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Arrowhead Pharmaceuticals Licenses ARO-PNPLA3 to Madrigal Pharmaceuticals in a ~$1B Deal

Shots: Arrowhead has granted Madrigal an exclusive global license to ARO-PNPLA3, a RNAi therapeutic designed to reduce liver expression of PNPLA3 as a potential treatment of metabolic dysfunction-associated steatohepatitis As per the deal, Arrowhead will receive $25M upfront & ~$975M in development, regulatory, & sales milestones, with tiered royalties ranging from high-single digits to the…

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Madrigal Pharmaceuticals Broadens MASH Pipeline with Pfizer’s Ervogastat Deal

Shots: Madrigal has entered into an exclusive global license agreement with Pfizer for ervogastat (PF-06865571; PO) to treat metabolic dysfunction-associated steatohepatitis (MASH) As per the deal, Madrigal will receive an exclusive global license to develop, manufacture & commercialize ervogastat & 2 additional early-stage MASH assets, paying Pfizer $50M upfront with further milestone payments & net…

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Madrigal Pharmaceuticals’ Rezdiffra (Resmetirom) Receives the EC’s Conditional Approval for MASH with Liver Fibrosis

Shots: The EC has granted conditional approval to Rezdiffra to treat adults with noncirrhotic metabolic dysfunction-associated steatohepatitis (MASH) with mod. to adv. liver fibrosis in 30 EEA states; launch is planned throughout EU starting with Germany in Q4’25 Approval was based on P-III (MAESTRO-NASH) trial assessing Rezdiffra (100 & 80mg, PO, QD) vs PBO in MASH pts, which…

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Madrigal Pharmaceuticals

Madrigal Pharmaceuticals’ Rezdiffra (resmetirom) Receives the US FDA’s Approval to Treat NASH with Liver Fibrosis 

Shots:  The US FDA has granted accelerated approval to Rezdiffra for treating noncirrhotic NASH with moderate to advanced liver fibrosis (F2 to F3) supported by the P-III (MAESTRO-NASH) study assessing its safety & efficacy at 100mg & 80mg dosing vs PBO in NASH patients (n=1,759)  The results after 52wks. showed improved NASH resolution (incl. a…

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