FDA Grants Conatus’ IDN-7314 Orphan Drug Designation

Conatus (CNAT) granted orphan drug designation for IDN-7314 for treatment of PSC

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Conatus Pharmaceuticals (CNAT) announced that the U.S. FDA has granted Orphan Drug Designation to Conatus’ drug candidate IDN-7314 for the treatment of primary sclerosing cholangitis, a disease affecting bile ducts in the liver which can lead to cirrhosis and liver failure.

The FDA’s Orphan Drug Designation program is intended to encourage the development of drugs and biologics that may provide benefit to patients suffering from rare diseases or conditions.

IDN-7314 is an orally active pan-caspase protease inhibitor designed to reduce the activity of enzymes that mediate inflammation and cell death, which has demonstrated reduction of relevant biomarkers in two preclinical models of PSC. One nonclinical model, the Mdr2-/- mouse model, is considered the current benchmark nonclinical model of PSC.

A new preclinical model, second mitochondria-derived activator of caspases-mimetic induced PSC in mice, has recently been reported that reproduces much of the phenotype of human PSC. IDN-7314 significantly improved biochemical indices of hepatic and biliary damage in these murine models of PSC, and these results suggest the involvement of caspases in the progression of PSC.

Other stocks to watch include: ICPT, INCY and AZN.

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Barron’s Is Bullish on Cigna, Red Hat

Barron’s is bullish on RHT, UTHR, ALXN, CI, AIZ, and NCR

Barron’s remains bearish on Foot Locker (FL)

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Barron’s, the weekly publication owned by the Wall Street Journal, in its latest issue is bullish on several names. They include:

Shares of NCR Corp. (NCR) could gain 30% in a year, Barron’s contends in a feature article. The publication argues that the cash-register company is a “rising software star with the discount valuation of a legacy hardware player,” and that NCR has opportunities to sell digital capabilities to retailers threatened by e-commerce leaders.

Assurant (AIZ) could double as investors reevaluate company.  Assurant is shifting toward a capital-light model, and some investors believe the stock could double in coming years as Wall Street begins to appreciate the company’s new focus on fee-based businesses, Barron’s contends in a feature article. In an interview with the publication, CEO Alan Colberg said Assurant is “on track for double-digit earnings-per-share growth this year.”

Alexion, United Therapeutics worth a look. After the recent jump in biotech stocks, Barron’s urges investors to look for companies that haven’t yet joined the rally, or that have unique reasons for potentially continuing higher. In a ‘Trader Extra’ column, Barron’s notes that a Credit Suisse screen of “fresh ideas” included Alexion Pharmaceuticals (ALXN) and United Therapeutics (UTHR), and the publication argues that both “could be attractive now” given the former’s now concluded sales investigation and the latter’s cheap valuation.

Red Hat may eke out double-digit returns.  Red Hat (RHT) investors shouldn’t take profits yet, as order momentum and Wall Street’s appetite for growth suggest the stock can “eke out” double-digit returns in the year ahead, Barron’s contends in a ‘Follow Up’ column. The publication cautions that “it’s a close call.”

Cigna could gain over 15% by end of next year.  The GOP healthcare plan looks like a boon for Cigna (CI) and other insurers, and the stock could gain more than 15% by the end of next year, Barron’s contends in a ‘Follow Up’ column. Passage of the plan is “far from certain,” but it proposes to remove taxes, inject funding into insurance markets, and ease requirements on how much insurers spend on health care, Barron’s explains. Cigna has taken a “cautious approach” to Obamacare, and the company seems to be “firing on all cylinders,” the publication adds.

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Rigs Counts Continue to Rise

Baker Hughes reports U.S. rig count up 8 to 941 rigs

This marks the 23rd straight week of increases

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Baker Hughes (BHI) reports that the U.S. rig count is up 8 rigs from last week to 941, with oil rigs up 11 to 758, gas rigs down 3 to 183.

 

The U.S. Rig Count is up 520 rigs from last year’s count of 421, with oil rigs up 428, gas rigs up 93, and miscellaneous rigs down 1 to 0.
The U.S. Offshore Rig Count is unchanged from last week at 22 and up 1 rig year over year.
The Canadian Rig Count is up 11 rigs from last week to 170, with oil rigs up 7 to 98 and gas rigs up 4 to 72.
The Canadian Rig Count is up 94 rigs from last year’s count of 76, with oil rigs up 62, gas rigs up 33, and miscellaneous rigs down 1 to 0.

 

This marks the 23rd straight week of increases, and comes despite oil prices having fallen below $43 bbl this week into bear market territory.

