Supervalu sold for $2.9 billion

United Natural Foods to acquire Supervalu for $32.50 per share in cash, or $2.9B

Supervalu sold for $32.50 per share in cash, or $2.9B, Stockwinners
Supervalu sold for $32.50 per share in cash, or $2.9B, Stockwinners

United Natural Foods (UNFI) and SUPERVALU (SVU) announced that they have entered into a definitive agreement under which UNFI will acquire SUPERVALU for $32.50 per share in cash, or approximately $2.9B, including the assumption of outstanding debt and liabilities.

UNFI expects to finance the transaction substantially with debt and Goldman Sachs provided committed financing in the transaction.

Over time, UNFI plans to divest SUPERVALU retail assets in a thoughtful and economic manner. Upon closing, UNFI’s net debt-to-EBITDA ratio is expected to be high.

With strong cash flows, proceeds from divestitures and commitment to reducing debt, the company anticipates reducing leverage by at least two full turns in the first three years.

The transaction has been approved by the boards of directors of both companies and is subject to antitrust approvals, SUPERVALU shareholder approval and other customary closing conditions, and is expected to close in the fourth quarter of calendar year 2018.

UNFI Chief Executive Officer and Chairman Steven Spinner will lead the combined entity. Sean Griffin, UNFI Chief Operating Officer, will lead the SUPERVALU integration efforts, post close and lead an integration committee comprised of executives from both companies to drive the implementation of best practices from each company and the delivery of important synergies and a rapid and smooth integration.

UNFI closed at $41.18.


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ResTORbio higher on data

ResTORbio announces ‘positive’ topline results in Phase 2b trial of RTB101

ResTORbio higher on data, Stockwinners
ResTORbio higher on data, Stockwinners

ResTORbio (TORC) announced positive topline results from its dose-ranging Phase 2b clinical trial that enrolled 652 elderly patients at increased risk of morbidity and mortality associated with respiratory tract infections.

In this trial, RTB101, an oral, selective, and potent inhibitor of target of rapamycin complex 1, demonstrated a statistically significant and clinically meaningful reduction in the percentage of patients with one or more laboratory-confirmed RTIs during the 16-week treatment period compared to placebo, the primary endpoint of the study, with the 10 mg once daily dose.

Greater TORC1 inhibition with RTB101 10 mg in combination with everolimus 0.1 mg did not meet the primary endpoint, suggesting that that less TORC1 inhibition with RTB101 10 mg once daily may have greater benefit in high-risk elderly patients.

The Phase 2b trial was a two-part, randomized, double-blind, placebo-controlled clinical trial conducted during the winter cold and flu season in the southern hemisphere and northern hemisphere.

Patients enrolled were those at increased risk of morbidity and mortality from RTIs including patients who were: 85 years of age or older, or 65 years of age or older with asthma, type 2 diabetes mellitus, chronic obstructive pulmonary disease, or current smokers.

The doses investigated in Part 1 were RTB101 5 mg and RTB101 10 mg once daily. The doses investigated in Part 2 were RTB101 10 mg once daily, RTB101 10 mg twice daily and RTB101 10 mg in combination with everolimus 0.1 mg once daily.

The following was observed in an analysis of the primary endpoint: A 30.6% decrease relative to placebo in the percentage of all patients treated with RTB101 10 mg once daily who developed one or more laboratory-confirmed RTs. A 20.6% decrease relative to placebo in the percentage of all patients treated with RTB101 5 mg once daily who developed one or more laboratory-confirmed RTIs.

No decrease relative to placebo in the percentage of patients treated with either RTB101 10 mg twice daily or the combination of RTB101 10 mg + everolimus 0.1 mg once daily who developed one or more laboratory-confirmed RTIs, suggesting that less TORC1 inhibition with RTB101 10 mg once daily may have greater benefit in high-risk elderly patients.

To better understand the activity observed in the RTB101 10 mg once daily cohort, a pre-specified analysis of each patient subgroup enrolled in the study was conducted.

