Tag Archives: kerendia

Pfizer Wins Metsera Bidding War; Lilly Partners for RNAi Drug Discovery; AZ Acquires Obesity Start-Up; Tandem’s Mobi Cleared for Android Use; Merck, Amgen, AZ, Ionis Data at AHA 2025; November CHMP Agenda 

A series of cardiometabolic-related news items have been observed from Metsera/Pfizer, Lilly, AstraZeneca, Tandem Diabetes Care, Merck, Amgen, Bayer, Ionis Pharmaceuticals, Camurus, and EMA. Below, FENIX provides highlights and insights for the respective news items.

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AstraZeneca Ph3 Baxdrostat Topline Results; FDA Approves Bayer’s Kerendia for HFpEF; Mattel Launches Barbie with T1DM 

Three cardiometabolic-related news items have been observed: AstraZeneca announced positive Ph3 topline results for baxdrostat in hypertension (view press release; view CT.gov record), Bayer announced FDA approval of Kerendia’s (finerenone) HEpEF indication (view press release), and Mattel announced the launch of a Barbie with diabetes (view press release). Below, FENIX provides highlights and insights for the respective news items.

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JPM 2025 Day 2: LLY, AZN, SNY, NVS, BAY, AKRO, SRRK, SDZ, MRK, TDOC, VTRS; Dario Partners for GLP-1RA Solution Expansion

On the second day of JPM 2025, FENIX has provided coverage of presentations by major CVRM companies, including Lilly, AstraZeneca, Sanofi, Novartis, Bayer, Akero, Scholar Rock, Sandoz, Merck, Teladoc, and Viatris. Of note, JPM experienced webcast issues during the 9:45 AM PT time slot. Separately, one CVRM-related news item has been observed: Dario partnered with MediOrbis for GLP-1RA solution expansion (view press release).

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JPM 2024 Day 2: ABT, PODD, NVO, LLY, AZN, BAY, BMF, TDOC; Embecta Files 510(k) for T2DM Patch Pump; Omada Partners with Amazon for Cardiometabolic Programs

On the second day of JPM 2024, FENIX has provided coverage of presentations by major CVRM companies, including Abbott, Insulet, Novo Nordisk, Lilly, AZ, Bayer, Biomea, and Teladoc. GSK and Sanofi also presented at JPM 2024 but had no meaningful discussion relating to their respective CVRM portfolios. Separately, two CVRM-related news items have been observed: Embecta announced it submitted a 510(k) filing to FDA for its open-loop patch pump for T2DM (view press release); and Omada Health announced a partnership with Amazon’s Health Condition Programs for its cardiometabolic programs (view press release).

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Insulet, Xeris, Madrigal, and Bayer Q2 ‘23 Earnings

Four cardiometabolic-related news items have been observed: Insulet (view press release; slides), Xeris Biopharma (press release), Madrigal Pharmaceuticals (press release), and Bayer (press release; slides) reported their respective Q2 ‘23 earnings. Below, FENIX provides highlights and insights into the respective news items.

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Bayer Q4 ’22 Earnings Update

Bayer hosted its Q4 ’22 earnings call (press release; slides) and provided updates across its business, including Kerendia (finerenone) in the context of the ongoing US launch and LCM initiatives. Below, FENIX provides highlights and insights from the call.

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Novo Nordisk and Heartseed Dose First Patient in Ph1/2 LAPiS Trial of HS-001; Finerenone Receives EU Approval for FIGARO-DKD Label Extension

Two cardiometabolic-related news items have been observed: Novo Nordisk and Heartseed announced the first patient has been dosed in the Ph1/2 LAPiS study (view CT.gov record) evaluating HS-001 in 10 patients with advanced HF caused by ischemic heart disease (view press release); and Kerendia (finerenone) has received EU approval for label extension to include CV outcomes in patients with CKD and T2DM (view Kerendia EPAR). Below, FENIX provides highlights and insights from the respective news items.

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Lilly Partners with Sosei Heptares for Metabolic Drug Discovery; FIGARO-DKD and DELIVER Positive CHMP Opinions

Three cardiometabolic-related news items have been observed: Sosei Heptares announced an R&D collaboration with Lilly for diabetes and metabolic diseases (view press release); Bayer announced Kerendia (finerenone) received a positive CHMP opinion for the FIGARO-DKD study (view press release); AZ’s Forxiga received a positive CHMP opinion to broaden its HF indication based on results from DELIVER (view opinion). Below, FENIX provides highlights and insights on the Lilly partnership and respective positive CHMP opinions.

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