Regeneron And Sanofi: Dupixent Granted FDA Breakthrough Therapy Designation For EoE
Regeneron Pharmaceuticals Inc. (REGN) and Sanofi (SNY) announced Monday that Dupixent (dupilumab) has received Breakthrough Therapy designation from the U.S. Food and Drug Administration.
The designation is for the treatment of patients 12 years and older with eosinophilic esophagitis or EoE. The decision is based on positive results from Part A of a Phase 3 trial in patients with EoE.
The companies noted that there are currently no FDA-approved medicines for EoE, a chronic and progressive type 2 inflammatory disease that damages the esophagus and prevents it from working properly.
Dupixent is the first and only biologic to show positive and clinically-meaningful Phase 3 results in patients 12 years and older with EoE.
Regeneron and Sanofi previously reported positive results from Part A of the pivotal Phase 3 trial evaluating Dupixent in patients with EoE.
Part A of the trial of 81 patients met both of its co-primary endpoints, as well as all key secondary endpoints.
The FDA’s Breakthrough Therapy designation is designed to expedite the development and review of drugs in the U.S. that target serious or life-threatening conditions.
Yoshihide Suga is set to become Japan's next prime minister after winning ruling party leadership race
- Yoshihide Suga, a long-time ally of outgoing Japanese Prime Minister Shinzo Abe, won a ruling Liberal Democratic Party leadership election on Monday, paving the way for him to become prime minister in a parliamentary vote this week.
Japan's Yoshihide Suga, a long-time ally of outgoing Prime Minister Shinzo Abe, won a ruling Liberal Democratic Party (LDP) leadership election on Monday, paving the way for him to become prime minister in a parliamentary vote this week.
Suga, 71, who served in the powerful post of chief cabinet secretary during Abe's nearly eight-year tenure, has said he will pursue his predecessor's "Abenomics" recipe of hyper-easy monetary policy, government spending and reform and follow a diplomatic line centred on the U.S.-Japan security alliance.
Vodafone Continues Talks With Saudi Telecom For Potential Stake Sale In Vodafone Egypt
Vodafone Group Plc (VOD,VOD.L) Monday said it continues to talk with Saudi Telecom Co. regarding the potential sale of its 55% stake in Vodafone Egypt, despite the expiry of the Memorandum of Understanding.
The company noted that due diligence has been substantively completed with respect to the potential sale.
Vodafone said it now looks to Saudi Telecom and Telecom Egypt to find a suitable agreement to enable the deal to close
It was in January that Vodafone signed a Memorandum of Understanding to sell its 55 percent shareholding in Vodafone Egypt to Saudi Telecom. The companies then had agreed for a cash consideration of $2.39 billion or 2.17 billion euros for the stake.
U.S. Treasury yields move lower as investors monitor vaccine news
- U.S. government debt prices rose on Monday as investors monitored news of a potential vaccine against Covid-19.
- Pfizer's CEO Albert Bourla said that a coronavirus vaccine could be distributed in the United States before the year-end. While AstraZeneca has resumed its phase three trials over the weekend.
U.S. government debt prices were higher on Monday as investors monitored news of a potential vaccine against Covid-19.
At around 2:30 a.m. ET, the yield on the benchmark 10-year Treasury note fell by 0.18% to trade at 0.6658%. The yield on the 30-year Treasury bond also dropped by 8 basis points to 1.4142%. Yields move inversely to prices.
On Sunday, Pfizer's CEO Albert Bourla said that a coronavirus vaccine could be distributed in the United States before the year-end.In addition, AstraZeneca has resumed its phase three trials over the weekend, after suspending them earlier in the week due to safety concerns.
There is no economic data scheduled for Monday.
In the meantime, the U.S. Treasury is due to auction $105 billion in 13 and 26-week bills.
Nestlé Initiates Tender Offer To Buy Aimmune Therapeutics For $34.50/ Share In Cash
Nestlé, S.A (NSRGY.OB) announced Monday that its unit Sociétés des Produits Nestlé S.A, through SPN Merger Sub, Inc., is commencing a cash tender offer to buy Aimmune Therapeutics, Inc. (AIMT).
As announced in late August, Nestlé is buying Aimmune, the maker of world’s first approved treatment for peanut allergy PALFORZIA, for approximately $2.6 billion, or $34.50 per share in cash.
The board members of Aimmune have declared the offer to be fair to and in the best interests of the company and its shareholders.
The offer will expire at 12:00 midnight, ET on October 9, unless extended or earlier terminated.
As said earlier, the transaction is expected to close in the fourth quarter of 2020. Until that time, Aimmune will continue to operate as a separate and independent company.
Socits des Produits Nestle is a part of Nestlé Health Science.
Unconventional Convention, U.K. Jobs, French Outlook: Eco Day
Welcome to Monday, Europe. Here’s the latest news and analysis from Bloomberg Economics to help you start the week:
- Global central bankers are discovering that monetary policies they once viewed as unconventional and temporary are now actually proving to beconventional and long-lasting
- Prime Minister Boris Johnson will send hisBrexit law-breaking proposals to Parliament this week, facing criticism at home and abroad and a growing rebellion from his own MPs. The U.K. and EU chief Brexit negotiatorssparred on Twitter over claims that food imports to Northern Ireland have been threatened in the talks
- The U.K. will see more than twice as manyjob losses in the coming months than in the recession following the financial crisis. Meanwhile,a new cap on social gatherings in the U.K. is due to start Monday as coronavirus cases rise sharply