Category Archives: Other

Eversense 365 Day CGM Receives FDA Clearance

Senseonics Holdings and Ascensia Diabetes Care announced FDA cleared the implantable Eversense 365 CGM as an iCGM system for people with T1DM and T2DM aged 18 years and older. Senseonics stated it is continuing to progress partnership discussions with various pump manufacturers looking to leverage Eversense 365 with AID systems. Ascensia plans to initiate the US launch of Eversense 365 in early Q4 2024. Below, FENIX provides brief insights into the 510(k) clearance.

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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September CHMP Agenda; Novo Collaboration with Korro; Jeff Wade Leaves Lexicon

Three cardiometabolic-related news items have been observed: the CHMP agenda for this month’s meeting (Sept 16-19) has been released (view here); Korro and Novo Nordisk initiated a collaboration for cardiometabolic disease drug discovery (view press release); and Lexicon Pharmaceuticals announced the departure of Jeff Wade, its president and COO (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.

Roche in Damage Control Mode After EASD Obesity Data Readout

Roche hosted a post-EASD investor event (view slides) where management reviewed its obesity data presentations and provided additional insight into the company’s obesity development strategy and pipeline. Of note, Roche spent a significant portion of the call discussing the emerging AE profile for its obesity assets and the company’s future plans to remain a player in the obesity market. Below, FENIX provides highlights and insights into the Roche event, including thoughts on whether Roche overpaid for Carmot.

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.

EASD 2024 Key Press Releases (Sep 12)

On the fourth day of EASD 2024, three key new items were observed from Noom, Lilly, and Sernova. The following topics are covered below (hyperlinks to external 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.

EASD 2024 Key Press Releases (Sep 10)

On the second day of EASD 2024, 8 key news items were observed from Lilly, Novo Nordisk, Abvance Therapeutics, Scholar Rock, Altimmune, Arrowhead Pharmaceuticals, Bayer, and Lexicon. The following topics are covered below (hyperlinks to external 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.

EASD 2024 Key Press Releases (Sep 09)

On the first day of EASD 2024, six key news items were observed from Terns Pharmaceuticals, Zealand Pharma, Diamyd Medical, Cytokinetics, Lilly/Superluminal Medical, and Akero Therapeutics. The following topics are covered below (hyperlinks to external 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.

FENIX Interview with TIXiMED – Oral T1DM Therapeutic Developer

FENIX sat down with Anath Shalev, founder of TIXiMED and licensed endocrinologist, and Stephen Daly, CFO of TIXiMED, for an in-depth interview on the company’s plan to enter the diabetes market with a first-of-its-kind oral non-immunosuppressive therapeutic (TIX100) targeting thioredoxin-interacting protein (TXNIP) for the potential treatment of T1DM, T2DM, and MASH. Recall, in July 2024, TIXiMED announced it obtained IND approval (previous FENIX insight). Below, FENIX provides highlights from our interview with TIXiMED senior leadership, including insight into TIXiMED’s TIX100 MOA and the company’s goal to bring the first oral T1DM therapy to market. 

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 QW Insulin QWINT-1 and -3 Topline Results; Lilly Initiates Ph3 Orforglipron Maintenance Study; Lilly-Backed OrsoBio Raises $67M in Series B for Obesity Development

Three cardiometabolic-related news items have been observed: Lilly announced positive topline results from its Ph3 QW insulin efsitora alfa trials, QWINT-1 and QWINT-3 (view press release); Lilly initiated a Ph3 study (ATTAIN-MAINTAIN; view CT.gov record) evaluating QD orforglipron in adults with overweight or obesity with weight-related comorbidities who have completed SURMOUNT-5 (tirzepatide vs. semaglutide); and OrsoBio raised $67M in a Series B financing round for the development of its mitochondrial protonophores for obesity (view article). 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.

Abbott Launches Lingo OTC CGM in the US

Abbott announced Lingo, its OTC CGM, is now available for purchase in the US via its website (view website). The launch announcement comes shortly after Dexcom announced the launch of its own Stelo OTC CGM (previous FENIX insight). Below, FENIX has conducted an analysis of the Lingo product, website, and pricing.

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.

Abbott Partners with Beta Bionics; Dexcom at Wells Fargo; Lilly Partners for Drug Discovery; AZ Initiates Oral GLP-1RA Ph2b Trial in T2DM; BioAge Files for IPO; Bayer, Arrowhead, and Lexicon Data at ESC 2024; Esperion Secures Additional Nexletol/Nexlizet Coverage; Skye Appoints New CMO; Scholar Rock Appoints New CBO

A series of cardiometabolic-related news items have been observed from Beta Bionics/Abbott, Dexcom, Lilly/HAYA, AstraZeneca, BioAge Labs, Bayer, Arrowhead Pharmaceuticals, Lexicon Pharmaceuticals, Esperion Therapeutics, Skye Biosciences, and Scholar Rock. 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.