Tag Archives: tirzepatide

ProRx FDA Warning Letter; Lilly Partners with UNICEF

Two cardiometabolic-related news items have been observed: FDA issued a warning letter to ProRx regarding GLP-1RA compounding (view FDA letter) and Lilly partnered with UNICEF (view press release). Below, FENIX provides highlights and insights for the respective news items.

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Kailera Files IPO; Diamyd Data Disappoints; Insilico and Lilly Partner for AI Drug Discovery; EMA Approves Bayer’s Kerendia for HFpEF; Gan & Lee QW Insulin; Roche Ph1 CAD Study; Lilly Ph3 TOGETHER-PsA Results

A series of cardiometabolic-related news items has been observed from Kailera Therapeutics, Diamyd Medical, Insilico, Bayer, Gan & Lee Pharmaceuticals, Roche, and Lilly. Below, FENIX provides highlights and insights for the respective news items.

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Structure’s Topline Ph2 Aleniglipron Data; Lilly Launches Zepbound KwikPen; Positive Topline Ph3 Finerenone FIND-CKD Results

Three cardiometabolic-related news items have been observed: Structure Therapeutics announced updated results from its aleniglipron Ph2 obesity ACCESS trials (view press release; view slides); Lilly announced Zepbound KwikPen is now available for cash-pay patients via LillyDirect and retail pharmacies (view press release); and Bayer announced positive topline results from the Ph3 finerenone FIND-CKD study in non-T2DM CKD (view press release). Below, FENIX provides highlights and insights from the respective news items.

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ATTD 2026 Key Press Releases (March 12)

On the second day of ATTD 2026, three cardiometabolic-related news items have been observed: Lilly issued a public warning letter regarding the risk of compounded tirzepatide (view press release); Breakthrough T1D released a statement on cadaver donor islet cells and the ISLET Act (view press release); and Abbott shared results from its FreeDM2 study comparing Libre vs. SMBG in T2DM basal patients (view press release). Below, FENIX provides highlights and insights into the respective news items.

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Novo and Hims Take Another Turn at a Partnership; AbbVie Reports Topline Ph1 Amylin Data; Regeneron & Hansoh Share Ph3 Olatorepatide China Results; Lilly Releases Statement on CMS Obesity BALANCE Model; Zepbound KwikPen Available on Amazon; Veru Enrolls First Patient in Ph2b PLATEAU Study; Sequel Expands AID Launch 

A series of cardiometabolic-related news items has been observed from Novo Nordisk/Hims & Hers, AbbVie, Regeneron Pharmaceuticals/Hansoh, Lilly, Amazon, Veru, and Sequel Med Tech. Below, FENIX provides highlights and insights into the respective news items.

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Cagrisema Gets Redefined

Novo Nordisk announced topline results from the open-label Ph3 REDEFINE-4 study evaluating 2.4mg cagrisema (QW SC GLP-1/amylin dual agonist) H2H vs. 15mg tirzepatide (QW SC GLP-1/GIP dual agonist) in patients with obesity (view CT.gov record). An associated call was held (view slides). Of note, the trial did not achieve its primary endpoint of demonstrating non-inferiority on weight loss for cagrisema compared to tirzepatide after 84 weeks. As a result, Novo’s stock is down ~15%. Additional details from the press release and call are outlined below, including FENIX’s thoughts if commercializing cagrisema still makes sense and what BD cravings may remain.

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