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.
Lilly, Novartis, Pfizer, and Merck each hosted their respective Q3 ’20 earnings calls and provided updates across a variety of topics. Importantly, it was disclosed that FDA has requested an advisory committee meeting to discuss Novartis’s Entresto PARAGON-HF submission. Below, FENIX provides highlights and insights from the respective earnings calls.
Two new Ph1 trials for Lilly’s LY3493269 GIP/GLP dual agonist have been observed on CT.gov (NCT04515576 and NCT04498390). Interestingly, the two trials are separately evaluating subcutaneous and oral administration of LY3493269. LY3493269 is believed to be a different molecule than tirzepatide (LY3298176) since it has a different LY number. Below, FENIX provides an overview of the studies as well as thoughts on why Lilly may have had to develop a next-gen tirzepatide for oral delivery.
Novo Nordisk hosted its post-Q2 ’20 earnings roadshow event (see previous FENIX insight on Q2 ’20 Novo earnings from August 6). Additionally, Provention Bio hosted its Q2 ’20 earnings call yesterday (press release), and Senseonics announced a positive coverage decision for its implantable CGM from Highmark. Below, FENIX provides highlights and insights from the respective news item and earnings calls.
Two diabetes-related news items have been observed: Merck announced it has entered into an exclusive licensing agreement with Hanmi for the development and commercialization of efinopegdutide, a QW GLP-1/glucagon dual agonist for the treatment of NASH (formerly HM12425A and JNJ-64565111) and Lupin received tentative FDA approval for its generic empagliflozin (view article). Below, FENIX provides thoughts on why Merck has Janssen and Novo to thank for the favorable deal terms.
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.
A series of diabetes-related news has been observed: Lilly announced it has dosed the first patient in the tirzepatide SURPASS-CVOT study, Dexcom received CE Mark for the G6 CGM to be worn on the back of the upper arm, and Nemaura Medical is set to join the Russell 2000 Index and Russell 3000 Index. Below, FENIX provides highlights and insights from the respective news items.
Late last week, Lilly announced that results from the AWARD-11 high-dose Trulicity trial had been published, with data showing up to -1.9% reduction in A1C and -10.4lb weight loss at 36 weeks with the 4.5mg dulaglutide dose (previous FENIX insight). Below, FENIX has conducted an AWARD-11 comparative analysis and provides thoughts on high-dose Trulicity in the context of Novo’s Ozempic and Lilly’s tirzepatide.
Novo Nordisk hosted its post-Q1 ’20 earnings roadshow event. Additionally, Xeris, Teva, and Becton Dickinson held their respective Q1 ’20 earnings calls. Teva did not discuss its generic liraglutide nor did BD discuss the status of its T2DM patch pump. Below, FENIX provides highlights and insights from the respective earnings calls.
Lilly hosted its Q1 ’20 earnings call and provided updates to its diabetes business. Of note, Lilly disclosed that the empa T1DM program has been discontinued. Separately, AstraZeneca announced plans to evaluate Farxiga as a treatment for hospitalized COVID-19 patients who are at increased risk of complications, such as organ failure. The trial is being conducted at Saint Luke’s Mid America Heart Institute and led by Mikhail Kosiborod. Below, FENIX provides highlights and insights from the Lilly earnings call as well as thoughts on the new AZ trial.