Category Archives: Other

New Zafgen Data Suggests Clinical Hold Will Remain; Strategic Options to be Explored

Zafgen announced that it is planning to “strategic options to maximize shareholder value,” including a merger, acquisition, or in-licensing opportunity. Following preliminary data from a new animal study, Zafgen believes that in the short-term, there is a low probability of resolving the clinical hold placed on ZGN-1061. Below, FENIX provides brief thoughts on potential outcomes for Zafgen and ZGN-1061. 

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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Biocon/Mylan Glargine CRL; BI/ZEAL Dual Agonist Moves to Ph2; Vertex Acquires Semma

Three key pieces of news have recently been observed: Biocon/Mylan received a CRL from FDA regarding their bs-glargine Malaysian manufacturing facility, Boehringer Ingelheim is advancing its dual agonist into Ph2 (licensed from Zealand), and Vertex entered into a definitive agreement to acquire Semma Therapeutics. Below, FENIX provides thoughts and insights on the respective news items including the uncertainty around Biocon/Mylan’s glargine in the context of the merger with Pfizer.

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 to Host EASD Social Event on Monday Sept 16

To celebrate our new office in Barcelona, FENIX will host a social event during EASD on Monday, September 16, 2019, from 7-10pm CET. The venue is in the heart of the city at: Cheri Restaurant (Carrer d’Enric Granados, 122, Barcelona https://goo.gl/maps/r4XujW93NVifKX7MA)

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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New Novo Nordisk Ph1 Compound With Unknown MOA

A new Novo Nordisk Ph1 first-in-human trial for an unknown compound (NNC0385-0434) has been observed on CT.gov. According to the CT.gov record, the trial will evaluate a single subcutaneous injection of NNC0385-0434 in both healthy volunteers and in patients with hypercholesterolemia. Below, FENIX provides potential insights into the new compound.

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.

Zealand to Launch HypoPal in the US Without a Partner; Zealand Q2 ’19 Earnings Update

Zealand hosted its Q2 ’19 earnings call and provided updates to its clinical and commercial activities. Of note, Zealand has begun ramping up US operations with the intention to commercialize the dasiglucagon HypoPal without a partner. 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.

Novo: Updated FENIX Viewpoint; Novo Q2 ’19 London Earnings Update

Novo Nordisk hosted its post-Q2 ’19 earnings event in London. Consistent with previous quarters, the session included a brief presentation from Novo management followed by Q&A. Below, FENIX provides highlights from the call including a scenario of reasonable likelihood around FENIX’s previous assertion questioning whether Novo is able to pursue accelerated approval for its anti-IL 21 + liraglutide T1DM beta cell preservation therapy. Additionally, FENIX includes an example of recent precedence set by FDA whereby FDA used an adcom to inform a regulatory decision about granting accelerated 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.

Forxiga DECLARE EU Approval, BTD For Provention Bio’s Teplizumab (PRV-031), And MannKind/One Drop Collaboration

Today, three key news items were observed including the Forxiga DECLARE EU approval, Breakthrough Therapy Designation to Provention Bio’s Teplizumab (PRV-031) and a MannKind/ One Drop collaboration. Below, FENIX provides context and analysis for these 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.

Roche Q2 ’19 Earnings Update

Roche hosted its Q2 ‘19 earnings call and provided brief updates to their diabetes business. Of note, Roche’s earnings press release stated that the  Accu-Chek Guide Me, a low-cost version of the Accu-Chek Guide, has been launched in the US. Below, FENIX provides 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.

Is Glooko Eying an IPO? New Partnership with Pack Health for Patient Coaching

Pack Health announced it has formed a partnership with Glooko to allow for the integration of Glooko’s patient data into Pack Health’s coaching platform. Of note, the press release states that the two companies have already completed a live beta test of the integrated systems. Below, FENIX provides thoughts on the partnership including insight as to how Glooko may be looking leverage Pack Health to follow in Livongo’s footsteps for a potential Glooko IPO.

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.

HF Trial Draft Guidance Issued by FDA; Public Hearing in July 2019

FDA announced it has issued draft guidance titled, “Treatment for Heart Failure: Endpoints for Drug Development Guidance for Industry” (download HF draft guidance here). Additionally, FDA will be hosting a public workshop on Friday, July 26, 2019, from 9am to 4pm ET at the White Oak Campus.

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.