Tag Archives: Rybelsus

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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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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Pfizer Acquires Oral GLP-1RA; FDA Grants AI Drug Development Tool in MASH; Lilly Discontinues Tempo; Novo Completes Akero Acquisition; Regeneron Registers siRNA Ph2 Study in DKD; December CHMP Agenda

A series of cardiometabolic-related news items has been observed from Pfizer, FDA, Lilly, Novo Nordisk/Akero, Regeneron Pharmaceuticals, and EMA. Below, FENIX provides highlights and insights for the respective news items.

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Novo Files 7.2mg Wegovy; CMS Cuts Semaglutide Prices; FDA Publishes Marketing Violation Letters

Three cardiometabolic-related news items have been observed: Novo Nordisk submitted its sNDA to FDA for high-dose (7.2mg) Wegovy in obesity (view press release); CMS announced the negotiated prices from the second round of IRA discussions, including Novo’s semaglutide (view press release; view fact sheet); and FDA published promotional activity violation letters from the OPDP (view letters). Below, FENIX provides highlights and insights for the respective news items, including the projected approval timeline for high-dose Wegovy in the US.

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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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