of three independent directors of AVX for purposes of evaluating and negotiating a potential transaction with Kyocera.

AVX Corp. sold to Kyocera, Stockwinners

Following the formation of the Special Committee, Kyocera and the Special Committee have been in discussions and negotiations regarding Kyocera’s proposal to acquire all of the outstanding shares of common stock of AVX not owned by Kyocera.

The board of AVX, acting on the recommendation of the Special Committee, has approved the Transaction and determined to recommend that the AVX stockholders tender their shares in the Tender Offer.

The Transaction is subject to customary closing conditions and is not subject to any financing condition. Kyocera has announced that it currently expects the Transaction to close in the fourth quarter of Kyocera’s fiscal year ending March 2020.

The Tender Offer will be subject to customary conditions and will not be subject to any minimum condition.

AVX is a leading worldwide manufacturer, supplier, and reseller of a broad line of electronic components, interconnect, sensing and control devices, and related products. Electronic components and connector, sensing and control products manufactured or resold by AVX are used in many types of end use products, including those in telecommunications, automotive, transportation, energy harvesting, consumer electronics, military/aerospace, medical, computer, and industrial markets. 

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Northview REIT sold for $4.8B

Northview REIT to be acquired by Starlight, KingSett for $36.25 per unit

Northview Apartment Real Estate Investment Trust (NPRUF) announced that it has entered into an arrangement agreement with affiliates of Starlight Group Property Holdings pursuant to which the Purchasers will acquire Northview, and the holders of Northview’s outstanding trust units will receive $36.25 per Unit in cash in a transaction valued at $4.8 billion including net debt.

Northview REIT sold for $4.8B, Stockwinners

Under the Arrangement Agreement, the Purchasers will acquire Northview, and the holders of Northview’s outstanding Units will receive $36.25 per Unit.

The Offer Price represents a total equity value of approximately $2.5 billion on a fully diluted basis and a total transaction value of approximately $4.8 billion including the assumption of net debt. The Transaction is not subject to a financing condition.

Unitholders will be able to elect to receive 100% of the Offer Price in the form of cash.

Starlight buys Northview REIT, Stockwinners

Alternatively, unitholders may elect to receive all or a portion of the Offer Price in units of a new, multi-residential fund that would own a geographically diverse portfolio of Northview properties located in six Canadian provinces and two territories.

The High Yield Fund will apply to list its units on a Canadian securities exchange concurrently with the close of the Transaction. The listing will be subject to the High Yield Fund fulfilling all of the initial listing requirements and conditions of the Exchange.

Further details with respect to the High Yield Fund will be provided in the management information circular to be mailed to Northview Unitholders. Elections to receive High Yield Fund units will be subject to proration.

All-Cash Elections will not be subject to proration. Unitholders not specifying an election will be deemed to have elected to receive the All-Cash Consideration.

Pursuant to the Arrangement Agreement, Northview has an initial 30-day go-shop period, beginning on February 19, 2020 and ending on March 20, 2020, during which it is permitted to actively solicit, evaluate and enter into negotiations with third parties that express an interest in acquiring Northview. Northview has the option to extend the Go-Shop Period by up to 30 days, in certain circumstances.

Mr. Daniel Drimmer, Chief Executive Officer and President of Starlight, has committed to vote the Units he beneficially owns, controls or directs in favour of, or tender his Units into, any all-cash superior proposal received during the Go-Shop Period, subject to certain terms and conditions, pursuant to a voting and support agreement.

The Arrangement Agreement also provides a two-tier termination fee structure such that if Northview is successful in completing a transaction pursuant to a superior proposal received during the Go-Shop Period, there will be a termination fee payable to the Purchasers of $37.7 million.

If a transaction is completed pursuant to a superior proposal received following the expiry of the Go-Shop Period, the Purchasers will be entitled to a termination fee of $88.0 million.

The Purchasers will have the right to match any superior proposals received either during or after the Go-Shop Period. The Transaction is structured as a statutory plan of arrangement under the Alberta Business Corporations Act.

Completion of the Transaction requires approval of at least 66 2/3% of the votes cast by unitholders and holders of special voting units, as well as the approval by a simple majority of votes cast by disinterested unitholders and holders of special voting units, excluding Starlight, its affiliates and any other unitholders required to be excluded under Multilateral Instrument 61-101 – Protection of Minority Security Holders in Special Transactions.

