This section highlights FDA-related milestones and regulatory updates for drugs developed by Sanofi (SNY).
Over the past two years, Sanofi has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
Amlitelimab, BEYFORTUS, Dupixent, Fitusiran, IPH6101/SAR443579, isatuximab, and Libtayo. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Amlitelimab - FDA Regulatory Timeline and Events
Amlitelimab is a drug developed by Sanofi for the following indication: In heterogeneous inflammatory asthma.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Amlitelimab
- Announced Date:
- April 15, 2025
- Indication:
- In heterogeneous inflammatory asthma
Announcement
Sanofi today shared new progress from its mid- to late-stage respiratory pipeline, including preliminary phase 2 results for amlitelimab in adults with moderate-to-severe asthma.
Read Announcement
BEYFORTUS - FDA Regulatory Timeline and Events
BEYFORTUS is a drug developed by Sanofi for the following indication: For RSV disease.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- BEYFORTUS
- Announced Date:
- September 16, 2024
- Indication:
- For RSV disease
Announcement
Sanofi is shipping BEYFORTUS (nirsevimab-alip) 50mg and 100mg Injection doses in the US to private healthcare providers and to the Centers for Disease Control and Prevention for its Vaccines for Children program to help ensure the majority of doses are available ahead of RSV season.
AI Summary
Sanofi announced it is shipping BEYFORTUS (nirsevimab-alip) 50mg and 100mg injection doses in the United States to both private healthcare providers and the Centers for Disease Control and Prevention. This delivery is part of its Vaccines for Children program and is designed to ensure that most doses are available well before the RSV season begins. The goal is to provide immunization during routine checkups for babies born outside the RSV season and immediately at birth for those born during the season.
BEYFORTUS is the first and only long-acting monoclonal antibody approved for preventing RSV-related lower respiratory tract disease in newborns and infants. By expanding production in collaboration with AstraZeneca, Sanofi is working to build an adequate supply ahead of the 2024/2025 RSV season, ensuring that every eligible baby can receive timely protection.
Read Announcement
Dupixent (dupilumab) - FDA Regulatory Timeline and Events
Dupixent (dupilumab) is a drug developed by Sanofi for the following indication: Moderate-to-severe asthma.
This drug is approved by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Dupixent (dupilumab)
- Announced Date:
- June 20, 2025
- Indication:
- Moderate-to-severe asthma
Announcement
Regeneron Pharmaceuticals, Inc and Sanofi today announced that the U.S. Food and Drug Administration (FDA) has approved Dupixent® (dupilumab) for the treatment of adult patients with bullous pemphigoid (BP).
AI Summary
Regeneron Pharmaceuticals and Sanofi announced that the FDA has approved Dupixent (dupilumab) for the treatment of adult patients with bullous pemphigoid (BP). BP is a rare, chronic skin disease that mainly affects older adults, causing painful blisters, intense itch, and skin lesions. In clinical trials, Dupixent showed significant improvements by helping patients achieve sustained disease remission, reducing itch, and minimizing the need for oral corticosteroids compared to a placebo.
This approval marks a major milestone as Dupixent becomes the first targeted therapy for BP. By addressing the underlying type 2 inflammation common in BP, Dupixent provides a new treatment option that may offer better disease management and quality of life for those affected. This breakthrough is important for a condition that has limited treatment choices and predominantly impacts an elderly patient population.
Read Announcement- Drug:
- Dupixent (dupilumab)
- Announced Date:
- May 1, 2025
- Indication:
- Moderate-to-severe asthma
Announcement
Regeneron Pharmaceuticals, Inc. announced 24 abstracts on Dupixent® (dupilumab) clinical data and real-world analyses in respiratory diseases will be presented at the American Thoracic Society (ATS) International Conference 2025 being held from May 18 to 21 in San Francisco, California.
AI Summary
Regeneron Pharmaceuticals, Inc. announced that 24 abstracts featuring new clinical and real-world analyses of Dupixent® (dupilumab) in respiratory diseases will be presented at the American Thoracic Society International Conference 2025 in San Francisco from May 18 to 21. Among these presentations are one oral presentation and four late-breaking poster sessions that focus on Dupixent’s benefits in patients with chronic obstructive pulmonary disease (COPD) and asthma. The data include findings from landmark Phase 3 trials, highlighting improvements in lung function, reductions in exacerbations, and enhanced health-related quality of life. The abstracts underscore Dupixent’s impact on targeting type 2 inflammation in a diverse patient population, including those with or without emphysema. This initiative, in collaboration with Sanofi, reflects Regeneron’s commitment to advancing the scientific understanding of respiratory diseases and improving patient outcomes.
Read Announcement- Drug:
- Dupixent (dupilumab)
- Announced Date:
- April 18, 2025
- Indication:
- Moderate-to-severe asthma
Announcement
Regeneron Pharmaceuticals, Inc. and Sanofi announced that the U.S. Food and Drug Administration (FDA) has approved Dupixent® (dupilumab) for the treatment of adults and adolescents aged 12 years and older with chronic spontaneous urticaria (CSU) who remain symptomatic despite histamine-1 (H1) antihistamine treatment.
AI Summary
Regeneron Pharmaceuticals, Inc. and Sanofi announced that the U.S. Food and Drug Administration (FDA) has approved Dupixent® (dupilumab) for treating chronic spontaneous urticaria (CSU) in adults and adolescents aged 12 and older who remain symptomatic despite treatment with histamine-1 antihistamines. This approval marks Dupixent as the first new targeted therapy for CSU in over a decade and the seventh indication for patients with conditions tied to type 2 inflammation. Based on Phase 3 trial data, Dupixent has been shown to significantly reduce intense itch and hives compared to placebo, offering a new therapeutic option for over 300,000 U.S. patients who previously had limited choices. Administered as a subcutaneous injection, Dupixent provides support for better disease management and improved quality of life for individuals suffering from CSU.