The following decreases in the percentage of patients with laboratory-confirmed RTIs were observed in the RTB101 10 mg once daily cohort as compared to the placebo cohort: A 68.4% decrease in all asthma patients.

A 66.7% decrease in all patients 85 years of age and older. A 26.9% decrease in all T2DM patients.

No decrease was observed in either COPD patients or current smokers; a 42.0% decrease in all patients was observed when excluding patients with COPD and a 43.9% decrease in all patients was observed when excluding current smokers.

All doses were observed to be well-tolerated. Data from the RTB101 10 mg once daily cohort are as follows: Adverse events were balanced between the RTB101 10 mg once daily and placebo treatment groups. 4.5% of subjects in the RTB101 10 mg once daily cohort and 7.2% of subjects in the placebo cohort had a serious adverse event, none of which were considered related to study drug. 4.5% of subjects in the RTB101 10 mg once daily cohort and 6.1% of subjects in the placebo cohort discontinued study drug due to an AE.

All AEs were mild or moderate except for 11 severe AEs in the RTB101 10 mg once daily cohort and 22 severe AEs in the placebo cohort.

TORC closed at $9.01, it last traded at $24.49.


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Synovus to acquire FCB Financial for $2.9B

Synovus to acquire FCB Financial for $2.9B

 

Synovus to acquire FCB Financial for $2.9B, Stockwinners
Synovus to acquire FCB Financial for $2.9B, Stockwinners

Synovus Financial Corp. (SNV) and FCB Financial Holdings, Inc. (FCB) jointly announced their entry into a definitive merger agreement under which Synovus will acquire FCB Financial Holdings, Inc., owner of Florida Community Bank.

The transaction is expected to close by the first quarter of 2019.

Following the closing, FCB will merge with Synovus Bank and operate under the Synovus brand, and FCB Financial Holdings President and CEO Kent Ellert will be executive vice president of Synovus and Florida market president.

Under the terms of the merger agreement, FCB shareholders will receive a fixed ratio of 1.055 shares of Synovus common stock for each common share of FCB in an all-stock transaction.

Based on Synovus’ closing share price on July 23, 2018, the transaction is valued at $58.15 per FCB share or $2.9 billion in aggregate.

Following completion of the merger, former FCB shareholders will own approximately 30% of the combined company. In addition, based on the exchange ratio, Synovus’ most recent quarterly dividend translates to a pro forma annualized dividend of $1.06 per FCB share.

The transaction is expected to be tax free to FCB shareholders. Synovus expects approximately $40 million in pretax synergies to be fully realized by 2020.

Excluding one-time charges, Synovus expects the acquisition to be approximately 6.5% accretive to earnings per common share in 2020 and to deliver strong returns on capital.

The transaction is expected to produce tangible book value per share dilution of 3.3% with an earnback period of less than two years.

The merger agreement has been unanimously approved by both companies’ Boards of Directors.

The merger is subject to customary closing conditions, including approval by Synovus and FCB Financial Holdings shareholders and approval by state and federal bank regulators. BofA Merrill Lynch and J.P. Morgan Securities LLC served as financial advisors to Synovus on this transaction, while Simpson Thacher & Bartlett LLP and Alston & Bird LLP served as legal advisors.

Sandler O’Neill + Partners L.P., Guggenheim Securities, LLC, and Evercore Group L.L.C. served as financial advisors to FCB Financial Holdings, and Wachtell, Lipton, Rosen & Katz served as legal advisor.


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Bristol-Myers treatment for colorectal cancer approved

Bristol-Myers’ Opdivo approved for MSI-H/dMMR metastatic colorectal cancer

Bristol-Myers treatment for colorectal cancer approved, Stockwinners
Bristol-Myers treatment for colorectal cancer approved, Stockwinners

Bristol-Myers (BMY) announced Opdivo – nivolumab – 3 mg/kg plus low-dose Yervoy – ipilimumab – 1 mg/kg injections for intravenous use received approval from the FDA for the treatment of adult and pediatric patients 12 years and older with microsatellite instability high or mismatch repair deficient metastatic colorectal cancer that has progressed following treatment with a fluoropyrimidine, oxaliplatin and irinotecan.