The Transaction is also subject to approval of the Alberta Court of Queen’s Bench, regulatory approvals, consents and approvals from Canada Mortgage and Housing Corporation and certain of Northview’s lenders and the satisfaction of other customary closing conditions.

Northview expects to continue to pay a monthly distribution of $0.1358 per trust unit through closing of the Transaction. The Transaction is expected to close by Q3 of 2020.

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Morgan Stanley to acquire E-Trade for $58.74 per share

Morgan Stanley acquires E-Trade in all-stock deal valued at $13B

Morgan Stanley (MS) and E-Trade Financial (ETFC) have entered into a definitive agreement under which Morgan Stanley will acquire E-Trade in an all-stock transaction valued at approximately $13B.

Etrade sold for $13 B, Stockwinners

Under the terms of the agreement, E-Trade stockholders will receive 1.0432 Morgan Stanley shares for each E-Trade share, which represents per share consideration of $58.74 based on the closing price of Morgan Stanley.

The acquisition is subject to customary closing conditions, including regulatory approvals and approval by E-Trade shareholders, and is expected to close in the fourth quarter of 2020.

Morgan Stanley pays $13B for Etrade. Stockwinners

The transaction provides “significant upside potential” for shareholders of both Morgan Stanley and E-Trade, the company said in a statement.

“Shareholders from both companies will benefit from potential cost savings estimated at approximately $400 million from maximizing efficiencies of technology infrastructure, optimizing shared corporate services and combining the bank entities, as well as potential funding synergies of approximately $150 million from optimizing E-Trade’s approximate $56 billion of deposits,” they said.

Morgan Stanley said its “full-service, advisor-driven model coupled with E-Trade”s direct-to-consumer and digital capabilities, will allow the combined business to have best-in-class product and service offerings to support the full spectrum of wealth.”

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Legg Mason sold for $6.5B including debt assumption

Franklin Templeton to acquire Legg Mason for $50.00 per share in cash

Franklin Resources (BEN) announced that it has entered into a definitive agreement to acquire Legg Mason (LM) for $50.00 per share of common stock in an all-cash transaction.

The company will also assume approximately $2B of Legg Mason’s outstanding debt.

Franklin Templeton buys Legg Mason for $4.5B, Stockwinners

The acquisition of Legg Mason and its multiple investment affiliates, which collectively manage over $806 billion in assets as of January 31, will establish Franklin Templeton as one of the world’s largest independent, specialized global investment managers with a combined $1.5 trillion in assets under management, or AUM, across one of the broadest ranges of high-quality investment teams in the industry.

Legg Mason sold for $4.5B cash and $2B debt assumptions, Stockwinners

The combined footprint of the organization will significantly deepen Franklin Templeton’s presence in key geographies and create an expansive investment platform that is well balanced between institutional and retail client AUM.

In addition, the combined platform creates a strong separately managed account business. Trian Fund Management, L.P. and funds managed by it, which collectively own approximately 4 million shares or 4.5% of the outstanding stock of Legg Mason, have entered into a voting agreement in support of the transaction.

With this acquisition, Franklin Templeton will preserve the autonomy of Legg Mason’s affiliates, ensuring that their investment philosophies, processes and brands remain unchanged.

As with any acquisition, the pending integration of Legg Mason’s parent company into Franklin Templeton’s, including the global distribution operations at the parent company level, will take time and only commence after careful and deliberate consideration.

Following the closing of the transaction, Jenny Johnson will continue to serve as president and CEO, and Greg Johnson will continue to serve as executive chairman of the Board of Franklin Resources, Inc.

There will be no changes to the senior management teams of Legg Mason’s investment affiliates.

Global headquarters will remain in San Mateo, CA and the combined firm will operate as Franklin Templeton.

The all-cash consideration of $4.5 billion will be funded from the Company’s existing balance sheet cash.

Franklin Templeton will also assume approximately $2 billion in Legg Mason’s outstanding debt.

Upon closing of the transaction, Franklin Templeton expects to maintain a robust balance sheet and considerable financial flexibility with pro forma gross debt of approximately $2.7 billion with remaining cash and investments of approximately $5.3 billion.

This transaction is designed to preserve the Company’s financial strength and stability with modest leverage, significant liquidity and strong cash flow to provide ongoing flexibility to invest in further growth and innovation.

This transaction is expected to generate upper twenties percentage GAAP EPS accretion in Fiscal 2021 (based on street consensus earnings estimates for each company), excluding one-time charges, non-recurring and acquisition related expenses.

