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Rilzabrutinib granted orphan drug designation in the US for two rare diseases with no approved medicines Designation granted for warm autoimmune hemolytic anemia and IgG4-related disease Rilzabrutinib is currently under regulatory review in the US, EU and China for potential use in immune thrombocytopenia  Paris, April 3, 2025. The US Food and Drug Administration (FDA) has granted orphan drug designation to rilzabrutinib, an investigational, novel, advanced, oral, reversible Bruton's tyrosine kinase (BTK) inhibitor, for two rare diseases, warm autoimmune hemolytic anemia (wAIHA) and IgG4-related disease (IgG4-RD).

The undisclosed target is a central regulator of inflammation that is distinct from the previously disclosed STAT6 program Nurix DEL-AI drug discovery engine generated a drug discovery program to this previously undruggable target Nurix received a $15 million license extension fee from Sanofi under its 2019 collaboration agreement, bringing the total amount received by Nurix to date to $105 million Nurix is eligible for an additional $465 million in development, regulatory and commercial milestones for this program as well as potential future royalties and retains an option to co-develop and co-promote in the United States with the parties splitting U.S. profits and losses SAN FRANCISCO, April 02, 2025 (GLOBE NEWSWIRE) -- Nurix Therapeutics, Inc. (Nasdaq: NRIX), a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of targeted protein degradation medicines, announced today that Sanofi has exclusively licensed an undisclosed Nurix program

The FDA approves Sanofi's Qfitlia as the first therapy in the United States to treat hemophilia A or B with or without inhibitors.

Qfitlia approved as the first therapy in the US to treat hemophilia A or B with or without inhibitors Qfitlia (fitusiran), the first antithrombin-lowering therapy in hemophilia, offers consistent protection with as few as six injections a year via a prefilled pen or vial and syringe Unique mechanism helps reduce the frequency of bleeding episodes for people with hemophilia Paris, March 28, 2025. The US Food and Drug Administration (FDA) has approved Qfitlia (fitusiran), the first antithrombin-lowering (AT) therapy for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients (aged 12 or older) with hemophilia A or B with or without factor VIII or IX inhibitors.

The U.S. Food and Drug Administration approved French drugmaker Sanofi's therapy, paving the way for a new type of treatment for patients 12 years of age and older with a rare disorder that prevents blood from clotting properly, the regulator said on Friday.

AbbVie and Sanofi occupy leading positions in the global immunology market. Each of them has advantages, as well as dark spots in the pipeline of drugs relative to the rival. In this article you will discover whether Sanofi or AbbVie is a more promising stock in the long term.

Dupixent approved as the first-ever biologic medicine in Japan for patients with COPD Following recent approvals in the EU, China, and the US, this approval was based on pivotal phase 3 results in adults with elevated eosinophils Approval marks the first new treatment approach for COPD in more than a decade in Japan and the sixth approved indication for chronic diseases with underlying type 2 inflammation Paris and Tarrytown, NY, March 28, 2025. The Ministry of Health, Labour and Welfare 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.

The FDA bestows a fast-track designation to SNY's mRNA vaccine candidate for the prevention of chlamydia infection.

If approved, SNY's tolebrutinib will be the first therapy to target smoldering neuroinflammation, a key driver of disability accumulation in multiple sclerosis.

Chlamydia vaccine candidate granted fast track designation by the US FDA Chlamydia infection can contribute to pelvic inflammatory diseases in women, which can lead to pregnancy complications or infertility A phase 1/2 clinical study evaluating the immunogenicity and safety of the vaccine candidate is due to start in coming days Paris, March 26, 2025. The US Food and Drug Administration has granted fast track designation to Sanofi's mRNA vaccine candidate for the prevention of chlamydia infection.