Tag Archives: Lilly

Lilly’s $6.5B Orforglipron Manufacturing Site; Novo Registers Ph2 Study of Triple Agonist; Ascletis Pharma Ph1 Results; Veru Progresses Enobosarm to Ph2b; FDA Delays T1DM Sota Decision; New O5 DTC Ad During NFL Sunday 

A series of cardiometabolic-related news items has been observed from Lilly, Novo Nordisk, Ascletis Pharma, Veru, Lexicon Pharmaceuticals, and Insulet. Below, FENIX provides highlights and insights for the respective news items.

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EASD 2025 Key Press Releases (September 18)

On the fourth day of EASD 2025, four key news items were observed from Roche, Novo Nordisk, and Lilly. Below, FENIX provides context and analysis for the announcements.

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EASD 2025 Key Press Releases (September 17)

On the third day of EASD 2025, four key news items were observed from Lilly, FDA, and Regeneron Pharmaceuticals. Below, FENIX provides context and analysis for the announcements, including thoughts on how orforglipron could potentially be approved as early as YE 2025.

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Novo Restructures with Workforce Cuts; Lilly Registers New Tirzepatide and Retatrutide Ph3 MASLD Study; Tzield Approved in China

Three cardiometabolic-related events have been observed: Novo Nordisk announced a restructuring plan including ~9,000 layoffs (view press release); Lilly registered its Ph3 SYNERGY-Outcomes study of tirzepatide or retatrutide in MASLD (view CT.gov record); and Sanofi announced Tzield has been approved in China (view press release). Below, FENIX provides highlights and insights for the respective news items.

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Lilly Initiates Muvalaplin CVOT; Vivani Plans Ph1 Sema Implant Study; WHO Adds GLP-1RAs to Essential Medicines List

Three cardiometabolic-related news items have been observed: Lilly initiates the Ph3 MOVE-Lp(a) CVOT of muvalaplin in patients with elevated Lp(a) and ASCVD (view CT.gov record); Vivani Medical announced updated development plans for its semaglutide implant (view press release); and WHO updates essential medicines list to include Novo’s and Lilly’s GLP-1RAs (view article; view list). Below, FENIX provides highlights and insight for the respective news items.

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Lilly Terminates Two Naperiglipron Studies; Lingo Advertisement on Reddit; Serena Williams Becomes Ro Ambassador; Another Novo Executive Steps Down; Esperion Embraces EU Recommendations for Bempedoic Acid; Daiichi Unveils Development of Fixed-Triple Combination Tablet for Lowering LDL-C

A series of cardiometabolic-related news items has been observed from Lilly, Abbott, Ro, Novo Nordisk, Esperion, and Daiichi Sankyo. Below, FENIX provides highlights and insight for the respective news items.

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Teva’s Generic Saxenda Approved by FDA; Dexcom Layoffs; FDA Accepts Proposal for MASH Surrogate Endpoint; Novo Partners with Replicate for srRNA R&D; Amylyx Prioritizes its GLP-1 Antagonist Development; Lilly Pauses Mounjaro Supply and Offers Discounts in UK

A series of cardiometabolic-related news items has been observed from Teva Pharmaceuticals, Dexcom, FDA, Novo Nordisk/Replicate Bioscience, Amylyx Pharmaceuticals, and Lilly. Below, FENIX provides highlights and insights for the respective news items.

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Wegovy MASH Label Analysis; Ozempic Offered Through NovoCare

FDA recently approved Wegovy (2.4mg semaglutide; QW SC GLP-1RA; view label) for the treatment of noncirrhotic MASH in adults with moderate to advanced liver fibrosis (F2-F3 MASH; view press release). The accelerated approval is based on results from Part 1 of the ongoing Ph3 ESSENCE study (view publication; previous FENIX insight). Additionally, Echosens and Novo Nordisk announced they are advancing their partnership to increase awareness and early diagnosis of MASH (view press release). Below, FENIX has conducted a Wegovy label analysis, including a comparison with Madrigal’s Rezdiffra (resmetirom), the only other approved treatment for MASH.

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