Category Archives: Topics

Novo Reports Final Sema Obesity Ph3 Topline Data; Jim Malone Joins Bigfoot; ADA 2020 Key Press Releases (June 12)

Today, two diabetes-related news items were observed: Novo reported topline results from the final semaglutide obesity Ph3a trials (STEP 2 and 3) and Bigfoot appointed Jim Malone as the company’s new CMO. Recall, Malone previously served as a Senior Medical Director for Lilly where he was responsible for the global development of Lilly insulin products and insulin delivery devices, including connected care. Below, FENIX provides context and analysis for the announcements. Medtronic-related coverage will be provided in a separate blast after their investor call.

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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Gilead Announces EMA Approval for End-to-End Yescarta CAR-T Manufacturing at Amsterdam Facility

On Friday, June 12, Gilead announced (press release) that the European Medicine Agency (EMA) has approved the company’s Amsterdam facility for end-to-end manufacturing of Yescarta. Below, FENIX highlights the potential impact on Yescarta’s EU turn-around-time (TAT), and the effect this may have on Kymriah sales.

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.

Thoughts on FDA Refusal-to-File for Ide-cel; bluebird bio Q1 2020 Earnings Update

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.

Biocon/Mylan Bs-glargine Approved; Novo to Acquire Corvidia; Lifescan Launches Verio Reflect; Lannett FDA Bs-glargine Meeting; Medtronic 780G CE Mark; Dexcom Launches G6 Pro; ADA ’20 Key Data and Partnership Press Releases (June 11)

Ahead of the ADA 2020 conference start, a series of diabetes-related press releases have been observed: Biocon/Mylan received FDA approval for its bs-glargine, Novo Nordisk is set to acquire Corvidia, Lannett provided an update on its meeting with FDA for bs-glargine, LifeScan launched the Verio Reflect BGM, Medtronic received CE Mark for the 780G system, Dexcom launches G6 Pro, and DarioHealth entered into new partnership agreements. Below, FENIX provides context and analysis for the announcements.

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.

Senseonics Q1 ’20 Earnings Update

Yesterday, Senseonics hosted its Q1 ’20 earnings call (press release) and provided updates to its business including the company’s new strategic priorities following the suspension of its commercial activities. Importantly, Q1 ’20 net revenue fell to $36k compared to $3.4M in Q1 ’19. Below, FENIX provides highlights and insights from the call.

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.

Tirzepatide CVOT Underway; Dexcom G6 CE Mark for Wear on Upper Arm; Nemaura Medical to Join Russell Indices

A series of diabetes-related news has been observed: Lilly announced it has dosed the first patient in the tirzepatide SURPASS-CVOT study, Dexcom received CE Mark for the G6 CGM to be worn on the back of the upper arm, and Nemaura Medical is set to join the Russell 2000 Index and Russell 3000 Index. Below, FENIX provides highlights and insights from 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.

New Pivotal ALLO-501A (ALPHA-2) Trial in DLBCL Posted

A new Allogene-sponsored ALLO-501A Ph1/2 ALPHA-2 trial has been observed on CT.gov. Below, FENIX provides insights on this new trial and how ALLO-501A could disrupt the autologous CD19 CAR-T market, currently being led by Novartis, Gilead, and BMS.

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.

Insulet Resumes Omnipod Horizon Pivotal Trial

Insulet announced it has resumed the Omnipod Horizon pivotal trial. Recall, the trial was paused in early March 2020 following a software anomaly that could lead to “using an incorrect glucose value which has the potential to impact insulin delivery.” According to the press release, Insulet expects a US launch of Omnipod Horizon in H1 ’21, which is consistent with the timeline stated during the company’s Q1 ’20 earnings call. Below, FENIX provides insight on the potential impact of the delayed launch.

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.

BCMA CAR-T Updates at ASCO 2020 – Ide-cel, Orva-cel, JNJ-4528

Three key oral presentations for BCMA CAR-Ts were presented at ASCO 2020: ide-cel (Ph2 KarMMa) and orva-cel (Ph1/2 EVOLVE) from BMS, and JNJ-4528 (Ph1b/2 CARTITUDE-1) from Janssen. All three studies evaluated CAR-T cells in ≥4L RRMM patients. Below, FENIX provides key data highlights and analysis on the competitiveness of each CAR-T.

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.

Autolus Ph1 Alexander Results and ASCO 2020 Investor Call Summary

On Monday, June 1, Autolus held an investor call (press release/presentation), highlighting updated clinical data from the AUTO3 (CD19/22 dual CAR-T) Ph1/2 Alexander study in ≥3L DLBCL. The data was also presented at ASCO (Wendy Osborne et al, May 2020). Below, FENIX provides thoughts on the significance of this data, and particularly how it compares to competitor autologous CD19 CAR-Ts from Novartis (Kymriah), Gilead (Yescarta), and BMS (liso-cel).

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.