Disney raises its offer for 21st Century Fox to $38 per share

Disney boosts offer for 21st Century Fox assets to $38 per share

Disney raises its offer for 21st Century Fox to $38 per share

Twenty-First Century Fox (FOXA) announced that it has entered into an amended and restated merger agreement with Walt Disney (DIS) pursuant to which Disney has agreed to acquire for a price of $38 per 21CF share the same businesses Disney agreed to acquire under the previously announced merger agreement between 21CF and Disney.

This price represents a “significant increase” over the purchase price of approximately $28 per share included in the Disney merger agreement when it was announced in December 2017.

The amended and restated Disney merger agreement offers a package of consideration, flexibility and deal certainty enhancements that is superior to the proposal made by the Comcast Corporation (CMCSA) on June 13, Fox stated.

Under the amended and restated Disney merger agreement, Disney would acquire those businesses on substantially the same terms, except that, among other things, Disney’s offer allows 21CF stockholders to elect to receive their consideration, on a value equalized basis, in the form of cash or stock, subject to 50/50 proration.

The collar on the stock consideration will ensure that 21st Century Fox shareholders will receive a number of Disney shares equal to $38 in value if the average Disney stock price at closing is between $93.53 and $114.32.

In light of the revised terms contained in the amended and restated Disney Merger Agreement, 21CF’s board, after consultation with its outside legal counsel and financial advisors, has not concluded that the unsolicited proposal it received on June 13, 2018 from Comcast could reasonably be expected to result in a “Company Superior Proposal” under the Disney merger agreement.

However, the amended and restated Disney merger agreement contains no changes to the provisions relating to the company’s directors’ ability to evaluate a competing proposal.

As announced on May 30, 2018, 21CF has established a record date of May 29, 2018 and a meeting date of July 10, 2018, for a special meeting of its stockholders to, among other things, consider and vote on a proposal to adopt the Disney merger agreement.

21CF has determined to postpone its special meeting of stockholders to a future date in order to provide stockholders the opportunity to evaluate the terms of Disney’s revised proposal and other developments to date.

Once 21CF determines the new date for 21CF’s special meeting of stockholders, the date will be communicated to 21CF stockholders.


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Bluebird Bio reports data from Phase 1 HGB-206

Bluebird Bio reports interim data from Phase 1 HGB-206 study of LentiGlobin

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Bluebird Bio reports interim data from Phase 1 HGB-206 study of LentiGlobin

bluebird bio (BLUE) announced new interim data from the ongoing HGB-206 Phase 1 multicenter clinical study of LentiGlobin investigational gene therapy in patients with severe sickle cell disease will be presented in an oral presentation on Saturday, June 16 at the 23rd Congress of the European Hematology Association by Julie Kanter, M.D., Medical University of South Carolina, Charleston, South Carolina.

“The consistent production of increased amounts of anti-sickling HbAT87Q in the Group C patients reflects the substantial positive impact of the changes introduced with the amended HGB-206 study protocol and refined manufacturing process.

All four Group C patients with greater than or equal to three months follow-up are making over 30 percent anti-sickling HbAT87Q.

The first patient treated, now with six months of follow-up, is producing over 60 percent anti-sickling HbAT87Q with a normal total hemoglobin level of 14.2 g/dL,” said David Davidson, M.D., chief medical officer, bluebird bio.

“The upward trajectory in Group C at these early time points suggests the potential for these patients to exceed the initially proposed therapeutic target of 30 percent anti-sickling HbAT87Q. We continue to define the development plan with regulatory authorities, and with further follow-up, we hope to see even higher levels of HbAT87Q, as well as sustained clinical benefit for patients.”

“The early data from Group C patients are very exciting and provide increasing confidence that LentiGlobin has the potential to deliver transformative benefit to patients. The longer-term data from patients treated earlier in the study show that levels of anti-sickling HbAT87Q in patients with SCD treated with LentiGlobin remain stable for at least two years,” said Dr. Kanter, a lead investigator of the HGB-206 study.

“Treatment options that can address the underlying cause of sickle cell disease are limited and LentiGlobin gene therapy has the potential to prevent or substantially reduce damaging symptoms associated with this debilitating disease.”

