Tag Archives: Awiqli

Wegovy Pill Shines As Novo Raises FY 2026 guidance; Q1 ’26 Earnings Update

Novo Nordisk hosted its Q1 ’26 earnings call and provided updates across its diabetes and obesity businesses (view press release; view slides). Of note, the company’s stock is up ~3% after raising its FY 2026 adjusted sales guidance to -4% to -12% (previously -5% to -13%), driven by a “best-in-class” US launch of Wegovy Pill and strong GLP-1RA demand in OUS markets. Below, FENIX provides highlights and insights from the Q1 ’26 earnings call.

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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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EASD 2024 Key Press Releases (Sep 11)

On the third day of EASD 2024, two key news items were observed from Novo Nordisk. Below, FENIX provides highlights and insights into the respective news items, including thoughts on how the icodec CRL from FDA could impact Awiqli uptake in Europe. The following topics are covered below (hyperlink to external items):

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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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SELECT up for CHMP Opinion?; April CHMP Agenda; BI Partners for MASH; Lilly Acquires Nexus Manufacturing Site

Three cardiometabolic-related news items have been observed: The CHMP agenda for this month’s meeting (April 22-25) has been released and SELECT is likely up for an opinion (view CHMP agenda); Ochre announced it entered into a partnership with BI for liver disease (view press release); and Lilly announced an agreement to acquire an injectables manufacturing facility from Nexus Pharmaceuticals (view press release). Below, FENIX provides highlights and insights into the respective news items.

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Awiqli (QW Insulin Icodec) Receives Positive CHMP Opinion; Oprah TV Special Spotlights Zepbound and Wegovy

Two cardiometabolic-related news items have been observed: CHMP adopted a positive opinion, recommending marketing authorization for “Awiqli” (QW insulin icodec) for the treatment of diabetes in adults (view press release); and Oprah hosted a show on ABC titled, “Shame, Blame, and the Weight Loss Revolution” which addressed the stigma associated with obesity and the success of GLP-1RAs (view article; watch episode on HULU). Below, FENIX provides highlights and insights for the respective news items, including brief thoughts on the social media hype following Oprah’s TV special.

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