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.

To read stories similar to this, sign up for a free trial membership to Stockwinners; be sure to check the Market Radar section. No credit card required. 

The article does not constitute investment advice. Each reader is encouraged to consult with his or her individual financial professional and any action a reader takes as a result of information presented here is his or her own responsibility.

 

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

Winning stock and option picks since 1998

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

Stockwinners offers stock research, winning stock and option picks since 1998

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.

To read stories similar to this, sign up for a free trial membership to Stockwinners; be sure to check the Market Radar section. No credit card required. 

The article does not constitute investment advice. Each reader is encouraged to consult with his or her individual financial professional and any action a reader takes as a result of information presented here is his or her own responsibility.

Chinese Internet Stocks Tumble

Chinese internet stocks fall following report of streaming ban

Stockwinners offers stock research, winning stock and option picks since 1998

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.

To read stories similar to this, sign up for a free trial membership to Stockwinners; be sure to check the Market Radar section. No credit card required. 

The article does not constitute investment advice. Each reader is encouraged to consult with his or her individual financial professional and any action a reader takes as a result of information presented here is his or her own responsibility.

EnerNOC Sold for $300 Million

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

Stockwinners, offers winning stock and option picks since 1998

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.

To read stories similar to this, sign up for a free trial membership to Stockwinners; be sure to check the Market Radar section. No credit card required. 

The article does not constitute investment advice. Each reader is encouraged to consult with his or her individual financial professional and any action a reader takes as a result of information presented here is his or her own responsibility.

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.

To read stories similar to this, sign up for a free trial membership to Stockwinners; be sure to check the Market Radar section. No credit card required. 

The article does not constitute investment advice. Each reader is encouraged to consult with his or her individual financial professional and any action a reader takes as a result of information presented here is his or her own responsibility.

Qatar Airways to Buy 10% of American Airlines

Qatar Airways intends to make ‘significant’ investment in American Airlines

In a regulatory filing, American Airlines Group recently received an unsolicited notice from Qatar Airways indicating Qatar Airways’ intention to make a significant investment in American Airlines.

As a publicly traded company, American Airlines’ common stock is available for purchase on the Nasdaq Stock Market, and Qatar Airways has indicated that its purchase would be made on the open market.

Consistent with the notice, Qatar Airways has also submitted a filing under the Hart-Scott-Rodino Act with respect to its potential investment in American Airlines common stock.

A filing under the HSR Act is required for an acquisition by Qatar Airways of more than approximately $81M of American Airlines common stock, and is subject to review by the Antitrust Division of the United States Department of Justice in accordance with the HSR Act.

The notice advised that Qatar Airways intends to purchase at least $808M and, in a conversation between the CEOs of the two companies initiated by the Qatar Airways CEO, Qatar Airways indicated that it has an interest in acquiring approximately a ten percent stake.

American Airlines will respond in due course with the appropriate filings required under the HSR Act.

The company’s Certificate of Incorporation prohibits anyone from acquiring 4.75% or more of the company’s outstanding stock without advance approval from the Board following a written request in accordance with the procedures set forth therein. The Board has not received any such request.

The company also notes that there are foreign ownership laws that limit the total percentage of foreign voting interest to 24.9%.

The proposed investment by Qatar Airways was not solicited by American Airlines and would in no way change the Company’s Board composition, governance, management or strategic direction. It also does not alter American Airlines’ conviction on the need to enforce the Open Skies agreements with the United Arab Emirates and the nation of Qatar and ensure fair competition with Gulf carriers, including Qatar Airways.

American Airlines (AAL) continues to believe that the President and his administration will stand up to foreign governments to end massive carrier subsidies that threaten the U.S. aviation industry and that threaten American jobs.

To read stories similar to this, sign up for a free trial membership to Stockwinners; be sure to check the Market Radar section. No credit card required. 

The article does not constitute investment advice. Each reader is encouraged to consult with his or her individual financial professional and any action a reader takes as a result of information presented here is his or her own responsibility.