While cost synergies have not been a strategic driver of the transaction, there are opportunities to realize efficiencies through parent company rationalization and global distribution optimization.

These are expected to result in approximately $200 million in annual cost savings, net of significant growth investments Franklin Templeton expects to make in the combined business and in addition to Legg Mason’s previously announced cost savings.

The majority of these savings are expected to be realized within a year, following the close of the transaction, with the remaining synergies being realized over the next one to two years.

The transaction has been unanimously approved by the boards of Franklin Resources, Inc. and Legg Mason, Inc.

This transaction is subject to customary closing conditions, including receipt of applicable regulatory approvals and approval by Legg Mason’s shareholders, and is expected to close no later than the third calendar quarter of 2020.

LM closed at $40.72. BEN closed at $24.36.

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SmilesDirect and NBC clash

NBC reports problems with SDC, company claims poor reporting

SmileDirectClub (SDC) promises to fix customers’ smiles for about a third of the cost of traditional braces with at-home teeth straightening, but a number of patients say the aligners instead caused painful problems, NBC News reported yesterday.

SmilesDirect sells braces directly to consumers, Stockwinners

The Better Business Bureau reports more than 1,800 complaints nationwide involving SmileDirectClub, according to the report. Last month, nine members of Congress asked the Food and Drug Administration and the Federal Trade Commission to investigate SmileDirectClub “to ensure that it is not misleading consumers or causing patient harm.”

SmileDirectClub issues the following statement in response to the NBC story on the company.

The company said, in part, “We are disappointed that though we provided NBC with the opportunity to obtain all relevant facts as to the safety and efficacy of teledentistry for the provision of clear aligner therapy, NBC failed to provide its viewers with a balanced and fair news story reflecting those facts.

SDC package, Stockwinners

The piece misrepresents SmileDirectClub and the quality of care provided by the over 250 state-licensed dentists and orthodontists across the country who use our platform to treat their patients. We are surprised by the journalist’s blatant disregard for the facts and failure to include all of the accurate information we provided.

Notably, the almost five-minute report and online story does not include one interview or statement from the more than 750,000 satisfied customers who have used our products to improve their lives, nor does it include a single interview with any of the hundreds of dentists who have publicly supported our technology.

NBC reports a negative story on SDC

In fact, though NBC conducted interviews over the last 30 days with these doctors and customers under the guise of providing a fair and balanced story, their statements were not included or referenced in this story.

NBC airs this report causing SDC shares to tumble, Stockwinners

SmileDirectClub made customers, doctors and team members available for hours of in-person interviews, phone calls and email correspondence. The Company provided a tremendous amount of critical information that would have allowed NBC to report a more accurate and balanced story…There is no investigation into SmileDirectClub by the Federal Drug Administration or the FTC, and SmileDirectClub is in full compliance with FDA regulations, including its 510K manufacturing certification.

The letter referenced from members of Congress to the FDA is based on misinformation originated by dental trade organizations and is nothing more than the latest in a series of anti-competitive publicity tactics designed to attempt to limit our success, which is a direct threat to traditional orthodontia.

Of the nine congressmen who signed this letter, five are dentists, an interest that should be noted by an organization such as NBC Nightly News…Lastly, the California law states that dentists should review the “…patient’s most recent diagnostic digital or conventional radiographs or other equivalent bone imaging suitable for orthodontia.

New radiographs or other equivalent bone imaging shall be ordered if deemed appropriate by the treating dentist.” The doctors who use our platform are required to comply with the laws in every state in which they practice when using our platform, including the laws of the State of California.

While SmileDirectClub disagrees that the legislature should be setting clinical standards, we ensure that our model requires compliance with all laws.”

SDC closed at $15.33, last traded at $14.78.

Note that in recent days, Fidelity and Blackrock took major positions in SmilesDirect.

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Watch shares of iCAD

iCAD announces first metastatic brain tumor treated with Xoft Axxent eBx System

iCAD (ICAD) announced the first metastatic brain tumor was treated in the U.S. with intraoperative radiation therapy, or IORT, using the Xoft Axxent Electronic Brachytherapy, or eBx, System.

This procedure is the start of a clinical trial on IORT for patients with large brain metastases treated with neurological resection with the Xoft System.

iCAD reports positive brain tumor data, Stockwinners

The Xoft System is also currently being studied for the treatment of other types of brain tumors in institutions worldwide, including the European Medical Center.

