Category Archives: Topics

Oramed Oral Insulin (ORMD-0801) Ph2b T2DM Results Unclear

Oramed announced topline results from the first cohort of the Ph2b study evaluating its prandial oral insulin (ORMD-0801) in T2DM patients. Of note, the study is evaluating QD, BID, and TID dosing, but only the QD and BID arms demonstrated a statistically significant result on A1C. Oramed projects data from the second cohort of this Ph2b study will be available in Q1 ’20. Below, FENIX provides thoughts on the potential commercial opportunity for oral insulin as well as unanswered questions into why the TID treatment arm did not reach statistical significance.

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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Senseonics Q3 ’19 Earnings Update

Senseonics hosted its Q3 ’19 earnings call (press release) and provided updates to its Eversense implantable CGM commercial and pipeline activities. Separately, Senseonics also announced Medicare has finalized a payment rate for Eversense through Medicare Part B. 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.

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Purchase Blast$599.00

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BI/Lilly Initiate Jardiance Acute HF Study (EMPULSE)

BI/Lilly announced the initiation of a new Jardiance study (EMPULSE) in T2DM and non-T2DM patients who have been hospitalized for acute heart failure. Below, FENIX provides an overview of the trial as well as insights into how the EMPULSE trial appears to be a natural progression of BI/Lilly’s Jardiance LCM strategy.

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.

Empa T1DM Adcom Could Be Easier Than Sota, But Still Difficult; Briefing Documents Analysis

Briefing documents for the BI/Lilly empagliflozin T1DM FDA adcom were posted today in advance of the November 13, 2019 meeting. Interestingly, BI/Lilly is only pursuing approval for the low, 2.5mg dose of empagliflozin, which demonstrated less DKA but also lower efficacy. Questions around the 2.5mg dose and its limited clinical data are likely to be the center of the adcom discussion. Below, FENIX provides thoughts on the empa T1DM adcom including analysis of the benefit/risk ratio, proposed risk mitigation strategy, and adcom panelists (9 of whom were also on the sota 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.

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.

Patient Dies on t:slim X2 with Basal IQ; Tandem Denies Involvement

A report has been published on the FDA MAUDE database indicating a patient using Tandem’s t:slim X2 insulin pump with Basal IQ technology passed away on October 3, 2019. However, in an emailed statement to media outlets, Tandem said the t:slim X2 pump with Basal IQ was not involved in the patient’s death. Below, FENIX provides context and insight related to this news including potential read-through to the impending Control IQ 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.

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.

Lexicon Disputes Sota CRL with FDA; Lexicon and Xeris Q3 ’19 Earnings Updates; Dexcom +30% Today

Lexicon hosted its Q3 ’19 earnings call and provided an update on the sotagliflozin T1DM regulatory situation as well as the T2DM Ph3 development program. Of note, Lexicon disclosed it has disputed the sota T1DM CRL with the Office of New Drugs, and it is awaiting a decision shortly. Additionally, Xeris released its Q3 ’19 earnings, and Dexcom stock has jumped +30% following its earnings beat. Below, FENIX provides insights on the sotagliflozin dispute including analysis of Peter Stein’s involvement in the Office of New Drugs review.

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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Dexcom and Livongo Q3 ’19 Earnings Updates

Dexcom and Livongo hosted their Q3 ’19 earnings calls and provided updates to their respective businesses. Below, FENIX provides highlights and insights from the respective earnings calls.

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.

MannKind Q3 ’19 Earnings Update

MannKind hosted its Q3 ’19 earnings call and provided updates to its diabetes business. Of note, MannKind disclosed a new, three-pronged strategy to drive Afrezza adoption. 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.

Insulet Q3 ’19 Earnings Update

Insulet hosted its Q3 ’19 earnings call and provided updates to its Omnipod business including the ongoing launch of Omnipod Dash as well as the development of the Omnipod Horizon hybrid closed-loop system. 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.

WaveForm CGM Receives CE Mark; Senseonics Sensor Recall

WaveForm, a subsidiary of AgaMatrix, announced it received CE Mark for its Cascade CGM system. Importantly, WaveForm also provided insight into its plans for US commercialization. Additionally, Senseonics recently initiated a voluntary recall on some of its Eversense implantable CGMs. Below, FENIX provides thoughts on the new CGM market entrant and the potential commercial outlook.

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.