Category Archives: SGLT2i

Novartis Q1 ’24 Earnings; Vertex Partners with TreeFrog for T1DM Manufacturing

Two cardiometabolic-related news items have been observed: Novartis hosted its Q1 ’24 earnings call (press release; slides); and Vertex announced an exclusive licensing agreement with TreeFrog Therapeutics for TreeFrog’s proprietary cell manufacturing technology (view press release). Below, FENIX provides highlights and insights for the respective news items.

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ACC 2024: Novo, Roche/Alnylam, Esperion, Novartis, and Amarin Present New Data; Novo Resubmits Catalent Acquisition Application; AZ Initiates Ph2 Balcinrenone/Dapa Trial in CKD; Silence Publishes Ph1 Lp(a) Results; Teladoc CEO Steps Down

A series of cardiometabolic-related news items have been observed from Novo Nordisk, AstraZeneca, Roche/Alnylam, Esperion, Novartis, Amarin, Silence Therapeutics, and Teladoc. Below, FENIX provides highlights and insights for the respective news items.

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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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CBO Hints at Medicare Coverage for Obesity Drugs; AZ Initiates Ph3 Balcinrenone/Dapa Trial

Two cardiometabolic-related news items have been observed: The CBO has hinted at potential Medicare coverage for obesity drugs, such as Wegovy and Zepbound (view article); and AZ initiated a Ph3 balcinrenone+dapa trial in HF and impaired kidney function (view CT.gov record). Below, FENIX provides highlights and insights from 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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Lilly Initiates Retatrutide T2DM Pivotal Program; Medtronic CY Q4 ’23 (FY Q3 ’24) Earnings; February CHMP Agenda; Inventiva Pauses Ph3 MASH Trial; Better Therapeutics Receives BDD for MASH

A series of cardiometabolic-related news items have been observed from Lilly, Medtronic, EMA, Inventiva, and Better Therapeutics. Below, FENIX provides highlights and insights for the respective news items, including thoughts on Lilly’s Ph3 T2DM pivotal program for retatrutide.

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