Separately, bluebird bio announced that new data from the completed Phase 1/2 Northstar (HGB-204) study in adolescents and adults with transfusion-dependent beta-thalassemia and any genotype, and its ongoing, Phase 3 Northstar-2 (HGB-207) multicenter clinical study of LentiGlobin investigational gene therapy in patients with TDT and non-beta0/beta0 genotypes, will be presented in an oral session on June 16 at the 23rd Annual Congress of the European Hematology Association by Franco Locatelli, M.D., Ph.D., of the IRCCS Ospedale Pediatrico Bambino Gesu of Rome, Italy.

“The maturing data from HGB-204 and HGB-207 suggest that one-time treatment with LentiGlobin may address the underlying genetic cause of TDT.

With our refined manufacturing process, the majority of patients with TDT and non-beta0/beta0 genotypes are transfusion-free and producing total hemoglobin at normal or near-normal levels,” said David Davidson, M.D., chief medical officer, bluebird bio.

“We are on track to submit a marketing authorization application in the European Union later this year, and we continue to work closely with clinical investigators and regulatory authorities to complete our ongoing clinical trials and bring this important treatment option to patients as soon as possible.”

“Consistently higher in vivo vector copy numbers and HbAT87Q hemoglobin levels in patients indicate that LentiGlobin manufacturing refinements have resulted in improved gene therapy characteristics and may enable sustained transfusion independence for a great majority of patients,” said Professor Locatelli, the lead investigator of the Northstar-2 study.

“Further, we are now seeing more than three years of data from the Northstar study indicating that LentiGlobin therapy may enable long-term transfusion independence in the majority of patients with non-beta0/beta0 genotypes.

These results hold the promise to change the natural history of many patients with this severe genetic disorder of hemoglobin production.”

BLUE closed at $197.00. It last traded at $204.65.


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Oracle lower after losing business to Amazon, Microsoft

Oracle slides as JPMorgan cuts rating on business lost to Amazon, Microsoft

Oracle slides as JPMorgan cuts rating on business lost to Amazon, Microsoft , Stockwinners
Oracle slides as JPMorgan cuts rating on business lost to Amazon, Microsoft ,

Shares of Oracle (ORCL) are sliding after JPMorgan analyst Mark Murphy downgraded the stock to Neutral, citing negative results from a survey of Chief Information Officers about their spending.

The analyst noted that the survey showed spending contraction ahead as Oracle’s databases are being unplugged in favor of Microsoft (MSFT) and Amazon (AMZN) databases.

SURVEY SAYS

In a research note this morning, JPMorgan’s Murphy downgraded Oracle to Neutral from Overweight as specific metrics in the firm’s large-scale CIO survey have arced over into negative territory.

The analyst told investors that while Oracle’s shares have risen from the $30s into the high $40s in the last 2 years, the company’s fundamental performance has remained inconsistent. Citing his survey of 154 CIOs, Murphy noted that Oracle received the largest number of indications for planned spending contraction this year, materially more than the second-worst company, which was IBM (IBM) with 25 indications of spending contraction.

Further, while ranking the top 8 or 9 mega-vendors in terms of who will be most critical and indispensable to CIOs’ IT environment in the future, Oracle only received 6.5% of votes, down from 11% in previous surveys, the analyst highlighted.

At the same time, Murphy pointed out that Amazon AWS improved from 9.5% of votes last year to 14.9% of votes this year, creating the appearance of a “sucking sound” out of Oracle and into AWS.

The company also ranked number 8 in terms of association with Digital Transformation projects, disappointing relative to its scale and lagging behind the likes of SAP (SAP), IBM, and Cisco (CSCO), he added, noting that despite Oracle’s efforts to build a Cloud presence, it rated no better than SAP in terms of association with Cloud Computing plans, and is nowhere close to the leaders Microsoft, Amazon, and Google (GOOGL; GOOG) in this respect. Oracle was mentioned by only 2% of the CIOs as the platform that will be “most integral” to their cloud computing plans, Murphy said.

Overall, the analyst questions where Oracle’s business and stock are heading in the next couple of years if the largest-scale CIO survey shows Oracle now has negative spending intentions, is lagging in Digital Transformation projects, is trailing in Cloud Computing plans, its databases are being unplugged in favor of Microsoft and Amazon databases, its applications are being unplugged in favor of Salesforce (CRM) and Workday (WDAY) applications, and customers are weary of its unpopular commercial tactics.

Murphy also lowered his price target on Oracle’s shares to $53 from $55.