 

#WTI is on track for its worst 1H since the 1990s. WTI crude prices are presently down by 20.2% on the year-to-date.

 

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Box Office Battle for this Weekend

‘Transformers’ expected to top ‘Cars 3,’ ‘Wonder Woman’

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Viacom (VIA, VIAB) subsidiary Paramount’s “Transformers: The Last Knight,” the fifth installment in the transforming robots series, is expected to open domestically at about $46M, after opening Wednesday to an estimated $15.7M, the lowest single-day opening for any film in the Transformers franchise, which hints at franchise fatigue.

Disney/Pixar’s (DIS) “Cars 3,” an animated film featuring anthropomorphic cars, is expected to take second place this weekend with a domestic gross of around $29M, after topping the box office in its opening weekend last week.

Time Warner’s (TWX) superhero flick “Wonder Woman,” starring Gal Gadot, is expected to take third place in its fourth weekend at theaters, earning an additional $28M-$29M, which would bring the domestic total for the film to $322M.

Lionsgate’s (LGF.A, LGF.B) Tupac biography “All Eyez on Me” is expected to earn an additional $9M-$10M domestically, after opening last weekend with $26.4M.

Other publicly traded companies in filmmaking include 21st Century Fox (FOX, FOXA), Comcast (CMCSA, CMCSK), and Sony (SNE).

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FDA Approves Portola Pharmaceuticals’ Bevyxxa

Portola Pharmaceuticals announces FDA approval of Bevyxxa, Shares rise 45%

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#Portola Pharmaceuticals (PTLA) announced the U.S. Food and Drug Administration has approved #Bevyxxa, which it said is “the first and only” anticoagulant for hospital and extended duration prophylaxis of venous thromboembolism, or #VTE, in adult patients hospitalized for an acute medical illness who are at risk for thromboembolic complications due to moderate or severe restricted mobility and other risk factors for VTE.

The drug, BevyxXa, known also as betrixaban, is the first oral treatment and first extended duration treatment for this patient population, the company said.

Roughly 200,000 people in the United States develop deep vein #thrombosis each year, with about 40,000 of them dying of pulmonary embolism, caused when a blood clot breaks loose and travels to the lungs, blocking blood flow, the company said.

The timeline on which Portola expects to launch Bevyxxa is between August and November 2017.

During this period, Portola will complete salesforce hiring and training, drug manufacturing validation and inventory buildup, the company said.

BevyxXa was tested using a novel clinical trial strategy designed to test a series of subgroups before testing the broader patient population. It first tested the highest risk patients. Then it tested a lower risk group, and finally the overall patient population.

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Siris Capital Offers $18 a Share for Synchronoss

Synchronoss surges after Siris Capital offers to Acquire Company for $18/share

SNCR receives a $18 per share offer. See Stockwinners.com Market Radar

Shares of Synchronoss have jumped after the company disclosed in a regulatory filing that Siris Capital Group delivered a letter to the company indicating that they believe they could be in a position to acquire the company in an all-cash acquisition at $18.00 per share of common stock, subject to completion of customary due diligence, including a review of outstanding shareholder litigation and the company’s financial statements, as well as the negotiation and execution of a transaction agreement acceptable to the company and Siris.

Synchronoss Technologies, Inc. provides cloud solutions and software-based activation for connected devices worldwide.

Siris, which holds a roughly 13% stake in Synchronoss, stated in its letter:

“We believe that we would be able to complete due diligence, obtain satisfactory financing commitments, and negotiate and sign a definitive agreement within six weeks from the date on which Synchronoss provides a fully-populated data room. We have engaged legal counsel and are prepared to engage financial and accounting advisors to assist us in this potential transaction. In order to commit the time and resources necessary to proceed on this expedited timeframe, we would request a limited period of exclusivity.”

Synchronoss shares have been heavily shorted and are getting a ‘short-squeeze’ today. As of May 31, a total of 7,678,091 shares have been shorted giving the stock a 4.8 days to cover. SNCR has a 52-week trading range of $10.11 to $49.94. SNCR last traded at $16.39, up 34% on the day!

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Glencore Raises Offer for Rio Tinto’s Coal & Allied

Glencore raises offer for Rio Tinto’s Coal & Allied to $2.675B plus royalties

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Glencore (GLNCY) announced that it has submitted an improved irrevocable binding offer to acquire Rio Tinto’s (RIO) 100% interest in Coal & Allied Industries Limited for $2.675B cash plus a coal price linked royalty.

