Category Archives: GLP-1RA

Holiday Hangover: FDA Approves Zepbound for OSA; NICE Finalizes Tirzepatide Guidelines; Abbott and Dexcom Reach Agreement; Arrowhead Ph1/2a ARO-INHBE Trial in Obesity; AZ Initiates Ph2 MASH Trial; Zealand Petrelintide Commentary; Generic Liraglutide Approvals; Lexicon Receives CRL for Zynquista

During the holiday break, a series of cardiometabolic-related news items were observed from Lilly, NICE, Dexcom/Abbott, Arrowhead Pharmaceuticals, AstraZeneca, Zealand Pharma, Biocon/Hakima, and Lexicon Pharmaceuticals. Below, FENIX provides highlights and insights for the respective news items.

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Cagrisema Misses Weight Loss Target

Novo Nordisk announced topline results from its first Ph3 pivotal cagrisema trial (REDEFINE 1; view CT.gov record) demonstrating -22.7% weight loss at Week 68, although Novo projected it would achieve 25%. For context, the trial evaluated cagrisema (a fixed-dose combination of cagrilintide 2.4mg and semaglutide 2.4mg) vs. cagrilintide 2.4mg, semaglutide 2.4mg, and placebo. Novo’s stock decreased by ~20% following the announcement. Below FENIX provides highlights and insights from the REDEFINE 1 trial, including readthrough to other obesity assets in development.

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FDA Releases Status on GLP-1RA Supply; AZ Initiates Baxdrostat/Dapa Trial in CKD and CV; TIXiMED Announces $2.65M Investment

Three cardiometabolic-related news items have been observed: FDA clarified the tirzepatide shortage resolution and impact on compounding pharmacies (view report); AstraZeneca initiated a Ph3 baxdrostat/dapagliflozin renal outcomes and CV mortality trial (view CT.gov record); and TIXiMED announced a $2.65M Helmsley Charitable Trust investment (view press release). Below, FENIX provides highlights and insights for the respective news items.

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Merck Buys Oral GLP-1RA; MetaVia Topline Ph2a MASH Data; Structure Reveals New DACRA Obesity Asset; Novo/Photys Enter Research Partnership; G&L Initiates H2H Tirzepatide Trial; EMA to Discuss Semaglutide Rare Eye Disease Association; Novo/Catalent Deal Complete

A series of cardiometabolic-related news items have been observed from Merck/Hansoh Pharma, Metavia, Structure Therapeutics, Novo Nordisk/Photys Therapeutics, Gan & Lee, Novo/EMA, and Novo/Catalent. Below, FENIX provides highlights and insights for the respective news items.

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ADA/EASD 2025 Guidelines; Ro/Lilly Zepbound SDV Partnership; Tirzepatide for Addiction Treatment

Three cardiometabolic-related news items have been observed: Updated ADA/EASD guidelines for 2025 have been released (view guidelines; view revisions); Lilly and Ro partnered for Zepbound single-dose vials (view press release); and Lilly announced potential plans for tirzepatide for treatment of addiction and inflammation (view article; view interview). Below, FENIX provides highlights and insights for the respective news items.

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GLP1-RAs Reduce Blood Clot Risk in T2DM; Zealand Initiates Ph2b Petrelintide Obesity Trial Enrollment; NewAmsterdam Positive CETPi Ph3 HeFH Data

Three cardiometabolic-related news items have been observed: GLP-1RAs reportedly demonstrated potential to decrease venous thromboembolisms (VTEs) in patients with T2DM (view article); Zealand initiated enrollment for the Ph2b ZUPREME-1 trial of petrelintide in obesity (view press release); and NewAmsterdam announced positive topline data from its Ph3 BROADWAY trial of obicetrapib in HeFH (view press release). FENIX will provide an overview of the updated ADA/EASD 2025 guidelines in tomorrow’s blast. Below, FENIX provides highlights and insights for the respective news items.

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December CHMP Agenda; Senseonics Eversense 365 Launch Updates; BioAge Discontinues Ph2 Obesity Trial

Three cardiometabolic-related news items have been observed: the CHMP agenda for this month’s meeting (Dec 9-12) has been released (view here); Senseonics announced commercial updates to its Eversense 365 launch (view press release); and BioAge announced the discontinuation of its Ph2 obesity trial (view press release). Below, FENIX provides highlights and insights for the respective news items.

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Zepbound Beats Wegovy in H2H Study; Novavax to Sell Manufacturing Facility to Novo; Antag $84M Series A Financing for Ph1 Obesity Trial

Three cardiometabolic-related news items have been observed: Lilly announced topline data from its SURMOUNT-5 trial where Zepbound was associated with higher weight loss compared to Wegovy (view press release); Novavax is selling a Czech manufacturing facility to Novo Nordisk (view press release); and Antag Therapeutics announced a $84M Series A financing round to support its QW SC GIPR antagonist for the treatment of obesity (view press release). Below, FENIX provides highlights and insights for the respective news items, including thoughts and implications of the H2H Zepbound vs. Wegovy data.

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