WHAT’S NOTABLE

In a research note of his own, Nomura Instinet analyst Christopher Eberle lowered his price target for Oracle to $60 from $64 ahead of the company’s fourth quarter results on June 19.

The analyst trimmed his estimates to account for currency and expectations for more modest revenue acceleration in fiscal 2019. He remains optimistic, however, on Oracle’s transition and model growth reacceleration as the year progresses. Eberle reiterated a Buy rating on the shares.

PRICE ACTION

In Wednesday’s trading, shares of Oracle dropped almost 5% to $46.14.


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Envision Healthcare sold for $9.9B

Envision Healthcare to be acquired by KKR for approximately $9.9B

 

Envision Healthcare sold for $9.9B, Stockwinners
Envision Healthcare sold for $9.9B, Stockwinners

Envision Healthcare (EVHC) announced it has entered into a definitive agreement to be acquired by global investment firm KKR (KKR) in an all-cash transaction for approximately $9.9B, including the assumption or repayment of debt.

Under the terms of the agreement, which has been unanimously approved by Envision’s Board of Directors, KKR will acquire all of the outstanding shares of Envision’s common stock for $46.00 per share in cash, representing a 32% premium to Envision’s volume-weighted average share price from November 1, 2017, the day immediately following the company’s first announcement that it was reviewing strategic alternatives.

The transaction price represents a multiple of 10.9x trailing 12 months Adjusted EBITDA and 10.1x 2018 anticipated Adjusted EBITDA.

The agreement represents the culmination of the Board’s comprehensive review of strategic alternatives to enhance shareholder value.

During the last seven months, the Board, with the assistance of three independent financial advisors and legal counsel, examined a full range of options to generate shareholder value, including capital structure alternatives, potential acquisitions, portfolio optimization, a potential sale of the whole company, and continued operation as a standalone business.

The Board oversaw an extensive process that involved outreach to 25 potential buyers, including financial sponsors and strategic entities, and invited proposals for all or parts of the business.

After consideration of the opportunities, risks and uncertainties facing the company and the broader sector, as well as the alternatives available to the company, the Board determined that the KKR proposal presented the best opportunity to maximize value for shareholders.

The completion of the transaction, which is targeted for the fourth quarter of 2018, is subject to customary closing conditions and regulatory approvals. Envision intends to present the proposed transaction to its shareholders for approval at the company’s 2018 Annual Meeting, which will be scheduled as soon as practicable following the filing and review of proxy materials.

The company intends to hold its Annual Meeting no later than October 1, 2018.

Upon the completion of the transaction, Envision will become a private company, and its common stock will no longer be traded on the New York Stock Exchange. KKR will be making the investment primarily from its KKR Americas Fund XII.


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Rockwell Automation to make $1B investment in PTC

Rockwell Automation to make $1B equity investment in PTC

Rockwell Automation to make $1B equity investment in PTC, Stockwinners
Rockwell Automation to make $1B equity investment in PTC

PTC (PTC) and Rockwell Automation (ROK) announced that they have entered into a definitive agreement for a strategic partnership that is expected to accelerate growth for both companies and enable them to be the partner of choice for customers around the world who want to transform their physical operations with digital technology.

As part of the partnership, Rockwell Automation will make a $1B equity investment in PTC, and Rockwell Automation’s Chairman and CEO, Blake Moret, will join PTC’s board of directors effective with the closing of the equity transaction.

Under the terms of the agreement relating to the equity investment, Rockwell Automation will make a $1 billion equity investment in PTC by acquiring 10,582,010 newly issued shares at a price of $94.50, representing an approximate 8.4% ownership interest in PTC based on PTC’s current outstanding shares pro forma for the share issuance to Rockwell Automation.

The price per share represents an 8.6% premium to PTC’s closing stock price on June 8, 2018, the last trading day prior to today’s announcement.

Rockwell Automation intends to fund the investment through a combination of cash on hand and commercial paper borrowings.

Rockwell Automation will account for its ownership interest in PTC as an Available for Sale security, reported at fair value.

As separately announced today, Rockwell Automation is increasing its share repurchase target for fiscal year 2018 to $1.5 billion.

This represents a $300 million increase to its previous plans to repurchase $1.2 billion of its stock in fiscal year 2018.

The investment transaction is subject to customary closing conditions and regulatory approvals, and is expected to close within 60 days.

PTC Inc. develops and delivers software products and solutions worldwide.


