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3 stories mentioning SAN.PAUpdated 6d ago

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Sanofi Terminates Late-stage Trial for Rare Neurological Disorder Treatment; 2026 Guidance Maintained
US Markets

Sanofi Terminates Late-stage Trial for Rare Neurological Disorder Treatment; 2026 Guidance Maintained

Sanofi (SAN.PA) confirmed its full-year 2026 outlook after announcing its decision to discontinue a late-stage clinical study of riliprubart in chronic inflammatory demyelinating polyneuropathy.The French drugmaker said Tuesday it does not expect "any significant financial cost" from the termination of its Mobilize phase 3 study. For 2026, the company expects high single-digit sales growth at constant exchange rates, with constant-currency business EPS projected to outpace sales prior to share buybacks.The study was evaluating riliprubart in patients with the rare neurological condition who are refractory to standard-of-care treatment. An independent data monitoring committee triggered the shutdown after its interim analysis found that the trial was "unlikely to provide sufficient efficacy."However, Sanofi noted that the data revealed no safety issues. The company added that it plans to assess the remaining studies for riliprubart, including a late-stage Vitalize study in patients receiving intravenous immunoglobulin therapy."Sanofi will work closely with investigators and site teams to ensure a wind-down of the MOBILIZE study, with appropriate transition of care for all enrolled patients. Sanofi will conduct a thorough analysis of the MOBILIZE data to inform future research directions and contribute to the broader scientific understanding of CIDP," the company said in its press release.Sanofi's Paris-listed stock was down 1% by Wednesday midday trade.

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Research

BNP Paribas Downgrades Sanofi to Neutral Rating, Cuts PT

BNP Paribas on Monday downgraded French drugmaker Sanofi (SAN.PA, SANNV.PA) to neutral from outperform and decreased its price target to 85.00 euros from 100.00 euros.(covers equity, commodity and economic research from major banks and research firms in North America, Asia and Europe. Research providers may contact us here: https://www..com/contact-us)

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US Markets

Sanofi, Regeneron's Dupixent Becomes First Targeted Treatment for Pediatric Chronic Spontaneous Urticaria in EU

The European Commission approved Sanofi (SAN.PA) and Regeneron Pharmaceuticals' (RGO.F, REGN.VI) Dupixent as the first targeted therapy for children aged two to 11 years with moderate-to-severe chronic spontaneous urticaria.The authorization extends the existing approval of Dupixent, or dupilumab, in the European Union for chronic spontaneous urticaria, an inflammatory skin condition characterized by "sudden and debilitating hives and recurring itch," according to a Monday release. The previous indication was for patients 12 years and older.The approval was supported by data from the Liberty-Cupid clinical program, which combined an extrapolation of efficacy data in adults from two late-stage studies and pediatric data from the CUPIDKids phase 3 study. CUPIDKids was a single-arm study that evaluated children with chronic spontaneous urticaria between two years old and 11 years old who were still symptomatic even with the use of antihistamines.The trials showed that Dupixent significantly outperformed placebo in reducing hives and itching by the 24-week mark, while also increasing the number of patients achieving a complete response. Across all studies, the safety profile remained consistent with Dupixent's safety results in other skin-related indications."Young children suffering from chronic spontaneous urticaria often experience an unpredictable barrage of unrelenting itch and visible hives during the critical years of their growth and development. As the first and only targeted medicine for young children in the EU with CSU, Dupixent has the potential to become the new standard of care for those who remain symptomatic despite other available treatments," Regeneron President and Chief Scientific Officer George D. Yancopoulos said.The US Food and Drug Administration is currently reviewing a supplemental biologics license application for Dupixent in the US for pediatric patients aged two to 11 years for chronic spontaneous urticaria. The treatment is already approved for the same indication in certain adults and teenagers in the US, Japan, and other countries.Approved in over 60 countries, Dupixent treats various type 2 inflammatory conditions, including asthma, chronic obstructive pulmonary disease, and atopic dermatitis, among others. Sanofi and Regeneron are also evaluating dupilumab in diseases such as chronic pruritus of unknown origin and lichen simplex chronicus.Sanofi's shares were down over 1% in Paris, while Regeneron's stocks listed in Frankfurt and Vienna were marginally higher by Monday midday.

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