Tag Archives: teplizumab

Tzield Stage 3 T1DM Approval; Stelo Pediatric Label Expansion; Marc Breton Joins Tandem

Three cardiometabolic-related news items have been observed: FDA approved Tzield for pediatric Stage 3 T1DM (view press release), Dexcom received FDA clearance of Stelo for people ≥2 years of age (view approval), and Marc Breton joined Tandem Diabetes Care (view LinkedIn post). Below, FENIX provides highlights and insights for the respective news items.

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Roche and Sanofi Q4 ’25 earnings; New Fractyl Revita Data

Three cardiometabolic-related news items have been observed: Roche (view press release; view slides) and Sanofi (view press release; view slides; view infographic) hosted their respective Q4 ’25 earnings calls; and Fractyl Health announced 6-month results from its REMAIN-1 Midpoint Cohort for the Revita procedure (view press release). Below, FENIX provides highlights and insights for the respective news items.

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JPM 2026 Day 1: DXCM, ARWR, NVS, ALNY, PFE, SNY, CYTK, MDT, MDGL, REGN; Skye 2026 Corporate Outlook; BioAge NLRP3i Ph1 Data; Kailera Ph3 KaiNETIC Program Update

On the first day of JPM 2026, FENIX has provided coverage of presentations by major CVRM companies, including Dexcom, Arrowhead, Novartis, Alnylam, Pfizer, Sanofi, Cytokinetics, Medtronic, Madrigal, and Regeneron. Additionally, three cardiometabolic-related news items have been observed: Skye Biosciences released its 2026 corporate outlook (view press release); BioAge Labs announced updated Ph1 data of its NLRP3i for CV risk reduction (view press release); and Kailera announced it randomized the first patients in its Ph3 KaiNETIC program (view press release). Below, FENIX provides highlights and insights for the respective news items.

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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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FDA Publishes Slew of CRLs in Effort to Increase Transparency

FDA announced it has published more than 200 CRLs to increase transparency. The CRLs were issued to applications submitted between 2020 and 2024, and all are for drugs that have since gained approval from the agency, a Department of Health and Human Services spokesperson told Fierce Biotech (view article). Below, FENIX provides an overview of select CRLs and brief insight into the FDA openness policy.

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Skye Partners for Obesity Development; May CHMP Agenda; Altimmune Initiates Ph2 Study in AUD; Zealand Appoints New CDO; Cytokinetics Presents Additional Aficamten Analyses; Ionis Ph3 Olezarsen Topline Data 

A series of cardiometabolic-related news items has been observed from Skye Bioscience, EMA, Altimmune, Zealand Pharma, Cytokinetics, and Ionis Pharmaceuticals. Below, FENIX provides highlights and insights for the respective news items.

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Novartis Q3 ’23 Earnings; Counterfeit Ozempic Hospitalizes Patients in Austria; NexImmune Extends Partnership with Yale and JDRF

Three cardiometabolic-related news items have been observed: Novartis hosted its Q3 ‘23 earnings call (press release; slides); several people have been reportedly hospitalized in Austria after using suspected fake versions of Novo’s Ozempic (view article); and NexImmune announced its research partnership with Yale and JDRF has been extended (view press release). Below, FENIX provides highlights and insights into the respective news items.

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Sanofi and AZ Q2 ’23 Earnings

Two cardiometabolic-related news items have been observed: Sanofi (press release; slides; infographic) and AstraZeneca (press release; slides) hosted their respective Q2 ’23 earnings calls. Below, FENIX provides highlights and insights into the respective news items.

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