Tuesday, September 28, 2021


Banco Santander (SAN)EUR3.08

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Corporate Profile

Activities

Banco Santander SA. (the Bank) is a financial group that offers a range of financial products. It is Spain's largest Bank by market capitalisation.


Contact Details

Websitehttp://www.gruposantander.com
Physical AddressCiudad Grupo Santander Boadilla del Monte Madrid, 28660 Spain



Industry & Sector

Classification LevelName of Sector
Business SectorBanking & Investment Services
Industry GroupBanking Services
IndustryBanks
Economic SectorFinancials



Dividend

Dividend History

In the past 5 years annual dividends have decreased by 17.5c from 20.2c to 2.8c. Based on a start date of 5 years ago, there has been only one rise in dividends over the last 5 years.
Date PaidValue (c)Type
30 Apr 20212.75Final
Tr 12 Months2.75
2019 - 20209.58
2018 - 201915.16
2017 - 201821.36
2016 - 201720.24



Board of Directors

Board and Management

NameDesignationSince Appointment
Jose Antonio AlvarezChief Executive Officer2 Yrs
Ana Patricia Botin-Sanz de Sautuola y O'SheaExecutive Director-
Juan Rodriguez InciarteExecutive Director-
Matias Rodriguez InciarteExecutive Director-
Ana Patricia BotinExecutive Director-
Homaira AkbariNon-Executive Independent Director-



Profiles

Jose Antonio Alvarez
CEO
Education: Graduate in Economics and Business Administration. MBA from the University of Chicago.
Experience: He joined Santander in 2002 and was appointed senior executive vice president of the Financial Management and Investor Relations division in 2004 (Group Chief Financial Officer). He also served as director at SAM Investments Holdings Limited, Santander Consumer Finance, S.A. and Santander Holdings US, Inc. He also sat on the supervisory boards of Santander Consumer AG, Santander Consumer Holding GmbH and Santander Bank Polska, S.A. He was also a board member of Bolsas y Mercados EspaNoles, S.A. (BME).
Shareholder Value:
Creation of shareholder value in Banco Santander:
Year of appointment: 2019
In the last 2 years the average annualized return to shareholders was 26.3%. The present value of Euro1,000 (PV1000) invested 2 years ago is now EUR1,595, a gain of EUR512 and dividend reinvested of EUR83.

Juan Rodriguez Inciarte
Executive Director
Born in Oviedo (Spain) in 1952. Joined the board in 2008. Graduate in Economics. Joined the Bank in 1985 as director and executive vice president of Banco Santander de Negocios. In 1989, he was appointed executive vice president of Banco Santander, S.A. From 1991 to 1999 he was a director of Banco Santander, S.A. He has been appointed director by co-option by the board at its meeting of 28 January 2008 and ratified by the annual general meeting held on 2008. He was re-elected by the general meeting of shareholders of 2012. Other significant positions: he is non-executive director of Santander UK plc and of Santander Consumer Finance, S.A.

Matias Rodriguez Inciarte
Executive Director
Born in 1948 in Oviedo (Spain).
Joined the board in 1988.
Graduate in Economics, and Government Economist. He also carried out Business Administration studies at the MIT.
Other significant positions: minister of the Presidency between 1981 and 1982, as well as technical general secretary of the Ministry of Finance, general secretary of the Ministry for European Community Relations and deputy secretary of state to the President. He is currently chairman of the Fundacion Princesa de Asturias and of the social council of the Universidad Carlos III de Madrid, as well as an external director of Sanitas, S.A. de Seguros and of Financiera Ponferrada, S.A., SICAV.

Ana Patricia Botin-Sanz de Sautuola y O'Shea
Executive Director
Born in Santander (Spain) in 1960.
Joined the board in 1989.
Graduate in Economics.
She was appointed for the first time a director of the Bank on 4 February 1989.
She was re-elected by the general meetings of shareholders of 1991, 1994, 1997, 2000, 2003 and 2006.

