Category Archives: Topics

Biomea Ph2 T2DM Results; AZ Ph3 Baxdrostat Data; Ionis 2025 Innovation Day; New Hanmi Ph2 Triple Agonist Study; MannKind Completes scPharmaceuticals Acquisition; Fractyl Health Preclinical Gene Therapy Data 

A series of cardiometabolic-related news items has been observed from Biomea Fusion, AstraZeneca, Ionis Pharmaceuticals, Hanmi Pharmaceuticals, Fractyl Health, and MannKind. Below, FENIX provides highlights and insights for the respective news items.

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Ed Cinca Rejoins Novo as SVP of US Marketing; Skye’s CB1 Ph2a Dose Suboptimal; Amgen Launches its DTP Program; Wegovy Pill Available DTP via Telehealth; Costco Sells Ozempic and Wegovy; Libre Featured on ESPN; Lilly Partners with Local Manufacturers in India

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

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New Orforglipron SUI Trial; Amgen VESALIUS-CV Results; EASO Recommends GLP-1RAs

Three cardiometabolic-related news items have been observed: Lilly initiated the Ph3 RESTRAIN-SUI study investigating orforglipron (QD oral GLP-1RA) in female participants with obesity or overweight and stress urinary incontinence (SUI; view CT.gov record); Amgen’s Repatha met primary endpoints for its Ph3 VESALIUS-CV trial in a primary prevention population (view press release); and EASO published a framework for obesity management, recommending semaglutide and tirzepatide as first-line AOMs (view publication). Below, FENIX provides highlights and insights for the respective news items.

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Alnylam/Roche Initiate Zilebesiran CVOT; Hanmi Files Obesity IND; Sagimet Ph1 MASH Study

Three cardiometabolic-related news items have been observed: Alnylam/Roche dosed the first patient in the Ph3 ZENITH CVOT study evaluating zilebesiran in uHTN (view press release); Hanmi Pharmaceuticals filed an IND for its muscle-sparing obesity candidate (view press release); and Sagimet Biosciences dosed the first participants in its Ph1 study of denifanstat + resmetirom (view press release). Below, FENIX provides highlights and insights for the respective news items. 

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Novo Resubmits Icodec BLA; BI and Novartis Launch DTP Platforms; t:slim X2 + Control-IQ+ Now Compatible with Lyumjev

Three cardiometabolic-related news items have been observed: Novo Nordisk resubmitted the Awiqli (insulin icodec) BLA but only for adults with T2DM (view press release); Boehringer Ingelheim (view press release) and Novartis (view press release) separately announced creation of DTP platforms; and Tandem Diabetes Care announced t:slim X2 with Control-IQ+ is now compatible with Lilly’s Lyumjev (view press release). Below, FENIX provides highlights and insights for the respective news items.

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Lilly’s $6.5B Orforglipron Manufacturing Site; Novo Registers Ph2 Study of Triple Agonist; Ascletis Pharma Ph1 Results; Veru Progresses Enobosarm to Ph2b; FDA Delays T1DM Sota Decision; New O5 DTC Ad During NFL Sunday 

A series of cardiometabolic-related news items has been observed from Lilly, Novo Nordisk, Ascletis Pharma, Veru, Lexicon Pharmaceuticals, and Insulet. Below, FENIX provides highlights and insights for the respective news items.

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Roche Pharma Day 2025

Roche hosted its 2025 Pharma Day (view slides) and provided updates on its CVRM development programs. Recall, earlier this month, Roche entered into a definitive merger agreement to acquire 89bio, thereby securing full rights to its Ph3 MASH asset, pegozafermin (FGF21 analog; previous FENIX insight). Below, FENIX provides highlights and insights from the call.

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