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Eli Lilly announces Alimta label expanded by FDA

Eli Lilly announces Alimta label expanded by FDA

Eli Lilly announces Alimta label expanded by FDA, Stockwinners
Eli Lilly announces Alimta label expanded by FDA

Eli Lilly (LLY) announced that the FDA has granted approval for a new indication for Alimta in combination with carboplatin and Keytruda for the initial treatment of patients with metastatic nonsquamous non-small cell lung cancer, or NSCLC, irrespective of PD-L1 expression status.

Under the FDA’s accelerated approval regulations, this indication is approved based on tumor response rate and progression-free survival, or PFS.

Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Merck (MRK) received accelerated approval for the combination of pembrolizumab with Alimta and carboplatin in May 2017.

This is the first and only combination of chemotherapy and immunotherapy to earn FDA approval for the first-line treatment of metastatic nonsquamous NSCLC.

This indication, now included in the Alimta prescribing information, is based on data from Merck’s KEYNOTE-021 study, Cohort G1.

The KEYNOTE-021, Part 2, Cohort G1, study included 123 previously untreated patients with locally advanced or metastatic nonsquamous NSCLC with no epidermal growth factor receptor, or EGFR, or anaplastic lymphoma kinase, or ALK, genomic tumor aberrations and irrespective of PD-L1 expression status.

The triplet combination of Alimta and carboplatin with pembrolizumab demonstrated a statistically significant improvement in objective response rate, or ORR, versus Alimta plus carboplatin alone and PFS.

Median PFS was 13 months for triplet and 8.9 months for Alimta plus carboplatin.

LLY closed at $85.07.


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Madrigal Pharmaceuticals sharply higher on NASH trial

Madrigal achieves liver biopsy endpoints in NASH trial of MGL-3196

Madrigal Pharmaceuticals higher on NASH trial, Stockwinners.com
Madrigal Pharmaceuticals higher on NASH trial,

Madrigal Pharmaceuticals (MDGL) announced top-line, 36-week results from a Phase 2 clinical trial in patients with biopsy-proven non-alcoholic steatohepatitis, or NASH.

In this trial, MGL-3196, a first-in-class, oral, once-daily, liver-directed, thyroid hormone receptor beta-selective agonist, demonstrated statistical significance in the primary endpoint, relative reduction of liver fat on magnetic resonance imaging-estimated proton density fat fraction at 12 Weeks in December 2017, and, reported here, statistically significant results in multiple Week 36 endpoints including key secondary endpoints, reduction and resolution of NASH.

“The degree of NASH resolution, an approvable FDA endpoint, in patients who received MGL-3196 for 9 months we believe suggests a high likelihood of success in a larger trial with a somewhat longer treatment period in a Phase 3 study designed similarly to this Phase 2 study, pending regulatory agreement with such a design. Further, considering what we have learned regarding drug exposure and dosing, we believe there is potential to resolve NASH in as little as 9 months in 30-40% of patients receiving only MGL-3196, a well-tolerated once a day oral therapy,” stated Paul Friedman, CEO of Madrigal.

In the trial, MGL-3196 demonstrated statistical significance in the primary endpoint, relative reduction of liver fat on magnetic resonance imaging-estimated proton density fat fraction at 12 weeks and statistically significant results in multiple week 36 endpoints.
Shares of Madrigal are up 67%, or $66.57, to $175.00 in premarket trading. Viking Therapeutics (VKTX), which has a thyroid beta agonist in Phase 2 development for the treatment of non-alcoholic fatty liver disease and hypercholesterolemia, is trading up 38% to $6.86. Intercept Pharmaceuticals (ICPT), which has a competing, and further along than Madrigal’s, drug to treat non-alcoholic steatohepatitis is trading down 6% to $69.01.

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Xcerra sold for $796 million

Cohu to acquire Xcerra in cash, stock deal valued around $796M

Xcerra sold for $796 million, Stockwinners
Xcerra sold for $796 million, Stockwinners

Cohu (COHU) and Xcerra (XCRA) announced they have entered into a definitive merger agreement pursuant to which Cohu will acquire Xcerra for a combination of cash and stock.

The acquisition is expected to make Cohu a global leader in semiconductor test, with combined sales for Cohu and Xcerra in excess of $800M for the last twelve months.

Upon the closing of the transaction, Xcerra shareholders will be entitled to receive $9.00 in cash and 0.2109 of a share of Cohu common stock, subject to the terms of the definitive agreement.