Approval for this indication has been granted under accelerated approval.

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

The application was granted Priority Review and Breakthrough Therapy Designation by the FDA.

Among the 82 patients who received prior treatment with a fluoropyrimidine, oxaliplatin and irinotecan, 46% responded to treatment with Opdivo + Yervoy.

The percentage of these patients with a complete response was 3.7%, and the percentage of patients with a partial response was 43%.

Among these 38 responders, the median DOR was not reached; 89% of those patients had responses of six months or longer, and 21% had responses of 12 months or longer.

This trial is ongoing. Among all enrolled patients, 49% responded to treatment with Opdivo + Yervoy; 4.2% experienced a complete response, while 45% experienced a partial response.

Opdivo was discontinued in 13% of patients and delayed in 45% of patients due to an adverse reaction.

Serious adverse reactions occurred in 47% of patients.

The Opdivo + Yervoy combination is also approved in two other tumor types, advanced renal cell carcinoma and unresectable or metastatic melanoma.

Continued approval for these accelerated approval indications may be contingent upon verification and description of clinical benefit in the confirmatory trials.

BMY closed at $56.18.


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Spero Therapeutics higher on data

Spero says clinical data demonstrates SPR994 to be well-tolerated 

Spero Therapeutics higher on data, Stockwinners
Spero Therapeutics higher on data, Stockwinners

Spero Therapeutics (SPRO) reported positive results from an interim analysis of its ongoing single ascending dose and multiple ascending dose Phase 1 clinical trial of SPR994, its investigational oral carbapenem product candidate designed for the treatment of Gram-negative infections, in healthy volunteers.

The data demonstrate that SPR994 has a favorable safety, pharmacokinetic and pharmacodynamic profile that supports the advancement of SPR994 to a pivotal Phase 3 clinical trial at a 300 mg dose administered three times per day.

The Phase 1 clinical trial of SPR994 is assessing the safety, tolerability and pharmacokinetics of orally administered SPR994.

Interim Phase 1 results from the SAD portion of the trial demonstrate SPR994 to be well tolerated at doses ranging from 100 mg to 900 mg daily, with linear human pharmacokinetics over the dose range tested.

The data also show that the mean free drug plasma concentrations of tebipenem, the active metabolite of SPR994, remained above the MIC90 for the relevant bacterial pathogens for greater than 50% of an 8-hour dosing interval, consistent with the targeted therapeutic range observed in Spero’s hollow fiber experiments.

The pharmacokinetic profile of SPR994 observed to date in both the SAD and MAD portions of the trial provides evidence supporting SPR994’s administration without regard to meals.

Urine concentration data support the use of SPR994 to treat cUTI, with peak urine concentrations 100-fold higher than maximum concentrations in plasma.

No serious adverse events have been reported in the Phase 1 clinical trial to date.

Oral administration of SPR994 has been well tolerated at all doses tested and results are consistent with available clinical and post-marketing data for Orapenem and other approved IV carbapenem antibiotics.

Orapenem is currently approved in Japan for the treatment of pediatric infections and has the same orally bioavailable active ingredient as SPR994.

To date, the Phase 1 clinical trial has enrolled 115 healthy adult volunteers into 14 SAD cohorts and 1 MAD cohort. The SAD portion of the Phase 1 clinical trial is evaluating formulations of SPR994 at single doses ranging from 100 mg to 900 mg daily.

The MAD portion of the trial is designed to assess the safety, tolerability and pharmacokinetics of SPR994 administered orally to healthy volunteers for 14 days.

The initial MAD cohort received 300 mg of SPR994 administered three times per day and the MAD portion of the trial will continue to dose escalate to determine the maximum tolerated dose.

SPRO closed at $16.89, it last traded at $18.21.


