Sanofi (SNY) wins FDA breakthrough, Japan orphan tags for Wayrilz
Rhea-AI Filing Summary
Sanofi reported that its BTK inhibitor Wayrilz (rilzabrutinib) received FDA breakthrough therapy designation in the US and orphan drug designation in Japan for treating warm autoimmune hemolytic anemia (wAIHA), a rare autoimmune disease that destroys red blood cells and can cause serious complications.
Both designations are based on clinical data from the ongoing LUMINA 2 phase 2b study, with a new LUMINA 3 phase 3 trial comparing rilzabrutinib to placebo in wAIHA. Rilzabrutinib is already approved as Wayrilz for immune thrombocytopenia (ITP) in the US, EU, and UAE, and remains investigational for wAIHA and other rare immune-mediated diseases.
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Insights
Regulatory designations advance Sanofi’s rare-disease BTK franchise but stop short of approval.
The FDA breakthrough therapy and Japan orphan designations for rilzabrutinib in warm autoimmune hemolytic anemia signal that regulators see promising early data in a serious, underserved disease. These pathways can support faster development, more guidance from agencies, and potential market exclusivity if approval is later granted.
However, rilzabrutinib is still in an ongoing phase 2b study, with a phase 3 LUMINA 3 trial just under way in wAIHA. The medicine is only approved today for immune thrombocytopenia in the US, EU, and UAE. Actual commercial impact will depend on future trial results and subsequent regulatory decisions described as possibilities in the company’s forward-looking statements.
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 6-K
REPORT OF FOREIGN PRIVATE ISSUER
PURSUANT TO RULE 13a-16 OR 15d-16
UNDER THE SECURITIES EXCHANGE ACT OF 1934
For the month of February 2026
Commission File Number: 001-31368
SANOFI
(Translation of registrant’s name into English)
46, avenue de la Grande Armée, 75017 Paris, FRANCE
(Address of principal executive offices)
Indicate by check mark whether the registrant files or will file annual reports under cover Form 20-F or Form 40-F.
Form 20-F ☒ Form 40-F ☐
1
In February 2026, Sanofi published the press release attached hereto as Exhibit 99.1 which is incorporated herein by reference.
Exhibit Index
| Exhibit No. |
Description | |
| Exhibit 99.1 | Press Release dated February 9, 2026: Sanofi’s rilzabrutinib designated breakthrough therapy in the US and orphan drug in Japan for the treatment of warm autoimmune hemolytic anemia | |
2
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
| Dated: February 17, 2026 | SANOFI | |||||
| By | /s/ Alexandra Roger | |||||
| Name: Alexandra Roger | ||||||
| Title: Head of Legal Corporate & Finance | ||||||
3
Exhibit 99.1
| Press Release |
|
Sanofi’s rilzabrutinib designated breakthrough therapy in the US and orphan drug in Japan for the treatment of warm autoimmune hemolytic anemia
| • | Rilzabrutinib is the first and only investigational BTKi for warm autoimmune hemolytic anemia to be designated Breakthrough Therapy by the FDA |
| • | Rilzabrutinib helps address complex immune-system dysregulation through multi-immune modulation |
| • | Rilzabrutinib holds global regulatory designations across multiple rare diseases, underscoring its broad therapeutic potential |
Paris, February 9, 2026. The US Food and Drug Administration (FDA) has granted a designation as breakthrough therapy to Wayrilz (rilzabrutinib), a novel oral, reversible Bruton’s tyrosine kinase (BTK) inhibitor, for the treatment of patients with warm autoimmune hemolytic anemia (wAIHA), a rare autoimmune disorder marked by the destruction of red blood cells. The Japanese Ministry of Health, Labour and Welfare has also provided rilzabrutinib an orphan designation for the same condition.
Both designations are based on clinical data from the ongoing LUMINA 2 phase 2b study (clinical study identifier: NCT05002777) assessing the efficacy and safety of rilzabrutinib for patients with wAIHA. In addition, the new LUMINA 3 phase 3 study (clinical study identifier: NCT07086976), is assessing rilzabrutinib compared with placebo in patients with wAIHA. There is currently no approved treatment that specifically targets the underlying cause of this rare autoimmune condition, which can lead to anemia, fatigue, and serious organ damage.
An FDA breakthrough therapy designation is designed to expedite the development and review of medicines in the US intended to treat serious or life-threatening conditions and where preliminary clinical evidence indicates the therapy may demonstrate substantial improvement over available treatment options. Orphan designation in Japan is granted to medicines intended to address rare diseases with high unmet medical need.
“These recognitions highlight the critical unmet need that persists for people living with wAIHA,” said Karin Knobe, Global Head of Development, Rare Diseases. “Furthermore, receiving such designations reinforces our commitment to advancing innovative medicines for rare diseases that currently have limited or no approved treatment options.”
Rilzabrutinib is approved in the US, the EU, and the United Arab Emirates (UAE) under the brand name Wayrilz for the treatment of adults with immune thrombocytopenia (ITP) and is currently under regulatory review for ITP in Japan. Other than the approved ITP indications in the US, EU, and UAE, these uses of rilzabrutinib are investigational and have not been evaluated by any regulatory authority.
