Category Archives: Other

Vertex Announces FDA Clearance of IND for VX-264 in T1DM; Akebia and Dario Q4 ’22 Earnings

Three cardiometabolic-related news items have been observed: Vertex announced FDA has cleared the VX-264 IND application for the treatment of T1DM (press release); and Akebia Therapeutics (press release) and Dario Health (press release) hosted their respective Q4 ’22 earnings calls. Below, FENIX provides highlights and insights into the respective news items.

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FDA Accepts Jardiance Pediatric sNDA; New Teplizumab Pediatric Trial; Sernova Completes Islet Transplantation in First Two Ph1/2 T1DM Patients; Xeris and vTv Therapeutics Q4 ’22 Earnings

A series of cardiometabolic-related news items have been observed: BI/Lilly announced FDA accepted the Jardiance (empagliflozin) pediatric T2DM sNDA (view press release); Provention Bio initiated a Ph4 open-label trial evaluating the safety and PK of teplizumab in participants with Stage 2 T1DM who are <8 years of age (PETITE-T1D; view CT.gov record); Sernova announced the first two patients in the second cohort of its US Ph1/2 clinical trial received their first islet transplant (view press release); and Xeris (press release) and vTv Therapeutics (press release) released their Q4 ’22 earnings. Below, FENIX provides highlights and insights from the respective news items. 

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CMS Expands CGM Coverage; New Novo R&D Presence in Boston; Bigfoot Unity Android App Approval; Cytokinetic Receives Omecamtiv CRL; Galectin Finalizes Ph2b/3 NAVIGATE Randomization; Imcyse Completes Trial Enrollment; and Zealand, Intercept, and Amarin Q4 ’22 Earnings

A series of cardiometabolic-related news items has been observed from CMS, Novo Nordisk, Bigfoot, Zealand, Intercept, Cytokinetics, Amarin, Galectin, and Imcyse. Below, FENIX provides highlights and insights into the respective news items.

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Bayer Q4 ’22 Earnings Update

Bayer hosted its Q4 ’22 earnings call (press release; slides) and provided updates across its business, including Kerendia (finerenone) in the context of the ongoing US launch and LCM initiatives. Below, FENIX provides highlights and insights from the call.

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Esperion Launches Website Featuring CLEAR Outcomes; Abbott Receives 510(k) Approval for APIs; Novartis Initiates Ph3 Inclisiran Primary Prevention Trial; Nemaura and Viatris Q4 ’22 Earnings Updates

Five cardiometabolic-related news items have been observed: Esperion announced it has launched a new website (esperionscience.com) featuring information about CLEAR Outcomes (view press release); Abbott received FDA 510(k) approval to add APIs to the FreeStyle Libre 2 and 3 CGM systems (view 510(k) decision letter); Novartis has initiated a Ph3 trial evaluating inclisiran vs. placebo in a primary prevention cohort (VICTORIAN-1 PREVENT; view CT.gov record); Nemaura Medical published its CY Q4 ‘22 (FY Q3 ‘23) business update (press release); and Viatris hosted its Q4 ’22 earnings call (press release; slides). Below, FENIX provides highlights and insights from the respective news items.

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Ionis Q4 ’22 Earnings; ATTD 2023 Key Press Releases

A series of cardiometabolic-related news items have been observed from Ionis, Dexcom, Ypsomed, Amgen, and MannKind. Below, FENIX provides highlights and insights into the respective news items.

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Medtronic and Esperion CY Q4 ’22 Earnings Updates; Akebia Receives Another FDA Response for Vadadustat; Wegovy and Vadadustat CHMP Opinions; February CHMP Agenda

A series of diabetes-related news items have been observed: Medtronic (press release; slides) and Esperion (press release; slides) hosted their respective CY Q4 ’22 earnings calls; Akebia received another FDA response regarding the vadadustat CRL appeal (press release); and the February CHMP Agenda was posted, including vadadustat and Wegovy (potential) opinions. Below, FENIX provides highlights and insights from the respective news items, including thoughts on Medtronic’s Simplera CGM approval timing.

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