Positive preliminary clinical data on Xoft IORT for the treatment of recurrent glioblastoma, or GBM, was presented at the European Association of Neurosurgical Societies, or EANS.

The Xoft System is made by iCAD, Stockwinners

In a matched pair study, 30 patients were treated for recurrent GBM.

The IORT group was treated with a single fraction of radiation immediately following surgical resection, without chemotherapy or temozolomide following surgery.

The comparison group was treated with routine postoperative adjuvant chemotherapy +/- concomitant or sequential EBRT. Median overall survival, or OS, in group A was 24 months; OS for group B was 21 months.

As of September 2019, nine patients were still alive from group A, whereas none of the patients in group B survived.

A retrospective analysis published in World Neurosurgery examined the repeat resection and the various methods of IORT for the treatment of malignant brain gliomas, including high-energy linear accelerators and modern, integrated brachytherapy solutions using solid and balloon applicators.

iCAD, Inc. provides image analysis, workflow solutions, and radiation therapy for the early identification and treatment of cancer in the United States and internationally. It operates through two segments, Cancer Detection and Cancer Therapy. The company provides electronic brachytherapy (eBX) products, including Axxent eBx systems for the treatment of early stage breast cancer, endometrial cancer, cervical cancer, and skin cancer, as well as for treating other cancers or conditions where radiation therapy is indicated comprising intraoperative radiation therapy.

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FGL Holdings sold for $2.7B

FGL Holdings to be acquired by Fidelity National for $12.50 per share

FGL Holdings (FG) announced that the company has entered into a merger agreement pursuant to which Fidelity National Financial (FNF) will acquire F&G for $12.50 per share, representing an equity value of approximately $2.7B.

The transaction was approved by a Special Committee of F&G Directors, a Special Committee of FNF Directors and the FNF board.

FGL sold for $2.7 billion, Stockwinners

Under the terms of the merger agreement, holders of F&G’s ordinary shares (other than FNF and its subsidiaries) may elect to receive either $12.50 per share in cash or 0.2558 of a share of FNF common stock for each ordinary share of F&G they own.

FGL Holdings sells individual life insurance products and annuities in the United States. The company offers deferred annuities, including fixed indexed annuity contracts and fixed rate annuity contracts; immediate annuities; and life insurance products. It also provides reinsurance on asset intensive, long duration life, and annuity liabilities, such as fixed, deferred and payout annuities, long-term care, group long-term disability, and cash value life insurance. 

This is subject to an election and proration mechanism such that the aggregate consideration paid to such holders of F&G’s ordinary shares will consist of approximately 60% cash and 40% FNF common stock. Upon closing of the transaction, F&G shareholders will own approximately 7% of the outstanding shares of FNF common stock.

FNF pays $2.7B for FGL Holdings, Stockwinners

This represents a premium of 28% to F&G’s 60-day volume-weighted average price and a premium of 17% to F&G’s all-time high closing stock price following its combination with CF Corp. of $10.70 prior to February 6, when the media reported a potential transaction.

FNF currently owns 7.9% of F&G’s outstanding ordinary shares and all of F&G’s Series B Preferred shares, and, in connection with and immediately prior to the closing of the proposed acquisition, will acquire all outstanding F&G Series A preferred shares, with a face value of approximately $321 million as of December 31, 2019. Including the assumption of F&G’s $550 million of senior notes due 2025, FNF’s pro forma debt to total capital is expected to be approximately 26% at the close of the transaction.

The transaction is expected to close in the second or third quarter of 2020, subject to the satisfaction of customary closing conditions, including the receipt of regulatory clearances and approval by F&G shareholders.

Following the close of the transaction, F&G will operate as a subsidiary of FNF. F&G is expected to remain headquartered in Des Moines, Iowa, and will continue to be led by Chris Blunt and F&G’s current management team.

The terms of the merger agreement provide that F&G will be permitted, with the assistance of its legal and financial advisors, to actively solicit alternative acquisition proposals from third parties during a 40-day “go-shop” period from the date of the merger agreement until Wednesday, March 18, 2020.

F&G may terminate the merger agreement to enter into a superior proposal with specified bidders identified in this period for a termination fee of $39.97M, subject to the terms and conditions of the merger agreement.

There is no guarantee that the “go-shop” process will result in any alternative acquisition proposal or that any alternative acquisition proposal will be identified at any time, or approved or completed.

