Tag Archives: Novo Nordisk

Novo SELECT AHA 2023 Investor Event

Novo Nordisk hosted a post-SELECT data readout investor event during AHA 2023 (view webcast). During the call, Novo reviewed the full SELECT results and provided additional commentary on the data. In case you missed it, FENIX recently conducted an analysis on the SELECT market implications (view here). Below, FENIX provides highlights and insights from the Novo AHA 2023 investor event.

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

SELECT Lives Up to the Hype; Full SELECT Results at AHA 2023

Novo Nordisk announced positive full results from the SELECT CVOT (view CT.gov record) demonstrating a -20% RRR in 3P-MACE for non-T2DM people with established CVD who were treated with QW 2.4mg semaglutide (Wegovy). The full results were presented at AHA 2023 and simultaneously published in the NEJM (view publication). Recall, SELECT was filed with US and EU regulators in September and October 2023, respectively, and FDA has granted priority review with a PDUFA date projected in March 2024 (previous FENIX insight). Below, FENIX provides thoughts on the SELECT results, including potential readthrough to Lilly and other manufacturers looking to enter the obesity market.

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

SELECT Receives Priority Review; High-dose Oral Sema Delayed; Novo Q3 ’23 Earnings

Novo Nordisk hosted its Q3 ’23 earnings call (press release; slides) and provided updates across its CVRM portfolio. Novo provided important new disclosures including SELECT’s priority review, a high-dose oral sema regulatory filing delay, and a new subcutaneous amycretin asset in Ph1 development. Below, FENIX provides highlights and insights from the call, including thoughts on why SC amycretin makes sense from a strategic standpoint.

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

Novo Partners with GE Healthcare for T2DM/Obesity; Cytokinetics’ Cardiac Myosin Inhibitor Programs Update; New Ph3 Dapa+Zibotentan Combination Trial in CKD and High Proteinuria

Three cardiometabolic-related news items have been observed: Novo Nordisk and GE HealthCare partner to further advance the clinical and product development of peripheral focused ultrasound (PFUS) for T2DM and obesity (view press release); Cytokinetics announced updates on its cardiac myosin inhibitor programs during its virtual Investor and Analyst Day (view webcast; slides); and AstraZeneca initiated a new Ph3 dapa+zibotentan combination trial in CKD and high proteinuria, called ZENITH High Proteinuria (view CT.gov record). Below, FENIX provides highlights and insights into the respective news items.

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

Novo to Displace Metformin as 1L T2DM Treatment?; Zealand Presents Amylin Analog Data at ObesityWeek; JNJ Q3 ‘23 Earnings

Three cardiometabolic-related news items have been observed: Novo Nordisk initiated a Ph3 study evaluating high-dose oral sema vs. Jardiance and vs. metformin in T2DM (view CT.gov record); Zealand announced presentations of clinical and non-clinical results from its amylin analog (ZP8396) at ObesityWeek 2023 (previous FENIX insight); and Johnson & Johnson hosted its Q3 ‘23 earnings call (view press release; slides). Below, FENIX provides highlights and insights into the respective new items, including thoughts on how Novo may be trying to displace metformin as first-line treatment for T2DM. 

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

SURMOUNT-3 Presented at ObesityWeek; Novo Adds to Its CKD Pipeline; Carmot Presents T2DM/Obesity Results; Better Therapeutics Launches AspyreRx for T2DM

Four cardiometabolic-related news items have been observed: Lilly announced detailed results from SURMOUNT-3, in which tirzepatide demonstrated an additional -21.1% weight loss after 12 weeks of intensive lifestyle management (view press release); Novo Nordisk announced it will acquire an MRA asset from KBP Biosciences for $1.3B (view press release); Carmot Therapeutics presented data from its T2DM/obesity pipeline at the 2023 ObesityWeek conference (view press release); and Better Therapeutics initiated the AspyreRx launch for T2DM (view press release). Below, FENIX provides highlights and insights into the respective news items.

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

Novo Raises 2023 Guidance; Glucotrack’s Implantable CGM Preclinical Results

Two cardiometabolic-related news items have been observed: Novo Nordisk announced it raised its 2023 sales and operating profit guidance (view press release); and Glucotrack announced results from the most recent preclinical testing study for its implantable CGM (view press release). Below, FENIX provides highlights and insights into the respective news items. 

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