Tag Archives: Madrigal Pharmaceuticals

Madrigal Submits Resmetirom NASH NDA

Madrigal Pharmaceuticals announced it initiated a rolling submission with FDA for an NDA seeking accelerated approval for resmetirom for the treatment of NASH with liver fibrosis. According to the press release, Madrigal has submitted the majority of the NDA to FDA and plans to submit the remaining components in July 2023 along with a request for priority review. For context, in April 2023, resmetirom received Breakthrough Therapy designation for the treatment of NASH with liver fibrosis (previous FENIX insight). Recall, on June 22, 2023, Madrigal announced new MAESTRO-NASH data at EASL 2023 (previous FENIX insight).

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EMA Raises Thyroid Safety Concern Over GLP-1RAs; Madrigal Presents New MAESTRO-NASH Data; Expanded Libre 2 Coverage in France; Bayer Initiates Finerenone CKD + T1DM study; Bigfoot RWE Data Published; Mannkind Initiates INHALE-3 Switching Study

A series of cardiometabolic-related news items have been observed from EMA, Madrigal, Abbott, Bayer, Bigfoot, and Mannkind. Below, FENIX provides highlights and insights in the respective news items.

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AZ’s Farxiga Receives FDA Approval for DELIVER; Esperion, Xeris, Madrigal, and Sigilon Q1 ’23 Earnings; Ascensia Expands Eversense PASS Program; and Glooko Redesigns App

A series of cardiometabolic-related news items have been observed from AstraZeneca, Ascensia, and Glooko. Additionally, Esperion, Xeris, Madrigal, and Sigilon provided Q1 ’23 earnings updates. Below, FENIX provides highlights and insights into the respective news items.

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Resmetirom Receives Breakthrough Therapy Designation; Tiziana Initiates Foralumab T1DM Program; Teladoc Expands Provider-Based Care; J&J Q1 ’23 Earnings

Four cardiometabolic-related news items have been observed: Madrigal announced resmetirom received Breakthrough Therapy Designation (BTD) from FDA for the treatment of NASH with liver fibrosis (view press release); Tiziana Life Sciences announced it is initiating a program to develop intranasal foralumab for the treatment or prevention of T1DM (view press release); Teladoc Health announced the expansion of its Provider-Based Care for weight management and prediabetes programs (view press release); and Johnson & Johnson hosted its Q1 ’23 earnings call (press release; slides). Below, FENIX provides highlights and insights into the respective news items. 

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Madrigal Announces Additional Positive MAESTRO-NASH Data; Bluebird Sells Second PRV to BMS for $95M

Two cardiometabolic-related new items have been observed: Madrigal Pharmaceuticals announced additional positive results from the pivotal Ph3 MAESTRO-NASH trial evaluating resmetirom in patients with NASH and liver fibrosis (view press release; CT.gov record); and bluebird bio announced it entered into a definitive agreement to sell its second Rare Disease PRV to BMS for $95M (view press release; view 8-K). Below, FENIX provides highlights and insights for the respective news items, including updated thoughts on the resmetirom filing discrepancy.

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Lilly Initiates Final Ph3 QWINT Trial; Madrigal Announces $300M+ in Financing Events to Advance Resmetirom; Akebia Receives Interim Response to Appeal for Vadadustat CRL

Three cardiometabolic-related news items have been observed: The final trial from Lilly’s Ph3 QW insulin QWINT program has been observed (QWINT-1; view CT.gov record); Madrigal announced plans to leverage $300M+ in financing events to support planned commercial and clinical activities for resmetirom in NASH (view press release); and Akebia announced it received an interim response from FDA to its Formal Dispute Resolution Request regarding the vadadustat CRL issued in March 2022 (view press release). Below, FENIX provides highlights and insight on the respective news items, including thoughts on Lilly’s strategy to pursue a QW insulin fixed-dose escalation regimen as well as readthrough from GSK’s impending daprodustat PDUFA to Akebia’s vadadustat.

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Insulet, Provention Bio, Madrigal, and Regeneron Q3 ’22 Earnings Updates

A series of cardiometabolic-related news items have been observed: Insulet (press release), Provention Bio (press release), and Regeneron (press release; slides) hosted their Q3 ’22 earnings calls and; Madrigal issued a press release for its Q3 ‘22 earnings, though it did not host an associated webcast. Below, FENIX provides highlights and insights for the respective news items.

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Ypsomed Launches Remote Bolus Feature; Lannett Completes Bs-glargine Pivotal Trial; Madrigal Initiates MAESTRO-NASH Outcomes Study for Resmetirom

Three cardiometabolic-related news items have been observed: Ypsomed announced the launch of a smartphone bolus delivery feature for its mylife YpsoPump using the mylife App; Lannett announced it completed subject dosing in its Ph1 bs-glargine pivotal trial (view CT.gov record); and Madrigal announced the initiation of a Ph3 MAESTRO-NASH Outcomes study evaluating the effect of QD oral 80mg resmetirom compared to placebo in patients with compensated NASH cirrhosis (view CT.gov record). Below, FENIX provides context and insight on the respective news items.

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Pfizer and Ionis Discontinue Vupanorsen in Dyslipidemia; Glooko Acquires xbird; Madrigal Announces Positive Ph3 MAESTRO-NAFLD-1 Topline Results

Three cardiometabolic-related news items have been observed: Pfizer and Ionis announced they are discontinuing vupanorsen development for dyslipidemia following Ph2b topline results; Glooko announced it has acquired xbird; and Madrigal Pharmaceuticals announced positive topline results from its Ph3 MAESTRO-NAFLD-1 resmetirom study and hosted an associated webcast (listen to webcast here; slides). Below, FENIX provides highlights and insights for the respective new items.

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