Sign in

You're signed outSign in or to get full access.

Sanofi (SNY)

--

Research analysts who have asked questions during Sanofi earnings calls.

FC

Florent Cespedes

Bernstein

6 questions for SNY

Also covers: NVO, NVS
PV

Peter Verdult

Citigroup Inc.

6 questions for SNY

Also covers: AZN, EVO, GMAB +4 more
DR

David Risinger

Leerink Partners

5 questions for SNY

Also covers: ABBV, AMGN, BMY +9 more
LH

Luisa Hector

Berenberg

5 questions for SNY

Also covers: ABBV, AZN, BMY +1 more
RV

Richard Vosser

JPMorgan Chase & Co.

5 questions for SNY

Also covers: ARGX, AZN, MOLN +2 more
SF

Seamus Fernandez

Guggenheim Partners

5 questions for SNY

Also covers: AMLX, ARCT, ARQT +9 more
SB

Simon Baker

Redburn Atlantic

5 questions for SNY

Also covers: AUTL, AZN, BNTX +5 more
Sarita Kapila

Sarita Kapila

Morgan Stanley

4 questions for SNY

Also covers: AZN, GSK
BJ

Ben Jackson

Jefferies

3 questions for SNY

Also covers: EVO, PHAR
Graham Parry

Graham Parry

Bank of America Corporation

3 questions for SNY

Also covers: GRFS, GSK, NVS
James Quigley

James Quigley

Goldman Sachs

3 questions for SNY

Also covers: EVO, NVO, NVS +1 more
Jo Walton

Jo Walton

UBS

3 questions for SNY

Also covers: AZN, GSK, NVO +1 more
MW

Matthew Weston

UBS Group AG

3 questions for SNY

Also covers: AZN, GSK, NVS
Sachin Jain

Sachin Jain

Bank of America

3 questions for SNY

Also covers: AZN, GMAB, GSK +2 more
Steve Scala

Steve Scala

Cowen

3 questions for SNY

Also covers: ABBV, AZN, BMY +6 more
Eric Le Berrigaud

Eric Le Berrigaud

Stifel

2 questions for SNY

Also covers: AZN, NVS
Michael Leuchten

Michael Leuchten

Jefferies

2 questions for SNY

Also covers: AZN, GSK, NVO +1 more
SC

Shirley Chen

Barclays

2 questions for SNY

Also covers: NVS
SS

Shirley Shin

Barclays

2 questions for SNY

CG

Colleen Garvey

Guggenheim Securities

1 question for SNY

Also covers: MLYS
EF

Emily Field

Barclays

1 question for SNY

Also covers: AZN, GMAB, GSK +2 more
EP

Emmanuel Papadakis

Deutsche Bank

1 question for SNY

Also covers: AZN, NVO, NVS
GS

Gary Steventon

BNP Paribas Exane

1 question for SNY

LC

Luisa Caroline Hector

Berenberg

1 question for SNY

PW

Peter Welford

Jefferies

1 question for SNY

Also covers: AZN, GSK, NVO +1 more
RB

Ricardo Benevides Freitas

Santander

1 question for SNY

TA

Timothy Anderson

BofA Securities

1 question for SNY

Also covers: ABBV, AMGN, AZN +10 more
XG

Xiaobin Gao

Barclays

1 question for SNY

Recent press releases and 8-K filings for SNY.