Read Announcement- Drug:
- Dupixent (dupilumab)
- Announced Date:
- March 28, 2025
- Indication:
- Moderate-to-severe asthma
Announcement
Regeneron Pharmaceuticals, Inc. announced that the Ministry of Health, Labour and Welfare (MHLW) in Japan has granted marketing and manufacturing authorization for Dupixent® (dupilumab) for the treatment of chronic obstructive pulmonary disease (COPD) in adults whose disease is not adequately controlled with existing therapy.
AI Summary
Regeneron Pharmaceuticals, Inc. announced that Japan’s Ministry of Health, Labour and Welfare has granted marketing and manufacturing authorization for Dupixent® (dupilumab) to treat adults with chronic obstructive pulmonary disease (COPD) whose condition is not well controlled with existing therapies. This approval followed a successful Phase 3 BOREAS trial that showed Dupixent significantly reduced flare-ups and improved lung function when added to standard inhaled therapy. The trial focused on patients with elevated blood eosinophils, a key marker linked to COPD exacerbations.
This milestone marks the first new treatment approach for COPD in Japan in more than a decade and extends Dupixent’s use beyond its originally approved indications. The drug is administered via subcutaneous injection every other week and maintains a safety profile consistent with its other approved uses, further solidifying its role in managing conditions driven by type 2 inflammation.
Read Announcement- Drug:
- Dupixent (dupilumab)
- Announced Date:
- March 8, 2025
- Indication:
- Moderate-to-severe asthma
Announcement
Regeneron Pharmaceuticals, Inc today presented positive results from the pivotal ADEPT Phase 2/3 trial evaluating the investigational use of Dupixent® (dupilumab) in adults with moderate-to-severe bullous pemphigoid (BP).
AI Summary
Regeneron Pharmaceuticals, Inc. presented promising results from the ADEPT Phase 2/3 trial evaluating Dupixent in adults with moderate-to-severe bullous pemphigoid, a chronic skin disease marked by intense itch and painful blisters. The trial showed that patients treated with Dupixent achieved sustained disease remission at 36 weeks at a rate five times higher than those on placebo. Additionally, significant improvements were noted with 40% of Dupixent-treated patients experiencing a near-complete reduction in disease severity and a meaningful reduction in itch. Dupixent also helped to significantly reduce the use of oral corticosteroids and rescue medications. These positive outcomes highlight the potential of Dupixent as a targeted treatment addressing the underlying type 2 inflammation that drives bullous pemphigoid, offering hope for transforming the management of this challenging condition.
Read Announcement- Drug:
- Dupixent (dupilumab)
- Announced Date:
- February 18, 2025
- Indication:
- Moderate-to-severe asthma
Announcement
Regeneron Pharmaceuticals, Inc announced that the U.S. Food and Drug Administration (FDA) has accepted for Priority Review the supplemental Biologics License Application (sBLA) for Dupixent® (dupilumab) to treat adults with bullous pemphigoid (BP).
AI Summary
The U.S. Food and Drug Administration (FDA) has accepted for Priority Review the supplemental Biologics License Application (sBLA) for Dupixent® (dupilumab) to treat adults with bullous pemphigoid (BP), a chronic, relapsing skin disease. If approved, Dupixent would become the first and only targeted treatment for BP in the United States, with the FDA decision expected by June 20, 2025.
The Priority Review was granted based on positive results from a pivotal study where patients treated with Dupixent achieved sustained disease remission at a rate five times higher than those on placebo. The study also showed significant improvements in reducing disease severity, itch, and reliance on oral corticosteroids. Dupixent’s potential approval would mark a major advance for approximately 27,000 U.S. adults suffering from BP uncontrolled by current treatments.
Read Announcement- Drug:
- Dupixent (dupilumab)
- Announced Date:
- November 15, 2024
- Indication:
- Moderate-to-severe asthma
Announcement
Regeneron Pharmaceuticals, Inc. and Sanofi announced that the U.S. Food and Drug Administration (FDA) has accepted for review the resubmission of the supplemental Biologics License Application (sBLA) for Dupixent® (dupilumab) to treat adults and pediatric patients aged 12 years and older with chronic spontaneous urticaria (CSU) whose disease is not adequately controlled with H1 antihistamine treatment.
AI Summary
Regeneron Pharmaceuticals and Sanofi announced that the U.S. FDA has accepted for review the resubmitted Supplemental Biologics License Application (sBLA) for Dupixent (dupilumab). This application targets the treatment of chronic spontaneous urticaria (CSU) in adults and pediatric patients aged 12 years and older whose symptoms remain uncontrolled despite H1 antihistamine treatment.
The resubmission, backed by new pivotal data from the LIBERTY-CUPID Phase 3 clinical program, shows that Dupixent significantly reduces both itch and hive activity. This is a crucial development for the more than 300,000 CSU patients in the US who have limited treatment options. The FDA is expected to make a decision by April 18, 2025, and, if approved, Dupixent would be the first targeted therapy for CSU in a decade.
