Tag Archives: Cytokinetics

Novo Partners with Broad Institute of MIT and Harvard for T2DM; Viking Initiates Ph2 Dual Agonist Obesity Trial; Cytokinetics Initiates Ph3 Aficamten Trial in Non-Obstructive HCM

Three cardiometabolic-related news items have been observed: The Broad Institute of MIT and Harvard announced a research partnership with Novo Nordisk to identify drug targets for T2DM and genetic roots of cardiac fibrosis (view press release); Viking Therapeutics initiated a Ph2 trial evaluating the company’s SC QW GLP-1 + GIP dual agonist, VK2735, in obese and overweight patients (view press release); and Cytokinetics initiated a pivotal Ph3 trial of aficamten in patients with non-obstructive hypertrophic cardiomyopathy (nHCM; view press release). Below, FENIX provides highlights and insights into 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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Senate Targets PBMs and Insulin Manufacturers; Zealand and Dario Q1 ’23 Earnings; Cytokinetics Initiates Ph1 Trial for Potential HFpEF Therapy

Four cardiometabolic-related news items have been observed: On May 10, 2023, the Senate Committee on Health, Education, Labor, and Pensions (HELP) held a widely covered hearing with Sanofi, Lilly, and Novo Nordisk’s CEOs as well as executives from top PBMs (view broadcast here); Zealand Pharma (view press release; slides) and Dario (press release) hosted their respective Q1 ‘23 earnings calls; and Cytokinetics announced the initiation of a Ph1 trial evaluating CK-4021586 (CK-586) as a potential treatment for HFpEF (view press release). Below, FENIX provides highlights and insights into 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

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CMS Expands CGM Coverage; New Novo R&D Presence in Boston; Bigfoot Unity Android App Approval; Cytokinetic Receives Omecamtiv CRL; Galectin Finalizes Ph2b/3 NAVIGATE Randomization; Imcyse Completes Trial Enrollment; and Zealand, Intercept, and Amarin Q4 ’22 Earnings

A series of cardiometabolic-related news items has been observed from CMS, Novo Nordisk, Bigfoot, Zealand, Intercept, Cytokinetics, Amarin, Galectin, and Imcyse. Below, FENIX provides highlights and insights into 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

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JPM 2023 Day 1: DXCM, MDT, PFE, AMGN, VRTX, NVS, CYTK, TDOC, ARWR, and AMGN; AZ Acquires CinCor; Viking Completes Ph2b NASH Enrollment; Ionis Sells Pelacarsen Royalties

On the first day of JPM 2023, FENIX has provided coverage of presentations by major CVRM companies including Dexcom, Medtronic, Pfizer, Amgen, Vertex, Novartis, Cytokinetics, Teladoc, and Arrowhead. Alnylam, Gilead, J&J, Regeneron, and Amgen also presented at JPM 2023, but none had any meaningful discussion relating to their respective CVRM portfolios. Additionally, three separate CVRM-related news items have been observed: AZ announced the acquisition of CinCor Pharma (view press release), Viking completed enrollment of the Ph2b VOYAGE NASH trial (view press release), and Ionis entered into an agreement with Royalty Pharma to sell rights to Spinraza and pelacarsen (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.

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Purchase Blast$599.00

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Tandem Acquires Sigi Patch Pump; Novo Reports Ozempic Supply Shortages; Novo Initiates Second 7.2mg Sema Ph3 Trial in T2DM; Cytokinetics Host Post-adcom Investor Call

A series of cardiometabolic-related news items have been observed: Tandem announced it entered into a definitive agreement to acquire AMF Medical SA (view press release); it has been reported that Novo Nordisk is experiencing a shortage of Ozempic (view article); Novo Nordisk initiated a second 7.2mg QW SC semaglutide Ph3 trial (view CT.gov record) in T2DM; and Cytokinetics hosted an investor event to discuss the results of the omecamtiv adcom (view press release; webcast). Below, FENIX provides highlights and insights on the respective news items, including questions regarding Tandem’s acquisition decision.

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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FDA Adcom Votes Against (3-8) Omecamtiv Approval

Today, FDA held an advisory committee meeting to discuss the use of Cytokinetics’s omecamtiv to reduce the risk of CV death and HF events in patients with HFrEF, and panelists voted overwhelmingly against (3-8) the omecamtiv benefit/risk profile. For context, in June 2022, FDA accepted the omecamtiv NDA and set a PDUFA date for February 28, 2023 (previous FENIX insight). Recall, the NDA submission is based on data from the Ph3 GALACTIC-HF trial (view CT.gov record) which were initially presented at AHA 2020 (previous FENIX insight) and published in the NEJM (view publication). Below, FENIX provides key commentary from the adcom panel as well as insight on the future for the asset.

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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Lilly Ends Ypsomed Partnership; Cytokinetics Adcom Documents Available

Two cardiometabolic-related news items have been observed: Ypsomed announced Lilly terminated the joint project with Ypsomed to enter the US insulin pump market in 2026 (view press release); and Cytokinetics announced FDA posted briefing documents (view here) for its upcoming omecamtiv adcom which is scheduled for December 13, 2022 (view press release). Below, FENIX provides brief insights on the news items, including how Lilly’s decision to terminate the partnership validates FENIX’s initial thoughts from 2020.

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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Novo to Initiate Ph1 Sema+Dapa FDC Ph1 Trial; ProKidney Publishes Data Supporting MoA of REACT in Patients with Diabetic CKD; Cytokinetics Announces Date for Omecamtiv FDA Adcom; Hygieia licenses d-Nav program in Israel

A series of cardiometabolic-related news items have been observed: a two-part Ph1 Novo-sponsored study evaluating a semaglutide/dapagliflozin FDC has been observed (view CT.gov record); ProKidney recently announced the publication of data from an MoA study of its Renal Autologous Cell Therapy (REACT) in Kidney International Reports (view publication here); Cytokinetics announced FDA informed the company the omecamtiv adcom has been scheduled for December 13, 2022; and Hygieia announced it licensed its d-Nav insulin management system to Movement Group in Israel. Below, FENIX provides highlights and insights for the respective new 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

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Novo Sues Teva Over Generic Saxenda; Cytokinetics Announces Disappointing METEORIC-HF Results; Zealand’s Pediatric Ph3 Dasiglucagon in CHI Trial Completes Enrollment

A series of cardiometabolic-related news items have been observed: It has been reported that Novo Nordisk has filed a suit against Teva regarding Teva’s recently filed generic version of Saxenda (view article); Cytokinetics announced topline results from the Ph3 METEORIC-HF trial which failed to demonstrate a benefit in exercise performance; and Zealand announced its Ph3 pediatric trial evaluating dasiglucagon in CHI has completed enrollment (view CT.gov record). Below, FENIX provides highlights and insights for the respective new 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.

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.