Category Archives: Topics

Diamyd Ph3 Recruitment Update

Diamyd Medical announced it has enrolled 180 patients in the Ph3 DIAGNODE-3 trial (view CT.gov record), exceeding the recruitment target set for the planned early readout in March 2026. For context, DIAGNODE-3 is evaluating the Diamyd diabetes vaccine in 330 recently diagnosed T1DM patients 12-28 years of age who carry the HLA DR3-DQ2 haplotype (previous FENIX insight). Recall, in September 2024, Diamyd announced it will pursue accelerated approval in the US (previous FENIX insight). Below, FENIX provides brief insight on the Diamyd approval timeline.

This content is for Read Less members only.
Register
Already a member? Log in here

Lilly and Laekna Obesity Partnership; Viking Ph2b MASH Data; Medtronic InPen App FDA Clearance; Omnipod 5 and FreeStyle Libre 2 Plus Integration; Flagship and Ampersand Obesity Partnership; NewAmsterdam Ph3 TANDEM CV Data

A series of cardiometabolic-related news items have been observed from Lilly, Viking, Medtronic, Insulet, Pfizer, and NewAmsterdam Pharma. Below, FENIX provides highlights and insights for the respective news items.

This content is for Read Less members only.
Register
Already a member? Log in here

Dexcom and Oura Partnership; Novo ESSENCE Data at AASLD; Medtronic CY Q3 ’24 (FY Q2 ’25) Earnings; Silence, Esperion, NewAmsterdam, and Arrowhead Data at AHA 2024; Aligos Ph2 MASH Data; Biomea COVALENT-111 Analysis

A series of cardiometabolic-related news items have been observed from Dexcom, Novo Nordisk, Medtronic, Silence Therapeutics, Aligos Therapeutics. Biomea Fusion, Esperion, NewAmsterdam Pharma, and Arrowhead. Below, FENIX provides highlights and insights for the respective news items.

This content is for Read Less members only.
Register
Already a member? Log in here

Boston Pharmaceuticals Ph2a MASH Topline Results

Boston Pharmaceuticals announced positive topline results from its Ph2a study (view CT.gov record) evaluating efimosfermin alfa (formerly BOS-580; SC QM FGF21 analog) in participants with F2/F3 fibrosis due to MASH. Of note, results will be presented at AASLD 2024 (Nov 15-19; San Diego, CA) and the company will host an investor event to discuss the data on November 21, 2024 (view webcast). Below, FENIX provides highlights and insights for the topline results.

This content is for Read Less members only.
Register
Already a member? Log in here

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.

This content is for Read Less members only.
Register
Already a member? Log in here

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.

This content is for Read Less members only.
Register
Already a member? Log in here