- Trial Phase
- Approved (US, FCS); Phase 3 (severe hypertriglyceridemia) ongoing; EU under review
- Time to Market
- Already approved and launched in the US (FDA, November 2025) for FCS. EU decision expected ~2026; SHTG label expansion ~2027 if the Phase 3 readout is positive.
- Why 6/10
- Next hard, dated catalyst: topline readouts from the two pivotal Phase 3 severe-hypertriglyceridemia trials (NCT06347003, n=446; NCT06347016, n=311 — estimated primary completion June 2026, estimated completion Sept 2026), expected within ~6 months on Arrowhead's lead asset; the FCS approval binary (Nov 2025) has already passed, and Arrowhead has other pipeline programs, so this lands at 6 rather than higher.
The main re-rating event for ARWR is the Phase 3 severe-hypertriglyceridemia (SHTG) topline readout, expected around mid-September 2026 per trial estimates — SHTG is a far bigger market than the ultra-rare FCS indication Redemplo was approved for. Also watch the Aug 4, 2026 earnings call for the first real Redemplo launch revenue commentary, the pending EU decision after the April 2026 CHMP opinion, and direct competition from Ionis' olezarsen (which had its own FDA decision date for SHTG on June 30, 2026).
Price Chart
Executive Summary
Redemplo (generic plozasiran, codes ARO-APOC3/VSA001/SAR449124) is Arrowhead Pharmaceuticals' (ARWR, Nasdaq) lead siRNA drug; the FDA approved it in November 2025 for familial chylomicronemia syndrome (FCS), an ultra-rare genetic disorder of extremely high triglycerides, and ARWR jumped ~30% (stored 1-day move: $44.26 → $57.71) around the approval-related catalyst dated Nov 25, 2025. The far larger prize is severe hypertriglyceridemia (SHTG): two Phase 3 trials are expected to read out around June–Sept 2026, and FDA granted Breakthrough Therapy designation in Feb 2026, with a positive EMA EPAR opinion in April 2026. The SNY/Sanofi hint appears to trace to the Sanofi-style code SAR449124 in a China FCS Phase 3 study sponsored by Visirna Therapeutics — Sanofi is not the US developer.
How It Works
An injected small interfering RNA (siRNA) drug that shuts down the liver's production of apoC-III, a protein that normally blocks clearance of fat-carrying particles from the blood. With apoC-III silenced, triglycerides drop sharply — important for FCS patients, whose sky-high triglycerides can trigger painful, dangerous pancreatitis. In trials it is dosed by subcutaneous injection about once every three months.
Trial Status
FDA approved REDEMPLO (plozasiran) as an adjunct to diet to reduce triglycerides in adults with FCS in November 2025 (NDA; Arrowhead's approval press-release 8-K was filed Nov 25, 2025). The pivotal Phase 3 FCS study (NCT05089084, n=75) is completed with results. Two Phase 3 SHTG trials (NCT06347003, n=446; NCT06347016, n=311) are active/not recruiting with estimated primary completion June 2026 and estimated completion September 2026. A Chinese Phase 3 FCS study (NCT05902598, n=37, sponsored by Visirna Therapeutics HK, listing codes VSA001/SAR449124) is completed with results. FDA granted Breakthrough Therapy designation for severe hypertriglyceridemia (Feb 2026).
The Two-Sided Case
Upcoming Catalysts
- Topline Phase 3 severe-hypertriglyceridemia data (estimated primary completion June 2026; estimated trial completion Sept 2026)
- European Commission decision on EU marketing authorization following the April 24, 2026 CHMP/EPAR opinion
- Q3 2026 earnings on Aug 4, 2026 — first meaningful Redemplo launch revenue commentary (EPS estimate -$1.35, revenue estimate ~$55.4M)
- Regulatory progress in China via Visirna Therapeutics (VSA001/SAR449124)
- Potential SHTG supplemental NDA filing in 2027 if Phase 3 succeeds
Source Filing
The SecBot filing or press-release report that triggered this drug report:
Sanofi 6-K SNY ·Originating report