On the fourth day of EASD 2022, three key news items were observed from Novo Nordisk, Merck, and Better Therapeutics. Separately, it has been observed that the start date has been delayed for Novo’s first cagrisema Ph3 pivotal trial (Ph3 REDEFINE-2). Below FENIX provides insights and context for the respective announcements.
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.
Recently, Novo announced plans to launch an authorized generic (AG) version of Tresiba (insulin degludec) which will be available in the US in Fall 2022 at a 65% discount to the Tresiba branded list price (previous FENIX insight). Below, FENIX has conducted a pricing analysis of the basal insulin market, including insight into how the market dynamics may be shifting.
Four cardiometabolic-related news items have been observed: Novo announced a partnership with Microsoft for drug development (view press release); Novo announced plans to launch an unbranded version of Tresiba (view press release); AZ partners with Gatehouse for HFpEF RNA-based drug development (view press release); the CHMP agenda for this month’s meeting (September 12-15) has been released and includes multiple cardiometabolic-related agenda items. Below, FENIX provides context and insight on the respective news items.
At its Q2 ’22 earnings in August, Novo Nordisk disclosed that SELECT, the Wegovy CVOT, would not stop for overwhelming efficacy at a pre-specified interim analysis (previous FENIX insight). With all the hype now passed, the trial design lens turns to Lilly’s tirzepatide obesity CVOT, SURMOUNT-MMO. Below, FENIX provides thoughts on SURMOUNT-MMO, including Lilly’s potential strategy to get a broad metabolic indication, similar to what BI/Lilly did in HF with Jardiance by eliminating LVEF label language.
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.
A series of cardiometabolic updates have been observed: Novo announced positive topline results from its Ph2 study of cagrisema in T2DM; Insulet announced Omnipod 5 received expanded FDA clearance in patients down to 2 years of age; Digbi Health has enrolled in Novo’s Global Prevention Accelerator program; an Inreda-sponsored study has been observed evaluating Lyumjev in its bi-hormonal closed loop system (FAST 1; view CT.gov record); and Amarin announced it is discontinuing Vazkepa in Germany. Below, FENIX provides context and insight on the respective news items.
A series of cardiometabolic updates have been observed: Novo’s PIONEER START trial (H2H oral sema vs. empa) has been withdrawn (CT.gov record); Onduo announced a partnership with Sword Health to integrate Sword Health’s musculoskeletal digital solution (press release); and Nemaura (press release) and Movano (press release; webcast) released their Q2 ’22 earnings. Below, FENIX provides highlights and insights from the respective news items.
A series of cardiometabolic-related news items have been observed: Novo Nordisk hosted its post-Q2 ’22 earnings (see previous FENIX insight on Q2 ’22 Novo earnings from August 3); Vertex (press release; slides), and Amgen (press release; slides) hosted their Q2 ’22 earnings calls. Below, FENIX provides highlights and insights from the respective news items.