Regulatory round-up: Novartis, Sanofi and Arrowhead secure CHMP blessings [Yahoo! Finance]
Arrowhead Pharmaceuticals, Inc. (ARWR)
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Source: Yahoo! Finance
recommended drugs by Novartis, Arrowhead Pharmaceuticals and Sanofi for approval across the continent. The first to announce a CHMP blessing for a drug in its pipeline today was Sanofi, which has received a positive opinion from the committee on its non-relapsing secondary progressive multiple sclerosis (nrSPMS) therapy, Cenrifki (tolebrutinib). The CHMP's decision comes despite a setback in the US, where regulators declined to approve the drug amid concerns around its potential liver injury risks. The Bruton's tyrosine kinase (BTK) inhibitor secured the CHMP's blessing based on Phase III data from the HERCULES trial (NCT04411641), which found that Cenrifki prolonged the time to six-month confirmed disability progression by 31% over placebo. Following the CHMP's verdict, the European Medicines Agency (EMA) will now decide whether to grant the drug an approval, which Sanofi expects “in the coming months.” Cenrifki's CHMP nod comes as similar safety issues continue to plague Roche
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News
- Arrowhead Pharmaceuticals Receives Positive CHMP Opinion Recommending Approval of REDEMPLO® (plozasiran) to Reduce Triglycerides in Adults with Familial Chylomicronemia Syndrome (FCS) in Europe [Yahoo! Finance]Yahoo! Finance
- Arrowhead Pharmaceuticals Receives Positive CHMP Opinion Recommending Approval of REDEMPLO® (plozasiran) to Reduce Triglycerides in Adults with Familial Chylomicronemia Syndrome (FCS) in EuropeBusiness Wire
- Arrowhead Pharmaceuticals (ARWR) was upgraded by Morgan Stanley from "equal weight" to "overweight". They now have a $100.00 price target on the stock.MarketBeat
- Arrowhead Pharmaceuticals to Webcast Fiscal 2026 Second Quarter ResultsBusiness Wire
- Arrowhead Plozasiran Data Supports Triglyceride Reduction And Valuation Upside Potential [Yahoo! Finance]Yahoo! Finance
ARWR
Earnings
- 2/5/26 - Miss
ARWR
Sec Filings
- 4/23/26 - Form 144
- 4/22/26 - Form 144
- 3/26/26 - Form SCHEDULE
- ARWR's page on the SEC website