Category Archives: Basal Insulin

Lilly Raises FY Guidance by $3B; Lilly Q2 ’24 Earnings; Novo Q2 ’24 London Event

Two cardiometabolic-related news items have been observed: Lilly hosted its Q2 ’24 earnings call (press release; slides) and raised its FY2024 revenue guidance by $3.0B; and Novo Nordisk hosted its post-Q2 ’24 earnings London analyst event (view webcast). Below, FENIX provides highlights and insights for the respective calls.

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Abbott/Medtronic Strategic Partnership; Simplera Updates; Madrigal and MannKind Q2 ’24 Earnings

Three cardiometabolic-related news items have been observed: Abbott announced a partnership with Medtronic for the development of a new CGM that is exclusively compatible with Medtronic’s AID and smart insulin pens (press release); Medtronic announced the FDA approval of its Simplera CGM (press release); Madrigal (press release; slides) and MannKind (press release; slides) hosted their respective Q2 ’24 earnings. Below, FENIX provides highlights and insights for the respective news items, along with an analysis of the Abbott/Medtronic partnership.

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STEP HFpEF Withdrawn; QM GLP/GIP Withdrawn; Novo Q2 ’24 Earnings

Novo Nordisk hosted its Q2 ’24 earnings call (press release; slides) and provided updates across its CVRM portfolio. Importantly, Novo disclosed it has withdrawn the STEP HFpEF sNDA and it discontinued development of its QM GLP/GIP dual agonist, among other updates. FENIX will cover Novo’s London Q2 ’24 earnings call tomorrow, August 8, 2024. Below, FENIX provides highlights and insights from the Q2 ’24 earnings call.

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Tirzepatide SUMMIT HFpEF Topline Results; Regeneron, Alnylam, Ionis, Teladoc, Amarin, and Biomea Q2 ’24 Earnings; Antag Increases Series A Funding for GIP Antagonism; Sanofi Expands Insulin Manufacturing in Germany; Boston Pharmaceuticals MASH Updates

A series of cardiometabolic-related news items have been observed from Lilly, Regeneron, Alnylam, Antag Therapeutics, Sanofi, Boston Pharmaceuticals, Ionis, Teladoc, Amarin, and Biomea Fusion. Below, FENIX provides highlights and insights for the respective news items, including initial thoughts on Lilly’s tirzepatide HFpEF results in the context of Novo’s STEP HFpEF and apparent regulatory delay.

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Novo Nordisk’s QW Insulin Icodec Receives CRL

Novo Nordisk announced FDA issued a CRL regarding the QW insulin icodec BLA for the treatment of diabetes. According to the press release, the CRL outlines requests related to the manufacturing process and the T1DM indication. Novo stated it is evaluating the content of the CRL and will work closely with FDA to fulfill the requests. Of note, Novo does not expect to be able to fulfill the requests during 2024. Below, FENIX provides brief thoughts on the CRL in the context of the recent negative FDA adcom vote.

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ADA 2024 Key Press Releases (June 23)

On the third day of ADA 2024, four cardiometabolic-related news items have been observed from Senseonics, Altimmune, Fractyl Health, and Gan & Lee. Below, FENIX provides context and analysis for the announcements.

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