All cash is payable in full immediately upon completion. Glencore’s offer is at least $225M greater than Yancoal’s proposal, the company stated.

The Glencore offer remains conditional only on approval from China, Korea, Taiwan and Australia. Japanese regulatory approval to acquire C&A has already been obtained. “Demonstrating our confidence in securing all approvals, Glencore’s Offer is supported by a $225M deposit which will be forfeited if the transaction does not complete as a result of a failure to obtain a regulatory approval.

Glencore believes that it will obtain all regulatory approvals in a timely manner and that its offer fully compensates Rio Tinto for any potential delays beyond Yancoal’s expected completion date as announced by Rio Tinto,” the company said.

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AVEO Oncology’s FOTIVDA Receives Europe’s Pre Approval for Renal Cell Carcinoma

AVEO Oncology reports positive CHMP opinion for tivozanib as RCC treatment

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AVEO Oncology (AVEO) announced that the Committee for Medicinal Products for Human Use, the scientific committee of the European Medicines Agency, has recommended #FOTIVDA for approval as a treatment for patients with advanced renal cell carcinoma.

The #CHMP’s recommendation is now referred to the European Commission.

The EC, which typically adheres to the recommendation of the CHMP, but is not obligated to do so, is expected to make its final decision in about 67 days.

If approved by the EC, marketing authorization for tivozanib will be granted in all 28 countries of the European Union, Norway, Iceland and Liechtenstein. EUSA Pharma, a specialty pharmaceutical company with a focus on oncology and oncology supportive care, is the European licensee for tivozanib.

Under the terms of their December 2015 agreement, EUSA Pharma has agreed to pay AVEO up to $394M in future research and development funding and milestone payments, assuming successful achievement of specified development, regulatory and commercialization objectives, as well as a tiered royalty ranging from a low double-digit up to mid-twenty percent on net sales of tivozanib in the agreement’s territories.

Thirty percent of milestone and royalty payments received by AVEO, excluding research and development funding, are due to Kyowa Hakko Kirin as a sublicensing fee in Europe.

In the United States, the royalty obligation to KHK ranges from the low- to mid-teens on net sales.

AVEO says, “If the European Commission grants marketing approval for #tivozanib, it would trigger a $4 million research and development reimbursement payment from EUSA, and AVEO will also be eligible for up to $12M in additional milestones from EUSA based on member state reimbursement and regulatory approvals.

These payments would add significant resources to our balance sheet as we work toward the anticipated readout of our U.S. pivotal trial in third-line RCC, the TIVO-3 trial, in the first quarter of 2018.”

AVEO closed at $0.72. Shares are up 50% in pre-market trading.


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Cara Therapeutics Sharply Higher on FDA Action

FDA has granted Breakthrough Therapy designation to I.V. CR845 for the treatment of moderate-to-severe uremic pruritus in chronic kidney disease patients undergoing hemodialysis

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Cara Therapeutics announced that the FDA has granted Breakthrough Therapy designation to I.V. CR845 for the treatment of moderate-to-severe uremic pruritus in chronic kidney disease patients undergoing hemodialysis.

Cara Therapeutics, Inc. (CARA) is a biopharmaceutical company. The company is focused on developing and commercializing new chemical entities designed to alleviate pain and pruritus by selectively targeting peripheral kappa opioid receptors.

“The FDA’s decision to grant Breakthrough Therapy designation is recognition of both the significant unmet medical need among CKD patients with UP and the potential of I.V. CR845 to address it,” said Derek Chalmers, Ph.D., D.Sc., President and Chief Executive Officer of Cara Therapeutics.

“We have already initiated our Phase 3 program and look forward to working closely with the FDA to bring this potential new treatment option to hemodialysis patients as quickly as possible.”

Breakthrough Therapy designation is granted to expedite the development and review process for new therapies addressing serious or life-threatening conditions, where preliminary clinical evidence indicates that the drug candidate may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints.

CARA closed at $24.25. Shares are up $2 in pre-market trading.

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FDA Grants Thermo Fisher Pre-Market Approval for Oncomine Test

Thermo Fisher says FDA grants premarket approval for Oncomine Dx Target Test that simultaneously screens tumor samples for three FDA-approved therapies for non-small cell lung cancer

Stocks to Buy Now

Thermo Fisher ( $TMO ) announced that the FDA has granted premarket approval for its #Oncomine Dx Target Test, which the company called the first next-generation sequencing-based test that simultaneously screens tumor samples for biomarkers associated with three FDA-approved therapies for non-small cell lung cancer.