The FDA previously granted rilzabrutinib orphan drug designation for autoimmune hemolytic anemia, as well as two other rare diseases, IgG4-related disease (IgG4-RD) and sickle cell disease (SCD). Rilzabrutinib also received FDA fast track designation for ITP and IgG4-RD and EU orphan designation in ITP, autoimmune hemolytic anemia, and IgG4-RD.
About wAIHA
wAIHA is a rare, potentially life-threatening, autoimmune disorder rooted in complex immune system dysregulation. It represents more than half of autoimmune hemolytic anemia cases. In wAIHA, autoantibodies lead to the premature destruction of the body’s own red blood cells (hemolysis), sometimes faster than the bone marrow can replace them. In the US and EU, autoimmune hemolytic anemia is estimated to affect four to 24 people out of 100,000, while in Japan it is rarer, affecting three to 10 people per million. People living with wAIHA may experience debilitating fatigue, dizziness, palpitations, and shortness of breath, and may face complications such as thromboembolism.
About rilzabrutinib
Rilzabrutinib, Wayrilz where approved, is a novel, oral, reversible covalent BTK inhibitor that has the potential to be an effective new medicine for several rare immune-mediated or inflammatory diseases by working to restore immune balance via multi-immune modulation. BTK, expressed in B cells, macrophages, and other innate immune cells, plays a critical role in multiple immune-mediated disease processes and inflammatory pathways. With the application of the TAILORED COVALENCY® technology, rilzabrutinib can selectively inhibit the BTK target. Wayrilz is now approved for the treatment of immune thrombocytopenia (ITP) in the US, the EU, and the UAE. Regulatory review for use in ITP is currently ongoing in Japan.
In addition to ITP and wAIHA, rilzabrutinib is being studied across a variety of rare diseases, including IgG4-RD and SCD. These additional indications are currently under investigation and have not been approved by regulatory authorities.
WAYRILZ (rilzabrutinib) Consumer Important Safety Information
What is WAYRILZ?
WAYRILZ is a prescription medicine that is used to treat adults with persistent or chronic immune thrombocytopenia (ITP) who received a prior treatment that did not work well enough.
It is not known if WAYRILZ is safe and effective in children.
IMPORTANT SAFETY INFORMATION
What should I tell my healthcare provider before taking WAYRILZ?
Tell your healthcare provider about all of your medical conditions, including if you:
| • | have liver problems |
| • | have kidney problems |
| • | are pregnant or plan to become pregnant. WAYRILZ may harm your unborn baby. If you are able to have a baby, your healthcare provider will do a pregnancy test before starting treatment with WAYRILZ. Females who are able to become pregnant should use an effective birth control during treatment with WAYRILZ and for 1 week after the last dose. |
| • | are breastfeeding or plan to breastfeed. Do not breastfeed during treatment with WAYRILZ and for at least 1 week after the last dose. |
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Taking WAYRILZ with certain other medicines may affect how WAYRILZ works and can cause side effects. WAYRILZ may also affect how other medicines work.
What should I avoid while taking WAYRILZ?
You should avoid grapefruit, starfruit and products that have these fruits, and Seville oranges (often used in marmalades) during treatment with WAYRILZ. These products may increase the amount of WAYRILZ in your blood, which increases the risk of side effects of WAYRILZ.
What are the possible side effects of WAYRILZ?
WAYRILZ may cause serious side effects, including:
| • | Serious infections. WAYRILZ can increase the risk of infections, including serious infections that can lead to death. Your healthcare provider will check you for signs and symptoms of infection during your treatment with WAYRILZ. Tell your healthcare provider right away if you get any signs or symptoms of infection, including fever, chills, or flu-like symptoms. |
| • | Liver problems including Drug-Induced Liver Injury (DILI). Liver problems, which may be severe, life-threatening, or lead to death have happened in people treated with Bruton’s tyrosine kinase (BTK) inhibitors. Your healthcare provider will do blood tests to check your liver before and as necessary during treatment with WAYRILZ. Tell your healthcare provider right away if you have any signs or symptoms of liver problems, including stomach-area (abdominal) pain or discomfort, dark or “tea-colored” urine, or yellowing of the skin or the white part of your eyes. |
The most common side effects of WAYRILZ include diarrhea, nausea, headache, stomach area (abdominal) pain, and COVID-19.
These are not all of the possible side effects of WAYRILZ.
Please see enclosed full Prescribing Information, including Patient Information.
About Sanofi
Sanofi is an R&D driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth. We apply our deep understanding of the immune system to invent medicines and vaccines that treat and protect millions of people around the world, with an innovative pipeline that could benefit millions more. Our team is guided by one purpose: we chase the miracles of science to improve people’s lives; this inspires us to drive progress and deliver positive impact for our people and the communities we serve, by addressing the most urgent healthcare, environmental, and societal challenges of our time.
Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY
Media Relations
Sandrine Guendoul | +33 6 25 09 14 25 | sandrine.guendoul@sanofi.com
Evan Berland | +1 215 432 0234 | evan.berland@sanofi.com
Timothy Gilbert | +1 516 521 2929 | timothy.gilbert@sanofi.com
Léo Le Bourhis | +33 6 75 06 43 81 | leo.lebourhis@sanofi.com
Victor Rouault | +33 6 70 93 71 40 | victor.rouault@sanofi.com
Léa Ubaldi | +33 6 30 19 66 46 | lea.ubaldi@sanofi.com
Ekaterina Pesheva | +1 410 926 6780 | ekaterina.pesheva@sanofi.com
Investor Relations
Thomas Kudsk Larsen | + 44 7545 513 693 | thomas.larsen@sanofi.com
Alizé Kaisserian | + 33 6 47 04 12 11 | alize.kaisserian@sanofi.com
Keita Browne | + 1 781 249 1766 | keita.browne@sanofi.com
Nathalie Pham | + 33 7 85 93 30 17 | nathalie.pham@sanofi.com
Nina Goworek | +1 908 569 7086 nina.goworek@sanofi.com
Thibaud Châtelet | + 33 6 80 80 89 90 | thibaud.chatelet@sanofi.com
Yun Li | +33 6 84 00 90 72 | yun.li3@sanofi.com
Sanofi forward-looking statements
This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates and their underlying assumptions, statements regarding plans, objectives, intentions, and expectations with respect to future financial results, events, operations, services, product development and potential, and statements regarding future performance. Forward-looking statements are generally identified by the words “expects”, “anticipates”, “believes”, “intends”, “estimates”, “plans” and similar expressions. Although Sanofi’s management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, the uncertainties inherent in research and development, future clinical data and analysis, including post marketing, decisions by regulatory authorities, such as the FDA or the EMA, regarding whether and when to approve any drug, device or biological application that may be filed for any such product candidates as well as their decisions regarding labelling and other matters that could affect the availability or commercial potential of such product candidates, the fact that product candidates if approved may not be commercially successful, the future approval and commercial success of therapeutic alternatives, Sanofi’s ability to benefit from external growth opportunities, to complete related transactions and/or obtain regulatory clearances, risks associated with intellectual property and any related pending or future litigation and the ultimate outcome of such litigation, trends in exchange rates and prevailing interest rates, volatile economic and market conditions, cost containment initiatives and subsequent changes thereto, and the impact that global crises may have on us, our customers, suppliers, vendors, and other business partners, and the financial condition of any one of them, as well as on our employees and on the global economy as a whole. The risks and uncertainties also include the uncertainties discussed or identified in the public filings with the SEC and the AMF made by Sanofi, including those listed under “Risk Factors” and “Cautionary Statement Regarding Forward-Looking Statements” in Sanofi’s annual report on Form 20-F for the year ended December 31, 2024. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements.
All trademarks mentioned in this press release are the property of the Sanofi group.
FAQ
What did Sanofi (SNY) announce about rilzabrutinib in warm autoimmune hemolytic anemia?
Sanofi announced that rilzabrutinib (Wayrilz) received FDA breakthrough therapy designation in the US and orphan drug designation in Japan for treating warm autoimmune hemolytic anemia. These recognitions are based on data from the ongoing LUMINA 2 phase 2b study and support further clinical development.
What is warm autoimmune hemolytic anemia (wAIHA) as described by Sanofi (SNY)?
wAIHA is a rare, potentially life-threatening autoimmune disorder where autoantibodies trigger premature destruction of red blood cells. Sanofi notes it represents more than half of autoimmune hemolytic anemia cases and can cause fatigue, dizziness, shortness of breath, and complications such as thromboembolism.
Which clinical trials are evaluating Sanofi’s (SNY) rilzabrutinib in wAIHA?
Rilzabrutinib is being evaluated in the LUMINA 2 phase 2b study (NCT05002777) to assess efficacy and safety in warm autoimmune hemolytic anemia. A new LUMINA 3 phase 3 trial (NCT07086976) is also comparing rilzabrutinib with placebo in patients with this rare autoimmune condition.
For which indications is Sanofi’s Wayrilz (rilzabrutinib) currently approved?
Wayrilz (rilzabrutinib) is currently approved in the US, European Union, and United Arab Emirates to treat adults with immune thrombocytopenia (ITP) who previously received an insufficiently effective treatment. Regulatory review for ITP is ongoing in Japan, and other indications like wAIHA remain investigational.
What other regulatory designations has rilzabrutinib received according to Sanofi (SNY)?
Sanofi states rilzabrutinib previously received FDA orphan drug designation for autoimmune hemolytic anemia, IgG4-related disease, and sickle cell disease, FDA fast track designation for ITP and IgG4-related disease, and EU orphan designation in ITP, autoimmune hemolytic anemia, and IgG4-related disease.
What safety information does Sanofi provide for Wayrilz in this update?
Sanofi notes that Wayrilz is a prescription treatment for adults with persistent or chronic immune thrombocytopenia after prior therapy. It highlights possible serious side effects and lists common reactions such as diarrhea, nausea, headache, abdominal pain, and COVID-19, advising review of full Prescribing Information.
Filing Exhibits & Attachments
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