Tag Archives: FDA

Novo Initiates Two Cagrisema Formulation/Device Trials; Lilly Initiates Third Ph3 Eloralintide Trial; FDA Approves Zepbound Kwikpen; Roche Increases Investment for Obesity Manufacturing Site; Abbott Q4 ’25 Earnings; CORXEL Closes $287M Series D1 Funding; Sesame Partners with Novo for Wegovy Pill

A series of cardiometabolic-related news items has been observed from Novo Nordisk, Lilly, Roche, Abbott, Corxel Pharmaceuticals, and Sesame. Below, FENIX provides highlights and insights for the respective news items.

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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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Holiday Hangover: Novo Launches Wegovy Pill; Additional Companies Engage in MFN Deals; Pfizer Initiates Ph3 Obesity Program of MET097i; and More

Over the holiday period, a series of cardiometabolic news items were observed from Novo Nordisk, The White House, Pfizer, Cytokinetics, Resoundant, Sanofi, Skye Biosciences, MetaVia, Dexcom, Abbott, MannKind, BI/Rectify, Ascletis Pharma, Laekna Pharma, CMS, and Caliway Biopharmaceuticals. Below, FENIX provides highlights and insights for the respective news items.

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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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Insulet O5 Algorithm Updates; BioAge Ph1 NLRP3i Data

Two cardiometabolic-related news items have been observed: Insulet announced it received 510(k) clearance for updates to the O5 algorithm (view press release); and BioAge Labs announced topline Ph1 data of its NLRP3i (BGE-102) in development for obesity (view press release). Below, FENIX provides highlights and insights for the respective news items.

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Lilly Cuts Zepbound Prices; Cagrisema Ph3 Pediatric Obesity Trial; Ascletis Selects Obesity Candidate; Altimmune Replaces CEO; Olazarsen Breakthrough Therapy Designation; New Ph3 Bofanglutide Study; Ikaria Registers Study for Obesity Asset Monotherapy and Combination with Tirzepatide

A series of cardiometabolic-related news items has been observed from Lilly, Novo Nordisk, Ascletis Pharma, Altimmune, Ionis Pharmaceuticals, Gan & Lee Pharmaceuticals, and Ikaria Bioscience. Below, FENIX provides highlights and insights for the respective news items.

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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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