Tag Archives: semaglutide

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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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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FDA Issues Warning Letters for Misleading Pharmaceutical Advertising; Veru Initiates Enobosarm Ph2b PLATEAU Study; Vanda Initiates Tradipitant Ph3 Study

Three cardiometabolic-related news items have been observed: FDA issued warning letters for illegal marketing of compounded GLP-1RAs (view press release; view letters) and warned Novo over Ozempic ad (view article; view letter); Veru initiated the Ph2b PLATEAU study of enobosarm (selective androgen receptor modulator) for obesity (view CT.gov record); and Vanda Pharmaceuticals initiated the Ph3 tradipitant trial for the treatment of nausea and vomiting induced by GLP-1RA use (view CT.gov record).

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Novo Reduces Semaglutide WAC Prices; Pfizer To Commercialize Ecnoglutide in China; Novo Ph2 GGG data; AbbVie Builds Out Obesity Manufacturing; Fortress Sells PRV; Alveus Closes $197M Series A; Beta Bionics FDA Warning Letter; Hims & Hers Q4 ’25 Earnings

A series of cardiometabolic-related news items has been observed from Novo Nordisk, Sciwind Biosciences/Pfizer, AbbVie, Fortress Biotech, Alveus Therapeutics, Beta Bionics, and Hims & Hers. Below, FENIX provides highlights and insights for 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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Lilly Retatrutide Risk Mitigation; Medtronic CY Q4 ’25 Earnings; 7.2mg Wegovy EU Approval; Lilly Targets India for Manufacturing Hub; EC Approval of Myqorzo; Esperion and Alkem Reach Generic BA Agreement

A series of cardiometabolic-related news items has been observed from Lilly, Medtronic, Novo Nordisk, Cytokinetics, and Esperion Therapeutics. Below, FENIX provides highlights and insights for the respective news items.

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Novo Super Bowl Ad; FDA Takes Stance on Compounding; Arrowhead Q4 ’25 Earnings

Three cardiometabolic-related new items have been observed: Novo Nordisk published its Wegovy Pill Super Bowl LX commercial (view press release); Marty Makary took a stance against compounders on X (view article; view post); and Arrowhead Pharmaceuticals hosted its Q4 ’25 earnings call (view press release). Additionally, TrumpRx (view here) has been officially launched, and FENIX will conduct an in-depth analysis early next week. Below, FENIX provides highlights and insights for the respective news items.

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Novo Headwinds to Persist in 2026; Q4 ’25 Earnings Updates

Novo Nordisk hosted its Q4 ’25 earnings call (view press release; view slides) and provided updates across its diabetes and obesity business. Of note, the company’s stock is down ~20% following lower than expected FY 2026 sales guidance of -5% to -13%, vs. the Street’s low-single-digit expectations (view article). Management attributed the outlook to increased incretin pricing pressure, intensifying US competition, and ex-US patent expiries. Of note, Novo will be hosting its 2026 Capital Markets Day on September 21 in London, UK. Below, FENIX provides highlights and insights from the Q4 ’25 earnings call.

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