Category Archives: Other

Novo to Displace Metformin as 1L T2DM Treatment?; Zealand Presents Amylin Analog Data at ObesityWeek; JNJ Q3 ‘23 Earnings

Three cardiometabolic-related news items have been observed: Novo Nordisk initiated a Ph3 study evaluating high-dose oral sema vs. Jardiance and vs. metformin in T2DM (view CT.gov record); Zealand announced presentations of clinical and non-clinical results from its amylin analog (ZP8396) at ObesityWeek 2023 (previous FENIX insight); and Johnson & Johnson hosted its Q3 ‘23 earnings call (view press release; slides). Below, FENIX provides highlights and insights into the respective new items, including thoughts on how Novo may be trying to displace metformin as first-line treatment for T2DM.

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SURMOUNT-3 Presented at ObesityWeek; Novo Adds to Its CKD Pipeline; Carmot Presents T2DM/Obesity Results; Better Therapeutics Launches AspyreRx for T2DM

Four cardiometabolic-related news items have been observed: Lilly announced detailed results from SURMOUNT-3, in which tirzepatide demonstrated an additional -21.1% weight loss after 12 weeks of intensive lifestyle management (view press release); Novo Nordisk announced it will acquire an MRA asset from KBP Biosciences for $1.3B (view press release); Carmot Therapeutics presented data from its T2DM/obesity pipeline at the 2023 ObesityWeek conference (view press release); and Better Therapeutics initiated the AspyreRx launch for T2DM (view press release). Below, FENIX provides highlights and insights into the respective news items.

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Novo Raises 2023 Guidance; Glucotrack’s Implantable CGM Preclinical Results

Two cardiometabolic-related news items have been observed: Novo Nordisk announced it raised its 2023 sales and operating profit guidance (view press release); and Glucotrack announced results from the most recent preclinical testing study for its implantable CGM (view press release). Below, FENIX provides highlights and insights into the respective news items.

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Lilly Initiates Tirzepatide Obesity Trial in Adolescents; Survodutide CVOT Observed; FDA Creates New Digital Health Advisory Committee; Better Therapeutics Announces AspyreRx Subgroup Topline Results; Virta Partners with Navitus for T2DM and Obesity

Five cardiometabolic-related news items have been observed: Lilly initiated a Ph3 study evaluating tirzepatide vs. placebo in adolescents who have obesity or are overweight with weight-related comorbidities (SURMOUNT-ADOLESCENTS; view CT.gov record); BI’s SYNCHRONIZE-CVOT, evaluating survodutide in people with overweight or obesity with CVD, CKD, or at least two risk factors for CVD was observed on CT.gov (view CT.gov record); FDA announced the creation of a new Digital Health Advisory Committee (view press release); Better Therapeutics announced topline results from a subgroup analysis of AspyreRx in T2DM (view press release); and Navitus Health Solutions announced a partnership with Virta Health to make Virta’s T2DM health solutions available to Navitus clients (view press release). Below, FENIX provides highlights and insights into the respective news items.

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Best Buy to Sell Dexcom G7; Gan & Lee Submits Bs-aspart and Bs-lispro MAAs; October CHMP Agenda; Tom Garner Joins Lexicon as SVP and CCO; Dario Partners with a Top Five Employee Benefits Consulting Firm; Senseonics and Ascensia Launch Eversense E3 Advertising Campaign

A series of cardiometabolic-related news items have been observed from BestBuy/Dexcom, Gan & Lee, EMA, Lexicon, Dario, and Senseonics/Ascensia. Below, FENIX provides highlights and insights into the respective news items.

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EASD Key Press Releases (Oct 5)

On the fourth day of EASD 2023, seven key news items were observed from BI/Zealand, Novo Nordisk, Fractyl, Sernova, Dexcom, and Biomea. The following topics are covered below (hyperlinks to external items):

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EASD Key Press Releases (Oct 4)

On the third day of EASD 2023, four key news items were observed from Lilly, Vertex, Phillips-Medisize, and Welldoc. The following topics are covered below (hyperlinks to external items):

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EASD 2023 Key Press Releases (Oct 03)

On the second day of EASD 2023, three key news items were observed from the Biden-Harris administration, Novo Nordisk, and Galectin Therapeutics. The following topics are covered below (hyperlinks to external items):

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EASD 2023 Key Press Releases (Oct 02)

On the first day of EASD 2023, two key news items were observed from Novo Nordisk and Dexcom. The following topics are covered below (hyperlinks below are to external items):

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Structure Announces Positive Topline Results from Ph1b Oral GLP-1RA Study; Better Therapeutics Completes Enrollment of AspyreRX Clinical Program in T2DM; Madrigal Commences $500M Public Offering

Three cardiometabolic-related news items have been observed: Structure Therapeutics announced positive topline results from its Ph1b MAD study evaluating QD doses of GSBR-1290, its oral GLP-1RA, in healthy overweight or obese individuals and provided updates regarding its GSBR-1290 development program (view press release); Better Therapeutics announced it completed enrollment of the AspyreRx clinical program to provide cognitive behavioral therapy for adults with T2DM (view press release); and Madrigal announced it commenced its $500M public offering in shares of its common stock and pre-funded warrants (view press release). Below, FENIX provides highlights and insights into the respective items.

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