Sanofi (NASDAQ:SNY) is among the ridiculously cheap stocks to buy now. On December 28, Jefferies reiterated its ‘Buy’ rating on Sanofi (NASDAQ:SNY) with an unchanged price target of €100. This reaffirmation comes despite worries about the FDA’s Complete Response Letter (CRL) for tolebrutinib, which the firm believes raises “tough questions about management communication.” The firm believes these concerns will continue to negatively impact market sentiment toward the company. Earlier, on December 23, Sano ...

Core Insights - Sanofi's new drug application (NDA) for tolebrutinib, a Bruton's tyrosine kinase (BTK) inhibitor for treating non-relapsing secondary progressive multiple sclerosis (nrSPMS), received a complete response letter (CRL) from the FDA [1] Regulatory Developments - The FDA's CRL for tolebrutinib was anticipated, as the review timeline had already been extended twice earlier this year [2] - The initial decision date of September 28, 2025, was pushed to December 28, 2025, due to Sanofi's submission of additional analyses deemed a major amendment [3] - Following the submission of an expanded access protocol at the FDA's request, the review date was revised again, with further guidance expected by the end of Q1 2026 [4] Market Performance - Over the past six months, Sanofi's shares have increased by 1.1%, while the industry has seen a rise of 20.4% [5] International Approvals - Tolebrutinib received provisional approval in the UAE for treating nrSPMS and slowing disability accumulation in adults [6] - A regulatory filing for a similar indication is currently under review in the European Union [6] Clinical Study Outcomes - The phase III PERCEUS study for tolebrutinib in primary progressive multiple sclerosis (PPMS) did not meet its primary endpoint [10] - Sanofi has decided not to pursue further development of tolebrutinib in PPMS, which represents 10% of the overall MS patient population [11] - In 2022, the FDA placed a partial clinical hold on phase III studies for tolebrutinib due to identified cases of drug-induced liver injury [11] Other Regulatory Approvals - The European Commission approved Wayrilz (rilzabrutinib) for immune thrombocytopenia (ITP) in adult patients refractory to other treatments [13] - The approval was based on data from the phase III LUNA 3 study, which met both primary and secondary endpoints [14]

Sanofi’s Wayrilz approved in the EU as the first BTK inhibitor to treat immune thrombocytopenia Novel treatment targets BTK through multi-immune modulation to help address the underlying causes of ITPApproval based on the LUNA 3 phase 3 study that demonstrated rapid and durable platelet response and improvements in other ITP symptomsITP is a rare disease of complex immune dysregulation leading to lower platelet counts, bleeding, and reduced quality of life Paris, December 23, 2025 – The European Commission ...

Core Viewpoint - Sanofi's Wayrilz (rilzabrutinib) has been approved by the European Commission as the first BTK inhibitor for treating immune thrombocytopenia (ITP) in adult patients who are refractory to other treatments, following a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) [1][3] Group 1: Treatment Mechanism and Impact - Wayrilz addresses the underlying causes of ITP through multi-immune modulation, targeting various pathways in the immune system [2] - Traditional management of ITP focuses on restoring platelet counts, but Wayrilz offers a new approach by targeting the disease's root causes, potentially improving overall quality of life for patients [3][6] Group 2: Clinical Study and Results - The approval is based on the pivotal LUNA 3 phase 3 study, which demonstrated that Wayrilz met both primary and secondary endpoints, showing a positive impact on sustained platelet counts and other ITP symptoms [4][6] - In the LUNA 3 study, 64% of patients in the Wayrilz arm achieved platelet count response at 12 weeks, compared to 32% in the placebo arm [4] - Patients receiving Wayrilz reported a 10.6-point improvement in overall quality of life compared to a 2.3-point increase in the placebo group, based on the Immune Thrombocytopenia Patient Assessment Questionnaire [5] Group 3: Efficacy and Safety - Statistically significant durable platelet response was observed at week 25, with 23% of patients in the Wayrilz arm achieving this compared to 0% in the placebo arm (p<0.0001) [7] - The time to first platelet response was faster in the Wayrilz arm, averaging 36 days, while the placebo arm did not reach this endpoint [7] - Common adverse reactions (≥10% incidence) included diarrhea, nausea, headache, abdominal pain, and COVID-19 [5] Group 4: Regulatory Status and Future Prospects - Wayrilz has already been approved in the US and UAE, with ongoing regulatory reviews in Japan and China [8] - The drug has received fast track and orphan drug designations in the US for ITP, along with similar designations in the EU and Japan [8] - Sanofi is also investigating Wayrilz for additional rare diseases, including warm autoimmune hemolytic anemia, IgG4-related disease, and sickle cell disease [11]

Core Viewpoint - The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of Wayrilz (rilzabrutinib) for treating immune thrombocytopenia (ITP) in adult patients who are refractory to other treatments, with a final decision expected soon [1][2] Group 1: Product Information - Wayrilz is the first BTK inhibitor for ITP, addressing the root cause of the disease through multi-immune modulation [5][7] - The drug has already received approval in the US and the UAE, and is under regulatory review in China [3] - Wayrilz has received fast track and orphan drug designations in the US, EU, and Japan for ITP and other rare diseases [3] Group 2: Clinical Study - The positive CHMP opinion is based on the LUNA 3 phase 3 study, which demonstrated that Wayrilz met both primary and secondary endpoints, showing a positive impact on sustained platelet counts and other ITP symptoms [2][4] - The LUNA 3 study involved a randomized, multicenter design, comparing Wayrilz to placebo over a treatment period of 12 to 24 weeks [4] Group 3: Disease Context - Immune thrombocytopenia (ITP) is characterized by low platelet counts (<100,000/μL), leading to various bleeding symptoms and risks, including potentially life-threatening episodes [8] - Patients with ITP may experience reduced quality of life, including physical fatigue and cognitive impairment [8]

