Category Archives: Other

Lannett Receives FDA Feedback for Bs-glargine; Adocia Initiates Ph2 M1Pram Trial; Vertex Receives Fast Track Designation for VX-880 in T1DM; Welldoc Hires New CMO; Intercept CFO to Depart

A series of diabetes-related news items has been observed: Lannett announced it received FDA feedback regarding its biosimilar insulin glargine Ph3 program; Adocia announced the initiation of a Ph2 study evaluating M1Pram (pramlintide+insulin FRC) vs. Humalog in patients with T1DM; Vertex announced FDA granted Fast Track Designation to VX-880 for the treatment of T1DM; Welldoc announced the hiring of Marina Dorotheo as CMO; and Intercept announced the resignation of CFO, Sandip Kapadia. 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.

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Xeris and Dario Q4 and FY ’20 Earnings Calls; Lilly Research Collaboration for Diabetes; Metacrine Initiates Ph2a Trial in NASH

A series of cardiometabolic-related news items have been observed: Xeris and Dario hosted their Q4 and FY ’20 earnings calls; Lilly announced it entered a research collaboration and license agreement with Biolojic Design for AI drug discovery of an antibody-based diabetes treatment; and Metacrine announced that it initiated a Ph2a trial of MET642 for the treatment of patients with NASH. 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.

Zealand R&D Day Highlights

Zealand hosted its R&D day (view slides) and provided updates to its diabetes and obesity development programs. Specifically, Zealand highlighted the near-term US approval and launch of the HypoPal glucagon rescue pen, medium-term development of the bi-hormonal iLet pump with Beta Bionics, and long-term research activities in obesity (e.g. amylin analog and GIP agonist). Below, FENIX provides highlights and insights from the events.

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 Q4 ’20 Earnings Update; Provention Bio Extended Follow-up Data Published; Voluntis Collaborates with Zendesk for Global Customer Support

A series of diabetes-related news items have been observed: Senseonics hosted its Q4 and FY ’20 earnings call; Provention Bio announced the extended follow-up data from the pivotal “At-Risk” TN-10 Study has been published in Science Translational Medicine; and Voluntis announced a collaboration with Zendesk to upgrade its global customer support infrastructure. 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.

BI and Gubra Partner for Obesity Drug Development; Diabeloop DBLG1 Integrates with Accu-Chek Insight Pump; Tandem Appoints Jordan Pinsker as VP and Medical Director

A series of cardiometabolic-related news items have been observed: Boehringer Ingelheim and Gubra announced a research and licensing agreement for discovering and evaluating targets and innovative peptide compounds for the treatment of obesity; Diabeloop announced the integration of the Accu-Chek Insight insulin pump into the DBLG1 System; Tandem announced Jordan Pinsker from Sansum has been appointed as VP and Medical Director. 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.

Thoughts on Sotagliflozin HF Indication after Entresto’s PARAGON Approval

Last week, Novartis received FDA approval for expanding the Entresto label in HF beyond HFrEF (previous FENIX insight). Ahead of Lexicon’s Q4 2020 earnings later in March, FENIX provides a reminder on the recent sequence of events in HF and thoughts on how the new HF labeling for Entresto could apply to Lexicon’s SGLTi, sotagliflozin.

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 Invests in Danish Facility for Oral Sema Production; MNKD, PRVB, ICPT, BAYRY, and IONS Q4 ’20 Earnings Updates

A series of cardiometabolic-related news items have been observed: Novo Nordisk announced plans to invest 500M DKK (~82M USD) to expand its oral tablet production facilities in Måløv, Denmark; and Mannkind, Provention Bio, Intercept, Bayer, and Ionis hosted their Q4 and FY ’20 earnings call. 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.

Insulet and Esperion Q4 ’20 Earnings Updates

Insulet and Esperion hosted their respective Q4 and full-year 2020 earnings calls and provided updates to their respective businesses. Of note, Insulet disclosed that its Omnipod 5 AID system will be launched in H1 ’21 at price parity to the current Omnipod DASH platform. Below, FENIX provides highlights and insights from the 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.

Novartis Wins with Entresto PARAGON-HF FDA Approval

Novartis announced FDA has approved the Entresto sNDA based on results from the PARAGON-HF CVOT (view updated label here). For context, the new indication eliminates the qualifier of HFrEF; however, an additional statement is included, stating the benefit is most clearly evident in patients with LVEF below normal. While the updated label does not include a pure HFpEF indication, it is thought to represent the best-case scenario for Novartis. Below, FENIX provides thoughts on the new Entresto HF indication as well as implications to the evolving HF market, notably Lexicon’s sotagliflozin.

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.

Nemaura Q4 ’20 earnings; MET409 POC Data Published in Journal of Hepatology

Two cardiometabolic-related news items have been observed: Nemaura Medical published its CY Q4 ’20 (FY Q3 ’21) earnings update and Metacrine announced the results of the MET409 proof-of-concept study were published in the Journal of Hepatology. 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.