Ana Patricia Botin
Executive Director
Main activity: chief executive officer of Santander UK plc. She joined the Bank after a period at JP Morgan (1981-1988). She has been executive vice president of Banco Santander, S.A. since 1992, and was executive chairwoman of Banesto from 2002 to 2010.
She was appointed for the first time a director of the Bank on 4 February 1989. She was re-elected by the general meetings of shareholders of 1991, 1994, 1997, 2000, 2003 and of 17 June 2006.
Other significant positions: she is a member of the International Advisory Board of the New York Stock Exchange and of the board of Georgetown University.

Homaira Akbari
Non-Executive Independent Director
Born in 1961 in Tehran (Iran).
Joined the board of directors in 2016.
Ph.D. in particle physics from Tufts University and holds an MBA from Carnegie Mellon University.
She is CEO of AKnowledge Partner, LLC.
Other significant positions: she is currently non-executive director of Gemalto NV, Landstar System, Inc. and Veolia Environment S.A. Ms Akbari was also chairman and CEO of Sky Bitz, Inc., executive vice-president at True Position Inc., non-executive director of Covisint Corporation and US Pack Logistics LLC and she held several positions for Microsoft Corporation and for Thales Group.


News Archives (Apr 2018 - Jun 2021)

Dividends

October 12 2019: Banco Santander announces dividend
Banco Santander today announced an interim dividend of 10.0c per share. The ex dividend date is Wednesday, October 30, 2019 and it is payable on Friday, November 01.

April 17 2019: Banco Santander announces dividend
Banco Santander today announced a final dividend of 6.50c per share. The ex dividend date is Monday, April 29, 2019 and it is payable on Thursday, May 02.

January 10 2019: Banco Santander announces dividend
Banco Santander today announced an interim dividend of 6.50c per share. The ex dividend date is Wednesday, January 30, 2019 and it is payable on Friday, February 01.

October 16 2018: Banco Santander announces dividend
Banco Santander today announced an interim dividend of 2.84c per share. The ex dividend date is Thursday, October 18, 2018 and the record date is Friday, October 19, 2018 and it is payable on Monday, November 05.

July 30 2018: Banco Santander announces dividend
Banco Santander today announced an interim dividend of 6.50c per share. The ex dividend date is Monday, July 30, 2018 and it is payable on Wednesday, August 01.

April 27 2018: Banco Santander announces dividend
Banco Santander today announced a final dividend of 6.0c per share. The ex dividend date is Friday, April 27, 2018 and it is payable on Wednesday, May 02.


Share Capital

June 30: Banco Santander Sanofi: Information concerning the total number of voting rights and shares - May 2021
Information concerning the total number of voting rights and shares, provided pursuant to article L. 233-8 II of the Code de commerce (the French Commercial Code) and article 223-16 of the Reglement general de lAutorite des Marches Financiers (Regulation of the French stock market authority)
Sanofia French societe anonyme with a registered share capital of 2,517,943,476 Registered office: 54, rue La Boetie - 75008 Paris - FranceRegistered at the Paris Commercial and Companies Registry under number 395030844
Source: West Corporation

May 31: Banco Santander Sanofi: Information concerning the total number of voting rights and shares - April 2021
Information concerning the total number of voting rights and shares, provided pursuant to article L. 233-8 II of the Code de commerce (the French Commercial Code) and article 223-16 of the Reglement general de lAutorite des Marches Financiers (Regulation of the French stock market authority)
Sanofi
a French societe anonyme with a registered share capital of 2,517,943,476
Registered office: 54, rue La Boetie - 75008 Paris - France
Registered at the Paris Commercial and Companies Registry under number 395030844
* Pursuant to article 223-11 of the Reglement general de lAutorite des Marches Financiers.
This information is also available on the internet website of sanofi under Regulated Information in France:https://www.sanofi.com/en/investors/sanofi-share-and-adrs/share-overview/shares-and-voting-rights/
Attachment
EN_number_of_shares_and_voting_rights_April_2021
Source: West Corporation

December 29 2020: Banco Santander Sanofi: Information concerning the total number of voting rights and shares - November 2020
Information concerning the total number of voting rights and shares, provided pursuant to article L. 233-8 II of the Code de commerce
Source: West Corporation

December 10 2020: Banco Santander announces Right Issue
Banco Santander has announced a 1 for 1 rights issue effective Friday, December 11. To subscribe to new shares the price has been fixed at 50.0c.