Based on the closing price of Cohu common stock as of May 7, 2018, the transaction values Xcerra at $13.92 per share, or approximately $796M in equity value, with a total enterprise value of approximately $627M, after excluding Xcerra’s cash and marketable securities net of the debt on its balance sheet as of January 31, 2018.

The transaction value represents a premium of 8.4% to Xcerra’s closing price on May 7, 2018, and a premium of 15.4% to Xcerra’s 30-day average closing price.

The transaction is expected to be immediately accretive to non-GAAP earnings per share and generate over $20M of annual run-rate cost synergies within 2 years of closing, excluding stock-based compensation and other charges.

Xcerra shareholders are expected to own approximately 30% of the combined company upon the closing of the transaction. The transaction has been unanimously approved by the boards of both companies.

The transaction is expected to close in the second half of calendar year 2018, subject to approval by both companies’ respective shareholders, antitrust regulatory approvals and other customary closing conditions.


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Esperion falls after drug failure

Esperion falls after Phase 3 study of bempedoic acid met primary endpoint

Esperion announces 'positive' top-line results from bempedoic acid study, Stockwinners.com
There were no clinically relevant differences between the bempedoic acid and placebo groups

Esperion (ESPR) announced top-line results from the second pivotal, Phase 3 study, the long-term safety study of bempedoic acid 180 mg, in this case evaluating the safety, tolerability and efficacy of bempedoic acid versus placebo in high-risk patients with atherosclerotic cardiovascular disease who are inadequately controlled with current lipid-modifying therapies, including maximally tolerated statin therapy.

The study included 2,230 patients and met the primary endpoint of safety and tolerability and the key efficacy endpoint with on-treatment LDL-C lowering of an additional 20% at twelve weeks, the company said.

Patients treated with bempedoic acid also achieved a significant reduction of 22% in high-sensitivity C-reactive protein, an important marker of the underlying inflammation associated with cardiovascular disease, Esperion added.

There were no clinically relevant differences between the bempedoic acid and placebo groups in the occurrence of adverse events with 78.5% and 78.7% respectively; or serious adverse events with 14.5% and 14.0% respectively, it added.

Discontinuations due to AEs were 10.9% and 7.1%, respectively for the bempedoic acid and placebo groups; discontinuations due to muscle-related AEs were 2.2% and 1.9%, respectively, in the bempedoic acid and placebo groups.

“In this study, the largest in our Phase 3 program, bempedoic acid was observed to be safe and well tolerated over a 52-week period, while providing clinically and statistically significant LDL-cholesterol lowering and reductions in hsCRP when added on to maximally tolerated statin therapy,” said Tim Mayleben, CEO of Esperion.

“In the coming months, results from our three remaining pivotal Phase 3 studies are expected to further validate the safety, efficacy and tolerability profile of bempedoic acid and the bempedoic acid / ezetimibe combination pill, definitively establishing these once-daily oral therapies as convenient and complementary to existing treatments for the 13 million people in the U.S. with ASCVD who live with elevated levels of LDL-cholesterol despite taking maximally-tolerated lipid-modifying therapy and remain at high risk for further cardiovascular disease or events, including heart attack and stroke.”

Esperion shares in premarket trading are down 27% to $52.40.


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Vectren Corporation sold for $72 a share

Vectren investors to receive $72/share cash for each share in CenterPoint deal

Vectren Corporation sold for $72 a share, Stockwinners
Vectren Corporation sold for $72 a share

CenterPoint Energy (CNP) and Vectren Corporation (VVC) announced they have entered into a definitive merger agreement to form an energy delivery, infrastructure and services company serving more than 7 million customers across the United States.

Under the terms of the agreement, which have been unanimously approved by both CenterPoint Energy’s and Vectren’s Boards of Directors, Vectren shareholders will receive $72.00 in cash for each share of Vectren common stock.

CenterPoint Energy will also assume all outstanding Vectren net debt.

Vectren Corporation sold for $72 a share, Stockwinners
Vectren Corporation sold for $72 a share, 

The combined company is expected to have electric and natural gas delivery operations in eight states with assets totaling $29 billion and an enterprise value of $27 billion.

With the merger, CenterPoint Energy expects to maintain an annual guidance basis EPS growth target of 5 to 7 percent in 2019 and 2020, excluding any one-time charges related to the merger.

At the closing of the transaction, Scott M. Prochazka will serve as president and CEO of the combined company.