Core Viewpoint - The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of Wayrilz (rilzabrutinib) for treating immune thrombocytopenia (ITP) in adult patients who are refractory to other treatments, with a final decision expected soon [1][2] Company Overview - Sanofi is an R&D driven biopharma company focused on improving lives through innovative medicines and vaccines, leveraging a deep understanding of the immune system [9] Product Information - Wayrilz is the first BTK inhibitor for ITP, addressing the root cause of the disease through multi-immune modulation, and is already approved in the US and the UAE [5][3] - The drug has received fast track and orphan drug designations in the US, EU, and Japan for ITP and is under regulatory review in China [3] Clinical Study Insights - The positive CHMP opinion is based on the LUNA 3 phase 3 study, which demonstrated that Wayrilz met both primary and secondary endpoints, showing a positive impact on sustained platelet counts and other ITP symptoms [2][4] - LUNA 3 involved a randomized, multicenter design, with patients receiving either Wayrilz or placebo over a treatment period of 12 to 24 weeks [4] Disease Context - ITP is characterized by low platelet counts (<100,000/μL), leading to various bleeding symptoms and a risk of thromboembolism, significantly affecting patients' quality of life [8]

Core Insights - Sanofi has received FDA approval for Wayrilz (rilzabrutinib), marking it as the first BTK inhibitor approved for treating persistent or chronic immune thrombocytopenia (ITP) in the United States [1][7] - The approval was based on the phase III LUNA 3 study, which demonstrated positive outcomes in sustained platelet counts and ITP symptoms, achieving both primary and secondary endpoints [2][7] - Wayrilz is also under review in the EU and China for ITP treatment and has been recently approved in the UAE for the same indication [3] Company Developments - Patients using Wayrilz will benefit from Sanofi's HemAssist program, which offers support for treatments related to rare blood disorders [3] - In addition to ITP, Wayrilz is being developed for other rare diseases, including IgG4-related disease (IgG4-RD) and warm autoimmune hemolytic anemia (wAIHA), with orphan drug designations from the FDA [5][9] - A phase II study is currently evaluating Wayrilz for IgG4-RD, a chronic immune-mediated condition affecting multiple organs [8] Stock Performance - Sanofi's shares have increased by 2.6% this year, contrasting with a 0.6% decline in the industry [4]

Core Insights - The US FDA has approved Wayrilz (rilzabrutinib) for adults with persistent or chronic immune thrombocytopenia (ITP) who have not responded adequately to previous treatments, based on the successful LUNA 3 phase 3 study [1][3] - Wayrilz is a novel oral Bruton's tyrosine kinase (BTK) inhibitor that targets multiple immune pathways to address the underlying causes of ITP [2][11] - The approval highlights Sanofi's commitment to developing innovative therapies for rare and immunological diseases [3][11] Study Results - The LUNA 3 study involved 202 adult patients and demonstrated that 64% of patients on Wayrilz achieved a platelet count response at 12 weeks compared to 32% in the placebo group [3][10] - Patients on Wayrilz reported a 10.6-point improvement in health-related quality of life measures, while the placebo group showed a 2.3-point increase [4] - Statistically significant results included a durable platelet response at week 25 (23% in Wayrilz vs. 0% in placebo; p<0.0001) and a faster time to first platelet response (36 days in Wayrilz vs. not reached in placebo; p<0.0001) [7] Treatment Implications - Wayrilz offers a new treatment option for patients who have not responded to steroids or existing therapies, potentially improving management of ITP [5][11] - The drug has received Fast Track and Orphan Drug Designations from the FDA for ITP and is under regulatory review in the EU and China [8][12] - Sanofi's HemAssist program will provide support for patients undergoing treatment with Wayrilz, including assistance with access and insurance coverage [9] Company Overview - Sanofi is an R&D driven biopharma company focused on innovative therapies for various diseases, including rare and immunological conditions [13] - The company is committed to leveraging its understanding of the immune system to develop effective treatments and improve patient outcomes [13]

Core Insights - The FDA has approved Wayrilz (rilzabrutinib) as the first BTK inhibitor for adults with persistent or chronic immune thrombocytopenia (ITP) who have not responded adequately to previous treatments [1][11] - The approval is based on the LUNA 3 phase 3 study, which demonstrated significant improvements in platelet counts and other ITP symptoms [1][6] Company Overview - Sanofi is committed to addressing unmet patient needs through innovative therapies, with Wayrilz representing a significant advancement in the treatment of ITP [3][11] - The company utilizes its TAILORED COVALENCY® technology to selectively inhibit BTK, which plays a critical role in immune-mediated disease processes [11] Study Details - The LUNA 3 study involved 202 adult patients and showed that 64% of patients on Wayrilz achieved a platelet count response at 12 weeks compared to 32% in the placebo group [3][10] - Patients on Wayrilz reported a 10.6-point improvement in health-related quality of life measures, while the placebo group showed a 2.3-point increase [4] Treatment Mechanism - Wayrilz functions as a novel oral, reversible BTK inhibitor that targets multiple pathways in the immune system, addressing the root causes of ITP through multi-immune modulation [2][11] - This approach is expected to provide a new treatment option for patients who have not responded to traditional therapies [5][6] Regulatory Status - Wayrilz has received Fast Track and Orphan Drug Designations from the FDA for ITP, and similar designations in Japan and the EU [8] - The drug is also under regulatory review for ITP in the EU and China, indicating potential for broader market access [8] Patient Support - Sanofi offers the HemAssist patient support program to assist patients with treatment navigation, insurance coverage, and financial assistance [9]