LabCorp’s ( $LH ) Diagnostics and Covance Businesses, NeoGenomics (NEO) Laboratories, and Cancer Genetics (CGIX) are among the first laboratories that will offer the Oncomine Dx Target Test as a service to oncologists, Thermo Fisher said.

All tests will be run on Thermo Fisher’s Ion PGM Dx System, which received FDA 510k clearance in parallel for use on formalin-fixed, paraffin-embedded tissue samples.

Thermo Fisher developed the Oncomine Dx Target Test in collaboration with Novartis (NVS) and Pfizer (PFE).

“This first iteration of the test is just the beginning since the diagnostic claims of the Oncomine Dx Target Test may be expanded in the future based on the existing panel.

Thermo Fisher has entered into discussions with several pharmaceutical companies looking to use the panel for FDA-approved targeted therapy applications beyond lung cancer,” the company noted.

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Republicans draft of ACA replacement bill Boosts Hospitals, Insurers

Funding for Medicaid will be phased out from 2020 to 2024 and additional cuts would begin in 2025

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Shares of hospital and health insurance stocks are rising this afternoon after Senate Republicans released a draft of their Affordable Care Act replacement bill.

WHAT’S NOTABLE

The draft includes cuts to #Medicaid and restructures the program from an open-ended government funding commitment to a limited federal payments system.

The bill also repeals billions of tax dollars used to expand coverage and abolishes the ACA’s mandates to purchase coverage.

Under the draft, federal funding for Medicaid will be phased out from 2020 to 2024 and additional cuts would begin in 2025, as the cap on Medicaid payments begins to grow at a slower rate.

While the bill retains some of the ACA’s tax credit structure, which assists citizens in buying private coverage, senators have reshaped the credits so they are less generous and less costly to the government. The bill is expected to be voted on next week.

COMPANIES TO WATCH

Publicly traded hospital operators include HCA Holdings (HCA), LifePoint (LPNT), Tenet Healthcare (THC), Community Health (CYH) and Quorum Health (QHC) and health insurance providers include Aetna (AET), Anthem (ANTM), Centene (CNC), Cigna (CI), Humana (HUM), Molina Healthcare (MOH), UnitedHealth (UNH) and WellCare (WCG).

PRICE ACTION

HCA was up 3.8%, LifePoint rose 3.3%, Tenet was up 8.7%, Community Health rose 8.4% and Quorum was up 8.3% in afternoon trading. Aetna, Anthem and Centene also rose 1.3%, 1% and 3.6%, respectively. Cigna was up 1.1%, Humana rose 1.5%, Molina gained 2.6%, UnitedHealth was up 1.5% and WellCare was up 3.5%.

Staples is For Sale

Reuters reported Sycamore Partners is near a deal buy the retailer for $6 billion or higher, about $8.66 a share

Staples intrinsic value closer to $12 per share, says Citi

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Private equity firm Sycamore Partners is in advanced talks to acquire Staples in a deal that could top $6 billion.

The acquisition would come a year after a US federal judge killed a merger between Staples and Office Depot on antitrust grounds.

It would represent a bet by Sycamore that Staples could more quickly shift its business model from serving consumers to catering to companies if it were to go private.

Staples, the office supply retailer, reported a smaller-than-expected fall in first-quarter comparable sales last month, while its profit met analyst estimates, helped by a growth in demand for facilities, breakroom supplies and technology solutions.

Staples has 1,255 stores in the United States and 304 in Canada. It has the largest market share of office supply stores in the United States at 48 percent.

Private-equity acquisitions of retailers have become a rare occurrence due to the tough retail environment due to online retailers such as Amazon.

A number of private equity-backed retailers, from Sports Authority to Payless ShoeSource, have filed for bankruptcy in the last few quarters.

Sycamore, however, has performed much better than its peers by investing in retailers. Its previous investments include department store operator Belk Inc., discount retailer Dollar Express and specialty retailer Hot Topic.

Citi analyst Kate McShane said the $6B offer appears low considering the value of the two business segments and things intrinsic value is closer to $12 per share based on the sum-of-the-parts valuation. McShane rates Staples a Buy with a $12 price target.

SPLS last traded at $9.23. It has a 52-weeks trading range of $7.24 – $10.25.

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Chinese Internet Stocks Tumble

Chinese internet stocks fall following report of streaming ban

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Shares of Chinese internet companies Sina (SINA), Weibo (WB), Phoenix New Media (FENG), YY (YY) and Momo (MOMO) are falling following reports that Chinese regulators are cracking down on online videos and streaming in an effort to police online content.