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Xplore Technologies sold for $90 million

Zebra Technologies to acquire Xplore Technologies for $6.00 per share 

 

Xplore Technologies sold for $90 million, Stockwinners
Xplore Technologies sold for $90 million, Stockwinners

Zebra Technologies (ZBRA) and Xplore Technologies (XPLR) announced that their boards of directors have approved a definitive agreement in which Zebra will acquire all outstanding common stock of Xplore for $6.00 per share in cash.

Under the terms of the agreement, Zebra plans to implement the acquisition via a tender offer. Xplore has established a leading position as an innovative developer of semi-, fully- and ultra-rugged tablets, 2-in-1 laptops, and a range of performance matched accessories.

These products serve existing vertical markets for Zebra such as retail, manufacturing, transportation & logistics and healthcare, and provide an inroad into new markets including oil & gas, utility, government and public safety. Xplore generated revenue of $87M in the 12-month period ended March 31.

Zebra is effecting the acquisition through a public tender offer for 100% of the shares of Xplore.

In connection with the execution of the merger agreement, certain Xplore shareholders have entered into tender support agreements with Zebra pursuant to which they have agreed to tender their shares to Zebra’s offer.

The aggregate consideration of the transaction, including assumed indebtedness, is expected to be less than or equal to $90M.

Zebra expects to fund the transaction with a combination of cash on hand along with fully committed financing available under its credit facility. The transaction is subject to customary closing conditions and is expected to close in Q3.

XPLR closed at $4.12.


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Compugen Higher as FDA lifts clinical hold on its cancer treatment 

Compugen Higher as FDA lifts clinical hold on its cancer treatment 

Compugen Higher as FDA lifts clinical hold on its cancer treatment , Stockwinners
Compugen Higher as FDA lifts clinical hold on its cancer treatment , Stockwinners

Shares of Compugen (CGEN) surged in pre-market trading after the Israeli biotech company said that the clinical hold on its investigational new drug application for COM701 was lifted by the U.S. Food and Drug Administration.

Separately, Compugen said the FDA cleared Bayer’s (BAYRY) IND application for BAY 1905254.

CLINICAL HOLD LIFTED

Compugen said this morning that the FDA has lifted the clinical hold on its IND for COM701, an immuno-oncology therapeutic antibody targeting PVRIG in patients with advanced solid tumors.

The FDA said the company may now begin a clinical study of the antibody. PVRIG is an investigational monoclonal antibody, a molecule that has the ability to bind with high specificity to a given target, being developed by Compugen to treat various types of cancer.

“We believe the COM701 preclinical data suggest that targeting PVRIG may effectively stimulate an anti-tumor immune response in certain cancers such as breast, endometrial, ovarian and lung, and specifically in patient populations that are unresponsive to current checkpoint inhibitors,” Compugen President and Chief Executive Officer Anat Cohen-Dayag stated.

Looking ahead, Compugen said it plans to initiate a first-in-human Phase 1 study in the U.S. in patients with advanced solid tumors and for whom standard of care therapies are currently ineffective.

In April, Compugen said the FDA requested additional CMC information from the company in support of the COM701 IND application.

At the time, the FDA recommended a lower starting dose of COM701 for the trial.

BAYER IND APPLICATION CLEARANCE

Additionally this morning, Computgen said that the FDA approved Bayer’s (BAYRY) IND application for BAY 1905254, a a first-in-class immuno-oncology therapeutic antibody targeting the ILDR2 protein in patients with advanced solid tumors.

Compugen is entitled to receive a milestone payment upon the first patient dosing with BAY 1905254 in the Phase 1 clinical trial expected in 2018.

PRICE ACTION

In pre-market trading, Compugen is up 45c, or 13.6% to $3.75 per share.


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Supreme Court ruling moves retail stocks

Physical retailers rise, online retailers drop after Supreme Court tax ruling

Supreme Court ruling moves retail stocks, Stockwinners
Supreme Court ruling moves retail stocks, Stockwinners

Shares of brick-and-mortar retailers are rising, while shares of e-commerce firms are slipping, after the Supreme Court ruled that online retailers can be required to collect sales taxes in states where they have no physical presence.

