Tag Archives: Alnylam

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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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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Amgen, Regeneron, and Alnylam Q1 ’24 Earnings

Three cardiometabolic-related news items have been observed: Amgen (press release; slides), Regeneron (press release; slides), and Alnylam (press release; slides) hosted their respective Q1 ’24 earnings calls. Below, FENIX provides highlights and insights for the respective news items.

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FLOW Topline Results; EMA Accepts Madrigal’s Resmetirom MAA; Lilly Saving Card Outage; Alnylam and Roche Report KARDIA-2 Topline Results; Dexcom, Insulet, and MannKind to Present at ATTD 2024

A series of cardiometabolic-related news items have been observed from Novo Nordisk, Madrigal, Lilly, Alnylam/Roche, Dexcom, Insulet, and MannKind. Below, FENIX provides highlights and insights on the respective news items.

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JPM 2024 Day 1: DXCM, MDT, AMGN, AKERO, ARWR, CYTO, NVS, VRTX, ALN, REGN; Tandem X2 Control-IQ Integrated with Libre 2 Plus; Supersapiens Launches Diabetes Platform; Novo Ph3 Icosema Results

On the first day of JPM 2024, FENIX has provided coverage of presentations by major CVRM companies, including Dexcom, Medtronic, Amgen, Akero, Arrowhead, Cytokinetics, Novartis, Vertex, Alnylam, and Regeneron. Pfizer and Merck also presented at JPM 2024 but had no meaningful discussion relating to their respective CVRM portfolios. Additionally, three separate CVRM-related news items have been observed: Tandem and Abbott announced the Tandem X2 Control-IQ AID system now integrates with Abbott’s Libre 2 Plus CGM (view press release); Novo announced topline results from the COMBINE 3 study evaluating icosema vs. basal-bolus treatment in T2DM (view press release); and Supersapiens announced the launch of its Supersapiens Diabetes platform (view post).

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Roche and Alnylam Report Topline Ph2 Hypertension Results; ITBMed Initiates Ph2 Siplizumab Study in New Onset T1DM Patients

Two cardiometabolic-related news items have been observed: Roche and Alnylam announced topline results from KARDIA-1, a Ph2 study of zilebesiran for the treatment of hypertension (view press release); and ITBMed initiated a Ph2 exposure-response study evaluating if treatment with siplizumab (TCD601) improves beta-cell function in adults recently diagnosed with T1DM (view CT.gov record). Below, FENIX provides highlights and insights into the respective news items.

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Alnylam and Regeneron Q2 ’23 Earnings; Ionis and Novartis Partner for New Lp(a) Therapy; NeuroBo Receives IRB Approval for Ph2a DA-1241 Study in NASH

Four cardiometabolic-related news items have been observed: Alnylam (press release; slides) and Regeneron (press release; slides) hosted their respective Q2 ’23 earning calls; Ionis announced it entered a collaboration and license agreement with Novartis for the discovery, development, and commercialization of a medicine for patients with Lp(a)-driven CVD (view press release); and NeuroBo Pharmaceuticals announced it received IRB approval for its first site to proceed with the Ph2a clinical trial of DA-1241 (GPR119 agonist) for the treatment of NASH (view press release). Below, FENIX provides highlights and insights for the respective news items.

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Biocon Receives Even More Form 483 Observations; Roche and Alnylam Partner for Hypertension RNAi; Dario Issues Preliminary Q2 ’23 Results and Business Update

Three cardiometabolic-related news items have been observed: Biocon announced FDA conducted two cGMP inspections at Biocon’s insulin manufacturing facility in Malaysia and issued eight Form 483 observations (view press release); Roche and Alnylam announced a strategic agreement to co-develop and co-commercialize zilebesiran for the treatment of hypertension; and Dario announced a new agreement with an undisclosed large regional health plan as well as preliminary Q2 ’23 results (view press release). Below, FENIX provides highlights and insights for the respective news items.

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