Tag Archives: pemvidutide

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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ADA 2024 Key Press Releases (June 23)

On the third day of ADA 2024, four cardiometabolic-related news items have been observed from Senseonics, Altimmune, Fractyl Health, and Gan & Lee. Below, FENIX provides context and analysis for the announcements.

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ADA 2024 Key Press Releases (June 22)

On the second day of ADA 2024, six cardiometabolic-related news items have been observed from Insulet, Medtronic, Terns Pharmaceuticals, MannKind, Tandem, and Altimmune. Below, FENIX provides context and analysis for the announcements.

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Pfizer Loses and Altimmune Wins with New Ph2 Obesity Data

Two cardiometabolic-related news items have been observed: Pfizer announced topline results from the danuglipron (BID oral GLP-1RA) Ph2b clinical trial and disclosed it will not be advancing the formulation into Ph3 (view press release); and Altimmune announced positive topline results from the Ph2 MOMENTUM study evaluating pemvidutide for the treatment of obesity (view press release). Following the results, Altimmune’s stock increased ~18%. Below, FENIX provides highlights and insights for the respective news items, including thoughts on how the Ph2b danuglipron data may impact Pfizer’s decision not to advance BID danuglipron.

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Altimmune’s Pemvidutide Receives Fast Track Designation in NASH; New Diamyd T1DM Results; Viking and Merck Q3 ’23 Earnings

Four cardiometabolic-related news items have been observed: FDA granted Fast Track Designation to Altimmune’s pemvidutide for the treatment of NASH (view press release); Diamyd announced results from a retrospective follow-up study of two prior trials, DiAPREV-IT and DiAPREV-IT2 (view press release); Viking (press release) and Merck (press release; slides) hosted their respective Q3 ’23 earnings call. Below, FENIX provides highlights and insights for the respective news items.

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Entera Bio to Collaborate with OPKO Biologics for Obesity; Dexcom Launches Dexcom ONE in France; Altimmune Completes Ph2 Obesity Trial Dosing; Vertex Acquires Novel GPCR-targeted Program

Four cardiometabolic-related news items have been observed: Entera Bio and OPKO Biologics entered into a research collaboration agreement for OPKO’s long-acting GLP-2 peptide and certain oxyntomodulin (OXM) analogs (view press release); Dexcom announced Dexcom ONE has been launched in France (with reimbursement) for patients two years of age and older with T1DM and T2DM, who are undergoing intensive insulin therapy (view press release); Altimmune announced the completion of dosing in its 48-week Ph2 MOMENTUM trial, evaluating the safety and efficacy of pemvidutide in patients with obesity or overweight (view press release); and Septerna announced it signed a definitive asset purchase agreement with Vertex for an undisclosed discovery-stage GPCR program (view press release). Below, FENIX provides highlights and insights into the respective news items.

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Altimmune Initiates Ph2b Pemvidutide NASH Trial; Pfizer, Esperion, and Merck Q2 ‘23 Earnings

Four cardiometabolic-related news items have been observed: Altimmune announced enrollment of the first subject in its Ph2b IMPACT trial evaluating the efficacy and safety of pemvidutide (QW GLP-1/GCG dual agonist) in NASH (view press release); and Pfizer (press release; slides), Esperion (press release; slides), and Merck (press release; slides) hosted their respective Q2 ‘23 earnings calls. Below, FENIX provides highlights and insights into the respective news items.

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