Six cardiometabolic-related news items have recently been observed from Dexcom, Abbott, Teladoc, Amarin, Biocon, and Merck. Below, FENIX provides highlights and insights for the respective news items.
Four cardiometabolic-related news items have been observed: Welldoc announced it recently received its 20th patent for “database management and graphical user interfaces for measurements collected by analyzing blood”; Nemaura Medical hosted a webcast and provided investors with brief updates to its business; and Sanofi and Teva hosted their respective Q1 ’21 earnings calls. Below, FENIX provides highlights and insights for the respective news items.
A series of cardiometabolic-related news items have been observed: Lilly and Novartis hosted their respective Q1 ’21 earnings calls; Lilly has initiated a new Trulicity DTC campaign; and Provention Bio announced it met with FDA on April 23, 2021 to discuss the ongoing teplizumab PK comparability issue. Importantly, Lilly disclosed that SURPASS-4 has accrued all of its pre-specified CV events and the trial is scheduled to close out in May with topline results expected by the end of Q2 ’21. Recall, Lilly has previously stated SURPASS 4 is the gating factor for tirzepatide T2DM global regulatory submissions later in 2021. Below, FENIX provides highlights and insights for the respective items.
Three cardiometabolic-related news items have been observed: Better Therapeutics announced the first patient has been enrolled in a pivotal study to evaluate the safety and efficacy of BT-001 for the treatment of T2DM; ProtoKinetix announced it has resumed the Ph1 trials of PKX-001 treated islet cells following a pause due to COVID-19; and Amarin announced it received Great Britain Marketing Authorization approval of Vazkepa (icosapent ethyl) to reduce the risk of CV events in high-risk, statin-treated adults with elevated triglycerides (≥150 mg/dL) and either established CVD or diabetes and at least one additional CV risk factor. Below, FENIX provides highlights and insights for the respective news items.
A series of diabetes-related news items have recently been observed: Novo Nordisk announced its intention to enter Ph3a development of oral semaglutide in obesity; Integrity Applications announced the appointment of notable diabetes device KOL, David Klonoff, to its Scientific Advisory Board; Roche hosted its Q1 ’21 earnings call; Poxel issued its Q1 ’21 earnings and provided an update across its business including imeglimin for T2DM and PXL770/PXL065 for NASH; and Adocia announced its Q1 ’21 earnings update. Below, FENIX provides highlights and insights for the respective news items.
A series of diabetes-related news items have been observed: a CT.gov record for Novo’s Ph3 QW insulin icodec T1DM trial (ONWARDS 6) has been observed; Dexcom announced Health Canada has authorize G6 for upper arm wear; Dario announced a virtual care initiative with MediOrbis for telehealth and remote patient monitoring; Abbott hosted its Q1 ’21 earnings call; and J&J hosted its Q1 ’21 earnings call. Below, FENIX provides highlights and insights for the respective news items.
A series of diabetes-related news items have recently been observed: Novo Nordisk’s Ozempic label has been updated once again to include an NDC for a 1mg x 4 dose 3mL pen; Diamyd announced a contract with ICON plc for the Ph3 DIAGNODE trial evaluating its Diamyd diabetes vaccine; and Nemaura Medical announced the appointment of Samantha Sanders as Global Head of Digital Programs. Below, FENIX provides highlights and insights for the respective news items, including the curious thoughts on why Novo may have had the 1mg x 4 dose pen removed from the label and added back.
A series of cardiometabolic-related new items have recently been observed from Boehringer Ingelheim/Zealand, vTv Therapeutics, Jaguar Gene Therapy, CeQur, Nemaura Medical, Biocorp/Roche, and Amarin. Below, FENIX provides highlights and insights for the respective news items.
A series of cardiometabolic-related news items have recently been observed from Provention Bio, Better Therapeutics, Dexcom, Sanofi, Medtronic, and JDRF Canada. Below, FENIX provides highlights and insights for the respective news items, including thoughts on how bad the teplizumab delay may really be.
Yesterday, Fibrogen issued a press release and hosted a call with investors in which the company provided clarification on certain prior disclosures of US primary CV safety analyses from the roxadustat Ph3 program for the treatment of CKD anemia. According to the press release, while senior management was preparing for the roxadustat adcom (tentatively scheduled for July 15, 2021), it became clear that the “primary cardiovascular safety analyses included post-hoc changes to the stratification factors.” Below, FENIX provides thoughts from various angles that suggest the ~40% share price hit to Fibrogen is a non-contextualized Wall Street overreaction.