November 30 2020: Banco Santander Sanofi: Disclosure of trading in own shares
Disclosure of trading in own shares from November 23, 2020 to November 27, 2020
Attachment
2020_11_27_Reporting_action_SANOFI_EN
Source: West Corporation

November 23 2020: Banco Santander Sanofi: Disclosure of trading in own shares
Disclosure of trading in own shares from November 17, 2020 to November 20, 2020
Attachment
2020_11_20_Reporting_action_SANOFI_EN
Source: West Corporation

September 11 2020: Banco Santander Sanofi : Information concerning the total number of voting rights and shares - July 2020
Information concerning the total number of voting rights and shares, provided pursuant to article L. 233-8 II of the Code de commerce (the French Commercial Code) and article 223-16 of the Reglement general de l'Autorite des Marches Financiers (Regulation of the French stock market authority)
Sanofia French societe anonyme with a registered share capital of 2,517,873,886 EURRegistered office : 54, rue La Boetie - 75008 Paris - FranceRegistered at the Paris Commercial and Companies Registry under number 395 030 844
Source: West Corporation

July 21 2020: Banco Santander Sanofi: Information concerning the total number of voting rights and shares - June 2020
Information concerning the total number of voting rights and shares, provided pursuant to article L. 233-8 II of the Code de commerce (the French Commercial Code) and article 223-16 of the Reglement general de l'Autorite des Marches Financiers (Regulation of the French stock market authority)
Sanofia French societe anonyme with a registered share capital of 2,507,692,222 EURRegistered office : 54, rue La Boetie - 75008 Paris - FranceRegistered at the Paris Commercial and Companies Registry under number 395 030 844
Source: West Corporation

June 19 2020: Banco Santander Sanofi: Information concerning the total number of voting rights and shares - May 2020
Information concerning the total number of voting rights and shares, provided pursuant to article L. 233-8 II of the Code de commerce (the French Commercial Code) and article 223-16 of the Reglement general de l'Autorite des Marches Financiers (Regulation of the French stock market authority)
Sanofia French societe anonyme with a registered share capital of 2,507,692,222 EURRegistered office : 54, rue La Boetie - 75008 Paris - FranceRegistered at the Paris Commercial and Companies Registry under number 395 030 844
Source: West Corporation

June 03 2020: Banco Santander Sanofi to launch "Action 2020", a worldwide employee stock purchase plan
Sanofi to launch "Action 2020", a worldwide employee stock purchase plan
A plan taking place in almost 75 countriesSubscription per five shares entitle the employee to one matching share1 PARIS - June 3, 2020 - Sanofi announces the launch of "Action 2020" on June 8, 2020, a worldwide stock purchase plan reserved for its employees, which should take place in almost 75 countries. Sanofi's strategy aims at providing long-term growth and value for its stakeholders while turning innovation into transformative medicines for patients. By doing such a capital increase, Sanofi intends to better associate its employees who are key contributors in this value creation, to the future development and results of the company.
On February 5, 2020 the Board of Directors authorized an issuance of ordinary shares of Sanofi for the benefit of employees participating in the Group Savings Plan. The subscription price is EUR70.67. It is equal to 80 % of the average of the opening price of the Sanofi share on Euronext Paris over the 20 stock exchange trading sessions preceding June 2, 2020. Any subscription per five shares as part of such issuance shall entitle the employee to one matching share. Subscriptions equal to or higher than 20 shares shall give right to 4 matching shares as an employer contribution. Employees may choose to subscribe a maximum of 1,500 shares within the limit of a maximum subscription amount which does not exceed 25% of their gross annual remuneration.
An eligibility condition of three months of seniority as at the closing date of the subscription period will be applied. The subscription period will run from June 8, 2020 (inclusive) until June 26, 2020 (inclusive).
Source: West Corporation

May 25 2020: Banco Santander Sanofi: information concerning the total number of voting rights and shares, April 2020
Information concerning the total number of voting rights and shares, provided pursuant to article L. 233-8 II of the Code de commerce (the French Commercial Code) and article 223-16 of the Reglement general de l'Autorite des Marches Financiers (Regulation of the French stock market authority)
Sanofia French societe anonyme with a registered share capital of 2,507,692,222 EURRegistered office : 54, rue La Boetie - 75008 Paris - FranceRegistered at the Paris Commercial and Companies Registry under number 395 030 844
Source: West Corporation

October 17 2018: Banco Santander announces Bonus issue
Banco Santander has announced a 123 for 1 bonus issue of shares, on Thursday, October 18.


