Category Archives: Other

Novo Discontinues its Dual/Triple Agonists for Obesity; Novo Q2 ’20 Earnings Update

Novo Nordisk hosted its Q2 ’20 earnings call (press release; slides) and provided updates to its diabetes, obesity, and NASH clinical and commercial activities, but much of the discussion was focused on Novo’s obesity portfolio. Importantly, Novo disclosed it has discontinued the development of its dual and triple agonists for the treatment of obesity following positive results from the recent semaglutide and AM833 data disclosures (semaglutide Ph3 STEP, Ph2 AM833, and Ph1 sema+AM833). Additionally, FENIX includes context from Novo’s invite-only R&D event on June 19 (view slides here). Below, FENIX provides highlights and insights from the call, including why it makes sense Novo would use its PRV for semaglutide in obesity.

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Livongo to Merge with Teladoc; AZ Partners for HF Diagnostic; ViaCyte Partners with Gore for Novel Membrane Development; Teva Q2 ’20 Earnings Update

A series of diabetes-related news items have been observed: Livongo and Teladoc Health announced they have entered into a definitive merger agreement; Eko announced it entered into a global partnership with AstraZeneca for a heart failure diagnostic tool; ViaCyte and Gore announced an agreement to further develop ViaCyte’s Encaptra Cell Delivery System to facilitate stem cell-derived islet replacement (press release); and Teva hosted its Q2 ’20 earnings call (press release; slides). Below, FENIX provides highlights for the respective news items including thoughts on the Livongo+Teladoc merger and insight into the AZ diagnostic partnership as a lead generation tool for Farxiga.

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Merck In-licenses Hanmi’s Dual Agonist for NASH; Generic Empagliflozin Tentative Approval

Two diabetes-related news items have been observed: Merck announced it has entered into an exclusive licensing agreement with Hanmi for the development and commercialization of efinopegdutide, a QW GLP-1/glucagon dual agonist for the treatment of NASH (formerly HM12425A and JNJ-64565111) and Lupin received tentative FDA approval for its generic empagliflozin (view article). Below, FENIX provides thoughts on why Merck has Janssen and Novo to thank for the favorable deal terms.

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Bayer Reports Finerenone T2DM DKD Renal Outcomes Trial Topline Results (FIDELIO-DKD) ; EMPEROR-Reduced at ESC 2020

Bayer announced positive topline results from its Ph3 FIDELIO-DKD trial evaluating finerenone in T2DM with CKD. Finerenone demonstrated a delayed progression to the primary composite endpoint (onset of kidney failure, sustained decrease of eGFR ≥ 40% from baseline over at least 4 weeks, or renal death). The specific risk reduction was not disclosed. Below, FENIX provides thoughts on the FIDELIO-DKD results including a curious observation that the press release did not mention anything about safety in the trial.

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Novo Reports Impressive AM833 Ph2 and AM833+sema Ph1 Topline Results

Novo Nordisk announced positive topline results for its Ph2 AM833 and Ph1 AM833+semaglutide trials, both for the treatment of obesity. Novo previously disclosed AM833 has been given the INN of “cagrilintide.” Recall, on June 12, 2020, Novo reported topline results from the final two trials in its Ph3 semaglutide obesity program (previous FENIX insight). Below, FENIX provides an overview of the topline data as well as brief thoughts on AM833 in the context of Novo’s injectable semaglutide Ph3 obesity program.

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Xeris Ph2 Pramlintide+insulin Co-formulation Topline Results

Xeris Pharmaceuticals announced positive topline results from a Ph2 trial evaluating its pramlintide-insulin co-formulation (XP-3924). Xeris said it is planning for an end-of-Ph2 meeting with FDA later in 2020 to discuss the XP-3924 development path. Below, FENIX provides an overview of the topline results as well as thoughts on the market potential of XP-3924 in the context of other similar products, notably Adocia’s ADO09 (M1pram).

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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.

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Welldoc Insulin Adjustment Program Approved by FDA; Fractyl to Initiate Study for Insulin-dependent T2DM Patients

Two diabetes-related news items have been observed: Welldoc announced FDA approval of an additional feature for the BlueStar platform called the Insulin Adjustment Program (IAP) and Fractyl Laboratories announced FDA approval of an Investigational Device Exemption (IDE) to initiate a study examining the effects of Revita DMR in T2DM patients treated with insulin. Below FENIX provides highlights and insights for the respective news items.

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Abbott Q1 ’20 Earnings Update; Provention Bio Initiates Rolling BLA for Teplizumab; Lilly Launches Additional Humalog AGs; Insulet’s COVID-19 Response

A series of diabetes-related news has been observed: Abbott hosted its Q1 ’20 earnings update, Provention Bio announced the initiation of a rolling BLA submission for teplizumab, Lilly announced the launch of lispro authorized generics (LAG) for Humalog Mix 75/25 and Humalog Junior, and Insulet initiated its COVID-19 response plan. Below, FENIX provides highlights and insights for the respective news items.

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Livongo Partners with Prognos Health

Livongo announced a partnership with Prognos Health to integrate Prognos’s clinical lab insights with the Livongo applied health signals platform. Prognos is a clinical data repository that uses AI to form data-driven insights for pharma, HCPs, and payers. Below, FENIX provides insights on the partnership and thoughts on how Prognos could improve outcomes in the wake of the COVID-19-driven movement toward telemedicine.

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