Tag Archives: compounders

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.

This content is for Read Less members only.
Already a member? Log in here

FDA and EMA Implement Anti-Compounding Measures; Novo and Novonesis Partner for Gut Microbiome Research; Lexicon Submits Additional Sota T1DM Data; Lingo Sponsors US Open Coverage; Hansoh Initiates Ph3 T2DM Program of Olatorepatide in China

A series of cardiometabolic-related news items has been observed from FDA/EMA, Novo Nordisk/Novonesis, Lexicon Pharmaceuticals, Abbott, and Hansoh Pharmaceuticals. Below, FENIX provides highlights and insights for the respective news items.

This content is for Read Less members only.
Already a member? Log in here

NewSelf Gains FDA Approval for Weight Loss Program; Merck Oral PCSK9i and Vericiguat Data; Argo and Novartis Expand CV Partnership; Novartis Ph4 Leqvio Results; Biophytis Receives EMA Authorization; Gan & Lee H2H Ph3 Trial vs. Wegovy

A series of cardiometabolic-related news items has been observed from NewSelf, Merck, Novartis, Biophytis, and Gan & Lee Pharmaceuticals. Below, FENIX provides highlights and insights for the respective news items.

This content is for Read Less members only.
Already a member? Log in here

Lilly Leaves Door Open for Novo; Lilly Q2 ‘25 Earnings

Lilly hosted its Q2 ‘25 earnings call (press release; slides) and provided updates across its CVRM portfolio. Separately, Lilly announced topline results from its Ph3 ATTAIN-1 trial evaluating orforglipron in 3,127 non-T2DM obese adults (view press release; CT.gov record). Of note, Lilly’s stock is down -15% due to the lower-than-expected ATTAIN-1 weight loss, despite raising revenue guidance. Below, FENIX provides highlights and insights from the call and data readout.

This content is for Read Less members only.
Already a member? Log in here

Novo Cleans Out Pipeline; Q2 ‘25 Earnings Update 

Novo Nordisk hosted its Q2 ’25 earnings call (press release; slides) and provided updates across its CVRM portfolio and near-term obesity pipeline. Recall, Novo recently promoted Mike Doustdar as its new CEO and lowered its FY 2025 sales guidance primarily due to the outsized impact of compounding on US GLP-1RA market penetration (previous FENIX insight). Importantly, Novo disclosed the discontinuation of five development programs. Below, FENIX provides highlights and insights from the Q2 ’25 earnings call, including thoughts on Novo reassessing its pipeline.

This content is for Read Less members only.
Already a member? Log in here

Novo Sues Compounders…Again; Pfizer, Madrigal, Vertex, Corbus, and Esperion Q2 ‘25 Earnings; Innovent Receives IND clearance for Oral GLP-1RA; Vivani Data for Semaglutide Implant 

A series of cardiometabolic-related news items has been observed from Novo Nordisk, Pfizer, Madrigal, Vertex, Innovent Biologics, Corbus, Esperion, and Vivani Medical. Below, FENIX provides highlights and insights for the respective news items.

This content is for Read Less members only.
Already a member? Log in here

Novo Appoints Mike Doustdar as CEO; Lowers FY ’25 Guidance

Novo Nordisk announced Mike Doustdar has been appointed as President and CEO, effective August 7, 2025. Additionally, Novo lowered its sales and operating profit guidance for 2025 (view press release). The company held an associated call to discuss the announcements (view webcast; view slides). Of note, Novo’s stock price dropped ~21% following the news. Below, FENIX provides highlights and insights on the updates.

This content is for Read Less members only.
Already a member? Log in here

Novo Q1 ‘25 Earnings

Novo Nordisk hosted its Q1 ’25 earnings call (press release; slides) and provided updates across its CVRM portfolio and Novo’s near-term obesity pipeline. Of note, Novo lowered its FY 2025 guidance due to reduced GLP-1RA market penetration as a result of compounding. Below, FENIX provides highlights and insights from the Q1 ’25 earnings call.

This content is for Read Less members only.
Already a member? Log in here