Category Archives: Other

Awiqli (QW Insulin Icodec) Receives Positive CHMP Opinion; Oprah TV Special Spotlights Zepbound and Wegovy

Two cardiometabolic-related news items have been observed: CHMP adopted a positive opinion, recommending marketing authorization for “Awiqli” (QW insulin icodec) for the treatment of diabetes in adults (view press release); and Oprah hosted a show on ABC titled, “Shame, Blame, and the Weight Loss Revolution” which addressed the stigma associated with obesity and the success of GLP-1RAs (view article; watch episode on HULU). Below, FENIX provides highlights and insights for the respective news items, including brief thoughts on the social media hype following Oprah’s TV special.

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Inventiva Interim Ph2a MASH Results; Madrigal Announces $600M Public Offering; 89bio Initiates Ph3 ENLIGHTEN-Fibrosis MASH Trial

Three cardiometabolic-related news items have been observed: Inventiva announced positive interim Ph2a LEGEND MASH trial results (press release; slides); Madrigal priced an upsized $600M public offering (view press release); and 89bio’s Ph3 ENLIGHTEN-Fibrosis trial in MASH has been posted to CT.gov (view CT.gov record). Below, FENIX provides highlights and insights for the respective new items.

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Icodec up for CHMP Opinion; March CHMP Agenda; Galmed Granted MASH Combo Patent; Sequel’s twiist AID Receives 510(k) Clearance

Three cardiometabolic-related news items have been observed: The CHMP agenda for this month’s meeting (March 18-21) has been released and Novo Nordisk’s insulin icodec is up for an opinion (view CHMP agenda); Galmed announced it was granted an EU patent for the combination of aramchol and resmetirom for the treatment of MASH and liver fibrosis (view press release); and Sequel Med Tech announced it received 510(k) clearance for the twiist AID system (view press release). Additionally, FENIX has provided a correction to Novo’s new Rybelsus doses based on information from its Q3 2023 earnings press release. Below, FENIX provides highlights and insights into the respective news items.

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Ionis Ph2 MASH Results; New BI Ph3 Survodutide MASH Trial; Silence Ph2 Lp(a) Results; Lilly Partners with Amazon Pharmacy; Arecor Partners for Oral GLP-1RA; Ascensia Expands PSP

A series of cardiometabolic-related news items have been observed from Ionis Pharmaceuticals, Boehringer Ingelheim, Silence Therapeutics, Lilly, Arecor Therapeutics, and Ascensia Diabetes Care. Below, FENIX provides highlights and insights for the respective news items.

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Lexicon Sota T1DM Indication and CKM; Lilly Expands Redwire Collaboration; 89bio Initiates Ph3 ENLIGHTEN MASH Program; Fractyl Reports Preclinical Rejuva Findings; Welldoc Receives CE Mark for Bluestar

A series of cardiometabolic-related news items have been observed from Lexicon, Lilly/Redwire, 89bio, Fractyl Health, and Welldoc. Below, FENIX provides highlights and insights for the respective news items, including thoughts on how Lexicon’s sotagliflozin T1DM indication may be linked to the future continuous ketone monitor from Abbott.

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