Category Archives: Other

FDA Leadership Pushes for Expedited Orforglipron Review; Novo and Cytokinetics Positive CHMP Opinions; Rezolute Misses Endpoints in Ph3 Study

A series of cardiometabolic-related news items has been observed from Lilly, Novo Nordisk, Rezolute, and Cytokinetics. Below, FENIX provides highlights and insights for the respective news items.

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Zealand 2025 CMD and Partnership for Obesity Drug Discovery; Lilly Shares Topline Retatrutide Results; Corbus Topline CB1 Data; Dexcom Launches G7 15 Day CGM; Prolynx Series A Funding and Names CEO

A series of cardiometabolic-related news items has been observed from Zealand Pharma, Lilly, Corbus Pharmaceuticals, Dexcom, and Prolynx. Below, FENIX provides highlights and insights for the respective new items.

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Pfizer Acquires Oral GLP-1RA; FDA Grants AI Drug Development Tool in MASH; Lilly Discontinues Tempo; Novo Completes Akero Acquisition; Regeneron Registers siRNA Ph2 Study in DKD; December CHMP Agenda

A series of cardiometabolic-related news items has been observed from Pfizer, FDA, Lilly, Novo Nordisk/Akero, Regeneron Pharmaceuticals, and EMA. Below, FENIX provides highlights and insights for the respective news items.

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Structure’s Topline Ph2 Aleniglipron Data; Ascletis Reports Topline Data from Ph1 Oral GLP-1RA; BI Advances Triple Agonist for Obesity; Wave Announces Ph1 Data from Muscle-Sparing Asset; Lingo Now Available on Android; Medtronic Shifts Exec to MiniMed

A series of cardio-metabolic-related news items has been observed from Structure Therapeutics, Ascletis Pharma, Boehringer Ingelheim, Wave Life Sciences, Abbott, and Medtronic. Below, FENIX provides highlights and insights for the respective news items.

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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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FDA Accepts AZ’s Baxdrostat NDA and MannKind’s sNDA for FUROSCIX in CHF + CKD; Medtronic Full US Launch for Abbott-Partnered CGM; Plozasiran Breakthrough Therapy Designation; New Fractyl Data; WHO Publishes GLP-1RA Guidelines

A series of cardiometabolic-related news items has been observed from AstraZeneca, MannKind, Medtronic, Arrowhead Pharmaceuticals, Fractyl Health, and the WHO. 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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Topline Amycretin Ph2 Data in T2DM; Abbott Libre 3/3+ CGM Issues

Two cardiometabolic-related news items have been observed: Novo announced topline Ph2 amycretin data in T2DM (view press release); and Abbott issued a medical correction for its Libre 3/3+ sensors in the US (view press release). Below, FENIX provides highlights and insights for the respective news items, including the potential readthrough from Novo’s amycretin data.

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Novo Misses Alzheimer’s Endpoint; Merck’s New Ph1 Asset in T2DM

Two cardiometabolic-related news items have been observed: Novo Nordisk announced topline EVOKE data for sema in Alzheimer’s (view press release); and Merck registered a Ph1 study of a new undisclosed oral coformulation in T2DM (view CT.gov record). Below, FENIX provides highlights and insights for the respective news items, including potential readthrough from EVOKE to Lilly’s plans in AD.

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