Meetings

May 19: Banco Santander Sanofi to showcase data from its transformative oncology pipeline at 2021 ASCO Meeting
Sanofi to showcase data from its transformative oncology pipeline at 2021 ASCO Meeting
Early clinical data for investigational oral selective estrogen receptor (SERD), amcenestrant, show potential to become a new endocrine backbone therapy in ER+ HER2- breast cancerData that reinforce Libtayo (cemiplimab-rwlc) as a standard of care in advanced non-melanoma skin cancer and advanced non-small cell lung cancer, including new data in historically underrepresented patients with brain metastasesLonger term data and new analyses for Sarclisa (isatuximab-irfc) further strengthen efficacy profile, including for elderly patients and patients with high-risk cytogenetic abnormalities PARIS May 19, 2021 New research being presented at the upcoming virtual American Society of Clinical Oncology (ASCO) Annual Meeting from June 4-8 highlights Sanofis transformative science and commitment to patient care across difficult-to-treat cancers, including multiple myeloma, skin, lung and breast cancers.Our pipeline of innovative investigational medicines continues to expand, supporting our goal to address critical gaps in treatment options for patients with cancers of high unmet need, says Peter C. Adamson, Global Development Head, Oncology at Sanofi. We look forward to presenting the latest data across our oncology portfolio and pipeline in four key areas multiple myeloma, skin cancers, lung cancers and breast cancer, including data supporting the potential for amcenestrant to become a best-in-class oral endocrine backbone therapy.
Early clinical data for amcenestrant, our investigational oral selective estrogen receptor degrader (SERD), show potential to become a new endocrine backbone therapy in ER+ HER2- breast cancer*
Source: West Corporation

May 03: Banco Santander Annual General Meeting of April 30, 2021
Board composition: renewals, ratification of a co-opting Director and appointment of one new Director
Source: West Corporation


Acquisitions

January 11: Banco Santander Sanofi to acquire Kymab, adding KY1005 to its pipeline, a human monoclonal antibody targeting key immune system regulator OX40L
Sanofi and Kymab, a clinical-stage biopharmaceutical company developing fully human monoclonal antibodies with a focus on immune-mediated diseases and immuno-oncology therapeutics, have entered into an agreement under which Sanofi will acquire Kymab for an upfront payment of approximately $1.1 billion and up to $350 million upon achievement of certain milestones.
Source: West Corporation

September 28 2020: Banco Santander Sanofi completes Principia Biopharma Inc. acquisition
The tender offer for all of the outstanding shares of Principia common stock expired as scheduled at one minute after 11:59 p.m., Eastern Time, on Friday, September 25, 2020. The minimum tender condition and all of the other conditions to the offer have been satisfied and on September 28, 2020, Sanofi and its wholly owned subsidiary Kortex Acquisition Corp. (aEURoePurchaseraEUR ), accepted for payment and will promptly pay for all shares validly tendered and not validly withdrawn.
Source: West Corporation

