Category Archives: Basal Insulin

Metsera Initiates Ph2b MET-097 Obesity Trial; Arrowhead Files for Ph1/2a Obesity Trial Initiation; Sanofi Invests in New Beijing Insulin Plant

Three cardiometabolic-related news items have been observed: Metsera initiated a Ph2b MET-097 (SC GLP-1RA) obesity trial (view CT.gov record); Arrowhead Pharmaceuticals filed for regulatory clearance to initiate a Ph1/2a ARO-ALK7 (RNAi) obesity trial (view press release); and Sanofi announced it invested €1B ($1.05B) for a new insulin manufacturing facility in Beijing (view article; view Chinese press release). Below, FENIX provides highlights and insights for the respective news items.

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New Zepbound DTC Observed; New Novo Insulin Trial; Amgen Damage Control; Lexicon, Fractyl, and Terns Q3 ‘24 Earnings; Metsera Series B Financing; G&L Oral GLP-1RA Data

A series of cardiometabolic-related news items have been observed from Lilly, Novo Nordisk, Amgen, Lexicon Pharmaceuticals, Fractyl Health, Terns Pharmaceuticals, Metsera, and Gan & Lee. Below, FENIX provides highlights and insights for the respective news items.

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November CHMP Agenda

The CHMP agenda (view here) for this month’s meeting (Nov 11-14) has been released and includes several cardiometabolic-related agenda items. Below, FENIX provides highlights and insights for the agenda.

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Lilly initiates Bimagrumab+Tirzepatide trial; Lexicon and Viatris Partner for Sotagliflozin Commercialization; Gan & Lee T2DM Assets Meet Primary Endpoints; Lipocine Virtual KOL Event; Noom Adds Body Composition to App

A series of cardiometabolic-related news items have been observed from Lilly, Lexicon Pharmaceuticals, Viatris, Gan & Lee Pharmaceuticals, Lipocine, and Noom. Below, FENIX provides highlights and insights for the respective news items.

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BI Receives BTD for Survodutide and Initiates 2 Ph3 MASH Trials; Roche Ph2 CT-388 Trial in Obesity+T2DM; Drug Compounder Group Sues FDA; WeightWatchers to Offer Compounded Semaglutide; Novo Invests $158M in Insulin Plant

A series of cardiometabolic-related news items have been observed from Boehringer Ingelheim, Roche, the Outsourcing Facilities Association, WeightWatchers, and Novo Nordisk. Below, FENIX provides highlights and insights for the respective news items.

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EASD 2024 Key Press Releases (Sep 11)

On the third day of EASD 2024, two key news items were observed from Novo Nordisk. Below, FENIX provides highlights and insights into the respective news items, including thoughts on how the icodec CRL from FDA could impact Awiqli uptake in Europe. The following topics are covered below (hyperlink to external items):

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EASD 2024 Key Press Releases (Sep 10)

On the second day of EASD 2024, 8 key news items were observed from Lilly, Novo Nordisk, Abvance Therapeutics, Scholar Rock, Altimmune, Arrowhead Pharmaceuticals, Bayer, and Lexicon. The following topics are covered below (hyperlinks to external items):

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Lilly QW Insulin QWINT-1 and -3 Topline Results; Lilly Initiates Ph3 Orforglipron Maintenance Study; Lilly-Backed OrsoBio Raises $67M in Series B for Obesity Development

Three cardiometabolic-related news items have been observed: Lilly announced positive topline results from its Ph3 QW insulin efsitora alfa trials, QWINT-1 and QWINT-3 (view press release); Lilly initiated a Ph3 study (ATTAIN-MAINTAIN; view CT.gov record) evaluating QD orforglipron in adults with overweight or obesity with weight-related comorbidities who have completed SURMOUNT-5 (tirzepatide vs. semaglutide); and OrsoBio raised $67M in a Series B financing round for the development of its mitochondrial protonophores for obesity (view article). Below FENIX, provides highlights and insights for the respective news items.

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