Category Archives: Insulin Delivery

Novo Cuts Cell Therapy R&D Division; FDA Accepts Afrezza Peds sBLA; Ascletis Selects Obesity Candidate; Lilly Initiates Ph2 Macupatide and Eloralintide Trial; October CHMP Agenda

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

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Ypsomed Builds US Manufacturing Site; Eccogene Eyes Hong Kong IPO; Former Novo CEO Joins Healthcare Denmark

Three cardiometabolic-related news items have been observed: Ypsomed announced an investment of $248M for a US manufacturing site (view press release); Eccogene filed an IPO on the Hong Kong Stock Exchange (view article; view prospectus); and Lars Fruergaard Jørgensen was appointed Chair of Healthcare Denmark (view LinkedIn post; view press release). Below, FENIX provides highlights and insights for the respective news items.

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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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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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Medtronic Launches Instinct CGM; SAB BIO Initiates Pivotal Ph2b T1DM Study; Lilly Terminates Ph2 Bimagrumab Study; Glooko Acquires Monarch Medical

A series of cardiometabolic-related news items has been observed from Medtronic, SAB BIO, Lilly, and Glooko. 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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Senseonics Loses Another Partner; Skye Hosts KOL Event and Shares DIO Data; Lilly Initiates New Ph1 Trial of Obesity Asset and Ph3 Orforglipron Trial in OA; MBX Doses First Patient with MBX 4291

A series of cardiometabolic-related news items has been observed from Senseonics/Ascensia Diabetes Care, Skye Bioscience, Lilly, and MBX Biosciences. Below, FENIX provides highlights and insights for the respective news items.

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ESC 2025: Novo, Roche/Alnylam, and AstraZeneca Present New Data; Medtronic Closes in on Abbott CGM Launch; Ionis Topline Ph3 Olezarsen Results; NMPA Accepts Hengrui’s Obesity Application; Ypsomed’s SmartPilot Receives 510(k) Clearance; Biophytis Ph2 BIO101 Obesity Study; Skye Completes Ph2 Nimacimab Dosing

A series of cardiometabolic-related news items has been observed from Novo Nordisk, Medtronic, Roche/Alnylam, AstraZeneca, Ionis Pharmaceuticals, Jiangsu Hengrui, Ypsomed, Biophytis, and Skye Bioscience. Below, FENIX provides highlights and insights for the respective news items.

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MannKind Acquires scPharmaceuticals; Amgen Olpasiran Primary Prevention Study; Repatha Label Expansion; Signos Launches OTC Weight Loss Platform with Dexcom’s Stelo; Roche Initiates New Ph1 Muscle Composition Study

A series of cardiometabolic-related events has been observed from MannKind, Amgen, Signos, and Roche. Below, FENIX provides highlights and insights for the respective news items.

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Viking’s Topline AE Data Scares the Street; Medtronic Q2 ‘25 Earnings; Novo Partners for Oral Peptide Research; Rezdiffra Gains EU Marketing Authorization; UK Approves Tzield; Luna Closes Series A Funding Round; Health Canada Approves FLOW; EMA Accepts NewAmsterdam’s Obicetrapib MAA

A series of cardiometabolic-related news items has been observed from Viking Therapeutics, Medtronic, Novo Nordisk, Madrigal Pharmaceuticals, Sanofi, Luna Health, and NewAmsterdam Pharma. Below, FENIX provides highlights and insights for the respective news items.

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