Read Announcement- Drug:
- Dupixent (dupilumab)
- Announced Date:
- November 15, 2024
- Estimated Event Date Range:
- April 18, 2025 - April 18, 2025
- Target Action Date:
- April 18, 2025
- Indication:
- Moderate-to-severe asthma
Announcement
Regeneron Pharmaceuticals, Inc announced that The target action date for the FDA decision is April 18, 2025.
AI Summary
Regeneron Pharmaceuticals announced a key milestone for Dupixent (dupilumab) as the FDA has set the target action date for its decision on the resubmitted supplemental biologics license application at April 18, 2025. This application focuses on the treatment of chronic spontaneous urticaria (CSU) in patients who do not achieve adequate control with H1 antihistamines. New pivotal data from the Phase 3 LIBERTY-CUPID clinical program showed that Dupixent significantly reduced both itch and hives in patients suffering from this condition. With over 300,000 Americans affected by CSU, the potential approval of Dupixent could offer a much-needed targeted therapy option. Regeneron’s positive developments reflect ongoing efforts to advance targeted therapies and improve patient care for those who have limited alternatives for managing CSU.
Read Announcement- Drug:
- Dupixent (dupilumab)
- Announced Date:
- September 27, 2024
- Indication:
- Moderate-to-severe asthma
Announcement
Regeneron Pharmaceuticals, Inc and Sanofi SA’s Dupixent (dupilumab) as an add-on maintenance treatment of inadequately controlled chronic obstructive pulmonary disease (COPD) and an eosinophilic phenotype, generally known as “smoker’s lung.” Dupixent is the first biologic medicine approved in the U.S. to treat these patients.
AI Summary
Regeneron Pharmaceuticals and Sanofi have received FDA approval for Dupixent (dupilumab) as an add-on maintenance treatment for adults with inadequately controlled chronic obstructive pulmonary disease (COPD) who have an eosinophilic phenotype, commonly referred to as “smoker’s lung.” This marks Dupixent as the first biologic medicine approved in the U.S. for this specific COPD patient group.
The approval is based on data from two landmark Phase 3 trials. Patients treated with Dupixent experienced notable reductions in moderate to severe COPD exacerbations along with improvements in lung function and overall quality of life compared to those receiving a placebo. Building on its success in treating conditions like asthma and atopic dermatitis, Dupixent now offers new hope for approximately 300,000 COPD patients in the U.S. who have struggled with daily symptoms and unpredictable flare-ups.
Read Announcement- Drug:
- Dupixent (dupilumab)
- Announced Date:
- September 11, 2024
- Indication:
- Moderate-to-severe asthma
Announcement
Regeneron Pharmaceuticals, Inc. announced that a Dupixent® (dupilumab) confirmatory Phase 3 trial (LIBERTY-CUPID Study C) met the primary and key secondary endpoints for the investigational treatment of patients with uncontrolled, biologic-naïve chronic spontaneous urticaria (CSU) receiving background therapy with antihistamines.
AI Summary
Regeneron announced that its confirmatory Phase 3 trial, LIBERTY-CUPID Study C, met both the primary and key secondary endpoints for Dupixent in treating uncontrolled chronic spontaneous urticaria (CSU). The study involved 151 biologic-naïve patients, all of whom were still experiencing symptoms despite using background H1 antihistamine therapy. Results showed nearly a 50% reduction in both itch and overall urticaria activity scores compared to placebo. These findings indicate that Dupixent may significantly relieve the debilitating symptoms of CSU, which affects a large number of people who do not respond well to standard treatments. Regeneron plans to share this positive data with the FDA, with the goal of supporting a supplemental biologics application, potentially offering a new therapeutic option for CSU patients.
Read Announcement- Drug:
- Dupixent (dupilumab)
- Announced Date:
- August 26, 2024
- Indication:
- Moderate-to-severe asthma
Announcement
Regeneron Pharmaceuticals, Inc announced 20 abstracts across Dupixent® (dupilumab) and investigational therapy itepekimab will be presented at the European Respiratory Society (ERS) Congress 2024 being held from September 7 to 11 in Vienna, Austria.
AI Summary
Regeneron Pharmaceuticals, Inc. announced that it will present 20 abstracts at the upcoming European Respiratory Society (ERS) Congress 2024 in Vienna, Austria, from September 7 to 11. These abstracts, which include four oral presentations, will showcase new research on Dupixent® (dupilumab) and the investigational therapy itepekimab. The studies focus on treating respiratory conditions such as chronic obstructive pulmonary disease (COPD), asthma, and chronic rhinosinusitis with nasal polyps (CRSwNP), and they highlight advances in reducing exacerbations, improving lung function, and enhancing overall patient quality of life.
In collaboration with Sanofi, the presented research emphasizes the potential of targeting key drivers of type 2 inflammation and other related pathways. With detailed clinical and real-world data, the presentations aim to provide fresh insights into managing difficult-to-treat respiratory diseases and demonstrate Regeneron’s commitment to improving patient outcomes worldwide.
Read Announcement- Drug:
- Dupixent (dupilumab)
- Announced Date:
- July 3, 2024
- Indication:
- Moderate-to-severe asthma
Announcement
Regeneron Pharmaceuticals, Inc announced that the European Commission (EC) has approved Dupixent® (dupilumab) as an add-on maintenance treatment for adults with uncontrolled chronic obstructive pulmonary disease (COPD) characterized by raised blood eosinophils.
AI Summary
Regeneron Pharmaceuticals, Inc. announced that the European Commission has approved Dupixent® (dupilumab) as an add-on maintenance treatment for adults with uncontrolled chronic obstructive pulmonary disease (COPD) characterized by raised blood eosinophils. This approval targets patients already taking standard-of-care inhaled therapies, including combinations of an inhaled corticosteroid (ICS), a long-acting beta2-agonist (LABA) and a long-acting muscarinic antagonist (LAMA), or a LABA and LAMA when ICS is not appropriate.
