UK MHRA Approves REDEMPLO for FCS, Completing Access Path With NICE Backing
ARWR sits 62% above its 52-week low of $37.06.
Summary
The UK MHRA granted marketing authorisation for REDEMPLO (plozasiran) in adults with familial chylomicronaemia syndrome, making it a new treatment option to reduce triglycerides in England and Wales. This lands alongside NICE's recommendation for NHS funding for genetically confirmed FCS, so the UK now has both the regulatory approval and the reimbursement decision in place. It follows the August launch of REDEMPLO in Germany, the first EU market, and adds a second commercial territory for the drug. The UK FCS population is small, so near-term revenue impact is modest, but it reinforces the European rollout story that underpins the REDEMPLO sales growth reported in Q3. Watch the US sNDA in severe hypertriglyceridemia, which the FDA placed in the STAR pilot program in October.
At the time of this announcement, ARWR was trading at $59.89 on NASDAQ in the Life Sciences sector, with a market capitalization of approximately $8.5B. The 52-week trading range was $37.06 to $95.49. This news item was assessed with positive market sentiment and an importance score of 7 out of 10. Source: Reuters.