August 28 2020: Banco Santander Sanofi to commence tender offer for acquisition of Principia Biopharma Inc.
Sanofi to commence tender offer for acquisition of Principia Biopharma Inc.
Paris, August 28 2020 - Sanofi announced today that it intends to commence a tender offer (the "Offer") today to acquire all of the outstanding shares of common stock of Principia Biopharma Inc. ("Principia") for $100 per share in cash, without interest thereon and net of any applicable withholding taxes.
The Offer is being made pursuant to the Agreement and Plan of Merger, dated as of August 16, 2020 (as it may be amended from time to time, the "Merger Agreement"), by and among Principia, Sanofi and Kortex Acquisition Corp., a Delaware corporation and an indirect, wholly-owned subsidiary of Sanofi ("Purchaser").
The Offer is scheduled to expire one minute past 11:59 p.m., Eastern Time, on Friday, September 25, 2020, unless the Offer is extended in accordance with the Merger Agreement and the applicable rules and regulations of the U.S. Securities and Exchange Commission (the "SEC").
The consummation of the Offer is subject to customary closing conditions, including the tender of at least a majority of the outstanding shares of Principia common stock, the expiration or termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, and other customary conditions. Following the successful completion of the Offer, Purchaser will merge with and into Principia pursuant to Section 251(h) of the General Corporation Law of the State of Delaware, with Principia continuing as the surviving corporation and becoming an indirect, wholly-owned subsidiary of Sanofi (the "Merger"). At the effective time of the Merger, the outstanding shares of common stock of Principia not tendered in the Offer will be converted into the right to receive the same $100 per share in cash that they would have received had they tendered their shares in the Offer.

August 17 2020: Banco Santander Sanofi to acquire Principia Biopharma
Sanofi to acquire Principia Biopharma
Further strengthens core R&D areas of autoimmune and allergic diseasesProvides full control of brain-penetrant BTK inhibitor SAR442168 in multiple sclerosis (MS), making commercialization more efficient and eliminating future royalty paymentsAllows expansion of SAR442168 development program into other central nervous system diseases and therapeutic areasAdds clinically advanced oral BTK inhibitor rilzabrutinib with potential across a range of immunology and inflammation indications, complementing Sanofi's existing R&D pipeline PARIS and SOUTH SAN FRANCISCO, Calif. - August 17, 2020 - Sanofi and Principia Biopharma Inc. (NASDAQ: PRNB), a late-stage biopharmaceutical company focused on developing treatments for immune-mediated diseases, entered into a definitive agreement under which Sanofi will acquire all of the outstanding shares of Principia for $100 per share in cash, which represents an aggregate equity value of approximately $3.68 billion (on a fully diluted basis). The Sanofi and Principia Boards of Directors unanimously approved the transaction.
"This acquisition advances our ongoing R&D transformation to accelerate development of the most promising medicines that will address significant patient needs," said Paul Hudson, Sanofi Chief Executive Officer. "The addition of multiple BTK inhibitors to our pipeline demonstrates our commitment to strategic product acquisitions in our priority therapeutic areas. Full ownership of our brain-penetrant BTK inhibitor '168 removes complexities for this priority development program and simplifies future commercialization."
Source: West Corporation


Litigation

June 11: Banco Santander New pivotal data at EHA 2021 reinforces sutimlimab as a first-in-class investigational C1s inhibitor with the potential to be the first approved treatment for hemolysis in people with CAD, a serious and chronic autoimmune hemolytic anemia
New pivotal data at EHA 2021 reinforces sutimlimab as a first-in-class investigational C1s inhibitor with the potential to be the first approved treatment for hemolysis in people with cold agglutinin disease, a serious and chronic autoimmune hemolytic anemia
Phase 3 data from the CADENZA study met the primary composite endpoint with statistical significance; secondary endpoint data were clinically meaningfulFindings provide further evidence that sutimlimab results in rapid inhibition of C1-activated hemolysis within one week of treatment and had a sustained treatment effect throughout the study PARIS June 11, 2021 Results from Part A of CADENZA, a pivotal Phase 3 double-blind, placebo-controlled study evaluating the safety and efficacy of sutimlimab in people with cold agglutinin disease (CAD) without a recent history of blood transfusion (within the prior six months), will be presented in an oral session at the European Hematology Association 2021 Congress. The data demonstrated treatment with sutimlimab resulted in rapid and sustained inhibition of C1-activated hemolysis in people with CAD, noted within one week of treatment, and clinically significant improvements in hemoglobin and fatigue when compared to placebo during the course of the study.
Cold agglutinin disease causes the bodys immune system to mistakenly destroy its healthy red blood cells. People living with cold agglutinin disease experience the crippling impact of chronic hemolysis that can cause severe anemia, profound fatigue and can have acute hemolytic crisis, said principal investigator and presenting author Professor Alexander Roth, M.D., Department of Hematology and Stem Cell Transplantation, University Hospital, University of Duisburg-Essen, Germany. The positive evidence from the CADENZA trial demonstrate significant improvements in hemolysis and meaningful impact on key measures of anemia and fatigue.

