Category Archives: Topics

Novo to Acquire Biocorp; Akero Announces Ph2b SYMMETRY Results; Enterin Initiates Ph1a ENT-03 Study

Novo to Acquire Biocorp; Akero Announces Ph2b SYMMETRY Results; Enterin Initiates Ph1a ENT-03 Study

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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Lilly Initiates Ph3 Retatrutide Obesity Program; UnitedHealthcare Expands Coverage to Eversense E3 CGM

Two cardiometabolic-related news items have been observed: Lilly initiated the first trial in the Ph3 retatrutide obesity program (TRIUMPH-3; view CT.gov record); and Senseonics announced UnitedHealthcare will cover the Eversense E3 CGM starting July 1, 2023, for T1DM and insulin-requiring T2DM patients. Below, FENIX provides highlights of the respective news items, including insight into the potential retatrutide Ph3 TRIUMPH program and Lilly’s strategy for an obesity CVOT.  

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.

Updated FDA Draft Guidance for Diabetes Trials; Esperion Files CLEAR Outcomes sNDAs; Positive Glyscend Topline Ph2a GLY-200 Results and ADA 2023 Presentations; Pharming Sells PRV to Novartis

A series of cardiometabolic-related news items have been observed from FDA, Esperion, Glyscend, and Pharming/Novartis. 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

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

Inpefa Label and Pre-launch Analysis

Following the Inpefa (sotagliflozin) approval on May 26, 2023 (view label; previous FENIX insight), FENIX has conducted an analysis of the Inpefa label and HCP website. Additionally, Lexicon hosted a post-approval investor call on May 30, 2023, where the company provided insight into its go-to-market strategy (view webcast). Of note, Lexicon plans to launch Inpefa in the US by the end of June 2023. Below, FENIX provides insights and thoughts on the Inpefa label and pre-launch activities.

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.

Akebia Rejected Again by FDA; Know Labs Announces Positive Bio-RFID Results; Lilly and XtalPi Collaborate for AI Drug Discovery; Structure Doses First Patient in Ph2a Oral GLP-1RA Study

Four cardiometabolic-related new items have been observed: Akebia Therapeutics announced it received a written response from FDA denying the vadadustat CRL (view press release); Know Labs published a report showing the accuracy of its non-invasive Bio-RFID blood glucose reading used in combination with algorithm optimization using a light gradient-boosting machine (lightGBM) machine learning model (view press release; view report); XtalPi announced a collaboration with Lilly, using AI plus robotics to uncover first-in-class therapeutics for undisclosed targets (view press release); and Structure Therapeutics announced the first patient has been dosed in its Ph2a study evaluating GSBR-1290 in overweight/obese patients with and without T2DM (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

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

Sotagliflozin approved in US as “INPEFA”

Lexicon announced the FDA approval of sotagliflozin as “INPEFA” to reduce the risk of CV death, hospitalization for HF, and urgent HF visit in adults with HF (across the full LVEF spectrum) or T2DM, CKD, and other cardiovascular risk factors. The May 26 approval is consistent with FENIX’s projection following Lexicon’s July 2022 announcement that FDA accepted the re-submission and assigned a full 10-month review period (previous FENIX insight). The Inpefa label has not yet been observed at the time of this publication. Of note, Lexicon is hosting a call with investors on Tuesday, May 30 at 8am ET. FENIX will conduct a full label analysis of sotagliflozin in the coming days once the label is available.

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.

Medtronic CY Q1 ‘23 (FY Q4 ‘23) earnings update

Medtronic hosted its CY Q1 ‘23 (FY Q4 ‘23) earnings call (press release; slides) and provided brief updates to its diabetes business. Importantly, Medtronic disclosed plans to acquire EOFlow Co. Ltd. for its patch pump technology (view press release). Additionally, Medtronic will be hosting an investor event at ADA 2023 where it will provide more details on its diabetes portfolio and pipeline. Below, FENIX provides highlights and insights from the earnings call, including thoughts on how the EOFlow acquisition fits into Medtronic’s strategy to turn around its struggling diabetes business.

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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.

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 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.

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.

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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