SUPREME COURT RULING

On Thursday, the Supreme Court sided with the state of South Dakota in a fight it brought against Wayfair (W) to require a business that has no physical presence in the state to collect its sales tax.

Supreme Court ruling moves retail stocks, Stockwinners
Supreme Court ruling moves retail stocks, Stockwinners

The Supreme Court ruled in a 5-to-4 vote that a 1992 judgement in Quill Corporation v. North Dakota regarding the physical presence rule was “unsound and incorrect,” according to a judgement posted to the high court’s website.

Justice Anthony Kennedy, in writing for the majority opinion, said the Quill decision had distorted the economy and resulted in states losing annual tax revenues between $8B-$33B.

“Quill puts both local businesses and many interstate businesses with physical presence at a competitive disadvantage relative to remote sellers,” he wrote.

“Remote sellers can avoid the regulatory burdens of tax collection and can offer de facto lower prices caused by the widespread failure of consumers to pay the tax on their own.”

WHAT’S NOTABLE:

Following the ruling, industry trade organization National Retail Federation issued a statement saying,

“Retailers have been waiting for this day for more than two decades. The retail industry is changing, and the Supreme Court has acted correctly in recognizing that it’s time for outdated sales tax policies to change as well.

This ruling clears the way for a fair and level playing field where all retailers compete under the same sales tax rules whether they sell merchandise online, in-store or both.”

ANALYST COMMENTARY

KeyBanc analyst Edward Yruma called the ruling a negative for Wayfair, arguing that it may reduce some of the price differential that has helped it gain share from traditional peers.

The ruling is also a negative, but to a lesser degree, for eBay (EBAY) and Etsy (ETSY), said Yruma, who views the impact on those two as more related to compliance and implementation.

He adds that the news could be a modest positive for retailers of high-ticket and branded products, such as Best Buy (BBY), Home Depot (HD), Lowe’s (LOW), La-Z-Boy (LZB), Kirkland’s (KIRK), RH (RH) and Williams-Sonoma (WSM).

PRICE ACTION

At Thursday midday, Target (TGT) rose 1.8%, Walmart (WMT) was up 0.7%, Costco (COST) rose roughly 1.1% while Amazon (AMZN) was down 0.4%, Etsy dropped about 2.5%, eBay fell 1.4% and Wayfair (W) was down 1.2%.

In addition, Avalara (AVLR), a software company focused on automated tax compliance that recently held its initial public offering, gained 17.1%.


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Heron Therapeutics HTX-001 achieves primary endpoints

Heron Therapeutics HTX-001 achieves primary endpoints in Study 209, 211

Heron Therapeutics HTX-001 achieves primary endpoints, Stockwinners
Heron Therapeutics HTX-001 achieves primary endpoints, Stockwinners
Heron Therapeutics (HRTX) announced positive topline results from two completed Phase 2b studies of HTX-011: Study 209 and Study 211.
HTX-011 achieved the primary endpoints in both studies.
Study 209 was a randomized, placebo- and active-controlled, double-blind, Phase 2b clinical study in patients undergoing primary unilateral total knee arthroplasty to evaluate the analgesic efficacy, safety and pharmacokinetics of HTX-011 locally administered into the surgical site.
Following a dose-escalation phase, 222 patients were randomized to receive: HTX-011 400 mg administered via instillation into the surgical site; HTX-011 400 mg administered via instillation into the surgical site with a low dose of ropivacaine injected into the posterior capsule (HTX-011 combination); bupivacaine 125 mg administered via multiple injections into the surgical site; and placebo.
Ropivacaine and bupivacaine are generically available standard-of-care local anesthetics used in the management of postoperative pain.
This study included a pre-specified hierarchical testing strategy for the primary and key secondary endpoints for the HTX-011 400 mg treatment groups. The primary endpoint was pain intensity as measured by the area under the curve, or AUC, from 0 to 48 hours post-surgery for HTX-011 compared to placebo.
The key secondary endpoint was pain intensity as measured by the AUC from 0 to 72 hours post-surgery for HTX-011 compared to placebo.
The primary and key secondary endpoints were achieved.
Study 211 was a randomized, placebo- and active-controlled, double-blind, Phase 2b dose-finding study in patients undergoing augmentation mammoplasty to evaluate the analgesic efficacy, safety and pharmacokinetics of HTX-011 when administered by instillation into the surgical site or via ultrasound-guided lateral and medial pectoral nerve block before surgery.
The study consisted of three cohorts comparing HTX-011 nerve block to the standard dose of bupivacaine 50 mg, administered as a nerve block, and placebo, and a final cohort comparing both HTX-011 400 mg administered by instillation and HTX-011 400 mg administered as a nerve block to the same two control groups.
A total of 243 patients were enrolled.
The primary endpoint was pain intensity as measured by the AUC from 0 to 24 hours post-surgery compared to placebo. The primary endpoint of the study was achieved.
HRTX closed at $30.70. it last traded at $40.00