November 19 2020: Banco Santander FDA issues Complete Response Letter for sutimlimab, an investigational treatment for hemolysis in adults with cold agglutinin disease
PARIS - November 14, 2020 - The U.S. Food and Drug Administration issued a Complete Response Letter (CRL) regarding the Biologics License Application (BLA) for sutimlimab, an investigational monoclonal antibody for the treatment of hemolysis in adults with cold agglutinin disease.
Source: West Corporation

June 16 2020: Banco Santander Sanofi's investigational enzyme replacement therapy shows clinically meaningful improvement in critical manifestations of late-onset Pompe disease
Sanofi's investigational enzyme replacement therapy shows clinically meaningful improvement in critical manifestations of late-onset Pompe disease
Avalglucosidase alfa showed a 2.4-point improvement in percent-predicted forced vital capacity, an important measure of respiratory function in Pompe disease, compared to alglucosidase alfa (standard of care) Patients treated with avalglucosidase alfa walked 30 meters farther than those treated with standard of care, as measured by the 6-minute walk testGlobal regulatory submissions anticipated in the second half of 2020 PARIS - June 16, 2020 - Sanofi's investigational enzyme replacement therapy (ERT), avalglucosidase alfa, showed clinically meaningful improvement in critical manifestations (respiratory impairment and decreased mobility) of late-onset Pompe disease (LOPD) according to results from the Phase 3 trial presented today at a Sanofi-hosted scientific session. Avalglucosidase alfa met the primary endpoint demonstrating non-inferiority in improving respiratory function compared to alglucosidase alfa (standard of care) in patients with LOPD. These data will form the basis for global regulatory submissions anticipated in the second half of this year. The U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy and Fast Track designations to avalglucosidase alfa for the treatment of patients with Pompe disease.
The trial primary endpoint evaluated the change in respiratory muscle function using percent-predicted forced vital capacity (FVC) in the upright position. Patients treated with avalglucosidase alfa had a 2.4-point greater improvement in percent-predicted FVC compared to patients treated with standard of care (95% CI, -0.13 / 4.99), a numerical improvement in respiratory function that surpassed the study-designed measure of non-inferiority (p=0.0074).


Press Releases

June 29: Banco Santander Sanofi launches dedicated vaccines mRNA Center of Excellence
Sanofi launches dedicated vaccines mRNA Center of Excellence
Approximately 400million investment annually to accelerate end-to-end R&D of next-generation vaccines, fully financed through resource reallocationFocus on innovating mRNA vaccines beyond pandemic to routine use in diseases with high unmet needExpected minimum of six clinical candidates by 2025 PARIS June 29, 2021 - Sanofi will invest approximately 400 million annually in a first-of-its kind vaccines mRNA Center of Excellence. The Center will work to accelerate the development and delivery of next-generation vaccines by bringing together approximately 400 dedicated employees integrating end-to-end mRNA vaccine capabilities with dedicated R&D, digital, and chemistry, manufacturing and controls (CMC) teams across sites at Cambridge, MA (US) and Marcy lEtoile, Lyon (France).During the COVID-19 pandemic, mRNA technologies demonstrated potential to deliver new vaccines faster than ever before. However, key areas of innovation such as thermostability and tolerability improvements will be critical to unlock the applications of mRNA in routine vaccination against a broader set of infectious diseases and across all ages. The Sanofi mRNA vaccines Center of Excellence aims to lead the field in this next chapter of vaccine innovation, said Jean-Francois Toussaint, Global Head of Research and Development, Sanofi Pasteur.
The Center of Excellence will enable acceleration of the vaccines mRNA portfolio developed through the Translate Bio collaboration established in 2018 and expanded in 2020.
Source: West Corporation

