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Sanofi Gets FDA Nod for Wayrilz in Immune Thrombocytopenia
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Key Takeaways
Sanofi gained FDA approval for Wayrilz to treat persistent or chronic immune thrombocytopenia.
Approval based on LUNA 3 study data showing sustained platelet gains and symptom improvement.
Wayrilz is also in studies for IgG4-RD and wAIHA, with orphan drug designations from the FDA.
Sanofi (SNY - Free Report) announced that the FDA has approved Wayrilz (rilzabrutinib), a novel BTK inhibitor, for the treatment of persistent or chronic immune thrombocytopenia (ITP) in adult patients who have had an insufficient response to a previous treatment.
Following the nod, Wayrilz became the first BTK inhibitor to be approved for treating ITP in the United States.
The latest FDA approval was based on data from the phase III LUNA 3 study, which showed that treatment with Wayrilz led to a positive impact on sustained platelet counts and other ITP symptoms, thus meeting both the primary and secondary endpoints.
Per management, Wayrilz works by modulating multiple immune pathways, helping to treat ITP at its root cause. Also, its selective BTK approach may be safer than the currently available drugs.
Patients prescribed Wayrilz will have access to Sanofi’s HemAssist program, which provides support across all treatments in the company’s portfolio of rare blood disorders.
Wayrilz is currently under review in the EU and China as a potential treatment for ITP. The drug was recently approved for treating adult patients with persistent or chronic ITP in the United Arab Emirates.
SNY’s Stock Performance
Shares of Sanofi have risen 2.6% so far this year against the industry’s decline of 0.6%.
Image Source: Zacks Investment Research
SNY Developing Wayrilz for Autoimmune Disorders
Besides ITP, Wayrilz is also being developed for treating several other rare diseases in the United States, the EU and other countries.
A phase II study is evaluating Wayrilz for treating IgG4-related disease (IgG4-RD), a chronic, immune-mediated rare condition that can affect multiple organs, causing inflammation, swelling and fibrosis.
The FDA and the European Medicines Agency (EMA) have granted orphan drug designation to Wayrilz for the treatment of IgG4-RD.
The FDA had previously granted orphan drug designation to Wayrilz for warm autoimmune hemolytic anemia (wAIHA) and sickle cell disease (SCD). Wayrilz is being developed in a mid-stage study for treating wAIHA, while it is yet to enter clinical development for SCD.
Wayrilz was added to Sanofi’s pipeline with the acquisition of Principia Biopharma in 2020.
In the past 60 days, estimates for Akero Therapeutics’ 2025 loss per share have narrowed from $3.93 to $3.85. Loss per share estimates for 2026 have narrowed from $4.27 to $4.14 during the same period. AKRO stock has surged 67.9% year to date.
Akero Therapeutics’ earnings beat estimates in three of the trailing four quarters while missing the same on the remaining occasion, the average surprise being 49.24%.
In the past 60 days, estimates for Adaptive Biotechnologies’ 2025 loss per share have narrowed from 87 cents to 71 cents. Loss per share estimates for 2026 have narrowed from 65 cents to 60 cents during the same period. ADPT stock has soared 119.5% year to date.
Adaptive Biotechnologies’ earnings beat estimates in each of the trailing four quarters, the average surprise being 23.99%.
In the past 60 days, estimates for Aligos Therapeutics’ 2025 loss per share have narrowed from $9.71 to $8.24. Loss per share estimates for 2026 have narrowed from $10.45 to $8.74 during the same period. ALGS stock has plunged 73.7% year to date.
Aligos Therapeutics’ earnings beat estimates in two of the trailing four quarters while missing the same on the remaining two occasions, the average negative surprise being 15.45%.
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Sanofi Gets FDA Nod for Wayrilz in Immune Thrombocytopenia
Key Takeaways
Sanofi (SNY - Free Report) announced that the FDA has approved Wayrilz (rilzabrutinib), a novel BTK inhibitor, for the treatment of persistent or chronic immune thrombocytopenia (ITP) in adult patients who have had an insufficient response to a previous treatment.
Following the nod, Wayrilz became the first BTK inhibitor to be approved for treating ITP in the United States.
The latest FDA approval was based on data from the phase III LUNA 3 study, which showed that treatment with Wayrilz led to a positive impact on sustained platelet counts and other ITP symptoms, thus meeting both the primary and secondary endpoints.
Per management, Wayrilz works by modulating multiple immune pathways, helping to treat ITP at its root cause. Also, its selective BTK approach may be safer than the currently available drugs.
Patients prescribed Wayrilz will have access to Sanofi’s HemAssist program, which provides support across all treatments in the company’s portfolio of rare blood disorders.
Wayrilz is currently under review in the EU and China as a potential treatment for ITP. The drug was recently approved for treating adult patients with persistent or chronic ITP in the United Arab Emirates.
SNY’s Stock Performance
Shares of Sanofi have risen 2.6% so far this year against the industry’s decline of 0.6%.
Image Source: Zacks Investment Research
SNY Developing Wayrilz for Autoimmune Disorders
Besides ITP, Wayrilz is also being developed for treating several other rare diseases in the United States, the EU and other countries.
A phase II study is evaluating Wayrilz for treating IgG4-related disease (IgG4-RD), a chronic, immune-mediated rare condition that can affect multiple organs, causing inflammation, swelling and fibrosis.
The FDA and the European Medicines Agency (EMA) have granted orphan drug designation to Wayrilz for the treatment of IgG4-RD.
The FDA had previously granted orphan drug designation to Wayrilz for warm autoimmune hemolytic anemia (wAIHA) and sickle cell disease (SCD). Wayrilz is being developed in a mid-stage study for treating wAIHA, while it is yet to enter clinical development for SCD.
Wayrilz was added to Sanofi’s pipeline with the acquisition of Principia Biopharma in 2020.
SNY's Zacks Rank & Stocks to Consider
Sanofi currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the biotech sector are Akero Therapeutics (AKRO - Free Report) , Adaptive Biotechnologies (ADPT - Free Report) and Aligos Therapeutics (ALGS - Free Report) , each carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
In the past 60 days, estimates for Akero Therapeutics’ 2025 loss per share have narrowed from $3.93 to $3.85. Loss per share estimates for 2026 have narrowed from $4.27 to $4.14 during the same period. AKRO stock has surged 67.9% year to date.
Akero Therapeutics’ earnings beat estimates in three of the trailing four quarters while missing the same on the remaining occasion, the average surprise being 49.24%.
In the past 60 days, estimates for Adaptive Biotechnologies’ 2025 loss per share have narrowed from 87 cents to 71 cents. Loss per share estimates for 2026 have narrowed from 65 cents to 60 cents during the same period. ADPT stock has soared 119.5% year to date.
Adaptive Biotechnologies’ earnings beat estimates in each of the trailing four quarters, the average surprise being 23.99%.
In the past 60 days, estimates for Aligos Therapeutics’ 2025 loss per share have narrowed from $9.71 to $8.24. Loss per share estimates for 2026 have narrowed from $10.45 to $8.74 during the same period. ALGS stock has plunged 73.7% year to date.
Aligos Therapeutics’ earnings beat estimates in two of the trailing four quarters while missing the same on the remaining two occasions, the average negative surprise being 15.45%.