Tag Archives: BMF-219

Zynquista Negative Adcom Vote; Novo STEP-9 Results Published; Wegovy Removed from FDA Shortage List; Amgen, Madrigal, Biomea, Teladoc, and Amarin Q3 ’24 Earnings; BI/Gubra Discontinue NPY2 for Obesity; Inventiva Positive DMC Recommendation for Ph3 MASH Trial

A series of cardiometabolic-related news items have been observed from Lexicon, Novo Nordisk, Amgen, Madrigal, Biomea Fusion, BI/Gubra, Inventiva, Teladoc, and Amarin. Below, FENIX provides highlights and insights for the respective news items.

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Metsera Partners with Amneal for Obesity Manufacturing; Rivus Obesity Data at HFSA 2024; Sagimet Receives BTD for Denifanstat; Biomea Establishes Scientific Advisory Board; Madrigal Appoints New SVP

A series of cardiometabolic-related news items have been observed from Metsera/Amneal Pharmaceuticals, Rivus Pharmaceuticals, Sagimet Biosciences, Biomea Fusion, and Madrigal Pharmaceuticals. Below, FENIX provides highlights and insights for the respective news items.

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FDA Lifts BMF-219 Clinical Hold; Abvance ABV 101 Virtual KOL Event

Two cardiometabolic-related news items have been observed: FDA lifted the clinical hold on Biomea Fusion’s clinical trials of BMF-219 in T2DM and T1DM (view press release; view webcast); and Abvance Therapeutics hosted a virtual KOL event for its ABV 101 asset (view webcast). Below, FENIX provides highlights and insights for the respective news items. 

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Tirzepatide SUMMIT HFpEF Topline Results; Regeneron, Alnylam, Ionis, Teladoc, Amarin, and Biomea Q2 ’24 Earnings; Antag Increases Series A Funding for GIP Antagonism; Sanofi Expands Insulin Manufacturing in Germany; Boston Pharmaceuticals MASH Updates

A series of cardiometabolic-related news items have been observed from Lilly, Regeneron, Alnylam, Antag Therapeutics, Sanofi, Boston Pharmaceuticals, Ionis, Teladoc, Amarin, and Biomea Fusion. Below, FENIX provides highlights and insights for the respective news items, including initial thoughts on Lilly’s tirzepatide HFpEF results in the context of Novo’s STEP HFpEF and apparent regulatory delay.

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BI Presents MASH Data at EASL 2024; Scholar Rock Initiates Ph2 Apitegromab Trial in Obesity; Biomea’s BMF-219 Placed on Clinical Hold

Three cardiometabolic-related news items have been observed: Boehringer Ingelheim announced full results from its Ph2 survodutide MASH trial were presented at the EASL 2024 conference (view press release); Scholar Rock’s Ph2 apitegromab obesity trial has been posted to CT.gov (view CT.gov record); and Biomea Fusion’s BMF-219 trials have been placed on clinical hold due to an increase in liver enzymes observed in the Ph1/2 trial (view press release). Below, FENIX provides highlights and insights into the respective news items.

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Biomea and Fractyl Q4 ’23 Earnings; Glucotrack Implantable CGM Update; Costco Weight Loss Program; D&D Fast Track Designation in MASH; New Aligos Ph2a MASH Trial; Sernova Cell Pouch Updates

A series of cardiometabolic-related news items have been observed from Biomea Fusion, Fractyl Health, Glucotrack, Sesame/Costco, D&D Pharmatech, Aligos Therapeutics, and Sernova. Below, FENIX provides highlights and insights for the respective news items.

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ATTD 2024 Key Press Releases Day 1 (March 6)

On the first day of ATTD 2024, seven cardiometabolic-related news items were observed from Roche, Dexcom, Abbott, Lilly, Know Labs, Akero, and Biomea Fusion. Below, FENIX provides highlights and insights for the respective news items.

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JPM 2024 Day 2: ABT, PODD, NVO, LLY, AZN, BAY, BMF, TDOC; Embecta Files 510(k) for T2DM Patch Pump; Omada Partners with Amazon for Cardiometabolic Programs

On the second day of JPM 2024, FENIX has provided coverage of presentations by major CVRM companies, including Abbott, Insulet, Novo Nordisk, Lilly, AZ, Bayer, Biomea, and Teladoc. GSK and Sanofi also presented at JPM 2024 but had no meaningful discussion relating to their respective CVRM portfolios. Separately, two CVRM-related news items have been observed: Embecta announced it submitted a 510(k) filing to FDA for its open-loop patch pump for T2DM (view press release); and Omada Health announced a partnership with Amazon’s Health Condition Programs for its cardiometabolic programs (view press release).

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