Category Archives: Topics

Novo Partners with Life Edit Therapeutics; Biocon FY Q4 ’23 Earnings; Lilly initiates second trial in orforglipron obesity pivotal program; Mannkind appoints Burkhard Blank as EVP of R&D and CMO

A series of cardiometabolic-related news items have been observed: Novo Nordisk announced a partnership with Life Edit Therapeutics to develop gene-editing therapies for rare disorders and cardiometabolic disease (view press release); Biocon hosted its FY Q4 ‘23 (CY Q1 ‘23) earnings call (view press release); Lilly has initiated ATTAIN-2, the second trial in the company’s orforglipron pivotal obesity program (view CT.gov record); and Mannkind announced the appointment of Burkhard Blank as EVP of R&D and CMO (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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Novo OASIS 1 Topline Results; Intercept Hosts Post-adcom Update; Lilly Initiates Oral Obesity GLP-1RA Program; May CHMP Agenda

A series of cardiometabolic-related news have been observed: Novo Nordisk announced topline results from its Ph3 oral GLP-1RA obesity trial (OASIS-1), demonstrating 15% weight loss at 68 weeks (view press release); Intercept hosted a company update to discuss the results of the OCA in NASH adcom (webcast); Lilly has initiated the orforglipron pivotal obesity program (view CT.gov record); and the CHMP agenda (view here) for this month’s meeting (May 22-25) has been released. 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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FDA Adcom Strongly Votes Against OCA NASH Approval (2-12-2)

Today, FDA held a Gastrointestinal Drugs Advisory Committee (GIDAC) meeting to discuss the use of Intercept’s obeticholic acid (OCA) for the treatment of pre-cirrhotic liver fibrosis due to NASH, and panelists voted overwhelmingly against (2-12) the OCA benefit/risk profile with two abstentions. The second voting question was consistent whereby the panel voted (15-1) to defer an approval decision until the full REGENERATE (view CT.gov record) data are available. For context, in January 2023, FDA accepted the NDA resubmission for OCA seeking accelerated approval as a Class 2 resubmission and assigned a PDUFA date of June 22, 2023 (previous FENIX insight). Of note, Intercept has halted stock trading today due to the adcom (view press release). Below, FENIX provides key commentary from the adcom panel as well as insight on the future of the asset.

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FDA Clears Beta Bionics iLet ACE Pump and iLet Dosing Decision Software

FDA announced it has cleared the Beta Bionics iLet ACE Pump and the iLet Dosing Decision Software, which form the insulin-only iLet Bionic Pancreas. A press release from Beta Bionics has not yet been observed. Recall, in May 2022, Beta Bionics presented results from its pivotal iLet Bionic Pancreas trial (view CT.gov record) at ATTD 2023 and disclosed that data from the trial was included in the comprehensive submission packaged filed with FDA (previous FENIX insight). Below, FENIX provides initial thoughts on the iLet approval.

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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US Supreme Court Rules in Favor of Regeneron/Sanofi Praluent Litigation

Regeneron and Sanofi announced that the US Supreme Court upheld a previous decision by the Delaware District Court and the US Court of Appeals which held that Amgen’s asserted US PCSK9 patent claims were invalid (previous FENIX insight). Of note, the unanimous Supreme Court decision ends a nearly decade-long dispute between Sanofi/Regeneron and Amgen. Below, FENIX provides brief thoughts on the ruling.

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.

Intercept Faces Uphill Battle for Impending FDA Adcom; Briefing Documents Released

Briefing documents have been posted (view here) for FDA’s Gastrointestinal Drugs Advisory Committee (GIDAC) meeting to discuss the use of Intercept’s obeticholic acid (OCA) for the treatment of pre-cirrhotic liver fibrosis due to NASH. For context, the OCA adcom is on Friday, May 19, 2023 (previous FENIX insight). Recall, in January 2023, FDA accepted the NDA for OCA seeking accelerated approval as a Class 2 resubmission and assigned a PDUFA date of June 22, 2023 (previous FENIX insight). Of note, Intercept’s stock price decreased as much as -22% in intraday trading following the release of the briefing documents. Below, FENIX provides insight into the potential outcome of the OCA FDA adcom.

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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Viking Topline Ph2b VK2809 NASH Data; Chinook and Ionis Partner to Develop ASO Therapy for CKD

Two cardiometabolic-related news items have been observed: Viking Therapeutics announced positive topline results from its Ph2b VOYAGE study evaluating VK2809, an oral thyroid beta receptor (TRβ) agonist, in patients with biopsy-confirmed NASH (F2 and F3; view CT.gov record) and hosted an associated call with investors (view press release; webcast); and Chinook Therapeutics announced it has entered into a collaboration agreement with Ionis for the discovery, development, and commercialization of an antisense oligonucleotide (ASO) therapy for a rare, severe CKD with significant unmet medical need (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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Farxiga DELIVER Label Analysis

Earlier this week, FDA approved Farxiga (dapagliflozin) to reduce the risk of CV death, hospitalization for HF, and urgent HF visit in adults with HF, regardless of baseline LVEF (view updated Farxiga label; previous FENIX insight). The label extension was based on positive results from the Ph3 DELIVER trial (view CT.gov record). Recall, in February 2023, Forxiga received EU approval for the expanded HF indication (previous FENIX insight). Below, FENIX has conducted a Farxiga HF label analysis in the context of the Jardiance HF indication.

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.

Structure Therapeutics Advances Oral GLP-1RA to Ph2; Embecta and Tidepool Partner for T2DM Patch Pump AID Development; New SOLOIST-WHF Analysis

Three cardiometabolic-related news items have been observed: Structure Therapeutics announced it is advancing its oral GLP-1RA (GSBR-1290) into Ph2a development for T2DM and obesity (view press release); Embecta announced it has partnered with Tidepool to develop an AID system for its T2DM patch pump (view press release); and Lexicon announced results from an investigator-initiated analysis of SOLOIST-WHF which demonstrated that sotagliflozin is cost-effective at commonly accepted willingness-to-pay thresholds in patients with diabetes and worsening HF (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.

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.

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.

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.