Category Archives: Other

Verquvo (Vericiguat) Approved by FDA; Label Analysis, Entresto and CYTK Implications

Merck and Bayer received FDA approval of vericiguat, branded as “Verquvo,” for symptomatic chronic HF (Merck press release here and Bayer press release here). Recall, vericiguat received Priority Review from FDA in July 2020 despite the modest 10% RRR in the VICTORIA CVOT primary endpoint (view NEJM publication). For context, Verquvo is the first treatment for chronic HF approved specifically for patients following a hHF or need for outpatient intravenous diuretics. Below, FENIX details its Verquvo label analysis, including the potential for counter-detail by SGLT2i manufacturers, as well as thoughts on the cumulative regulatory tailwinds for Cytokinetics’s omecamtiv.

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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High-Dose Ozempic Filed with FDA; Andy Ajello Joins Vifor

Novo Nordisk announced it has filed the sNDA for high-dose Ozempic (2.0mg) based on results from the SUSTAIN FORTE trial, which read out in November 2020 (previous FENIX insight). Additionally, Andrew (Andy) Ajello, former Lexicon Commercial Lead and Novo SVP of  US Diabetes/Obesity Sales, has joined Vifor Pharma as the VP of US sales (view LinkedIn profile). Below, FENIX provides thoughts and insights on 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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Purchase Blast$599.00

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

Metacrine NASH Fast Track Designation; Senseonics Receives Positive Coverage Decision for EmblemHealth; Insulet Launches Omnipod DASH in Canada

A series of cardiometabolic-related news items have been observed: Metacrine announced FDA granted Fast Track designation to MET642 for the treatment of NASH; Senseonics announced a positive coverage decision for its implantable CGM from EmblemHealth; and yesterday, Insulet announced the Canadian launch of Omnipod DASH. 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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Purchase Blast$599.00

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

JPM 2021 Day 4: Lexicon Poised for a Strong Comeback; Lexicon, Viatris, and Intercept @ JPM; Poxel/Metavant Partnership Terminated

On the final day of JPM 2021, FENIX has provided coverage of presentations by cardiometabolic companies including Lexicon, Viatris, and Intercept. Additionally, two separate cardiometabolic-related news items have been observed: Lexicon announced it received FDA feedback stating SOLOIST and SCORED results support a sotagliflozin NDA submission for a broad HF indication; and Poxel/Metavant announced the termination of their partnership. Below, FENIX provides a topline summary of key takeaways followed by more in-depth coverage, including Lexicon’s proposed broad HF label for sotagliflozin and Viatris’s biosimilar Toujeo.

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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Purchase Blast$599.00

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JPM 2021 Day 3: Bayer, Esperion, Precision Bio, Hikma, Vifor; High-dose Oral Sema PIONEER PLUS Trial Posted on CT.gov; Dario Announces Two New Additions to Scientific Advisory Board

On day three of JPM 2021, FENIX has provided coverage of presentations from Bayer, Esperion, Precision Biosciences, Hikma, and Vifor. Additionally, two separate cardiometabolic-related news items have been observed: a CT.gov record has been observed for Novo Nordisk’s PIONEER PLUS trial investigating high-dose oral semaglutide in people with T2DM; and DarioHealth announced Marilyn Ritholz and David Horwitz will be joining the Scientific Advisory Board. Below, FENIX provides a topline summary of key takeaways followed by more in-depth coverage.

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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Purchase Blast$599.00

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

JPM 2021 Day 2: LLY, NVO, ABT, PODD, AMRN, and IONS; Bayer’s Finerenone Receives Priority Review for DKD

On day two of JPM 2021, FENIX has provided coverage of presentations by Lilly, Novo Nordisk, Abbott, Insulet, Amarin, and Ionis. Additionally, one separate cardiometabolic-related news item has been observed: Bayer announced FDA granted priority review of finerenone for patients with DKD. Below, FENIX provides a topline summary of key takeaways followed by more in-depth coverage.

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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Purchase Blast$599.00

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

CORRECTING AND REPLACING: JPM 2021 Day 1: DXCM, MDT, TDOC, NVS; FDA Accepts EMPEROR-Reduced sNDA Without Priority Review; Adocia to Develop Beta Cell Therapy for T1DM Treatment

On the first day of JPM 2021, FENIX has provided coverage of presentations by major cardiometabolic companies including Dexcom, Medtronic, Teladoc, and Novartis. Additionally, three separate cardiometabolic-related news items have been observed: BI/Lilly announced FDA has accepted the Jardiance sNDA for the reduction of HFrEF in patients with and without T2DM; Dexcom and Teladoc announced the pilot launch of the new “CGM-powered insights” feature for Livongo for Diabetes users; and Adocia filed a patent for cell therapy in patients with T1DM. Below, FENIX provides a topline summary of key takeaways by company followed by more in-depth coverage.

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.

Novo Selects First Liver Therapy From Dicerna Collab; Metacrine Initiates Ph2a Jardiance Combo Trial in T2DM/NASH; Terns Pharma Raises $87M in Series C Funding; Dario Announces First Self-insured Employer Client

A series of cardiometabolic-related news items have been observed: Dicerna announced Novo Nordisk selected its first GalXC RNAi candidate for IND-enabling studies in liver-related cardiometabolic diseases; Metacrine announced the initiation of a Phase 2a combination trial of MET409 50g with empagliflozin in patients with T2DM and NASH; Terns Pharmaceuticals announced the closing of its Series C funding round with $87M raised for NASH-related trials; Dario announced an agreement with the first self-insured employer group to come from its partnership with Vitality Group. 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.

Happy Holidays from FENIX!

This holiday season, we genuinely thank you for your readership to our FENIX cardiometabolic syndicated service. Despite the COVID-19-related challenges in 2020, we successfully shared 300+ updates on the most current CV-Met news with impactful market insights using our deep thought leadership. The FENIX team will be back to delivering the latest in cardiometabolic news on January 4, and we look forward to another successful year in 2021.

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Servier Terminates Omecamtiv Agreement; Oramed Oral Leptin PoC Results

Two CV-met news items have been observed: Cytokinetics announced Servier has decided to terminate its sublicense agreement with Amgen for the development and commercialization of omecamtiv in EU and CIS; and Oramed announced topline results from a PoC study of its oral leptin drug candidate. 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.