A series of cardiometabolic-related news items have been observed from Novo Nordisk, Arrowhead Pharmaceuticals, Vertex Pharmaceuticals, and Oramed Pharmaceuticals. Below, FENIX provides highlights and insights for the respective news items.
A series of cardiometabolic-related news items have been observed from CHMP, Oramed, Diamyd Medical, and Noom. Below, FENIX provides highlights and insights for the respective news items.
A series of diabetes-related news items have been observed: Novo Nordisk presented results from the STEP 4 semaglutide 2.4mg obesity trial at the ENDO 2021 conference (view press release); Oramed announced it has screened the first patients in its second oral insulin Ph3 trial; Dexcom has promoted Jereme Sylvain to CFO, allowing Quentin Blackford to take over Steve Pacelli’s responsibilities for strategy and corporate development (view press release); and vTv announced the USPTO issued patent 10,952,993 protecting methods of treatment using TTP399, a novel GKA. Below, FENIX provides highlights and insights from the respective news items, including updated perspective on Oramed’s potential regulatory timeline.
Two diabetes-related news items have been observed: Oramed has begun randomizing patients into its Ph3 ORMD-0801 T2DM study (view press release) and Dario announced the hiring of Chris Chan as the company’s new SVP of employer sales (view press release). Below, FENIX provides highlights and insights from the respective news items.
A series of diabetes-related news items have been observed: Medtronic hosted its CY Q3 ’20 (FY Q2 ’21) earnings call (press release; slides); Dario signed a deal with a Fortune 500 company (press release); and Oramed announced it has screened the first patients in its Ph3 oral insulin (ORMD-0801) trial. Below, FENIX provides highlights and insights from the respective news items.
A CT.gov record for Oramed’s first oral insulin (ORMD-0801) Ph3 trial has been observed. Recall, Oramed recently announced it had come to an agreement with FDA on the Ph3 program design, which will include two 26-week Ph3 trials in 1,125 adult T2DM patients (previous FENIX insight). The second Ph3 study has not yet been observed on CT.gov. Below, FENIX provides additional trial details, insight into the puzzling primary completion date, and thoughts on why the ORMD-0801 filing timeline may be different between the US and Europe.
Three diabetes-related news items have been observed: DAPA-HF received a positive CHMP opinion (view here); Oramed announced it has come to an agreement with FDA regarding the Ph3 T2DM program design for its oral insulin (ORMD-0801), with the company planning to initiate the trials in Q4 ’20; and Livongo has partnered with Guidewell (Florida Blue) to expand access to Livongo’s Diabetes platform in Florida. As of this publication, an AstraZeneca press release regarding the DAPA-HF CHMP opinion has not been observed. Below, FENIX provide highlights and insights for the respective news items.
On Day 2 of EASD, five key press releases and news items were observed from Novo Nordisk, Dexcom, Ascensia, Lilly, and Oramed. Below FENIX provides insights and context from each respective announcement.
Oramed announced it had a positive end-of-Ph2 meeting with FDA for its oral insulin (ORMD-0801). Following the meeting, Oramed said it plans to initiate two concurrent Ph3 trials. The company did not provide an updated timeline for Ph3 trial initiation, but it previously indicated the trials would begin in Q3 ’20 (previous FENIX insight). Below, FENIX provides brief thoughts on the Oramed news, including readthrough to Biocon’s oral insulin tregopil.
Today, twelve diabetes-related news items were observed: DAPA-HF delays T2DM onset, teplizumab follow-up results, Arecor uRAI Ph1 data, new Afrezza practical data, Diasome HDV Ph2 results, Hua Medicine Ph3 GKA data, ORMD-0801 in NASH, Glytec CGM POC data, Biolinq’s first-in-human CGM data, and more. Below, FENIX provides context and analysis for the announcements.