Sanofi Announces Acquisition of Dynavax for $2.2 Billion
SNY
M&A
New Projects/Investments
  • Sanofi has entered into an agreement to acquire Dynavax Technologies Corporation for approximately $2.2 billion in total equity value, offering a cash tender of $15.50 per share for all outstanding shares.
  • The acquisition will integrate Dynavax's marketed adult hepatitis B vaccine, HEPLISAV-B®, and a phase 1/2 shingles vaccine candidate (Z-1018) into Sanofi's portfolio, strengthening its adult immunization presence.
  • The transaction has been unanimously approved by the Dynavax board of directors and is anticipated to close in the first quarter of 2026.
  • Sanofi plans to fund the acquisition with available cash resources and expects no impact on its financial guidance for 2025.
2 days ago
Sanofi's Wayrilz Approved in EU for Immune Thrombocytopenia
SNY
Product Launch
  • Sanofi's Wayrilz (rilzabrutinib) has received European Commission approval as the first BTK inhibitor to treat immune thrombocytopenia (ITP) in adult patients who are refractory to other treatments.
  • The approval is based on the LUNA 3 phase 3 study, which demonstrated a statistically significant durable platelet response at week 25 (23% of patients in the Wayrilz arm vs. 0% in the placebo arm) and a faster time to first platelet response (36 days in the Wayrilz arm).
  • Wayrilz, an oral, reversible BTK inhibitor, addresses the underlying causes of ITP through multi-immune modulation.
  • Wayrilz has previously been approved in the US and the United Arab Emirates (UAE), and is currently under regulatory review for ITP in Japan and China.
2 days ago
Sanofi Receives FDA Complete Response Letter for Tolebrutinib
SNY
Product Launch
New Projects/Investments
  • The US Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) for Sanofi's new drug application for tolebrutinib, intended to treat non-relapsing secondary progressive multiple sclerosis (nrSPMS).
  • Sanofi expressed disappointment with the FDA's decision, noting it was a significant change from prior feedback, and affirmed its commitment to finding a path forward for tolebrutinib.
  • An impairment test on tolebrutinib's intangible asset value is underway, with results expected in January 2026, but this will not impact business net income/EPS or alter the 2025 financial guidance.
  • Tolebrutinib received provisional approval in the United Arab Emirates in July 2025 and is under regulatory review in the EU and other global jurisdictions.
2 days ago
Sanofi receives FDA Complete Response Letter for tolebrutinib
SNY
Product Launch
Guidance Update
New Projects/Investments
  • Sanofi received a Complete Response Letter (CRL) from the US Food and Drug Administration (FDA) on December 24, 2025, for the new drug application of tolebrutinib to treat non-relapsing secondary progressive multiple sclerosis (nrSPMS).
  • The company expressed disappointment, noting this decision is a significant change from previous FDA feedback, especially as tolebrutinib had previously received breakthrough therapy designation.
  • Sanofi will conduct an impairment test on the intangible asset value attached to tolebrutinib, with results to be provided with Q4 and FY 2025 results in January 2026; however, this will not impact business net income/business EPS and there is no change to the financial guidance for 2025.
  • Tolebrutinib was provisionally approved in the United Arab Emirates in July 2025 and is currently under regulatory review in the EU and other jurisdictions worldwide.
8 days ago
Sanofi's efdoralprin alfa receives EU orphan designation
SNY
New Projects/Investments
  • The European Medicines Agency (EMA) has granted orphan designation to Sanofi's efdoralprin alfa for the potential treatment of alpha-1 antitrypsin deficiency (AATD) related emphysema.
  • Efdoralprin alfa, an investigational recombinant therapy, recently met all primary and key secondary endpoints in a global Phase 2 study, demonstrating superiority to a standard of care plasma-derived therapy.
  • The US Food and Drug Administration (FDA) had previously granted both Fast Track and Orphan Drug designations to efdoralprin alfa for AATD related emphysema.
  • This designation reinforces Sanofi's commitment to developing treatments for rare diseases with significant unmet medical need, as no new therapies for AATD have been introduced since 1987.
Dec 23, 2025, 2:52 PM
Sanofi and Regeneron's Dupixent receives expanded approval in Japan
SNY
Product Launch
  • Sanofi and Regeneron's Dupixent (dupilumab) has been granted marketing and manufacturing authorization in Japan for the treatment of bronchial asthma in children aged 6 to 11 years with severe or refractory disease.
  • The approval, issued by the Ministry of Health, Labour and Welfare in Japan on December 23, 2025, expands the existing approval for patients aged 12 years and older in this indication.