June 28: Banco Santander Nirsevimab shows positive topline results in RSV Phase 2/3 MEDLEY trial
Nirsevimab shows positive topline results in RSV Phase 2/3 MEDLEY trial
Respiratory syncytial virus (RSV) is the leading cause of hospitalization in all infants1,2Nirsevimab is being investigated as a first-in-class single dose immunization to provide protection for all infants entering their first RSV season MEDLEY is the third pivotal trial to report positive data for nirsevimab; regulatory submissions planned for the first half of 2022 PARIS June 28, 2021 - In positive topline results from the Phase 2/3 MEDLEY trial, nirsevimab showed a similar safety and tolerability profile compared to palivizumab when administered to preterm infants or those with chronic lung disease (CLD) or congenital heart disease (CHD) entering their first respiratory syncytial virus (RSV) season.3 Safety and tolerability were assessed by the occurrence of all treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs).
RSV, a seasonal virus that typically circulates in autumn through spring in temperate regions, is the most common cause of lower respiratory tract infections (LRTI) and the leading cause of hospitalizations in all infants.1,2,4These data for nirsevimab are important as they show a safety and tolerability profile comparable to the only available preventative option against lower respiratory tract infections caused by RSV for preterm infants and those with health conditions, said Dr. Joseph Domachowske, Professor of Pediatrics and Professor of Microbiology and Immunology at the State University of New York, Upstate Medical Center and MEDLEY trial primary investigator. Given the typical RSV season lasts nearly five months, there is a potential advantage to providing a preventative option that could help protect all infants with one dose for the entire season.MEDLEY is the third pivotal trial to report positive data for nirsevimab.

June 28: Banco Santander Dupixent (dupilumab) SmPC updated with long-term data reinforcing well-established safety profile in adults with moderate-to-severe atopic dermatitis
Dupixent (dupilumab) SmPC updated with long-term data reinforcing well-established safety profile in adults with moderate-to-severe atopic dermatitis
PARIS and TARRYTOWN, N.Y. June 28, 2021- Long-term safety data from a study of adults with moderate-to-severe atopic dermatitis treated with Dupixent will be added to the Dupixent Summary of Product Characteristics (SmPC) following a positive opinion issued by the European Medicines Agencys Committee for Medicinal Products for Human Use.
Data from a single-arm Phase 3 open label extension (OLE) trial showed the long-term safety profile in adults with moderate-to-severe atopic dermatitis treated with Dupixent and observed up to three years was generally consistent with what was observed in the controlled pivotal Phase 3 trials. The OLE trial assessed the long-term safety of Dupixent 300 mg weekly in adults who had previously participated in Dupixent trials or had been screened for a Phase 3 trial. The approved Dupixent dose in adults is 300 mg every other week.
Atopic dermatitis is a chronic inflammatory disease of the skin that can be debilitating. Moderate-to-severe atopic dermatitis is characterized by intense persistent itch and skin lesions that can cover much of the body, resulting in skin dryness, cracking, redness or darkening, crusting and oozing. Itch is one of the most burdensome symptoms for patients. Moderate-to-severe atopic dermatitis can also have a substantial emotional and psychosocial impact on patients and their families, causing sleep disturbance, anxiety, depression and feelings of isolation.
Source: West Corporation

June 26: Banco Santander Sanofi: Availability of the Q2 2021 Memorandum for modelling purposes
Sanofi announced today that its Q2 2021 Memorandum for modelling purposes is available on the "Investors" page of the company's website:
Source: West Corporation

June 25: Banco Santander Sanofi: Libtayo (cemiplimab) approved by the European Commission as the first immunotherapy indicated for patients with advanced basal cell carcinoma
Libtayo (cemiplimab) approved by the European Commission as the first immunotherapy indicated for patients with advanced basal cell carcinoma
Approval based on data from the largest trial to date in patients with advanced basal cell carcinoma previously treated with a hedgehog pathway inhibitorLibtayo now approved by the European Commission for three advanced cancers PARIS and TARRYTOWN, NY June 25, 2021 The European Commission (EC) has approved Sanofi and Regenerons PD-1 inhibitor Libtayo (cemiplimab) to treat adults with locally advanced or metastatic basal cell carcinoma (BCC) who have progressed on or are intolerant to a hedgehog pathway inhibitor (HHI).
BCC is the most common type of skin cancer worldwide, representing up to 80% of non-melanoma skin cancers, and incidence is increasing across many European countries. While the large majority of BCCs are caught early and easily cured with surgery and/or radiation, a small proportion of cases can develop into advanced BCC and penetrate deeper into surrounding tissues (locally advanced) or spread to other parts of the body (metastatic), becoming more difficult to treat.
Since its launch in Europe just two years ago, Libtayo has redefined the standard of care for advanced CSCC and has the potential to do the same in advanced BCC, said Peter C. Adamson, M.D., Global Development Head, Oncology at Sanofi. Together with Regeneron, were committed to addressing gaps in the treatment of advanced forms of non-melanoma skin cancer.
Source: West Corporation