The full executive team for the combined company will be announced prior to or in conjunction with the closing of the merger.

The natural gas utilities operations of the combined company, as well as that businesses’ lead executive, will be headquartered in Evansville.

Additionally, CenterPoint Energy will establish a chief business officer for Vectren’s electric business who will directly report to CenterPoint Energy’s CEO and spearhead southwestern Indiana’s electric grid modernization and generation transition initiatives recently underway.

In addition to utility field employees, CenterPoint Energy will retain key operational activities in support of the utilities in Evansville.

Pursuant to the merger agreement, CenterPoint Energy will contribute an additional $3 million per year for a minimum of five years after the closing of the merger to the Vectren Foundation, which will continue to operate out of Evansville.

The closing of the transaction is subject to Vectren shareholder approval, approvals from the Federal Energy Regulatory Commission and Federal Communications Commission, and expiration or termination of the Hart-Scott-Rodino waiting period.

In addition to these conditions, the company will make certain regulatory filings in Indiana and Ohio. Subject to these conditions, the merger is expected to close by the first quarter 2019. Until the closing, CenterPoint Energy and Vectren will remain separate companies.


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Ionis Pharmaceuticals is in focus

Biogen, Ionis Pharmaceuticals expand drug development collaboration

Biogen will pay Ionis $1B in cash

Biogen (BIIB) and Ionis Pharmaceuticals (IONS) announced they have expanded their strategic collaboration through a new ten-year collaboration agreement to develop novel antisense drug candidates for a broad range of neurological diseases.

This collaboration capitalizes on Biogen’s expertise in neuroscience research and drug development and Ionis’ leadership in RNA targeted therapies with the goal of developing a broad pipeline of investigational therapies.

Biogen says BAN2401 did not meet primary endpoint. Stockwinners.com
Biogen will pay Ionis $1B in cash

It builds upon a productive collaboration that produced SPINRAZA, the first and only approved treatment for patients with spinal muscular atrophy.

Under the terms of the collaboration, Biogen will pay Ionis $1B in cash, which will include $625M to purchase 11,501,153 shares of Ionis common stock at a price of $54.34 per share, at an approximately 25% cash premium, and a $375M upfront payment.

Biogen will have the option to license therapies arising out of this collaboration and will be responsible for their development and commercialization.

In addition, Biogen may pay milestone payments, license fees and royalties on net sales.

The companies plan to advance programs for a broad range of neurological diseases for which few treatment options exist today.

Disease areas include dementia, neuromuscular diseases, movement disorders, ophthalmology, diseases of the inner ear, and neuropsychiatry.

Biogen will have the first choice of neurology targets on which to exclusively collaborate with Ionis.

In this collaboration, Ionis will be responsible for the identification of antisense drug candidates based on selected targets, while Biogen will be responsible for and pay for non-clinical studies, clinical development, manufacturing, and commercialization. Biogen and Ionis expect the deal to close in the second quarter of 2018.

IONS closed at $45.85. BIIB closed at $266.02.


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Amazon higher on Prime members

Amazon rises as Prime reaches 100M paid members

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Amazon higher on Prime members

Amazon’s (AMZN) CEO Jeff Bezos told investors that the company has exceeded 100M paid members globally and has shipped more than 5B items with Prime worldwide.

The good news for the e-commerce giant may not end there, as Morgan Stanley analyst Brian Nowak told investors that his analysis shows that Amazon has gained 1.5% of U.S. apparel market share in 2017 and may achieve number one U.S. apparel market share in 2018 as Prime members and Millennials shift spending to Amazon and away from traditional brick and mortar retailers.

100M PAID MEMBERS

According to a regulatory filing, Amazon said that it has exceeded 100M paid Prime members globally 13 years post-launch.

In 2017, Amazon shipped more than 5B items with Prime worldwide, and more new members joined Prime than in any previous year — both worldwide and in the U.S., the company said, adding that members in the U.S. now receive unlimited free two-day shipping on over 100M different items. The company expanded Prime to Mexico, Singapore, the Netherlands, and Luxembourg, and introduced Business Prime Shipping in the U.S. and Germany.

Additionally, CEO Jeff Bezos informed shareholders that Amazon Music now has tens of millions of paid customers, with Amazon Music Unlimited expanding to more than 30 new countries in 2017.