F&G does not intend to disclose developments with respect to the “go-shop” process unless and until F&G’s Special Committee and/or F&G’s board makes a determination requiring further disclosure.

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L3Harris Security Detection sold for $1 B

Leidos to acquire L3Harris security detection, automation businesses

Leidos (LDOS) announced that it has entered into a definitive agreement to acquire L3Harris Technologies’ (LHX) security detection and automation businesses, for $1B in cash.

The boards of both companies unanimously approved the transaction. L3Harris’ security detection and automation businesses provide airport and critical infrastructure screening products, automated tray return systems and other industrial automation products.

L3Harris sells its security division for $1B, Stockwinners

With headquarters in Tewksbury, Massachusetts and Luton, England, the combined businesses have 1,200 employees and a global sales and services operations footprint with more than 20,000 systems deployed world-wide across more than 100 countries.

The businesses serve customers in the aviation, transportation, government and critical infrastructure markets.

Leidos goes on $1B shopping spree, Stockwinners

This acquisition adds products that expand Leidos’ offerings to create a security and detection platform.

These products include checkpoint security products like checkpoint CT scanners, people scanners, comprehensive explosives trace detectors, checked baggage screeners and automated tray return systems, or ATRS.

This business expands customer penetration internationally, helping deliver on a stated objective to diversify revenue globally.

The deal will increase Leidos’ international security products revenue more than six-fold. The acquisition also enables the company to leverage technology investments across the combined portfolio to accelerate innovation and improve service efficiency for customers.

The transaction is expected to be immediately accretive to Leidos’ revenue growth, EBITDA margins, and non-GAAP diluted earnings per share upon closing.

Leidos expects to fund the $1B cash transaction through a combination of cash on hand and incremental debt.

The transaction is expected to close by the end of Q2, subject to the satisfaction of customary closing conditions, including receipt of regulatory approvals.

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Miragen Therapeutics shares soar on leukemia data

Miragen Therapeutics announces data from Phase 1 trial of cobomarsen

Miragen Therapeutics (MGEN) announced new efficacy and safety data from the ATLL arm of its ongoing Phase 1 clinical trial of cobomarsen, which will be presented at the 12th Annual T-Cell Lymphoma Forum in La Jolla, CA, which is taking place from January 30th to February 1st.

Miragen shares soar on its test data, Stockwinners

Of note are the data from the subtype of aggressive ATLL patients (Adult T-Cell Leukemia Lymphoma (ATLL)) who at study entry had persistent residual disease after chemotherapy or other therapy.

In the trial, six patients of this subtype had an MST of 26 months with three patients still on treatment at the time of data analysis.

Adult T-Cell Leukemia Lymphoma does not have a cure, Stockwinners

The Company was most encouraged, however, by the observed biomarker activity showing that disease stabilization is marked by a decrease in biomarkers of tumor cells activation and proliferation, providing evidence of the biological mechanism effect of cobomarsen on disease stabilization.

The Company is evaluating cobomarsen in an ongoing Phase 1 basket trial of cancers where the disease process appears to be correlated with an increase in miR-155 levels, including ATLL, diffuse large B-cell lymphoma, and chronic lymphocytic leukemia.

Today’s announcement includes results for the first 15 patients with aggressive subtypes of ATLL who were treated with three doses of cobomarsen by intravenous infusion, including 600, 900 and 1200 mg doses.

The preliminary results from this first-in-human Phase 1 clinical trial of the miR-155 inhibitor, cobomarsen, in patients with ATLL was observed to improve disease stabilization and reduce biomarker expression associated with ATLL cellular proliferation and activation in patients with persistent residual disease after chemotherapy and other therapies.

Of the 15 ATLL patients treated with cobomarsen, nine were actively relapsing at the time of screening, and six had residual nodal or circulating leukemic disease after chemotherapy or other systemic therapies.

For these six patients, the duration of cobomarsen treatment ranged from 4.5 to 23.7 months, with three patients still on study as of October 17, 2019.

MST of these patients was 26 months, compared with the 7.4 months MST from a retrospective external historical cohort based on a literature search of peer-reviewed papers. The Company compiled a historical external control which includes a series of studies with ATLL patients treated with standard of care over the past 10 years.

These studies included more than 6,000 ATLL patients. The Company calculated an MST from diagnosis of 7.4 months for patients with the aggressive ATLL subtypes, regardless of the type of therapy or number of therapies administered.