June 25: Banco Santander Sanofi: Libtayo (cemiplimab) approved by the European Commission for first-line treatment of patients with advanced non-small cell lung cancer with 50% PD-L1 expression
Libtayo (cemiplimab) approved by the European Commission for first-line treatment of patients with advanced non-small cell lung cancer with 50% PD-L1 expression
Approval based on a Phase 3 trial demonstrating Libtayo significantly improved overall survival compared to chemotherapy in advanced NSCLC that included challenging-to-treat patient populationsLibtayo now approved by the European Commission for three advanced cancers PARIS and TARRYTOWN, NY June 25, 2021 - The European Commission (EC) has approved Sanofi and Regenerons PD-1 inhibitor Libtayo (cemiplimab) for the first-line treatment of adults with non-small cell lung cancer (NSCLC) whose tumor cells have 50% PD-L1 expression and no EGFR, ALK or ROS1 aberrations. Patients must have metastatic NSCLC or locally advanced NSCLC and not be a candidate for definitive chemoradiation.
Libtayo is now approved for three advanced cancers in the European Union. The EC also approved Libtayo in advanced basal cell carcinoma, the first treatment to be indicated for those patients who have progressed on or are intolerant to a hedgehog pathway inhibitor (HHI). In 2019, Libtayo was approved by the EC as the first treatment for adults with metastatic or locally advanced cutaneous squamous cell carcinoma (CSCC) who are not candidates for curative surgery or curative radiation. Across all of its approved indications, Libtayo had a generally consistent safety profile. Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue during or after treatment with Libtayo.We are confident that Libtayo has the potential to become an important treatment option for patients in the European Union and thank all the investigators, patients and their families who helped us reach this milestone, said Peter C.

June 18: Banco Santander European Commission approves Aubagio (teriflunomide) as the first oral MS therapy for first-line treatment of children and adolescents living with relapsing-remitting multiple sclerosis
European Commission approves Aubagio (teriflunomide) as the first oral MS therapy for first-line treatment of children and adolescents living with relapsing-remitting multiple sclerosis
PARIS June 18, 2021 - The European Commission (EC) has approved Aubagio (teriflunomide) for the treatment of pediatric patients 10 to 17 years of age with relapsing-remitting multiple sclerosis (RRMS). The EC approval is based on data from the Phase 3 TERIKIDS study. The approval confirms Aubagio as the first oral multiple sclerosis (MS) therapy for first-line treatment of children and adolescents with MS in the European Union.
MS affects an estimated 2.8 million people around the world, with children and adolescents representing at least 30,000 of those impacted.1,2 Pediatric MS is a rare condition and onset follows a relapsing-remitting disease course in 98 percent of pediatric patients.3,4 Compared with adult-onset MS, pediatric patients often present with higher relapse rates and a greater lesion burden.5 Due to the earlier onset of disease, irreversible disability and secondary progression often occur at an earlier age than with adult counterparts.3 The symptoms of MS can impact all aspects of a young persons life from physical health to social development and self-esteem.6Pediatric multiple sclerosis remains an area of significant unmet medical need, said Erik Wallstrom, MD, PhD, Therapeutic Area Head, Neurology Development at Sanofi Genzyme. The European approval of Aubagio in pediatrics means young people with MS have a new treatment option, and importantly - one that can offer meaningful improvement in managing this serious disease. Aubagio was initially approved in the EU in 2013 for the treatment of adult patients with RRMS and the EC approval for the pediatric indication provides an additional year of marketing protection in the European Union.


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