Tag Archives: MNKD

MannKind Receives Warning for Afrezza Facebook Promo

FDA’s Office of Prescription Drug Promotion (OPDP) issued a letter to MannKind claiming misleading/false advertising for Afrezza Facebook posts. According to the letter, on February 9 and March 19, 2018, MannKind posted advertisements on Facebook that made “false or misleading claims and/or representations about the risks associated with Afrezza by suggesting that there are no safety concerns associated with the use of the drug.” The Facebook posts have since been deleted. Below, FENIX provides thoughts on the warning letter including any potential impact to the Afrezza brand.

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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Dance Biopharm Raises $24.5M for Inhaled Insulin Development

Dance Biopharm announced it has raised $24.5M in private equity financing to help support the development of its inhalable insulin, Dance 501. According to the press release, Dance Biopharm plans to initiate Ph3 studies in 2019. Below, FENIX provides thoughts on Dance 501 including potential read through from Afrezza.

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 Partners for Pulmonary Hypertension; $MNKD up ~100%

Yesterday, MannKind announced a partnership with United Therapeutics for dry powder delivery of treprostinil (pulmonary hypertension) and another non-disclosed R&D project. MannKind will receive $45M in an upfront payment and is eligible for up to $50M in additional milestones as well as “low double-digit” royalties” for the tresprostinil development and commercialization. Since the partnership announcement, $MNKD is up ~100% (+89% on Sept 4 and an additional +10% in Sept 5 pre-market trading shown below). Interestingly, the news came 21 years after treprostinil first became available through the MiniMed 407c, a pump created in part by Al Mann.

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 Q2 ’18 Earnings Update

Yesterday, MannKind hosted its Q2 ’18 earnings call and provided updates on its clinical and commercial activities. Of note, MannKind recently hired a new Chief Marketing Officer, Garrett Ingram, who formerly held positions as SVP Managed Markets at Dexcom, VP Market Access at Sanofi, and VP Market Access Strategy at BMS. Additionally, MannKind discussed BlueHale, its connected care attachment for the Dreamboat device, which measures successful dose administration via a pressure gauge. Below are highlights 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.

MannKind Re-Initiates TV DTC; Hosts Analyst Meeting

MannKind hosted an Institutional Investor and Analyst Meeting that was largely focused on providing an overview of the company with the intention of attracting new investors. Of note, senior management disclosed that they have re-initiated itsAfrezza TV DTC campaign. Below, FENIX provides highlights of the event including Afrezza EASD data presentations and Afrezza LCM roadmap as well as thoughts on the future for the Afrezza brand.

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.

Drug ADA ‘18 Key Data Press Releases (June 23)

21 major press releases featuring new data presented at ADA ’18 were observed across diabetes drugs, devices, and apps, a major increase from 9 on the first day of ADA ‘17. Below, FENIX has provided context and analysis for 14 drug-related announcements, with analysis of device and app-related announcements to follow in a separate alert.

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 Analysis: Post-AACE 2018 Drug Promotional Material

In advance of ADA 2018 beginning June 21, FENIX has conducted a comprehensive analysis of new and recent promotional materials obtained at AACE 2018. Notably, this was the first major conference opportunity for Novo to promote both Ozempic and the Tresiba DEVOTE label 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.

MannKind Q1 ’17 Earnings Update

MannKind held its Q1 2017 earnings call and provided updates on commercial and clinical activities for Afrezza.

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 and One Drop enter collaboration for better diabetes outcomes

MannKind Corporation and One Drop are entering into a collaborative agreement that would extend One Drop’s subscription service and digital health platform through the addition of Afrezza as a rapid-acting insulin offering integrated in-app with Bluetooth technology.

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 Sponsors Reality TV Show

In an effort to increase diabetes awareness, MannKind and Bella & Elle Media LLC are collaborating on “Reversed,” a “Diabetes Reality TV Show” to air on Discovery Life Channel in the summer of 2017.

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.