WHAT’S NEW

The State Administration of Press, Publication, Radio, Film and Television of the People’s Republic of China has ordered internet platforms Sina Weibo, Phoenix New Media’s iFeng and ACFUN to stop all video and streaming services as China increases its efforts to cut down the dissemination of “vulgar content.”

The regulator said the companies do not have the necessary license to stream content and were “not in line with national audiovisual regulations and propagating negative speech.” The move is seen as a blow to Sina Weibo which has invested in livestreaming companies and announced a partnership in December with the National Football League to stream games.

It is unclear if the ban on streaming is temporary or permanent.

WEIBO CONFIRMS RECEIPT OF NOTICE

Following the report, Weibo announced that it became aware of a public notice issued by The State Administration of Press, Publication, Radio, Film and Television of the People’s Republic of China stating that the SAPPRFT had recently requested the local competent authorities to take measures to suspend several companies’ video and audio services due to their lacking of an internet audio/video program transmission license and posting of certain commentary programs with content in violation of government regulations on their sites, and Weibo is named as one of these companies.

The company said it is “communicating with the relevant government authorities to understand the scope of the notice” and “intends to fully cooperate with the relevant authorities.”

PRICE ACTION

Sina was down 7.5% to $85.07, Weibo fell 9.6% to $69.57, Phoenix New Media was down 2.2% to $2.69, YY dropped 3.5% to $56.90 and Momo fell 2.5% to $37.75 in morning trading.

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EnerNOC Sold for $300 Million

EnerNOC enters into agreement to be acquired by Enel Group for $7.67 per share

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EnerNOC (ENOC) announced that it has entered into an agreement to be acquired by the Enel Group, a multinational power utility and leading integrated electricity and gas operator present in over 30 countries across five continents with a managed capacity of approximately 85 GW and more than 65 million business and household customers worldwide.

Under the terms of the agreement, the Enel Group, through its subsidiary Enel Green Power North America, or EGPNA, will purchase EnerNOC for $7.67 per share in an all-cash transaction valuing the company at over $300M, including EnerNOC’s net debt.

EGPNA will commence a tender offer to acquire all of EnerNOC’s shares of common stock for $7.67 per share, representing an approximate 42% premium to the Company’s closing stock price on June 21, 2017 and a 38% premium to the 30-day volume-weighted average price.

EGPNA’s obligation to purchase the shares of EnerNOC’s common stock tendered in the tender offer is subject to certain conditions, including that holders of a majority of the shares are tendered during the tender offer period and receipt of antitrust clearance in the United States.

Following completion of the tender offer, the remaining shares will be acquired in a second step merger at the same cash price per share as paid in the tender offer.

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Novartis Reports Positive Results, Shares Rise

Novartis Phase III CANTOS study met primary endpoint

Durect (DRRX) completes enrollment in Phase 3 trial for pain relief candidate Posimir

#Novartis (NVS) announced topline results from the global Phase III CANTOS study investigating the efficacy, safety and tolerability of ACZ885 in combination with standard of care in people with a prior heart attack and inflammatory atherosclerosis.

With more than 10,000 patients enrolled in the study over the last six years, #CANTOS is one of the largest and longest-running clinical trials in Novartis’ history.

The CANTOS study met the primary endpoint, demonstrating that when used in combination with standard of care ACZ885 reduces the risk of major adverse cardiovascular events, or MACE, a composite of cardiovascular death, non-fatal myocardial infarction and non-fatal stroke, in patients with a prior heart attack and inflammatory atherosclerosis.

The full data from the study will be submitted for presentation at a medical congress and for peer reviewed publication later this year.

Durect Data

Separately, Novartis announced that #Durect (DRRX) has completed patient enrollment in PERSIST, the pivotal Phase 3 clinical trial of Posimir, an investigational locally acting, non-opioid analgesic intended to provide up to three days of continuous pain relief after surgery.

The company expects to complete patient follow-up visits during Q3 and announce top-line data in Q4.

In May 2017, Durect signed a development and commercialization agreement with Sandoz AG, a division of Novartis (NVS), covering the U.S.

Under the terms of the agreement, #Sandoz made an upfront payment to Durect of $20M following review under the HSR Antitrust Improvements Act of 1976, with the potential for up to an additional $43M in development and regulatory milestones, up to an additional $230M in sales-based milestones, as well as a tiered double-digit royalty on product sales in the U.S. Durect remains responsible for the completion of the ongoing PERSIST Phase 3 clinical trial for #Posimir as well as FDA interactions through approval.

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