Ionis’ Olezarsen sNDA Secures the US FDA Priority Review for Severe Hypertriglyceridemia

Shots: The US FDA has accepted sNDA & granted priority review to olezarsen for the treatment of severe hypertriglyceridemia (sHTG), with a PDUFA action date of Jun 30, 2026 sNDA was backed by the P-III (CORE: n=617 & CORE2: n=446) trials assessing olezarsen (50 or 80mg, SC, Q4W) vs PBO for 12mos. in sHTG adults…

ByRidhi Rastogi13 hours ago

NEWS

OrsoBio Reports P-IIa Trial Data on TLC-2716 in Severe Hypertriglyceridemia and Metabolic Liver Disease

Shots: OrsoBio has reported topline P-IIa PoC trial data assessing TLC-2716 (6 or 12mg, QD, PO) vs PBO in 30 overweight pts with severe hypertriglyceridemia & metabolic dysfunction–associated steatotic liver disease (MASLD) The study met its 1EP, showing statistically significant reductions in fasting triglycerides & remnant cholesterol, plus improved liver fat by MRI-PDFF, with stronger lipid…

ByRidhi RastogiFebruary 11, 2026

NEWS

Ionis Highlights P-III (CORE & CORE2) Trials Results of Olezarsen for Severe Hypertriglyceridemia (sHTG) at AHA 2025

Shots: The P-III (CORE: n=617 & CORE2: n=446) trials assessed olezarsen (50 or 80mg, SC, Q4W) vs PBO for 12mos. in sHTG adults; the US FDA’s sNDA filing is expected by 2025 end Both trials met their 1EP with ~72% PBO-adjusted fasting triglyceride (TG) reduction at 6mos., sustained to 12mos., while 89% (50mg) & 88%…

ByRidhi RastogiNovember 10, 2025

NEWS

Argo Biopharma Inks a ~$5.3B Deal with Novartis for Multiple Cardiovascular Assets, Expanding their Existing Partnership

Shots: Argo has entered into an additional strategic collaboration with Novartis for multiple CV assets Novartis has obtained an option to license ex-China rights to two discovery-stage molecules for sHTG & mixed dyslipidemia, plus first negotiation rights to BW-00112 (ANGPTL3), a P-II asset. Deal also incl. a reciprocal P&L-sharing license for a hepatic siRNA asset…

ByRidhi RastogiSeptember 4, 2025

NEWS

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

NEWS

Ionis Reveals Topline P-III (ESSENCE) Trial Data of Olezarsen for Moderate Hypertriglyceridemia

Shots: Ionis has reported topline P-III (ESSENCE) trial data assessing olezarsen (50mg: 276 pts or 80mg: 832 pts, SC, Q4W for 12mos.) vs PBO (n= 369) in 1,478 adults with mod. hypertriglyceridemia (fasting TG ≥150mg/dL to <500mg/dL) with or at risk of ASCVD Trial met its 1EP with significant PBO-adjusted TG reductions of 61% (80mg)…

ByRidhi RastogiMay 19, 2025

Ionis’ Olezarsen sNDA Secures the US FDA Priority Review for Severe Hypertriglyceridemia

OrsoBio Reports P-IIa Trial Data on TLC-2716 in Severe Hypertriglyceridemia and Metabolic Liver Disease

Ionis Highlights P-III (CORE & CORE2) Trials Results of Olezarsen for Severe Hypertriglyceridemia (sHTG) at AHA 2025

Argo Biopharma Inks a ~$5.3B Deal with Novartis for Multiple Cardiovascular Assets, Expanding their Existing Partnership

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

Ionis Reveals Topline P-III (ESSENCE) Trial Data of Olezarsen for Moderate Hypertriglyceridemia

Contact US

FOLLOW US