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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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BAE Systems receives contract for submarines

BAE Systems receives contract for payload tubes for Virginia-class submarines 

BAE Systems receives contract for submarines, Stockwinners
BAE Systems receives contract for submarines

BAE Systems (BAESY) has received a contract to produce payload tubes for two of the U.S. Navy’s new Virginia-class submarines to support increased firepower on the Block V version of the attack subs.

Under the contract with General Dynamics Electric Boat, a builder of the Virginia class, BAE Systems will deliver two sets, each consisting of four tubes, for the Virginia Payload Modules on the SSN 804 and SSN 805.

The Virginia Payload Module extends the length of the Block V submarines over previous versions of the Virginia-class by adding an additional mid-body section to create more payload space for greater firepower.

Each large-diameter payload tube can store and launch up to seven Tomahawk cruise missiles.

The VPM offers exceptional flexibility as well for the integration of future payload types, such as unmanned systems or next-generation weapons.

BAE Systems, which is also providing payload tubes for the SSN 803 under a previously awarded VPM contract, has a long history of supporting the Navy’s submarine fleet as the leading provider of propulsors and other submarine systems.

The company was selected to provide propulsors, spare hardware, and tailcones for Block IV Virginia-class vessels and stands ready to provide the same support for the Block V subs.

Under this most recent contract, BAE Systems will also develop the processes and tooling necessary for the Block V payload tube production.

Work will be performed at the company’s facility in Louisville, Kentucky, with deliveries scheduled to begin in 2020.

BAESY last traded at $35.39


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SoftBank to invest $2.25B in GM

SoftBank Vision Fund to invest $2.25B in GM Cruise 

 

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SoftBank Vision Fund to invest $2.25B in GM Cruise 

General Motors (GM) announced that the SoftBank Vision Fund will invest $2.25B in GM Cruise Holdings, further strengthening the company’s plans to commercialize AV technology at large scale.

GM will also invest $1.1B in GM Cruise upon closing of the transaction.

“Our Cruise and GM teams together have made tremendous progress over the last two years,” said GM Chairman and CEO Mary Barra.

“Teaming up with SoftBank adds an additional strong partner as we pursue our vision of zero crashes, zero emissions and zero congestion.”

“GM has made significant progress toward realizing the dream of completely automated driving to dramatically reduce fatalities, emissions and congestion,” said Michael Ronen, managing partner, SoftBank Investment Advisers.

“The GM Cruise approach of a fully integrated hardware and software stack gives it a unique competitive advantage. We are very impressed by the advances made by the Cruise and GM teams, and are thrilled to help them lead a historic transformation of the automobile industry.”

The SoftBank Vision Fund investment will be made in two tranches.

At the closing of the transaction, the Vision Fund will invest the first tranche of $900M. At the time that Cruise AVs are ready for commercial deployment, the Vision Fund will complete the second tranche of $1.35B, subject to regulatory approval.

