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Sanofi records win and loss with rare disease drug in Phase III trials
02 Feb 2026 21:47 GMT
… address critical unmet medical needs. A daily pill could make a … migalastat). The drug will soon fall into BioMarin Pharmaceutical’s ownership … 2026, the FDA approved an expanded label for Cerezyme to include … company of the Clinical Trials Arena.
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Sanofi drug, inherited from Genzyme, goes 1-for-2 in rare disease trials
02 Feb 2026 20:02 GMT
… French pharmaceutical company said Monday.
According to Sanofi, the drug, … In a Phase 3 trial, venglustat wasn’t associated … Sanofi sells one called Cerezyme — those treatments don’t help with … to address critical unmet medical needs,” said Houman Ashrafian …
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Sanofi Rare Disease Drug Scores a Hit and a Miss in Phase III Tests
02 Feb 2026 14:59 GMT
… disease drug venglustat split a pair of Phase III clinical trials, with … in the late-stage LEAP2MONO trial. The drug also matched ERT on … that the Phase III PERIDOT trial did not meet its … well as Cerezyme and Cerdelga for Gaucher.
The FDA previously granted …
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Sanofi Plans Regulatory Submission For Investigational Drug For Rare Disease Despite Mixed Data From Pivotal Trials
02 Feb 2026 14:02 GMT
… and placebo tablet.
The trial demonstrated that venglustat met the … also being studied for the treatment of Fabry disease, another … for Fabry disease, and Cerezyme and Cerdelga for Gaucher disease … 2026, the FDA approved an expanded label for Cerezyme to include …
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Sanofi's genetic disorder drug shows mixed results in late-stage trials
02 Feb 2026 06:12 GMT
… drugmaker Sanofi said on Monday that its experimental genetic disorder treatment … in a separate trial. The oral drug, venglustat, was … body. Previous failures in trials of patients with Parkinson … disease, and markets Cerezyme and the oral drug Cerdelga for …
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Mixed data mars Sanofi's venglustat programme
02 Feb 2026 19:49 GMT
… the new trial showed that a daily dose of the drug achieved … (ERT) for Gaucher disease.
The drug also improved non-neurological symptoms … a 'pipeline-in-a-pill' candidate with big sales … ;s type 1 and 3 treatment Cerezyme (imiglucerase), there are a …
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Press Release: Sanofi’s venglustat met all primary endpoints in a phase 3 study of type 3 Gaucher disease
02 Feb 2026 06:00 GMT
… address critical unmet medical needs. A daily pill could make … reported adverse events during treatment among patients receiving venglustat … an expanded label for Cerezyme to include non-central … US Food & Drug Administration (FDA) for its potential use …
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Communiqué de presse : Le venglustat de Sanofi a atteint tous les critères d'évaluation principaux dans une étude de phase 3 sur la maladie de Gaucher de type 3
02 Feb 2026 06:00 GMT
… 'indication aux États-Unis, Cerezyme peut désormais être prescrit à … accélérée dela Food & Drug Administration (FDA) américaine pour son utilisation potentielle … demande d’autorisation concernant un médicament, dispositif ou produit biologique, ainsi …
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STAT+: As its immunology work draws attention, Sanofi also pushes forward in rare disease
02 Feb 2026 17:15 GMT
… ’s Cerezyme has long been used as a treatment for Gaucher … that clinical trial results showed its experimental oral drug venglustat improved … now plans to submit the drug to regulators.
“For many … amp;D, referring to drugs like Cerezyme that work by effectively …
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Sanofi (NASDAQ:SNY) Q4 2025 Earnings Call Transcript
31 Jan 2026 13:32 GMT
… ITP in the EU, Cerezyme for Gaucher disease Type 3 … commitment to bringing innovative medicines and treatments to Chinese patients and … cost versus building your drug pipeline? And then perhaps … by interactions with the FDA predominantly to establish exactly …