Tag Archives: Farxiga

AZ Q4 ’22 Earnings; Oramed to Consider M&A Opportunities

Two cardio-metabolic related news items have been observed: AstraZeneca hosted its Q4 ’22 and FY ‘22 earnings call and provided brief updates to its CVRM business, including the ongoing Farxiga LCM initiatives (press release; slides); and Oramed issued an update to shareholders (view here) in which it said the company is conducting a comprehensive analysis of the data from its discontinued Ph3 oral insulin trials. Below, FENIX provides highlights and insights into the respective news items, including thoughts on AZ’s dapa LCM initiatives ahead of its anticipated 2025 LOE.

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

AZ Q2 ’21 Earnings Updates

AstraZeneca hosted its Q2 ’21 earnings call, and once again, much of the prepared remarks and Q&A focused on the company’s COVID-19 vaccine development and oncology portfolio. Below, FENIX provides highlights and insights from the call.

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

Meet AZ Management Investor Event Highlights

AstraZeneca hosted its virtual Meet AZ BioPharmaceuticals Management investor event (view slides) in which it provided updates across its business, including CVRM near-term opportunities (view slides) and its emerging pipeline (view slides). Below, FENIX provides highlights and insights from the event.

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

DAPA-CKD filed with EMA; February 22-25 CHMP Agenda; G&L Partners with IDF

A series of cardiometabolic-related news items have been observed: the CHMP agenda for this month’s meeting (February 22-25, 2021) has been released, and it includes one notable item: DAPA-CKD appears for the first time; and Gan & Lee announced a new partnership with IDF. Below, FENIX provides highlights and insights from the respective news items.

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

AZ, DXCM, and Teva Q4 ’20 Earnings Updates; Supersapiens Partners with Ironman; Praluent Patent Litigation Upheld by US Court of Appeals; REGN Evinacumab Approved in US as Evkeeza; Former Novo Exec Hired as CMO for Hepion Pharma

Seven cardiometabolic-related news items have recently been observed from AstraZeneca, Dexcom, Supersapiens, Regeneron, Hepion Pharmaceuticals, and Teva. 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

AZ, Provention Bio, Teva, and BD Q3 ’20 Earnings Updates

AstraZeneca (press release; slides), Provention Bio (press release), Teva (press release; slides), and Becton Dickinson (press release) hosted their respective Q3 ’20 earnings calls. Below, FENIX provides diabetes-related highlights and insights from the calls, including insight into AZ’s curious move to advance the development of its PCSK9i mAb.

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

New AZD9977 + Dapa Ph2b Trial in HF+CKD (MIRACLE)

A CT.gov record has been observed for a new Ph2b trial evaluating AZD9977, a novel mineralocorticoid receptor modulator (MCR), as add-on to dapagliflozin in patients with HF and CKD. The trial initiation is in-line with AZ’s commentary from its Q2 ’20 earnings call (previous FENIX insight). Of note, John McMurray is the PI for the MIRACLE trial. McMurray previously served as the PI for DAPA-HF and a member of the executive committee for DAPA-CKD. Below, FENIX provides an overview of the MIRACLE trial as well as why AZ’s pursuit of accelerated approval for AZD9977 could make sense.

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

AZ Provides Additional DAPA-CKD Commentary During Post-Results Investor Call

Following the DAPA-CKD results, which were presented at ESC 2020 on August 30 (previous FENIX insight), AZ hosted a call with investors (view slides here). Beyond reviewing the DAPA-CKD results, AZ senior management and DAPA-CKD investigators provided commentary on the trial results and the new Farxiga market potential. Below, FENIX provides highlights from the investor call as well as additional perspective on the impact of DAPA-CKD.

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

DAPA-CKD Results Highly Positive; AZ Winning in SGLT2i LCM

Full results from the DAPA-CKD renal outcomes trial were presented at the 2020 virtual ESC conference (view AstraZeneca press release), but it does not appear the results have been published. Results demonstrated a highly impressive 39% RRR in the primary composite endpoint (sustained ≥50% decline in eGFR, ESKD, renal death, or CV death). Curiously, the CV death component of the primary endpoint failed to demonstrate a statistically significant benefit (HR=0.81; p=0.20); however, there was a statistically significant 31% RRR in all-cause mortality. Below, FENIX provides thoughts on the DAPA-CKD results in the context of the Invokana CREDENCE study (DKD), the ongoing EMPA-KIDNEY trial from BI/Lilly, and Lexicon’s SOLOIST and SCORED CVOTs.

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