  • Clinical data from the VOYAGE global phase 3 study showed Dupixent significantly reduced exacerbations by 54% to 65% and improved lung function by 4.68% to 5.32% compared to placebo in the 6 to 11 years age group.
  • Dupixent is noted as the first and only biologic medicine to demonstrate improved lung function in this young patient group in a randomized phase 3 study.
Dec 23, 2025, 6:00 AM
Sanofi reaches agreement with US government on medicine costs and innovation
SNY
New Projects/Investments
  • Sanofi announced an agreement with the US government on December 19, 2025, to lower medicine costs for American patients and support US biopharmaceutical manufacturing and innovation.
  • The agreement will reduce Medicaid prices by an average of 61 percent for certain medicines and offer consumers direct access to medicines with an average savings of nearly 70 percent.
  • Sanofi will build on its $20 billion planned investment in US manufacturing and receive a three-year period free from Section 232 tariffs on imported products.
  • The agreement does not impact Sanofi's financial outlook or growth strategy during its three-year term.
Dec 22, 2025, 5:25 PM
Sanofi's efdoralprin alfa receives EU orphan designation for AATD-related emphysema
SNY
New Projects/Investments
  • Sanofi's investigational recombinant therapy, efdoralprin alfa (SAR447537), has been granted orphan designation by the European Medicines Agency (EMA) for the treatment of alpha-1 antitrypsin deficiency (AATD) related emphysema.
  • This designation is for potential new medicines addressing rare, life-threatening or debilitating medical diseases or conditions that affect no more than 5 in 10,000 individuals in the EU.
  • Efdoralprin alfa previously received both fast track and orphan drug designation from the US Food and Drug Administration (FDA) for the same condition.
  • The therapy recently met all primary and key secondary endpoints in its global phase 2 ElevAATe study, demonstrating superiority to a standard of care plasma-derived therapy in adults with AATD.
Dec 17, 2025, 6:00 AM
Sanofi Provides R&D Pipeline Update and 2025 Approvals
SNY
New Projects/Investments
Product Launch
  • Sanofi announced three key approvals in 2025: Fitusiran for hemophilia A and B in the U.S. and China, Rilzabrutinib for ITP in the U.S. (with a positive CHMP recommendation in the EU), and Nuvaxovid as the first recombinant COVID-19 vaccine fully approved in the U.S. and EU.
  • The company reported positive Phase 3 results for Amlitelimab in atopic dermatitis (Quest 1 study), Efdamrofusp alfa in alpha-1 antitrypsin deficiency emphysema, and the subcutaneous formulation of Sarclisa in refractory multiple myeloma.
  • In neurology, Tolebrutinib demonstrated a 31% delay in time to onset of six-month confirmed disability progression in secondary progressive multiple sclerosis, with a regulatory decision anticipated in the U.S. and EU during the first half of 2026, though it did not meet the primary endpoint in primary progressive multiple sclerosis.
  • Sanofi anticipates significant near-term pipeline activity, with more than 15 regulatory decisions, over 30 regulatory submissions, and more than 15 Phase 3 readouts across biopharma and vaccines expected in 2026 and 2027.
Dec 16, 2025, 4:15 PM
Sanofi Provides 2025 R&D Achievements and Pipeline Outlook
SNY
Product Launch
New Projects/Investments
Guidance Update
  • Sanofi reported three new product approvals in 2025: Qfitlia for hemophilia A and B in the U.S. and China, Wayrilz for ITP in the U.S. (with EU recommendation), and NUVAXOVID as the first recombinant COVID-19 vaccine in the U.S. and EU. Additionally, Dupixent received U.S. approval for bullous pemphigoid and approval for chronic spontaneous urticaria in the U.S., EU, and Japan.
  • In clinical development, Amlitelimab met primary and secondary endpoints in its first Phase III study for atopic dermatitis, demonstrating clinically meaningful improvements and potential for quarterly dosing. Conversely, Tolebrutinib did not meet its primary endpoint in non-relapsing and primary progressive multiple sclerosis but showed a 31% delay in disability progression in secondary progressive multiple sclerosis, with a regulatory decision anticipated in H1 2026 for SPMS.
  • The company anticipates substantial pipeline activity in 2026 and 2027, projecting over 15 regulatory decisions, more than 30 new regulatory submissions, and over 15 Phase III readouts across its biopharma and vaccine portfolios.
  • Sanofi is actively replenishing its pipeline through internal innovation and external opportunities, including seven new molecules entering Phase I development, three AAV gene therapy programs, and strategic acquisitions such as Blueprint and Dren Bio.
Dec 16, 2025, 4:15 PM
Fintool

Ask Fintool AI Agent

Get instant answers from SEC filings, earnings calls & more