The decision is a groundbreaking step in COPD treatment, offering a new option for about 220,000 EU patients. Data from two Phase 3 trials showed that Dupixent significantly reduces exacerbations, improves lung function, and enhances health-related quality of life. Regeneron’s achievement marks the first global approval of a biologic for COPD driven by type 2 inflammation, setting the stage for further reviews in other regions worldwide.
Read Announcement- Drug:
- Dupixent (dupilumab)
- Announced Date:
- May 31, 2024
- Indication:
- Moderate-to-severe asthma
Announcement
The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending the approval of Dupixent (dupilumab) in the European Union (EU) as an add-on maintenance treatment in adults with uncontrolled chronic obstructive pulmonary disease (COPD) characterized by raised blood eosinophils.
AI Summary
The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending Dupixent (dupilumab) for approval as an add-on maintenance treatment in the European Union. This treatment is specifically aimed at adults with uncontrolled chronic obstructive pulmonary disease (COPD) who have raised blood eosinophils. The recommendation comes after two Phase 3 trials, which showed that Dupixent significantly reduced moderate to severe COPD exacerbations and improved lung function across a 52-week period.
If approved by the European Commission in the coming months, Dupixent will become the first-ever targeted therapy for COPD in the EU and the first new treatment approach for this disease in more than a decade. This development could offer a valuable option for patients struggling with a challenging respiratory condition that impacts daily life and overall health.
Read Announcement- Drug:
- Dupixent (dupilumab)
- Announced Date:
- May 31, 2024
- Estimated Event Date Range:
- September 27, 2024 - September 27, 2024
- Target Action Date:
- September 27, 2024
- Indication:
- Moderate-to-severe asthma
Announcement
Regeneron Pharmaceuticals, Inc announced the U.S. Food and Drug Administration (FDA) has extended by three months the target action date of its priority review of the supplemental Biologics License Application (sBLA) for Dupixent® (dupilumab) as an add-on maintenance treatment in certain adult patients with uncontrolled chronic obstructive pulmonary disease (COPD). The revised target action date is September 27, 2024.
AI Summary
Regeneron Pharmaceuticals has announced that the U.S. FDA has extended the target action date for its priority review of the supplemental Biologics License Application (sBLA) for Dupixent® (dupilumab). The review now has a revised target action date of September 27, 2024. Dupixent is being examined as an add-on maintenance treatment for adult patients with uncontrolled chronic obstructive pulmonary disease (COPD) who show signs of type 2 inflammation.
This extension comes after the agency received additional efficacy analyses from pivotal clinical trials, which the FDA determined to be a major amendment to the sBLA. Regeneron and its partner Sanofi remain confident that this extra data strongly supports Dupixent’s potential benefits for patients with COPD, reinforcing their commitment to advancing new treatment options for this challenging condition.
Read Announcement- Drug:
- Dupixent (dupilumab)
- Announced Date:
- May 20, 2024
- Indication:
- Moderate-to-severe asthma
Announcement
Regeneron Pharmaceuticals, Inc and Sanofi today presented late-breaking data from the NOTUS Phase 3 trial evaluating the investigational use of Dupixent® (dupilumab) as an add-on maintenance treatment in adults with uncontrolled COPD on maximal standard-of-care inhaled therapy (nearly all on triple therapy) and evidence of type 2 inflammation (i.e., blood eosinophils ≥300 cells per μL).
AI Summary
Regeneron Pharmaceuticals, Inc. and Sanofi presented late-breaking data from the Phase 3 NOTUS trial, which evaluated the investigational use of Dupixent® (dupilumab) as an add‑on maintenance treatment for adults with uncontrolled COPD. In this trial, nearly all patients were already receiving maximal standard‑of‑care inhaled therapy, including triple therapy, and showed evidence of type 2 inflammation with blood eosinophils of at least 300 cells per μL. The NOTUS trial confirmed positive outcomes from an earlier trial by significantly reducing moderate or severe COPD exacerbations by 34% over 52 weeks. Additionally, patients treated with Dupixent experienced markedly improved lung function at both 12 and 52 weeks as well as better health-related quality of life. These results suggest that Dupixent could become the first targeted therapy for COPD in over a decade if approved by regulatory authorities.
Read Announcement- Drug:
- Dupixent (dupilumab)
- Announced Date:
- May 13, 2024
- Indication:
- Moderate-to-severe asthma
Announcement
Regeneron Pharmaceuticals, Inc announced that the U.S. Food and Drug Administration (FDA) has accepted for Priority Review the supplemental Biologics License Application (sBLA) for Dupixent® (dupilumab) as an add-on maintenance treatment for adolescents aged 12 to 17 years with inadequately controlled chronic rhinosinusitis with nasal polyposis (CRSwNP).
AI Summary
Regeneron Pharmaceuticals announced that the U.S. Food and Drug Administration (FDA) has accepted the supplemental Biologics License Application (sBLA) for Dupixent® (dupilumab) for Priority Review. The application seeks approval for using Dupixent as an add-on maintenance treatment for adolescents aged 12 to 17 years with inadequately controlled chronic rhinosinusitis with nasal polyposis (CRSwNP).
