Category Archives: GLP-1RA

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.

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

Structure’s Topline Ph2 Aleniglipron Data; Ascletis Reports Topline Data from Ph1 Oral GLP-1RA; BI Advances Triple Agonist for Obesity; Wave Announces Ph1 Data from Muscle-Sparing Asset; Lingo Now Available on Android; Medtronic Shifts Exec to MiniMed

A series of cardio-metabolic-related news items has been observed from Structure Therapeutics, Ascletis Pharma, Boehringer Ingelheim, Wave Life Sciences, Abbott, and Medtronic. Below, FENIX provides highlights and insights for the respective news items.

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

FDA Accepts AZ’s Baxdrostat NDA and MannKind’s sNDA for FUROSCIX in CHF + CKD; Medtronic Full US Launch for Abbott-Partnered CGM; Plozasiran Breakthrough Therapy Designation; New Fractyl Data; WHO Publishes GLP-1RA Guidelines

A series of cardiometabolic-related news items has been observed from AstraZeneca, MannKind, Medtronic, Arrowhead Pharmaceuticals, Fractyl Health, and the WHO. Below, FENIX provides highlights and insights for the respective news items.

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

Lilly Cuts Zepbound Prices; Cagrisema Ph3 Pediatric Obesity Trial; Ascletis Selects Obesity Candidate; Altimmune Replaces CEO; Olazarsen Breakthrough Therapy Designation; New Ph3 Bofanglutide Study; Ikaria Registers Study for Obesity Asset Monotherapy and Combination with Tirzepatide

A series of cardiometabolic-related news items has been observed from Lilly, Novo Nordisk, Ascletis Pharma, Altimmune, Ionis Pharmaceuticals, Gan & Lee Pharmaceuticals, and Ikaria Bioscience. Below, FENIX provides highlights and insights for the respective news items.

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

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.

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

Novo Misses Alzheimer’s Endpoint; Merck’s New Ph1 Asset in T2DM

Two cardiometabolic-related news items have been observed: Novo Nordisk announced topline EVOKE data for sema in Alzheimer’s (view press release); and Merck registered a Ph1 study of a new undisclosed oral coformulation in T2DM (view CT.gov record). Below, FENIX provides highlights and insights for the respective news items, including potential readthrough from EVOKE to Lilly’s plans in AD.

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

Lilly and Novo Establish New Obesity Channels; Orforglipron CVOT Initiated; Lilly Ph2 Study in Chemo-Induced Nausea and Vomiting 

Three cardiometabolic-related news items have been observed: Lilly, Novo, and other partners announced direct-to-employer programs for obesity medications (view article); Lilly initiated a Ph3 CVOT for orforglipron in people with ASCVD and/or CKD (view CT.gov record); and Lilly initiated a Ph2 study of its GIP agonist for chemotherapy-induced nausea and vomiting (view CT.gov record). Below, FENIX provides highlights and insights for the respective news items.

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

Viking Completes Ph3 Obesity Study Enrollment; FDA Clears Dexcom’s Smart Basal Feature; Modular Medical Files Patch Pump

Three cardiometabolic-related news items have been observed: Viking Therapeutics completed enrollment for its Ph3 VK2735 obesity non-T2DM study (view press release); Dexcom received FDA clearance for its Smart Basal feature (view press release) and announced plans to launch its 15 day G7 CGM in the US (view press release); and Modular Medical submitted a 510(k) for its Pivot patch pump (view press release). Below, FENIX provides highlights and insights for the respective news items.

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

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.

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