Tag Archives: CMS

Dexcom 2026 Investor Day; “Self-Adapting” G8 CGM to Launch Late-2027

Dexcom hosted its 2026 Investor Day and provided updates across its diabetes business, including the ongoing launch of the G7 15-day, its next-gen G8 CGM, as well as a new dual glucose-potassium sensor (view slides). Following the call, Dexcom’s stock is up ~6% today. In conjunction with the Investor Day, Dexcom also announced updates to its governance structure, including the planned addition of two new independent board members (view press release). Below are highlights and insights from the investor event.

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Foundayo Available in the US; FDA Issues Warning Letters for Unapproved GLP-1RAs; EMA Wegovy Label Update; Novo’s Lotte Bjerre Knudsen Departs; 23andMe Study Identifies Genetic Connection for GLP-1RA-Induced Weight Loss; Noom Partnership

A series of cardiometabolic-related news items has been observed by Lilly, FDA, Novo Nordisk, 23andMe, and Noom. Below, FENIX provides highlights and insights for the respective news items.

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Novo and Hims Take Another Turn at a Partnership; AbbVie Reports Topline Ph1 Amylin Data; Regeneron & Hansoh Share Ph3 Olatorepatide China Results; Lilly Releases Statement on CMS Obesity BALANCE Model; Zepbound KwikPen Available on Amazon; Veru Enrolls First Patient in Ph2b PLATEAU Study; Sequel Expands AID Launch 

A series of cardiometabolic-related news items has been observed from Novo Nordisk/Hims & Hers, AbbVie, Regeneron Pharmaceuticals/Hansoh, Lilly, Amazon, Veru, and Sequel Med Tech. Below, FENIX provides highlights and insights into the respective news items.

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Trulicity on Medicare Negotiation List; Novo Outspends Lilly on GLP-1RA Advertising; Ro’s GLP-1RA Super Bowl Commercial

Three cardiometabolic-related news items have been observed: CMS included Lilly’s Trulicity for the third round of Medicare price negotiations (view press release); Novo spent nearly $500M on US advertising of Wegovy and Ozempic (view article); and Ro announced plans to air a “Healthier on Ro” Super Bowl commercial (view press release). Below, FENIX provides highlights and insights for the respective news items.

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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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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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