Sanofi Secures China Approval for Myqorzo and Redemplo in oHCM and FCS

Shots: China’s NMPA has approved Sanofi-licensed Myqorzo (aficamten) for the treatment of obstructive hypertrophic cardiomyopathy (oHCM) and Redemplo (plozasiran) for triglyceride reduction in adults with familial chylomicronemia syndrome (FCS) on dietary control The approval of Myqorzo was based on the pivotal P-III (SEQUOIA-HCM) study in pts with symptomatic oHCM, while Redemplo’s approval was supported by…

ByDipanshu DixitJanuary 15, 2026

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Ionis’ Tryngolza (Olezarsen) Receives the EC’s Approval for Familial Chylomicronemia Syndrome

Shots: The EC has approved Tryngolza (olezarsen) as an adjunct to diet in adult patients for the treatment of genetically confirmed familial chylomicronemia syndrome Approval was based on P-III (Balance) trial assessing Tryngolza (Q4W) vs PBO, which showed reduced triglyceride levels at 6mos., sustained through 12mos., with decrease in acute pancreatitis events over 12mos.; data…

ByRidhi RastogiSeptember 23, 2025

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Sanofi Enters a ~$395M Asset Purchase Agreement with Visirna Therapeutics (Arrowhead) for Plozasiran in Greater China

Shots: Visirna Therapeutics, a subsidiary of Arrowhead, has granted Sanofi exclusive rights to develop & commercialize plozasiran for treating familial chylomicronemia syndrome (FCS) & severe hypertriglyceridemia (SHTG) in Greater China As per the deal, Visirna will receive $130M upfront & ~$265M in milestone payments across indications, along with net sales-based royalties in Greater China, as…

ByRidhi RastogiAugust 4, 2025

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Ionis Reports the CHMP’s Positive Opinion on Tryngolza for Familial Chylomicronemia Syndrome

Shots: The CHMP has recommended Tryngolza (olezarsen) as an adjunct to diet in adult patients for the treatment of genetically confirmed familial chylomicronemia syndrome; EC’s decision is expected in Q4’25 Opinion was based on P-III (Balance) trial assessing (Q4W) vs PBO, which showed reduced triglyceride levels at 6mos., sustained through 12mos., with decrease in acute…

ByRidhi RastogiJuly 29, 2025

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Ionis Partners with Sobi for Olezarsen to Treat Familial Chylomicronemia Syndrome (FCS) & Severely Elevated Triglycerides

Shots: Ionis has granted Sobi global exclusive rights of olezarsen excl. the US, Canada & China to treat familial chylomicronemia syndrome (FCS) & severely elevated triglycerides; Ionis to independently market Olezarsen in the US, whereas Theratechnologies holds the rights in Canada As per the deal, Ionis will get an upfront, with potential milestone payments &…

ByRidhi RastogiMarch 27, 2025

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Ionis’ Tryngolza (Olezarsen) Receives the US FDA’s Approval to Treat Adults with Familial Chylomicronemia Syndrome (FCS)

Shots: The US FDA has approved Tryngolza (80mg, QM, self-administered via an auto-injector) as an adj. for reducing triglycerides (TG) in FCS patients, based on a P-III (BALANCE) study. Further submission is under review in the EU, with more filings planned The P-III study involved FCS patients with fasting TG levels of ≥880mg/dL. Trial showed…

ByDipanshu DixitDecember 19, 2024

Sanofi Secures China Approval for Myqorzo and Redemplo in oHCM and FCS

Ionis’ Tryngolza (Olezarsen) Receives the EC’s Approval for Familial Chylomicronemia Syndrome

Sanofi Enters a ~$395M Asset Purchase Agreement with Visirna Therapeutics (Arrowhead) for Plozasiran in Greater China

Ionis Reports the CHMP’s Positive Opinion on Tryngolza for Familial Chylomicronemia Syndrome

Ionis Partners with Sobi for Olezarsen to Treat Familial Chylomicronemia Syndrome (FCS) & Severely Elevated Triglycerides

Ionis’ Tryngolza (Olezarsen) Receives the US FDA’s Approval to Treat Adults with Familial Chylomicronemia Syndrome (FCS)

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