Together, this will result in the SoftBank Vision Fund owning a 19.6-percent equity stake in GM Cruise and will afford GM increased flexibility with respect to capital allocation.

The GM and SoftBank Vision Fund investments are expected to provide the capital necessary to reach commercialization at scale beginning in 2019.

GM (GM) Chairman and CEO Mary Barra confirmed the automaker’s plans to launch an autonomous ride-hailing vehicle in 2019.

President Dan Ammann noted that talks with SoftBank occurred over the course of several months. He said GM wasn’t looking for a partner, but found one that was “uniquely aligned” with it.

Ammann added that the Cruise team has grown to over 800 since the acquisition two years ago. He said the decision to report GM Cruise as a standalone segment is intended to enhance transparency around this part of the business.

ANALYST COMMENTS

Evercore ISI analyst George Galliers upgraded General Motors (GM) to Outperform from In Line after SoftBank’s (SFTBF) Vision Fund agreed to invest in the company’s Cruise autonomous driving unit in a deal that values the unit at $11.5B.

Galliers said he had been assigning no value to the Cruise assets before the announcement.

Under his new sum-of-the-parts valuation, Galliers applies a 6.0x multiple on GM’s core, attributes a value of about $8 per share for the Cruise assets and about 60c per share for GM’s stake in Lyft before applying a 25% discount to both of the latter. He raised his price target on GM shares to $50 from $47.


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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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AbbVie to buyback $7.5 billion of its own shares

AbbVie commences self-tender offer for up to $7.5B of common stock

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AbbVie to buyback $7.5 billion of its own shares

AbbVie (ABBV) announced that it has commenced a modified “Dutch auction” tender offer to purchase for cash up to $7.5 B of its common stock at a price not less than $99.00 per share and not more than $114.00 per share.

AbbVie stockholders may tender all or a portion of their shares at a price specified by the tendering stockholder within this range.

When the tender offer expires, AbbVie will determine the lowest price within the range of prices specified above that allows AbbVie to purchase up to an aggregate of $7.5B of its common stock.

The tender offer and withdrawal rights will expire at midnight Eastern Time, at the end of the day on May 29, 2018, unless extended or terminated by AbbVie.

Tenders of shares must be made prior to the expiration of the tender offer and may be withdrawn at any time prior to the expiration of the tender offer. Morgan Stanley & Co. is acting as dealer manager, and Wachtell, Lipton, Rosen & Katz is acting as legal advisor.

ABBV closed at $96.55. Shares have a 52-week trading range of $64.61 – $125.86.


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FDA approves Bydureon for use in T2D patients

AstraZeneca announces FDA approval of Bydureon for use in T2D patients

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FDA approves Bydureon for use in T2D patients

 

AstraZeneca (AZN) announced the FDA has approved BYDUREON for injectable suspension as an add-on therapy to basal insulin in adults with type 2 diabetes with inadequate glycemic control.

 

BYDUREON is approved for adults with T2D whose blood sugar remains uncontrolled on one or more antidiabetic medicines in addition to diet and exercise, to improve glycemic control.

 

The expanded use is based on results from the 28-week DURATION-7 study, which examined the effect of BYDUREON or placebo as add-on therapy to insulin glargine, with or without metformin, in adults with T2D.

 

Mean HbA1c was reduced by 0.9% in the BYDUREON group compared to 0.2% in the placebo group in patients with a mean baseline HbA1c of 8.5%.

 

Furthermore, 32.5% of patients in the BYDUREON group reached an HbA1c of less than 7.0% compared to 7.0% of patients in the placebo group.

 

There were no new safety findings in the DURATION-7 study.

 

Overall hypoglycemia was similar between the groups, with no reported major hypoglycemia.

 

In both arms, the same percentage of patients reported minor hypoglycemia. Like other GLP-1 receptor agonists, the risk of hypoglycemia is increased when BYDUREON is co-administered with insulin. Prescribers should consider lowering the dose of insulin when co-administering BYDUREON.


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