Category Archives: Topics

FDA Accepts Plozasiran NDA for FCS; Cytokinetics Opens Ph2 AMBER-HFpEF Trial Enrollment

Two cardiometabolic-related news items have been observed: Arrowhead Pharmaceuticals announced FDA accepted the plozasiran NDA for familial chylomicronemia syndrome (FCS; view press release) and Cytokinetics started enrollment in the Ph2 AMBER-HFpEF trial (view press release). Below, FENIX provides highlights and insights for the respective news items.

About The Author

Matthew Maryniak

|
President of Fenix Group International

Matthew has been a thought leader in the high-growth therapeutic areas of diabetes and cardiovascular medicine since 2006, making regular attendance at large and small CV/met scientific meetings and an architect of novel methods for assessing market opportunities. He has over a decade of experience in leading CV/met consulting engagements, is a published author in PM360 and Diabetes Technology & Therapeutics, and has been quoted in The Pink Sheet on anti-thrombotics.

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Sema on Medicare Negotiation List; STEP UP Topline Results; Long-Term Cagrisema Trial; EMA Reviewing Sema for NAION Risk

A series of cardiometabolic-related news items has been observed by CMS, Novo Nordisk, and EMA. Below, FENIX provides highlights and insights for the respective news items, including thoughts on Novo’s high-dose semaglutide readout.

About The Author

Matthew Maryniak

|
President of Fenix Group International

Matthew has been a thought leader in the high-growth therapeutic areas of diabetes and cardiovascular medicine since 2006, making regular attendance at large and small CV/met scientific meetings and an architect of novel methods for assessing market opportunities. He has over a decade of experience in leading CV/met consulting engagements, is a published author in PM360 and Diabetes Technology & Therapeutics, and has been quoted in The Pink Sheet on anti-thrombotics.

If you receive our email blasts, you already have an account.

Purchase Blast$599.00

You can read the article’s full content online after purchase.

JPM 2025 Day 4: SKYE, ESPR, TRNS, IVA

On the fourth and final day of JPM 2025, FENIX has provided coverage of presentations by Skye Bioscience, Esperion Therapeutics, Terns Pharmaceuticals, and Inventiva Pharma.

About The Author

Matthew Maryniak

|
President of Fenix Group International

Matthew has been a thought leader in the high-growth therapeutic areas of diabetes and cardiovascular medicine since 2006, making regular attendance at large and small CV/met scientific meetings and an architect of novel methods for assessing market opportunities. He has over a decade of experience in leading CV/met consulting engagements, is a published author in PM360 and Diabetes Technology & Therapeutics, and has been quoted in The Pink Sheet on anti-thrombotics.

If you receive our email blasts, you already have an account.

Purchase Blast$599.00

You can read the article’s full content online after purchase.

JPM 2025 Day 3: PODD, MDGL, BMEA, IONS, SANA; Novo Wins PRV; Mounajro DTC; Lexaria Oral Liraglutide; Wisp Sublingual Sema

On the third day of JPM 2025, FENIX has provided coverage of presentations by major CVRM companies, including Insulet, Madrigal, Biomea Fusion, Ionis, and Sana Biotechnology. Separately, a series of CVRM-related news items has been observed:

About The Author

Matthew Maryniak

|
President of Fenix Group International

Matthew has been a thought leader in the high-growth therapeutic areas of diabetes and cardiovascular medicine since 2006, making regular attendance at large and small CV/met scientific meetings and an architect of novel methods for assessing market opportunities. He has over a decade of experience in leading CV/met consulting engagements, is a published author in PM360 and Diabetes Technology & Therapeutics, and has been quoted in The Pink Sheet on anti-thrombotics.

If you receive our email blasts, you already have an account.

Purchase Blast$599.00

You can read the article’s full content online after purchase.

JPM 2025 Day 2: LLY, AZN, SNY, NVS, BAY, AKRO, SRRK, SDZ, MRK, TDOC, VTRS; Dario Partners for GLP-1RA Solution Expansion

On the second day of JPM 2025, FENIX has provided coverage of presentations by major CVRM companies, including Lilly, AstraZeneca, Sanofi, Novartis, Bayer, Akero, Scholar Rock, Sandoz, Merck, Teladoc, and Viatris. Of note, JPM experienced webcast issues during the 9:45 AM PT time slot. Separately, one CVRM-related news item has been observed: Dario partnered with MediOrbis for GLP-1RA solution expansion (view press release).

About The Author

Matthew Maryniak

|
President of Fenix Group International

Matthew has been a thought leader in the high-growth therapeutic areas of diabetes and cardiovascular medicine since 2006, making regular attendance at large and small CV/met scientific meetings and an architect of novel methods for assessing market opportunities. He has over a decade of experience in leading CV/met consulting engagements, is a published author in PM360 and Diabetes Technology & Therapeutics, and has been quoted in The Pink Sheet on anti-thrombotics.

If you receive our email blasts, you already have an account.

Purchase Blast$599.00

You can read the article’s full content online after purchase.

