Sanofi SEC Filings

Sanofi reports that the US FDA has granted priority review to its new drug application for venglustat, an oral glucosylceramide synthase inhibitor, to treat type 3 Gaucher disease, a rare lysosomal storage disorder with neurological symptoms. If approved, venglustat would be the first US therapy aimed at the progressive neurological manifestations of this disease. The FDA’s target action date is November 25, 2026.

The application is backed by the phase 3 LEAP2MONO study in adults and adolescents with stabilized systemic disease on enzyme replacement therapy. Venglustat met both primary neurological endpoints and three of four key secondary endpoints and was generally well tolerated, with no new safety signals.

Sanofi reported phase 2 ElevAATe data showing its investigational AATD therapy efdoralprin alfa outperformed standard plasma-derived augmentation in raising and sustaining functional alpha-1 antitrypsin (fAAT) levels in adults with AATD-related emphysema.

Efdoralprin alfa given every three weeks achieved mean fAAT trough increases more than three times higher than weekly plasma-derived protein and met the primary endpoint with strong statistical significance (p<0.0001). All key secondary endpoints were also met. In the three‑week dosing arm, fAAT remained above the normal threshold of 23.8 µM for 100% of days over the 32‑week study versus 41% of days on standard therapy.

The safety profile was comparable to current treatment, with no treatment-emergent adverse events leading to permanent discontinuation and similar rates of common side effects such as COPD exacerbations, headache and COVID‑19 infection. Efdoralprin alfa has fast track and orphan drug designations in the US and orphan designation in the EU and remains in clinical development with ongoing long-term evaluation.

Sanofi filed a Form 13F reporting institutional holdings managed by its investment unit. The submission lists 9 information-table entries with a reported aggregate value of $335,959,156. The report is signed by Alexandra Roger and indicates 0 other included managers.

Sanofi held its Mixed General Meeting of Shareholders on April 29, 2026, where all resolutions were approved with strong support. Shareholders appointed Belén Garijo to the Board and confirmed that, in line with a prior Board decision, she will assume the role of Chief Executive Officer on May 1, 2026.

The meeting approved the social and consolidated accounts for fiscal year 2025 and decided on an ordinary annual dividend of €4.12 per share, with payment on May 7, 2026. The Board renewed mandates for Christophe Babule and Jean-Paul Kress and appointed Christel Heydemann, CEO of Orange, as an independent director, strengthening digital and AI expertise. Sanofi’s Board now has 16 members and a high level of independence and gender diversity.

Sanofi has successfully priced an offering of €2.3 billion of notes, issued in three tranches under its Euro Medium Term Note programme. This debt financing provides the company with additional funding through the bond market.

Sanofi intends to use the net proceeds from the notes for general corporate purposes, giving it flexibility to support its operations, investments, or balance sheet needs as management decides over time.

Sanofi reported Q1 2026 net sales of €10,509 million, up 13.6% at constant exchange rates, with business EPS rising to €1.88, an increase of 14.0% at CER. Growth was driven by pharma launches, Dupixent, and recent acquisitions.

Pharma launch sales climbed 49.6% at CER to €1.2 billion, while Dupixent sales rose 30.8% to €4.17 billion. Vaccines sales reached €1.29 billion, up 2.1% at CER, supported by newly acquired Heplisav‑B and Beyfortus. Business operating income grew 10.9% at CER to €2.97 billion, despite higher Regeneron profit sharing.

The company completed the $2.2 billion Dynavax acquisition and executed €921 million of a planned €1 billion share buyback, while net debt increased to €12.9 billion. Sanofi affirmed 2026 guidance for high single‑digit sales growth at CER, with business EPS expected to grow slightly faster than sales.

Sanofi reports two major immunology updates. Its experimental drug lunsekimig met primary and key secondary endpoints in phase 2 respiratory studies in moderate-to-severe asthma (AIRCULES) and chronic rhinosinusitis with nasal polyps (DUET), showing fewer exacerbations and better lung function or polyp scores versus placebo, with a generally acceptable safety profile. A separate phase 2b atopic dermatitis study (VELVET) missed its primary endpoint but improved key skin-clearance measures. Lunsekimig is progressing into new phase 2 and phase 3 programs in high-risk asthma.

Sanofi also announces that the European Commission approved Dupixent for moderate-to-severe chronic spontaneous urticaria in children aged two to 11 years who do not respond adequately to antihistamines and are naïve to anti-IgE therapy. This expands Dupixent’s prior EU approval in CSU for adults and adolescents, based on the LIBERTY-CUPID phase 3 program, where Dupixent reduced itch and hives and improved disease control with a safety profile consistent with earlier dermatology uses.

SANOFI reported a Schedule 13G/A showing Amundi and Amundi Asset Management beneficially own 61,506,935 shares, representing 5.04% of the class.

The filing states Amundi holds shared voting power for 30,913,607 shares and shared dispositive power for 61,506,935. It notes 27,407,379 shares are held in an employee FCPE whose voting rights are exercised by the FCPE supervisory board.

Sanofi files a Form 6-K highlighting multiple March 2026 R&D and regulatory milestones across immunology and oncology. Dupixent won approval in Japan as the first targeted medicine for adults with moderate-to-severe bullous pemphigoid, based on the LIBERTY‑BP‑ADEPT phase 2/3 study where 18% of treated patients achieved sustained disease remission versus 4% on placebo at Week 36.

The European regulator’s CHMP issued a positive opinion for a subcutaneous Sarclisa formulation delivered by on-body injector for multiple myeloma, supported by the phase 3 IRAKLIA study and other trials. Sanofi also reported positive phase 3 results for amlitelimab in three large atopic dermatitis studies (COAST 1, COAST 2 and SHORE), showing improved skin clearance and symptom relief with both every-four-week and every-12-week dosing.

Additionally, the European Commission granted conditional marketing authorisation for Rezurock to treat chronic graft-versus-host disease in patients aged 12 and older when prior systemic therapies are inadequate. This decision drew on phase 2 ROCKstar data, where Rezurock delivered a 74% best overall response rate, and supports Sanofi’s expansion in serious immune-mediated diseases.