GAINING APPAREL MARKET SHARE

In a research note to investors this morning, Morgan Stanley’s Nowak said his analysis shows that Amazon gained 1.5% of U.S. apparel market share in 2017, largely at the expense of department stores.

According to his work around Amazon’s apparel gross merchandise value, the analyst estimates the e-commerce giant continues to be the second largest U.S. apparel retailer, trailing only Walmart (WMT), as the company has grown to about 7.9% of the overall U.S. apparel market, excluding shoes, or $21.1B apparel gross merchandise value.

Further, #Nowak told investors he expects Amazon to achieve the number one spot in 2018, as Prime members and Millennials shift spending to Amazon and away from traditional brick and mortar retailers.

The analyst pointed out that Amazon’s 2017 share gains look to have come largely at the expense of department stores, estimating Sears (SHLD), Macy’s (M) and J.C. Penney (JCP) lost 0.8% share in 2017, with shareholding remaining roughly flat for Target (TGT) and Kohl’s (KSS).

L Brands (LB) lost share due to the elimination of its swimwear and apparel categories, he contended.

Additionally, his U.S. apparel market deep-dive indicated that Walmart and Costco (COST) showed “impressive gains” despite a weak industry backdrop. Among the Softline retailers, Gap’s (GPS) Old Navy, Ross Stores (ROSS) and Nordstrom’s (JWN) Nordstrom Rack also added 10-15 bps of market share in 2017, he added.

Nowak reiterated an Overweight rating and $1,550 price target on Amazon shares.

PRICE ACTION

In Thursday’s trading, shares of Amazon have gained 2% to $1,554.90.


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GW Pharmaceuticals could soar on its epilepsy drug

GW Pharma seen nearing historic approval for cannabinoid epilepsy treatment

GW Pharmaceuticals could soar on its epilepsy drug, Stockwinners
GW Pharmaceuticals could soar on its epilepsy drug, Stockwinners

GW Pharmaceuticals’ (GWPH) cannabis-based epilepsy treatment associated with Lennox-Gastaut syndrome and Davret syndrome, #Epidiolex, received what analyst called a favorable review from Food and Drug Administration staff ahead of an advisory committee meeting scheduled later this week.

Both Goldman Sachs and Leerink argued that the documents bode well for Epidiolex approval by its June 27 PDUFA date.

FDA ADCOM DOCUMENTS

The FDA released its advisory committee meeting briefing documents regarding CBD-OS for the treatment of LGS and DS ahead of the advisory panel vote on Thursday.

According to the documents: “In 3 consecutive Phase 3 studies, CBD-OS added to other AED therapy met the primary endpoint of reduction in seizure frequency in patients with LGS and DS. Doses of CBD-OS at 10mg/kg/day and 20mg/kg/day were superior to placebo at reducing drop seizure frequency, and efficacy was maximized during the 12-week maintenance period once the target dose was achieved in LGS patients.

Similar results were also seen in DS patients treated with CBD-OS 20mg/kg/day. […] The safety and tolerability profile of CBD-OS is predictable, and the potential risks are manageable through the proposed label and medication guide. […] Elevated transaminases were observed more frequently in CBD-OS patients than placebo, and increased AST and increased ALT were the most common reasons for discontinuing CBD-OS treatment.

Therefore, routine liver tests prior to CBD-OS use and periodically during treatment are recommended.

In addition, GW will implement a post-marketing enhanced pharmacovigilance program to monitor the safety profile of CBD-OS, with a focus on liver abnormality reports.

Overall, CBD-OS provides a positive benefit-risk for patients with drug-resistant LGS or DS and can satisfy an unmet need by providing an additional treatment option to reduce the number of seizures in LGS and the first indicated treatment option for DS.” CBD-OS, or cannabidiol oral solution, is the first-in-class antiepileptic drug for the adjunctive treatment of seizures associated with LGS and DS in patients 2 years of age and older.

GW Research, which is a part of GW Pharmaceuticals and operates under Greenwich Biosciences in the U.S., holds the Investigational New Drug application for CBD-OS.

DOCUMENTS SUPPORT APPROVAL

Commenting on the briefing documents, Goldman Sachs analyst Salveen Richter told investors that the “brevity of the relatively benign documents” along with the half day panel duration suggest a likely straightforward meeting.

The analyst noted that there is only one question for discussion – “Is the benefit-risk profile of cannabidiol favorable for the treatment of seizures associated with Lennox-Gastaut syndrome and Dravet syndrome in patients 2 years of age and older?” – which could support a broad label in “seizures associated with LGS/DS” and in children/adults.