The Priority Review designation is given to promising therapies that could address unmet medical needs and speed up the process for potential patient benefit. If approved, Dupixent may offer a new treatment option for young patients who suffer from this chronic condition, helping to manage their symptoms more effectively. The FDA’s decision to fast-track the review underlines the potential of Dupixent to become a significant therapy in this age group, emphasizing Regeneron’s commitment to improving patient outcomes in challenging chronic conditions.
Read Announcement
Fitusiran - FDA Regulatory Timeline and Events
Fitusiran is a drug developed by Sanofi for the following indication: Hemophilia A or B.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Fitusiran
- Announced Date:
- March 28, 2025
- Indication:
- Hemophilia A or B
Announcement
Alnylam Pharmaceuticals, Inc today highlighted the significance of the U.S. Food and Drug Administration's (FDA) approval of Qfitlia™ (fitusiran), the sixth Alnylam-discovered RNAi therapeutic approved in the U.S., and the first and only therapeutic to lower antithrombin (AT), a protein that inhibits blood clotting, with the goal of promoting thrombin generation to rebalance hemostasis and prevent bleeds.
AI Summary
Alnylam Pharmaceuticals recently celebrated the U.S. FDA approval of Qfitlia™ (fitusiran), marking a major breakthrough as the sixth RNAi therapeutic discovered by the company to gain approval and the first and only one that lowers antithrombin (AT). By reducing AT, Qfitlia works to promote thrombin generation, helping to rebalance hemostasis and prevent bleeding episodes in patients with hemophilia A or B, with or without inhibitors. This unique approach sets Qfitlia apart from other treatments and offers a new non-factor option for patients. The approval highlights the drug's potential to significantly reduce the frequency of bleeds as shown in clinical studies. Patients aged 12 and older can now benefit from this innovative subcutaneous injection treatment that offers routine prophylaxis against bleeding, representing a significant advancement in hemophilia care.
Read Announcement
IPH6101/SAR443579 - FDA Regulatory Timeline and Events
IPH6101/SAR443579 is a drug developed by Sanofi for the following indication: Solid Tumors.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- IPH6101/SAR443579
- Announced Date:
- September 12, 2024
- Indication:
- Solid Tumors
Announcement
Innate Pharma SA reported its consolidated financial results for the six months ended June 30, 2024. The consolidated financial statements are attached to this press release.
AI Summary
Innate Pharma SA has released its consolidated financial results for the six months ended June 30, 2024. According to the press release, the company disclosed its full set of consolidated financial statements in the attached documents. The financial report highlights key metrics and details the firm's financial position during the period. Notably, the results show a strong cash position with a total of €102.1 million in cash, cash equivalents, short-term investments, and financial assets as of June 30, 2024. The report includes comprehensive information on operating results, research and development expenses, and general administrative costs as part of its overall strategy. With a focus on advancing its growth strategy and innovative pipeline, the CEO Hervé Brailly emphasized the importance of these results in guiding the company's next steps. The detailed financial statements provide investors and stakeholders with insight into the company’s current financial health and strategy moving forward.
Read Announcement- Drug:
- IPH6101/SAR443579
- Announced Date:
- June 17, 2024
- Indication:
- Solid Tumors
Announcement
Innate Pharma SA announced that updated efficacy and safety results from the dose-escalation part of the Phase 1/2 study with SAR443579/IPH6101 (SAR'579), an investigational CD123 targeting NKp46/CD16-based Natural Killer Cell Engager (NKCE), from a joint research collaboration between Innate Pharma and Sanofi and ANKET® platform lead asset, were shared in an oral presentation at the European Hematology Association 2024 Congress in Madrid, Spain on Sunday, June 16 at 11:45 CEST.
AI Summary
Innate Pharma SA recently announced updated results from the dose-escalation part of its Phase 1/2 study with SAR443579/IPH6101, an investigational NK cell engager that targets CD123. This molecule, part of the ANKET® platform and developed in collaboration with Sanofi, was designed to treat challenging blood cancers such as relapsed/refractory acute myeloid leukemia (R/R AML), B‑cell acute lymphoblastic leukemia (B-ALL), and high‑risk myelodysplasia (HR‑MDS).
During an oral presentation at the European Hematology Association 2024 Congress held in Madrid, Spain on Sunday, June 16 at 11:45 CEST, the updated efficacy and safety findings were detailed. The study demonstrated promising and durable clinical benefits, including several complete remissions, with a favorable safety profile. These results are expected to guide the selection of optimal dosing as the trial advances into Phase 2.
Read Announcement- Drug:
- IPH6101/SAR443579
- Announced Date:
- May 21, 2024
- Indication:
- Solid Tumors
Announcement
Innate Pharma SA announced that in an abstract published on 14 May 2024 for the European Hematology Association 2024 Congress on SAR443579/IPH6101, submitted by Sanofi, it was mentioned that the molecule received breakthrough designation
AI Summary
Innate Pharma SA recently clarified an error regarding the regulatory designation of its molecule SAR443579/IPH6101. An abstract submitted by Sanofi for the European Hematology Association 2024 Congress on May 14, 2024, mistakenly mentioned that the molecule received breakthrough designation. According to the company, this is incorrect. In fact, the molecule has been granted the US FDA Fast Track Designation, a status communicated previously in June 2023.
This correction is significant because it emphasizes the specific regulatory recognition that the molecule holds. The Fast Track Designation is intended to speed up the development and review process for new treatments that address unmet medical needs. By drawing attention to this clarification, Innate Pharma aims to ensure that stakeholders have an accurate understanding of the regulatory status and the progress of its innovative cancer treatment platform.
