Press Releases

-- The preclinical prototype vaccine is well-tolerated and provides strong protection against coxsackievirus B infections and diabetes in relevant animal models

Sutimlimab targets C1-activated hemolysis in cold agglutinin disease (CAD)

- Emerging data demonstrate commitment to advancing cancer care, including two fully in-house investigational compounds: a potential best-in-class oral SERD for breast cancer and a first-in-class anti-CEACAM5 antibody-drug conjugate for non-small cell lung cancer

- IKEMA trial results released early based on recommendation of an Independent Data Monitoring Committee

- Company on Track to Complete Submission of Rolling Biologics License Application for Teplizumab in Q4 2020 -

Objective responses seen in 29% of patients with locally advanced basal cell carcinoma (BCC)

- Libtayo decreased the risk of death by 32.4% compared to chemotherapy

• Independent Data Monitoring Committee recommended continuing ongoing Phase 3 trial only in the more advanced “critical” group with Kevzara higher-dose versus placebo and discontinuing less advanced “severe” group

Latest innovation in quadrivalent meningococcal vaccination designed for use in persons 2 years of age and older in the U.S.

Primary and secondary objectives were met with 85% or greater relative reduction achieved in the number of new gadolinium-enhancing T1 and new or enlarging T2 hyperintense lesions

- Companies to negotiate a collaboration on the development of a breakthrough COVID-19 self-test solution based on Luminostics’ proprietary technology.

- Rolling BLA Submission Initiated Under Breakthrough Therapy Designation

Companies to combine innovative technologies to develop an adjuvanted COVID-19 vaccine

The award showcases innovative game-changers who are setting the standard for pharmaceutical facilities of the future

- Detailed data to be presented at the Revolutionizing Atopic Dermatitis Conference show adding Dupixent to topical corticosteroids improved skin clearance; average overall disease improved by approximately 80%

* The two companies will jointly investigate multiple candidates with the goal of advancing an efficacious and safe SARS-CoV-2 vaccine into clinical development

- PROTECT Study Randomization to be Paused Temporarily in Response to the Ongoing Public Health Crisis

* U.S. Phase 2/3 trial initiated and will begin enrolling patients immediately

- Expect to Complete Submission of a BLA for PRV-031 (Teplizumab) in Q4 2020

-PRV-3279 Inhibited the Function of B Cells, Durably and Without Depletion-

* Sarclisa in combination with pomalidomide and dexamethasone (pom-dex) significantly reduced the risk of disease progression or death by 40% compared to pom-dex alone in a pivotal trial

- Work with Biomedical Advanced Research and Development Authority (BARDA) will utilize Sanofi's well-established recombinant technology platform to expedite a potential COVID-19 vaccine

JDRF T1D Fund Study Estimates 2.3 Million People at Risk Globally to Develop Stage 3 T1D, Which Already Affects 18 Million People Globally

- Acid sphingomyelinase deficiency (ASMD) is a rare, progressive and potentially life-threatening disease for which no treatments are approved

If approved, Dupixent would be the first biologic medicine available in the U.S. for these children

* Synthorx, Inc. is now a fully owned subsidiary of Sanofi

Expects to Complete Submission of a BLA for PRV-031 (Teplizumab) in Q4 2020

- U.S.-based, state of the art facilities to be established for sustainable production of adjuvanted recombinant vaccine for use in the event of a pandemic

- Sutimlimab, an investigational targeted C1s inhibitor, met its primary efficacy endpoint in Phase 3 trial for patients with cold agglutinin disease (CAD)

*Oncology: New data from investigational isatuximab pivotal study for the treatment of relapsed/refractory multiple myeloma

- PRV-031 (teplizumab) Granted Breakthrough Therapy and PRIME Designations -

* Will be available in fall 2020, in time for the 2020-2021 flu season

-Study Did Not Achieve Primary Endpoint Due to High Placebo Effect-

- One of the first digital manufacturing facilities in the world to use continuous, intensified biologics production technology

Add-on payment to provide additional Medicare reimbursement for Medicare patients prescribed Cablivi in eligible hospital inpatient settings

- CARD is a treatment sequencing trial investigating the efficacy and safety of Jevtana versus abiraterone or enzalutamide after disease progression following initial androgen receptor-targeted agent therapy and docetaxel