Sanofi initiates phase 3 program for PCV21 and expands collaboration with SK bioscience for next-generation pneumococcal conjugate vaccines Pneumococcal disease remains a major global health challenge despite the availability of current vaccines This 21-valent pneumococcal conjugate vaccine (PCV21) is the first pneumococcal conjugate vaccine candidate with more than 20 serotypes to enter phase 3 in infants & toddlers Paris, December 23, 2024. Sanofi and SK bioscience have entered into a new chapter of thei ...

Core Insights - Sanofi and Teva Pharmaceuticals announced positive results from the phase IIb RELIEVE UCCD study for their investigational anti-TL1A therapy, duvakitug, targeting Ulcerative Colitis (UC) and Crohn's disease (CD) [1][2] - The study met its primary endpoints for both UC and CD, showing significant clinical remission and endoscopic response rates compared to placebo [2][3] Company Performance - Sanofi's stock rose nearly 7% following the announcement, although it has seen a year-to-date decline of 1.6% against the industry's 5.3% growth [5] - Teva's shares jumped 26%, reaching a six-year high of $21.05, with a year-to-date market value increase of 100% compared to the industry's 11.2% growth [7] Partnership Terms - Sanofi and Teva have a partnership where Teva leads commercialization in Europe and other specified regions, while Sanofi handles North America, Japan, and other parts of Asia [9] - Both companies will share development costs and net profits, with Sanofi making an upfront payment of $500 million to Teva and being eligible for up to $1 billion in milestone payments [10] Market Competition - The IBD market is highly competitive, with key players including Johnson & Johnson and AbbVie, which have strong portfolios of immunology drugs [11][12] - Johnson & Johnson's Stelara and Tremfya have generated significant sales, with Stelara alone bringing in over $8 billion in the first nine months of 2024 [13][14] - AbbVie has also seen success with its products Skyrizi and Rinvoq, generating nearly $10 billion in sales in the same period [15][16] Regulatory and Future Plans - Sanofi and Teva plan to initiate a late-stage study for duvakitug based on the positive results and will present detailed findings at a medical meeting next year [3]

Sanofi (SNY) shares soared 6.7% in the last trading session to close at $48.94. The move was backed by solid volume with far more shares changing hands than in a normal session. This compares to the stock's 5.4% loss over the past four weeks.This jump in share price came after management reported positive results from a mid-stage study on its experimental anti-TL1A therapy, duvakitug, in Ulcerative Colitis and Crohn's disease, which are the two main types of inflammatory bowel disease. The study achieved it ...

Key TakeawaysTeva Pharmaceuticals and Sanofi on Tuesday reported positive results in a Phase 2b trial of their drug for ulcerative colitis and Crohn's disease.The companies plan to provide further details about the research at a scientific forum in 2025.Teva and Sanofi said they would start a Phase 3 study of the treatment pending discussions with regulators.Both pharmaeuticals companies' U.S.-traded stocks gained after the news Tuesday, with Teva at its highest level in six years. U.S.-traded shares of Tev ...

On Tuesday, Teva Pharmaceutical Industries Ltd. TEVA and Sanofi SA’s SNY Phase 2b RELIEVE UCCD study met its primary endpoints in patients with ulcerative colitis (UC) and Crohn’s disease (CD).RELIEVE UCCD investigated duvakitug (TEV’574/SAR447189), a human IgG1-λ2 monoclonal antibody targeting TL1A, for moderate-to-severe inflammatory bowel disease (IBD).In the RELIEVE UCCD study, 36.2% (low-dose) and 47.8% (high-dose) of patients with ulcerative colitis treated with duvakitug achieved clinical remission c ...

Duvakitug positive phase 2b results demonstrate best-in-class potential in ulcerative colitis and Crohn’s disease Primary endpoints met in ulcerative colitis (UC) and Crohn’s disease (CD), the most common forms of inflammatory bowel disease (IBD) Primary endpoint results in UC and CD for high dose represent the highest achieved with any TL1A monoclonal antibodySanofi and Teva plan to initiate phase 3 development in IBD, pending regulatory discussionsProgram underscores Sanofi's Immunology leadership ambitio ...

Primary endpoints met in ulcerative colitis (UC) and Crohn’s disease (CD), the most common forms of inflammatory bowel disease (IBD)Primary endpoint results in UC and CD for high dose represent the highest achieved with any TL1A monoclonal antibodySanofi and Teva plan to initiate Phase 3 development in IBD, pending regulatory discussions PARSIPPANY, N.J. and PARIS, Dec. 17, 2024 (GLOBE NEWSWIRE) -- Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), and Sanof ...

Tolebrutinib designated Breakthrough Therapy by the FDA for non-relapsing secondary progressive multiple sclerosis Designation is based on positive results from the HERCULES study in adults with non-relapsing secondary progressive multiple sclerosis (nrSPMS)Tolebrutinib is the first and only brain-penetrant BTK inhibitor in MS to be designated Breakthrough Therapy by the FDA  Paris, December 13, 2024. The US Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to tolebrutinib for ...

A Sanofi logo sits on the facade of the company's headquarters on December 11, 2020 in Gentilly near Paris, France.SINGAPORE — French pharmaceutical giant Sanofi on Wednesday opened a 800 million Singapore dollar ($595 million) "evolutive vaccine facility," or EVF, in Singapore — the only such facility the company has outside of France.This plant, known as Modulus, can switch between making different vaccines or treatments in a matter of days, compared to several weeks or months in more conventional facilit ...

Sanofi (SNY) and partner Regeneron (REGN) announced that the FDA has accepted their resubmitted supplemental biologics license application (sBLA) seeking approval of Dupixent for the treatment of chronic spontaneous urticaria (CSU).The sBLA seeks approval for CSU in people aged 12 years and older whose disease is not adequately controlled with existing therapies like H1 antihistamines. The FDA’s decision on the sBLA is expected on April 18, 2025.The FDA had issued a complete response letter (CRL) for the fi ...