Read Announcement- Drug:
- IPH6101/SAR443579
- Announced Date:
- May 15, 2024
- Indication:
- Solid Tumors
Announcement
Innate Pharma SA announced that four abstracts with Innate's drug candidates have been accepted for the European Association of Hematology (EHA) 2024 Congress, taking place June 13-16, 2024 in Madrid, Spain.
AI Summary
Innate Pharma SA announced that four abstracts featuring its innovative drug candidates have been accepted for presentation at the European Association of Hematology (EHA) 2024 Congress. The event will be held from June 13-16, 2024 in Madrid, Spain. The abstracts include two focused on SAR443579 (IPH6101), a trifunctional NK cell engager developed in collaboration with Sanofi, which is being studied as a monotherapy for treating blood cancers with high unmet needs. The remaining two abstracts detail IPH6501, Innate’s second-generation ANKET® designed for relapsed or refractory CD20-expressing B-cell Non-Hodgkin’s Lymphoma, currently under evaluation in a Phase 1/2 clinical trial. This inclusion in the EHA Congress underscores the continued momentum and potential impact of Innate Pharma’s novel NK cell engager therapies in addressing severe blood cancers.
Read Announcement- Drug:
- IPH6101/SAR443579
- Announced Date:
- April 15, 2024
- Indication:
- Solid Tumors
Announcement
Innate Pharma SA announced that the first patient was dosed in the Phase 2 dose expansion part of the Sanofi-sponsored clinical trial of SAR443579 / IPH6101 (NCT05086315), evaluating SAR443579 as a monotherapy for the treatment of blood cancers with high unmet needs, including relapsed or refractory acute myeloid leukemia (R/R AML), B-cell acute lymphoblastic leukemia and high-risk myelodysplasia.
AI Summary
Innate Pharma SA announced exciting progress in its clinical research as the first patient was dosed in the Phase 2 dose expansion phase of a Sanofi-sponsored trial. The trial is testing SAR443579 / IPH6101, an innovative NK cell engager, as a monotherapy in patients with blood cancers that have high unmet treatment needs. Specifically, the study evaluates its use for relapsed or refractory acute myeloid leukemia (R/R AML), B-cell acute lymphoblastic leukemia, and high-risk myelodysplasia. This advancement marks an important step forward in the program’s development and demonstrates the potential of SAR443579 to provide a critical new treatment option for patients facing these challenging blood cancers. The shared progress underlines continued collaboration between Innate Pharma and Sanofi in addressing significant clinical gaps in cancer therapy.
Read Announcement
isatuximab - FDA Regulatory Timeline and Events
isatuximab is a drug developed by Sanofi for the following indication: For the treatment of patients with transplant-ineligible newly diagnosed multiple myeloma (NDMM).
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- isatuximab
- Announced Date:
- September 4, 2024
- Indication:
- For the treatment of patients with transplant-ineligible newly diagnosed multiple myeloma (NDMM).
Announcement
ALX Oncology Holdings Inc. announced the first patients have been dosed in an arm of the randomized UMBRELLA phase 1/2 clinical study partnered with Sanofi that is evaluating evorpacept in combination with SARCLISA® (isatuximab-irfc).
AI Summary
ALX Oncology recently announced that the first patients have been dosed in an arm of the randomized UMBRELLA phase 1/2 clinical study in collaboration with Sanofi. This trial is evaluating evorpacept, ALX Oncology’s investigational CD47-blocking therapeutic, in combination with SARCLISA® (isatuximab-irfc), a CD38 monoclonal antibody used to treat relapsed or refractory multiple myeloma. The combination aims to address resistance seen with CD38 therapies and may help re-sensitize tumors to treatment. By blocking the CD47 immune checkpoint, evorpacept could enhance the anti-tumor effects of SARCLISA while maintaining a favorable safety profile. The study will assess the safety, pharmacokinetics, and efficacy of the combination, marking an important step forward in developing innovative treatments for multiple myeloma patients in need of new therapeutic options.
Read Announcement- Drug:
- isatuximab
- Announced Date:
- May 27, 2024
- Indication:
- For the treatment of patients with transplant-ineligible newly diagnosed multiple myeloma (NDMM).
Announcement
Sanofi announced that The U.S. Food and Drug Administration (FDA) has accepted for Priority Review the supplemental Biologics License Application (sBLA) for the investigational use of Sarclisa (isatuximab) in combination with bortezomib, lenalidomide and dexamethasone (VRd) for the treatment of patients with transplant-ineligible newly diagnosed multiple myeloma (NDMM).
Read Announcement- Drug:
- isatuximab
- Announced Date:
- May 27, 2024
- Estimated Event Date Range:
- September 27, 2024 - September 27, 2024
- Target Action Date:
- September 27, 2024
- Indication:
- For the treatment of patients with transplant-ineligible newly diagnosed multiple myeloma (NDMM).
Announcement
Sanofi announced that The target action date for the FDA decision is September 27, 2024.
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Libtayo (cemiplimab) - FDA Regulatory Timeline and Events
Libtayo (cemiplimab) is a drug developed by Sanofi for the following indication: Advanced Cervical Cancer.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Libtayo (cemiplimab)
- Announced Date:
- May 31, 2025
- Indication:
- Advanced Cervical Cancer
Announcement
Regeneron Pharmaceuticals, Inc. announced detailed analyses from the Phase 3 C-POST trial, which evaluated PD-1 inhibitor Libtayo® (cemiplimab) in patients with high-risk cutaneous squamous cell carcinoma (CSCC) after surgery.