Thus, Richter believes these documents should bode well for Epidiolex approval by the June 27 date assigned by the FDA.

The analyst recommended owning GW Pharmaceuticals shares into the Epidiolex launch, assuming widespread off-label use per physician feedback and optionality from Epidiolex Phase 2/3 Part A data in infantile spasms in the second quarter of 2018.

He reiterated a Buy rating and $177 price target on the stock.

Meanwhile, his peer at #Leerink told investors in a research note of his own that his review of the meeting materials suggests that the FDA is likely to approve Epidiolex, and the outcome of the advisory panel vote on April 19 should be positive.

Additionally, analyst Geoffrey Porges argued that Epidiolex’ review bodes well for Zogenix’ (ZGNX) ZX0008. The latter’s unprecedented efficacy in reducing seizures will allow it to gain significant market share within its first 12 months of approval, he contended.

PRICE ACTION

Shares of GW gained about 11% yesterday following the release of the documents, though they have given back about 2% in Wednesday’s trading to trade near $131 per share.


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Solid Biosciences is in focus

Solid Biosciences receives full clinical hold letter from FDA on IGNITE DMD 

Solid Biosciences is in focus, Stockwinners.com
Solid Biosciences is in focus

Solid Biosciences  (SLDB) announced that the company has received a letter from the U.S. Food and Drug Administration relating to the previously-announced full clinical hold on IGNITE DMD, the company’s Phase I/II clinical trial for its investigational gene therapy, SGT-001, for the treatment of Duchenne muscular dystrophy.

The company plans to submit a response to this letter to the FDA in the coming weeks.

The FDA also informed Solid that the company has satisfactorily addressed manufacturing-related questions that led to the previously-announced partial clinical hold on the high dose of SGT-001 in IGNITE DMD.

“We believe SGT-001 has the potential to significantly benefit patients with DMD. We are working with the FDA to better understand the unexpected event that resulted in the clinical hold and put a plan in place to monitor and manage potential events in the future. I am happy to share that the treating physician has reported the patient is doing well,” said CEO Ilan Ganot.

“We are also pleased that we were able to lift the earlier partial clinical hold on the high dose of SGT-001 through our existing manufacturing process, which is an important ongoing development effort for our company.”

The full clinical hold was in response to the company’s report of a Serious Adverse Event in the first patient dosed with SGT-001 in IGNITE DMD, where several days after administration the patient was hospitalized due to laboratory findings that included a decrease in platelet count followed by a reduction in red blood cell count and evidence of complement activation.

The patient showed no signs or symptoms of coagulopathy and no relevant changes from baseline in liver function tests.

Following medical treatment, all of his laboratory parameters have either improved or returned to normal.

In its full clinical hold letter, the FDA requested additional information that is required prior to resuming the clinical trial, including an assessment of the underlying etiology of the event, the patient’s clinical status and laboratory parameters, and any additional measures to address patient safety. Solid will work closely with the FDA to address these questions.

SLDB closed at $10.56.


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Netflix and Comcast join forces

Netflix, Comcast announce expansion of Netflix-Xfinity packages 

Disney loss having minimal impact on Netflix subscribers. See Stockwinners.com Market Radar to read more
Netflix and Comcast join forces

Comcast (CMCSA) and Netflix (NFLX) announced an expansion of their partnership that will provide Comcast the ability to include a Netflix subscription in new and existing Xfinity packages.

In 2016, Comcast launched Netflix on the X1 platform, offering customers a fully integrated entertainment experience featuring voice control and seamless access to the Netflix service.

Netflix has quickly become one of the most popular voice searches and highly-viewed services on the platform; and among households watching Netflix on X1, X1 has quickly become the most used platform for Netflix viewing.

Comcast has integrated the Netflix service with the X1 user experience, enabling customers to easily browse and access the entire Netflix service, including TV shows, films, documentaries, stand-up comedy, kid’s titles and a catalog of Ultra HD 4K and HDR programming-alongside the live, on demand, DVR and web video from hundreds of networks, studios and digital brands available with their Xfinity TV subscription.

Comcast will launch a variety of initial offers this month that include a Netflix subscription. Offers and availability will vary by market and be open to new and existing customers.

Netflix-related billing will be handled directly by Comcast, giving customers one, simple monthly statement.


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