Novartis hosted its 2022 Meet the Management event where the company provided details regarding its new focused strategy, the Sandoz spin-off, and R&D priorities (press release; view slides). Of note, the event was primarily comprised of multiple Q&A sessions. Below, FENIX provides highlights and insights from the event relating to Novartis’s CVRM business.
On the third day of EASD 2022, three key press releases were observed from Zealand, Carmot Therapeutics, and Abbott. Separately, Lilly’s Tempo Smart Button received FDA 510(k) clearance on September 16, 2022 (view FDA website), although Lilly has not issued a press release. Below FENIX provides insights and context for the respective announcements.
On the second day of EASD 2022, three key press releases were observed from Insulet, Novo Nordisk, and Diamyd. Below FENIX provides insights and context for the respective announcements.
On the first day of EASD 2022, Biocorp announced it received CE Mark for SoloSmart, an accessory medical device for Sanofi’s SoloStar/DoubleStar pens that records dose information (e.g., dose amount, time, and date). According to the press release, Biocorp will provide more details regarding the SoloSmart launch during its CY Q3 ’22 earnings call scheduled for September 29th. Below, FENIX provides brief thoughts on the new SoloSmart device as well as potential implications for Novo Nordisk, Lilly, and other insulin pen manufacturers.
FDA has requested an advisory committee on October 26, 2022, to discuss the use of GSK’s daprodustat for the treatment of anemia due to CKD in non-dialysis dependent (NDD) and dialysis-dependent (DD) adults (view FDA document here). Recall, in April 2022, FDA accepted the daprodustat NDA and set a PDUFA date for February 1, 2023, suggesting a standard review of 12 months total for an NME (previous FENIX insight). The NDA was based on positive results from five Ph3 studies in the ASCEND program which were reported in July 2021 (previous FENIX insight). Below, FENIX provides brief thoughts on the dapro adcom in the context of roxadustat and vadadustat.
A series of cardiometabolic-related updates have been observed: Dexcom announced Jake Leach (view LinkedIn) has been promoted to COO; Biocon announced it received more Form 483 observations; Seraxis announced the appointment of Paul Strumph (view LinkedIn) to CMO; and Intarcia Therapeutics received a letter from FDA (view here) denying a hearing for ITCA-650. Below, FENIX provides context and insight on the respective news items.
Three cardiometabolic-related news items have been observed: Ypsomed announced the launch of a smartphone bolus delivery feature for its mylife YpsoPump using the mylife App; Lannett announced it completed subject dosing in its Ph1 bs-glargine pivotal trial (view CT.gov record); and Madrigal announced the initiation of a Ph3 MAESTRO-NASH Outcomes study evaluating the effect of QD oral 80mg resmetirom compared to placebo in patients with compensated NASH cirrhosis (view CT.gov record). Below, FENIX provides context and insight on the respective news items.
Results from AZ’s Ph3 DELIVER (Farxiga HF outcomes trial in HFpEF; press release) and new results from a pre-specified pooled analysis from the Ph3 DAPA-HF and DELIVER trials (press release) were presented at ESC 2022 and simultaneously published in the NEJM (view publication) and Nature Medicine (view publication), respectively. Of note, an 18% RRR was observed in the DELIVER primary composite endpoint (hHF+urgent hospitalization and CV death). Below, FENIX provides highlights, insights, and implications from DELIVER in the context of BI/Lilly’s EMPEROR-Preserved and the evolving CVRM global landscape.
Two cardiometabolic-related news items have been observed: an AZ-sponsored Ph2 dapa + zibotentan combination trial in cirrhosis (ZEAL) has been observed (view CT.gov record); and Esperion announced the ACC’s ECDP guidelines now include bempedoic acid as an oral non-statin therapy to lower LDL-C. Below, FENIX provides context and insight on the respective news items.
A series of cardiometabolic-related updates have been observed: Beta Bionics has reportedly laid off an unknown number of employees (view LinkedIn post); a Novo-sponsored Ph3 trial evaluating Ozempic and lower-dose insulin glargine has been observed (SUSTAIN OPTIMIZE; view CT.gov record); Novartis announced plans to spin off Sandoz (press release); Lannett (press release) and Adocia (press release) released their Q2 ’22 earnings; and Hygieia announced the appointment of a new CEO. Below, FENIX provides context and insight on the respective news items.