Tag Archives: Ozempic

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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Thoughts on The TrumpRx Launch: The Future Booking.com of Obesity Drugs?

The White House recently launched TrumpRx.gov (view website), an online platform that allows consumers to search for the lowest available cash-pay prices for their prescription medications (view image below). Importantly, the website itself is not the direct point of purchase for consumers; instead, it is a central hub that informs patients of the available out-of-pocket pricing options before redirecting them to purchase the drug by what appears to be two contrasting pathways (discussed below). Below, FENIX outlines how TrumpRx operates, its potential value creation, and why the platform may disproportionately benefit AOM manufacturers.

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Hims Launches Compounded Sema Pill; Novo London, AbbVie, GSK, and Novartis Q4 ’25 Earnings; Stelo Smart Meal Logging Updates; Abbott FDA Warning Letter and Class I Recall; Rare Pediatric PRV Program Reauthorized; Sciwind Ph3 OSA Study

A series of cardiometabolic-related news items has been observed from Hims & Hers, Novo Nordisk, AbbVie, GSK, Novartis, Dexcom, Abbott, the White House, and Sciwind Biosciences. 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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Trulicity on Medicare Negotiation List; Novo Outspends Lilly on GLP-1RA Advertising; Ro’s GLP-1RA Super Bowl Commercial

Three cardiometabolic-related news items have been observed: CMS included Lilly’s Trulicity for the third round of Medicare price negotiations (view press release); Novo spent nearly $500M on US advertising of Wegovy and Ozempic (view article); and Ro announced plans to air a “Healthier on Ro” Super Bowl commercial (view press release). Below, FENIX provides highlights and insights for the respective news items.

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Roche Initiates Ph3 Obesity Program; Novo Partners for T1DM and Launches New Ozempic Campaign; Ascletis Selects Obesity Candidate; BioAge Expands NLRP3i Development; Richard DiMarchi Featured in IU Commercial

A series of cardiometabolic-related news items has been observed from Roche, Novo Nordisk, Ascletis Pharma, BioAge Labs, and Indiana University. Below, FENIX provides highlights and insights for the respective news items.

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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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Novo Reduces Wegovy and Ozempic US DTP Pricing

Novo Nordisk announced that effective today (November 17), it is reducing the US cash-pay price of injectable Wegovy and Ozempic to $199/month for the first two months and $349/month for subsequent months (down from $499/month). Below, FENIX provides insight into Novo’s pricing updates, including a curious observation (and hypothesis) regarding the 2.0mg Ozempic dose.

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