JPM 2025 Day 1: DXCM, AMGN, VKTX, PFE, ZEAL, MDT, REGN, VTX, ALNY, CYTK; Metsera Files for IPO; Fractyl REVEAL-1 Data; Ro Zepbound DTC; 89bio 2025 Outlook

On the first day of JPM 2025, FENIX has provided coverage of presentations by major CVRM companies, including Dexcom, Amgen, Viking, Pfizer, Zealand, Medtronic, Regeneron, Vertex, Alnylam, and Cytokinetics. Roche also presented at JPM 2025 but had no meaningful discussion relating to its CVRM portfolio. Additionally, a series of CVRM-related news items have been observed:

About The Author

Matthew Maryniak

|
President of Fenix Group International

Matthew has been a thought leader in the high-growth therapeutic areas of diabetes and cardiovascular medicine since 2006, making regular attendance at large and small CV/met scientific meetings and an architect of novel methods for assessing market opportunities. He has over a decade of experience in leading CV/met consulting engagements, is a published author in PM360 and Diabetes Technology & Therapeutics, and has been quoted in The Pink Sheet on anti-thrombotics.

If you receive our email blasts, you already have an account.

Purchase Blast$599.00

You can read the article’s full content online after purchase.

Diamyd Type C Meeting Updates; Kardigan Launches as CV Company; Regor Topline Ph2a Results for Oral GLP-1RA

Three cardiometabolic-related news items have been observed: Diamyd provided details on the meeting minutes from its Type C meeting with FDA regarding accelerated approval of Diamyd (view press release); Kardigan announced its launch as a CV-focused company (view press release); and Regor Therapeutics announced topline Ph2a results for its oral QD GLP-1RA in obesity (view press release). Below, FENIX provides highlights and insights for the respective news items.

About The Author

Matthew Maryniak

|
President of Fenix Group International

Matthew has been a thought leader in the high-growth therapeutic areas of diabetes and cardiovascular medicine since 2006, making regular attendance at large and small CV/met scientific meetings and an architect of novel methods for assessing market opportunities. He has over a decade of experience in leading CV/met consulting engagements, is a published author in PM360 and Diabetes Technology & Therapeutics, and has been quoted in The Pink Sheet on anti-thrombotics.

If you receive our email blasts, you already have an account.

Purchase Blast$599.00

You can read the article’s full content online after purchase.

Zepbound OSA Label and Website Analysis

FDA recently approved the Zepbound label expansion to treat moderate-to-severe obstructive sleep apnea (OSA) in adults with obesity (view label; previous FENIX insight). The label expansion is based on Lilly’s Ph3 SURMOUNT-OSA trial evaluating tirzepatide in participants with OSA and obesity (view publication; previous FENIX insight). Below, FENIX has conducted an analysis of the updated Zepbound label and patient/HCP/employer websites.

About The Author

Matthew Maryniak

|
President of Fenix Group International

Matthew has been a thought leader in the high-growth therapeutic areas of diabetes and cardiovascular medicine since 2006, making regular attendance at large and small CV/met scientific meetings and an architect of novel methods for assessing market opportunities. He has over a decade of experience in leading CV/met consulting engagements, is a published author in PM360 and Diabetes Technology & Therapeutics, and has been quoted in The Pink Sheet on anti-thrombotics.

If you receive our email blasts, you already have an account.

Purchase Blast$599.00

You can read the article’s full content online after purchase.

FENIX Analysis: How Will Amgen Price MariTide in Obesity?

With the recent Amgen MariTide Ph2 data readout (previous FENIX insight), a natural question becomes: how will it be priced in the context of the evolving US obesity market? For context, Amgen management highlighted it is in discussions with regulators to “rapidly advance” the initiation of its Ph3 MARITIME program (view website) following the topline Ph2 readout (view CT.gov record; previous FENIX insight).

About The Author

Matthew Maryniak

|
President of Fenix Group International

Matthew has been a thought leader in the high-growth therapeutic areas of diabetes and cardiovascular medicine since 2006, making regular attendance at large and small CV/met scientific meetings and an architect of novel methods for assessing market opportunities. He has over a decade of experience in leading CV/met consulting engagements, is a published author in PM360 and Diabetes Technology & Therapeutics, and has been quoted in The Pink Sheet on anti-thrombotics.

If you receive our email blasts, you already have an account.

Purchase Blast$599.00

You can read the article’s full content online after purchase.

Lilly/Thrive Partnership for LillyDirect; Verdiva Lauches as Obesity Company; Senseonics Business Updates

Three cardiometabolic-related news items have been observed: Lilly and Thrive Global announced a partnership to implement healthy behaviors on LillyDirect (view press release); Verdiva Bio announced its launch as a cardiometabolic company (view press release); and Senseonics released its YE 2024 business update (view press release). Below, FENIX provides highlights and insights for the respective news items.

About The Author

Matthew Maryniak

|
President of Fenix Group International

Matthew has been a thought leader in the high-growth therapeutic areas of diabetes and cardiovascular medicine since 2006, making regular attendance at large and small CV/met scientific meetings and an architect of novel methods for assessing market opportunities. He has over a decade of experience in leading CV/met consulting engagements, is a published author in PM360 and Diabetes Technology & Therapeutics, and has been quoted in The Pink Sheet on anti-thrombotics.

If you receive our email blasts, you already have an account.

Purchase Blast$599.00

You can read the article’s full content online after purchase.