AI Summary
Regeneron Pharmaceuticals announced new detailed analyses from the Phase 3 C-POST clinical trial, which evaluated the PD-1 inhibitor Libtayo (cemiplimab) in patients with high-risk cutaneous squamous cell carcinoma (CSCC) after surgery. The trial showed that Libtayo reduced the risk of disease recurrence or death by 68% compared to placebo, marking a significant improvement in disease-free survival. Additionally, Libtayo reduced the risk of locoregional recurrence by 80% and distant recurrence by 65% when compared with placebo.
These promising results were presented at the 2025 American Society of Clinical Oncology Annual Meeting and published in the New England Journal of Medicine. The findings suggest that cemiplimab could become an important systemic therapy to prevent relapse in high-risk CSCC patients following surgery. Regulatory applications for this new potential indication have been submitted in both the United States and the European Union.
Read Announcement- Drug:
- Libtayo (cemiplimab)
- Announced Date:
- May 1, 2025
- Indication:
- Advanced Cervical Cancer
Announcement
Regeneron Pharmaceuticals, Inc. announced new and updated data from its oncology and hematology portfolio will be shared at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting, taking place from May 30 to June 3 in Chicago, IL.
AI Summary
Regeneron Pharmaceuticals announced that it will share new and updated data from its oncology and hematology portfolio at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting, which will be held from May 30 to June 3 in Chicago, IL. The company plans to showcase 18 presentations covering findings from both approved and investigational treatment regimens.
Key highlights include updates from trials involving the PD-1 inhibitor Libtayo and early data from studies on the investigational BCMAxCD3 bispecific antibody linvoseltamab. These studies focus on difficult-to-treat cancers such as various skin cancers, lung cancer, lymphoma, and multiple myeloma, aiming to improve treatment outcomes. Regeneron’s research efforts promise to offer fresh insights and potential new therapeutic options for patients battling these challenging diseases.
Read Announcement- Drug:
- Libtayo (cemiplimab)
- Announced Date:
- January 13, 2025
- Indication:
- Advanced Cervical Cancer
Announcement
Regeneron Pharmaceuticals, Inc announced positive results from the Phase 3 C-POST trial, which demonstrated that adjuvant treatment with PD-1 inhibitor Libtayo® (cemiplimab) led to a statistically significant and clinically meaningful improvement in the primary endpoint of disease-free survival (DFS) in patients with high-risk cutaneous squamous cell carcinoma (CSCC) after surgery.
AI Summary
Regeneron Pharmaceuticals announced positive Phase 3 C-POST trial results for Libtayo® (cemiplimab) used as an adjuvant treatment in patients with high-risk cutaneous squamous cell carcinoma (CSCC) after surgery. The study’s first prespecified interim analysis, with a median follow-up of 24 months, showed that Libtayo reduced the risk of cancer recurrence or death by 68% compared to placebo, marking a statistically significant and clinically meaningful improvement in disease-free survival (DFS).
This achievement positions Libtayo as the first immunotherapy to show such benefits in the adjuvant setting for high-risk CSCC, highlighting its potential role in delaying cancer recurrence in patients who have limited treatment options. The trial enrolled 415 patients, and further follow-up is planned, including an analysis of overall survival, to solidify these promising results.
Read Announcement- Drug:
- Libtayo (cemiplimab)
- Announced Date:
- September 9, 2024
- Indication:
- Advanced Cervical Cancer
Announcement
Regeneron Pharmaceuticals, Inc announced five-year results from the final pre-specified overall survival (OS) analysis of the Phase 3 EMPOWER-Lung 1 trial, which evaluated Libtayo® (cemiplimab) monotherapy versus chemotherapy as a first-line treatment for adults with advanced non-small cell lung cancer (NSCLC) with ≥50% PD-L1 expression and no EGFR, ALK or ROS1 aberrations.
AI Summary
Regeneron Pharmaceuticals recently announced five-year results from the final overall survival (OS) analysis of the Phase 3 EMPOWER-Lung 1 trial. The study compared Libtayo® (cemiplimab) as a monotherapy with chemotherapy for adults with advanced non-small cell lung cancer (NSCLC) that has high PD-L1 levels (≥50%) and without EGFR, ALK, or ROS1 mutations. Libtayo nearly doubled the median OS compared to chemotherapy and reduced the risks of death and disease progression by 41% and 50%, respectively.
The results underscore Libtayo’s durable survival benefit and its effectiveness as a first-line treatment in patients with high PD-L1 expression. Moreover, the trial provided data on patients who added chemotherapy after their disease progressed on Libtayo, showing further improvements in survival and response rates. These findings offer important insights for doctors in developing treatment strategies for advanced NSCLC patients.
Read Announcement- Drug:
- Libtayo (cemiplimab)
- Announced Date:
- June 3, 2024
- Indication:
- Advanced Cervical Cancer
Announcement
FibroGen, Inc announced a clinical trial supply agreement with Regeneron Pharmaceuticals to evaluate FibroGen's immuno-oncology assets, FG-3165 and FG-3175, in combination with Regeneron's anti-PD-1 therapy, LIBTAYO® (cemiplimab), in patients with solid tumors.
AI Summary
FibroGen, Inc. recently announced a clinical trial supply agreement with Regeneron Pharmaceuticals. The deal will evaluate FibroGen’s immuno-oncology assets, FG-3165 and FG-3175, when combined with Regeneron’s anti-PD-1 therapy, LIBTAYO® (cemiplimab), in patients with solid tumors. In preclinical studies, both FG-3165, an antibody targeting galectin-9, and FG-3175, an antibody targeting CCR8, showed complementary effects when paired with PD-1 inhibitors. The collaboration aims to explore whether combining these drugs might enhance the overall treatment benefits. Under the agreement, Regeneron will supply the drugs while FibroGen will sponsor the Phase 1 clinical trials testing these combination therapies. Both companies maintain full rights to their individual compounds. This partnership highlights a promising new approach in cancer treatment by potentially improving outcomes for patients with select solid tumors.