Five of these six patients treated with cobomarsen were alive as of the October 17, 2019 data analysis. In the trial, disease stabilization was marked by an observed decrease in Ki-67, a biomarker of cell proliferation, as well as other biomarkers of cell activation on circulating tumor cells, providing evidence of the biological mechanism effect of cobomarsen on disease stabilization.

For the clinical trial, the Company established a retrospective external historical cohort based on a literature search of peer-reviewed papers which reported MST from diagnosis and PFS on large cohorts of ATLL patients over the last decade.

A total of 16 papers describing unique cohorts of patients from Japan, the United States, South America and Europe were included in the MST retrospective analysis, of which 12 included data regarding MST for combined aggressive subtypes and eight reported MST for both acute and lymphomatous sub-types separately but not for the combined aggressive subtypes.

The number of patients included in each publication varied from 54 to 1,792, for a total of 6,440 patients.

Chronic administration of cobomarsen has been generally safe and well tolerated with a favorable safety profile over one year of dosing on a weekly basis.

There were 196 total reported adverse events as of October 17, 2019, with only 22% of the total AEs considered possibly related to study drug, and 86% of the total AEs considered mild or moderate. 14% of the total AEs were Grade 3 or 4 and most resolved within 11 days.

With no drug related deaths and only two serious adverse events occurring in the same patient and deemed possibly related to the study drug, the observed safety profile of cobomarsen in ATLL through October 17, 2019 appears to be benign and well tolerated with chronic dosing.

MGEN closed at $1.69, last traded at $2.80.

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Gilat Satellite Networks sold for $532M

Comtech to acquire Gilat Satellite Networks for $10.25 per share

Comtech Telecommunications Corp. (CMTL) and Gilat Satellite Networks Ltd. (GILT) jointly announced that Comtech has agreed to acquire Gilat in a cash and stock transaction for $10.25 per Gilat ordinary share of which 70% will be paid in cash and 30% in Comtech common stock, resulting in an enterprise value of approximately $532.5 million.

Gilat sold for $522M, Stockwinners

Founded in 1987 with its headquarters in Israel, Gilat is a worldwide leader in satellite networking technology, solutions and services with market leading positions in the satellite ground station and in-flight connectivity solutions markets and deep expertise in operating large network infrastructures.

Comtech goes shopping by buying Gilat, Stockwinners

Based on Comtech’s fiscal year 2019 actual results and Gilat’s trailing twelve-month results through June 30, 2019, on a pro-forma basis, Comtech would have reported approximately $926.1M of revenue with Adjusted EBITDA of approximately $130.2M.

The combined companies would employ approximately 3,000 people and offer best-in-class satellite technology, public safety and location technology and secure wireless solutions to commercial and government customers around the world.

Fred Kornberg, Chairman of the Board and CEO of Comtech, said,

“I am excited to have reached this agreement with Gilat and believe this combination is beneficial to the stakeholders of both companies. The acquisition better positions Comtech to take advantage of key marketplace trends, particularly the growing demand for satellite connectivity and the enormous long-term opportunity set that is emerging in the secure wireless communications market.

I believe that the combination of accelerating satellite connectivity demand and the increasing availability of low-cost satellite bandwidth, makes this a perfect time to unify Comtech and Gilat’s solutions and offer our combined customers best-in-class platform-agnostic satellite ground station technologies.

Gilat is an exceptional business that has developed extraordinary technology and has a well-respected product portfolio supported by strong research and development capabilities. I welcome Gilat’s entire talented workforce to the Comtech family.”

Dov Baharav, Chairman of the Board of Gilat, said, “The Gilat Board of Directors and management believe this highly strategic combination is compelling.

Gilat equipment allows reliable communication, Stockwinners

It is an excellent outcome for our shareholders who receive both cash and an equity interest in a strong company with a broader range of products and the benefits of combined expertise and resources that is well positioned to create future value against a highly favorable industry backdrop.

I have long admired Comtech’s commitment to technology leadership and I firmly believe that employees will have expanded opportunities for career development. No doubt, the future will be very bright for Comtech and Gilat and all of our stakeholders.”

In light of the agreement between Comtech (CMTL) and Gilat (GILT), Gilat has cancelled its fourth quarter and fiscal 2019 year-end conference call and webcast previously scheduled for February 19, 2020. Once the transaction closes, Comtech will provide combined revenue, Adjusted EBITDA and diluted earnings per share guidance in a future announcement.

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