Tag Archives: Lilly

Orforglipron Approved by FDA as “Foundayo”

FDA has approved Lilly’s orforglipron (branded Foundayo) as the company’s first oral GLP-1RA therapy for the treatment of obesity (view press release; view label). Lilly stated orforglipron will be available immediately, with shipping beginning April 6, 2026. Recall, Lilly has stockpiled $1.5B worth of orforglipron in anticipation of the launch (previous FENIX insight). In the coming days, FENIX will conduct a detailed analysis of orforglipron’s label, pricing, and website, as well as an in-depth comparison to Novo Nordisk’s Wegovy Pill.

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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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Retatrutide T2DM Data Continue to Impress; FDA Approves Novo’s High Dose Sema

Two cardiometabolic-related news items have been observed: Lilly shared positive topline data from its Ph3 TRANSCEND-T2D-1 study of retatrutide (view press release), and Novo Nordisk received FDA approval for its 7.2mg Wegovy (view press release). Below, FENIX provides highlights and insights on the respective news items, including a safety/efficacy analysis of how the TRANSCEND results position retatrutide relative to tirzepatide and cagrisema.

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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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ATTD 2026 Key Press Releases (March 11)

On the first day of ATTD 2026, four cardiometabolic-related news items have been observed from Skye Bioscience, Lilly, MiniMed, and LifeScan. Below, FENIX provides highlights and insights into the respective news items.

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Kailera Initiates Another Ph2 Ribupatide Study; Ascletis Reports Topline Ph2 Data; Laekna Announces Topline Ph1 Data; Glooko Connects with Roche’s CGM; SK pharmteco to Manufacture Long-Acting API for Current Lilly Product; Novo Acknowledges FDA Form 483

A series of cardiometabolic-related news items has been observed from Kailera, Ascletis Pharma, Laekna, Glooko, SK pharmteco, and Novo Nordisk. 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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Topline Petrelintide Ph2 Results; Potential Brand Name for Orforglipron?; New Novo Ph1 Obesity Asset; Altimmune and Lexicon Q4 ’25 Earnings; Lilly Launches New DTE Platform; Tandem Mobi Now Available on Android

A series of cardiometabolic-related news items has been observed from Zealand/Roche, Lilly, Novo Nordisk, Altimmune, Lexicon, and Tandem Diabetes Care. Below, FENIX provides highlights and insights on the respective news items.

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Ionis, Wave, and MannKind Q4 ’25 Earnings; New Ph2 Olatorepatide Study; ACHIEVE-3 Full Results; MindRank Doses First Patient in Ph3 Oral GLP-1RA Study; Fractyl Completes Pivotal Enrollment

A series of cardiometabolic-related news items has been observed from Ionis Pharmaceuticals, Wave Life Sciences, Regeneron, Lilly, MannKind, MindRank, and Fractyl Health. Below, FENIX provides highlights and insights for the respective news items.

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