Read Announcement- Drug:
- Libtayo (cemiplimab)
- Announced Date:
- May 23, 2024
- Indication:
- Advanced Cervical Cancer
Announcement
Regeneron Pharmaceuticals announced positive new results from an ongoing Phase 1/2 trial evaluating its first-in-class costimulatory bispecific antibody, REGN7075 (EGFRxCD28), in combination with Libtayo® (cemiplimab) in patients with advanced solid tumors.
AI Summary
Regeneron Pharmaceuticals recently announced promising early results from its ongoing Phase 1/2 trial evaluating REGN7075 (EGFRxCD28), a first-in-class costimulatory bispecific antibody, in combination with Libtayo® (cemiplimab) for patients with advanced solid tumors. In the trial’s dose-escalation phase, the combination showed anti-tumor activity in patients with microsatellite stable colorectal cancer (MSS CRC), a type that typically does not respond to immunotherapy. Among the MSS CRC patients treated, some achieved a complete or partial response, while others experienced stable disease. The safety profile was acceptable with manageable infusion-related reactions and no dose-limiting toxicities observed. These early findings are significant as they represent one of the first indications of potential immunotherapy activity in MSS CRC, supporting further evaluation of this novel treatment strategy across additional tumor types.
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Riliprubart - FDA Regulatory Timeline and Events
Riliprubart is a drug developed by Sanofi for the following indication: Treatment in chronic inflammatory demyelinating polyneuropathy.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Riliprubart
- Announced Date:
- June 26, 2024
- Indication:
- Treatment in chronic inflammatory demyelinating polyneuropathy
Announcement
Sanofi announced that complement C1s inhibitor, riliprubart, showed encouraging efficacy and safety for participants with chronic inflammatory demyelinating polyneuropathy (CIDP) in the latest findings from an ongoing phase 2 study. In part A results at 24 weeks, riliprubart showed promising disease-controlling benefits, with improving or stable disease, including for participants who experienced failure or inadequate response to SOC treatment and participants with residual disability on SOC.
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siltuximab - FDA Regulatory Timeline and Events
siltuximab is a drug developed by Sanofi for the following indication: For adult patients with newly diagnosed multiple myeloma (NDMM).
This drug is approved by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- siltuximab
- Announced Date:
- September 23, 2024
- Indication:
- For adult patients with newly diagnosed multiple myeloma (NDMM)
Announcement
Sanofi announced that the FDA approved Sarclisa (siltuximab) in combination with bortezomib, lenalidomide, and dexamethasone (VRd) as a first-line treatment option for adult patients with newly diagnosed multiple myeloma (NDMM) who are not eligible for autologous stem cell transplant (ASCT).
AI Summary
Sanofi announced that the FDA has approved Sarclisa (isatuximab) in combination with bortezomib, lenalidomide, and dexamethasone (VRd) as a first-line treatment option for adult patients with newly diagnosed multiple myeloma (NDMM) who are not eligible for autologous stem cell transplant (ASCT). This approval is significant as it is the first time an anti-CD38 therapy has shown such promising results when combined with the standard VRd regimen for this patient group. The decision was made under the FDA’s Priority Review process and is based on data from the phase 3 IMROZ study. Clinical findings showed that patients receiving Sarclisa-VRd experienced a 40% reduction in the risk of disease progression or death compared to those on VRd alone. With this approval, Sarclisa now has its third indication in the U.S. and adds a new option for first-line treatment in NDMM.
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Tolebrutinib - FDA Regulatory Timeline and Events
Tolebrutinib is a drug developed by Sanofi for the following indication: Bruton’s tyrosine kinase (BTK) inhibitor.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Tolebrutinib
- Announced Date:
- March 25, 2025
- Estimated Event Date Range:
- September 28, 2025 - September 28, 2025
- Target Action Date:
- September 28, 2025
- Indication:
- Bruton’s tyrosine kinase (BTK) inhibitor
Announcement
Sanofi announced that the US Food and Drug Administration (FDA) is evaluating under priority review the regulatory submission of tolebrutinib to treat non-relapsing secondary progressive multiple sclerosis (nrSPMS) and to slow disability accumulation independent of relapse activity in adult patients. The target action date for the FDA decision is September 28, 2025.
Read Announcement- Drug:
- Tolebrutinib
- Announced Date:
- March 25, 2025
- Indication:
- Bruton’s tyrosine kinase (BTK) inhibitor
Announcement
Sanofi announced that The US Food and Drug Administration (FDA) is evaluating under priority review the regulatory submission of tolebrutinib to treat non-relapsing secondary progressive multiple sclerosis (nrSPMS) and to slow disability accumulation independent of relapse activity in adult patients.
Read Announcement- Drug:
- Tolebrutinib
- Announced Date:
- September 2, 2024
- Indication:
- Bruton’s tyrosine kinase (BTK) inhibitor
Announcement
Sanofi’ announced Positive results from the HERCULES phase 3 study showed that tolebrutinib oral brain-penetrant BTK inhibitor, met the primary endpoint of improvement over placebo in delaying time to onset of confirmed disability progression (CDP) in people with non-relapsing secondary progressive MS (nrSPMS).
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