Category Archives: Dual/triple agonist

UK MHRA Approves SELECT; Skye Obesity Development Plans; New Lilly Obesity Ads Observed

Three cardiometabolic-related news items have been observed: The UK’s MHRA approved SELECT (view press release); Skye Biosciences hosted a virtual KOL event discussing the nimacimab obesity development program and timeline (view press release); and new Lilly obesity awareness ads have been observed. Below, FENIX provides highlights and insights for the respective news items.

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BioAge Initiates Ph2 POC Oral Azelaprag+Tirzepatide Combination Trial in Obesity; TIXiMED Receives IND Approval from FDA for Oral Non-Immunosuppresive T1DM Drug; Novo Buys Land in Denmark for Potential Production Plant

Three cardiometabolic-related news items have been observed: BioAge Labs initiated a Ph2 POC study evaluating co-administered oral azelaprag QD or BID with QW SC injection of tirzepatide in obesity (STRIDES; view CT.gov record); TIXiMED announced it obtained IND approval from FDA for its oral T1DM drug, TIX100 (view press release); and Novo Nordisk reportedly will begin construction for a potential new production plant in Denmark (view article). Below, FENIX provides highlights and insights for the respective news items.

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July CHMP Agenda; Hims & Hers Appoints Kåre Schultz to BOD; G&L Ph2b Obesity Results; Tirzepatide and Semaglutide Approved in China for Obesity

A series of cardiometabolic-related news items have been observed from EMEA, Hims & Hers, Gan & Lee, and Lilly. Below, FENIX provides highlights and insights for the respective news items.

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Roche Ph1b Obesity Results; CordenPharma Invests $982M to Expand GLP-1RA Capacity in US and EU; Lexicon Receives PDUFA Date for Sotagliflozin in T1DM; Lexicon Publishes Additional Inpefa Cost-Effectiveness Analysis

A series of cardiometabolic-related news items have been observed from Roche, CordenPharma, and Lexicon Pharmaceuticals. Below, FENIX provides highlights and insights for the respective news items.

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Pfizer Advances QD Danuglipron; Skye Establishes Clinical Advisory Board; Tonghua Dongbao Discontinues BioChaperone Combo Partnership with Adocia; FTC Prepares to Sue Three Largest PBMs

A series of cardiometabolic-related news items have been observed from Pfizer, Skye Biosciences, Adocia, and the FTC. Below, FENIX provides highlights and insights for the respective news items.

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Roche CGM Receives CE Mark; Lilly Beats Novo in GLP-1RA Observational Study; Pfizer Leadership Change; FTC Releases Prescription Drug Middlemen Interim Staff Report

A series of cardiometabolic-related news items have been observed from Roche, Lilly, Pfizer, and the FTC. Below, FENIX provides highlights and insights for the respective news items.

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Mounjaro Olympics DTC; Xeris CEO Succession Plan; Lexicon Appoints New CEO and Director; Inventiva NATiV3 Lanifibranor Updates

A series of cardiometabolic-related news items have been observed from Lilly, Xeris Biopharma, Lexicon Pharmaceuticals, and Inventiva. Below, FENIX provides highlights and insights for the respective news items.

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BI Announces Triple Agonist for Obesity Treatment; Merck Initiates Ph2a Trial of Efinopegdutide in MASLD

Two cardiometabolic-related news items have been observed: Boehringer Ingelheim and Gubra announced the launch of a Ph1 trial evaluating its triple agonist, BI 3034701, in obesity (view press release); and Merck initiated a Ph2a trial evaluating Q2W vs. QW administration of efinopegdutide (MK-6024) in MASLD (view CT.gov record). Below, FENIX provides highlights and insights for the respective news items, including thoughts on potential MOAs for BI’s triple agonist.

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Ionis’s Olezarsen FCS Filing Accepted with Priority Review; Scholar Rock Obesity Development Updates; Zealand Raises $900M Towards Obesity Development; Sernova Ph1/2 Cell Pouch T1DM Updates; Fractyl Pipeline Updates; New Dario Digital Health GLP-1RA Data

A series of cardiometabolic-related news items have been observed from Ionis, Scholar Rock, Zealand, Sernova, Fractyl Health, and Dario Health. Below, FENIX provides highlights and insights for the respective news items.

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ADA 2024 Key Press Releases (June 24)

On the final day of the ADA 2024 conference, nine cardiometabolic-related news items have been observed from Novo Nordisk, Adipo Therapeutics, Trinity Biotech, Alnylam, Viking, Teva, Teladoc Health, and CHMP. Below, FENIX provides context and analysis for the announcements, including thoughts on the potential FLOW label.

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