Tag Archives: CNPV

JPM 2026 Day 4: IVA, JNGHF, LXRX, BMEA, ESPR; FDA Delays CNPV Approvals

On the fourth and final day of JPM 2026, FENIX has provided coverage of presentations by Inventiva Pharma, Jiangsu Hengrui Pharmaceuticals, Lexicon Pharmaceuticals, Biomea Fusion, and Esperion. Separately, one CVRM-related news item has been observed: FDA has delayed CNPV approval of Tzield and orforglipron (view article). Below, FENIX provides highlights and insights from the JPM presentations as well as insight into the CNPV delays.

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Lilly’s Ph3 ATTAIN-MAINTAIN Results; Orforglipron Filed; Novo Files Cagrisema and Receives FDA Warning Letter; Merck to Receive CNPV; SAB BIO Pivotal Ph2b T1DM Trial; Sagimet Enters Agreement for Resmetirom

A series of cardiometabolic-related news items has been observed from Lilly, Novo Nordisk, Merck, SAB Biotherapeutics, and Sagimet Biosciences. Below, FENIX provides highlights and insights for the respective news items, including what Sagimet could be thinking vs. Madrigal.

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Novo Files 7.2mg Wegovy; CMS Cuts Semaglutide Prices; FDA Publishes Marketing Violation Letters

Three cardiometabolic-related news items have been observed: Novo Nordisk submitted its sNDA to FDA for high-dose (7.2mg) Wegovy in obesity (view press release); CMS announced the negotiated prices from the second round of IRA discussions, including Novo’s semaglutide (view press release; view fact sheet); and FDA published promotional activity violation letters from the OPDP (view letters). Below, FENIX provides highlights and insights for the respective news items, including the projected approval timeline for high-dose Wegovy in the US.

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