Tag Archives: insulin icodec

Novo to Face Uphill Battle; Insulin Icodec Adcom Briefing Documents Available

Briefing documents have been posted for FDA’s Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) meeting to discuss the use of Novo Nordisk’s QW insulin icodec in T1DM patients (view here) which is being held on May 24, 2024. Below, FENIX provides an overview of FDA’s thoughts/concerns about the icodec benefit/risk profile and a prediction on how the adcom will turn out.

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Novo London, Tandem, and Lexicon Q1 ’24 Earnings

Three cardiometabolic-related news items have been observed: Novo hosted its post-Q1 ’24 earnings London analyst event (view webcast); and Tandem (press release) and Lexicon (press release) hosted their respective Q1 ’24 earnings calls. Below, FENIX provides highlights and insights for the respective news items.

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Icodec FDA Adcom Scheduled for May 2024

FDA has requested an adcom meeting on May 24, 2024, to discuss Novo Nordisk’s QW insulin icodec (view unpublished FDA document here). Recall, Novo previously disclosed FDA extended the icodec regulatory review by three months, with a decision now anticipated in Q3 2024 (previous FENIX insight). Below, FENIX provides insight on the potential implications and reasoning for an icodec adcom, including readthrough to Lilly’s QW insulin, efistora alfa.

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SELECT Receives Priority Review; High-dose Oral Sema Delayed; Novo Q3 ’23 Earnings

Novo Nordisk hosted its Q3 ’23 earnings call (press release; slides) and provided updates across its CVRM portfolio. Novo provided important new disclosures including SELECT’s priority review, a high-dose oral sema regulatory filing delay, and a new subcutaneous amycretin asset in Ph1 development. Below, FENIX provides highlights and insights from the call, including thoughts on why SC amycretin makes sense from a strategic standpoint.

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Novo Nordisk Q2 ’23 Earnings Update

Novo Nordisk hosted its Q2 ’23 earnings call (view press release; slides) and provided updates across its CVRM portfolio, including the recently announced SELECT CVOT topline results, Wegovy supply, and the high-dose oral semaglutide regulatory submission. Importantly, senior management disclosed plans to present full SELECT CVOT results at AHA 2023 in Philadelphia (November 11-13). Below, FENIX provides highlights and insights from the earnings call.

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STEP HFpEF Topline Results; Novo ADA 2023 Investor Event

Novo Nordisk hosted an investor event during ADA 2023 (view slides) and also raised its FY 2023 financial guidance to 24-30%. During the call, Novo provided an overview of the QW insulin icodec Ph3 program and value proposition, insight into the Ph3 cagrisema T2DM program, high-dose oral semaglutide in T2DM and obesity, and topline STEP-HFpEF results. Of note, management briefly mentioned that SELECT CVOT data will be presented in the near future. Below, FENIX provides highlights and insights from the Novo ADA 2023 investor event.

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