Tag Archives: Afrezza

Insulet, Mannkind, and Lannett Q3 ’20 Earnings Updates

Insulet (press release), Mannkind (press release), and Lannett (press release) hosted their respective Q3 ’20 earnings calls. Of note, Insulet provided updates to its Omnipod 5 development plans, including the recent initiation of a T2DM feasibility study. Furthermore, following a meeting between Lannett and FDA in June 2020, Lannett said it is finalizing the trial protocol evaluating its bs-glargine in healthy volunteers. Below, FENIX provides highlights and insights from the calls.

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David Kendall to Leave MannKind; MannKind Q2 ’20 Earnings Update

MannKind hosted its Q2 ’20 earnings call (press release) and provided updates to its business, particularly around how the company is continuing to cope with the COVID-19 pandemic. Importantly, MannKind disclosed the company’s CMO, David Kendall, will be leaving the company. Below, FENIX provides highlights and insights from the call.

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Dapa Reduces Progression to T2DM; Teplizumab Continues to Delay T1DM Onset; Arecor AT247 Faster than Fiasp; ADA Key Press Releases (June 15)

Today, twelve diabetes-related news items were observed: DAPA-HF delays T2DM onset, teplizumab follow-up results, Arecor uRAI Ph1 data, new Afrezza practical data, Diasome HDV Ph2 results, Hua Medicine Ph3 GKA data, ORMD-0801 in NASH, Glytec CGM POC data, Biolinq’s first-in-human CGM data, and more. Below, FENIX provides context and analysis for the announcements.

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Trulicity, Ozempic, Afrezza, Libre, Control IQ, and Onduo RWE at ADA 2020; Sota T2DM CKD Data; vTv Presents TTP399 Ph2 Results; ADA 2020 Key Press Releases (June 13)

Today, nine diabetes-related news items were observed: Trulicity, Ozempic, Afrezza, Libre, Control IQ, and Onduo RWE data were presented at ADA 2020 as well as new data from Lexicon (sota T2DM Ph3 CKD), vTv (Ph2 Simplici-T1), and Zealand (V-Go patch pump). Below, FENIX provides context and analysis for the announcements.

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Livongo, MannKind, and Lannett Q1 ’20 Earnings Updates; Senseonics Receives Positive BCBS Coverage Decisions

Livongo, MannKind, and Lannett each hosted their Q1 ’20 earnings call and provided updates to their respective businesses. Senseonics also announced positive coverage decisions from three BCBS plans. Importantly, Lannett said it believes it can file their bs-glargine with FDA as early as 2022. Below, FENIX provides highlights and insights from the calls.

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Afrezza Promotional Update; MannKind Receives $4.9M Forgivable Loan

MannKind recently updated the Afrezza patient website with new promotional messaging, which aligns with the recent corporate rebranding. Additionally, MannKind announced the company has received a forgivable loan under the Paycheck Protection Program of the CARES Act. Below, FENIX provides an analysis of the updated Afrezza messaging as well as brief thoughts on the impact of COVID-19 to MannKind and the Afrezza brand.

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MannKind Q4 ’19 Earnings Update

MannKind hosted its Q4 and FY 2019 earnings call and highlighted its new strategy to focus on two therapy areas: endocrinology and orphan lung diseases. Additionally, MannKind laid out its roadmap for an Afrezza pediatric indication. Below, FENIX provides highlights and insights from the call.

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Farxiga DAPA-HF receives priority review; Fiasp pediatric approval in US; MannKind launching in Brazil

A series of diabetes-related news items were observed today from AstraZeneca, Novo Nordisk, and MannKind. AZ announced FDA filing acceptance and granting of priority review for the Farxiga DAPA-HF sNDA. According to AZ, the PDUFA date is in Q2 2020. Additionally, Novo announced US approval of Fiasp for pediatric populations. Further, MannKind announced that it has received approval of the proposed price of Afrezza in Brazil, and intends to commence marketing and distribution the week of January 13, 2020. Below, FENIX provides context and insights regarding these news items.

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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.

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New MannKind and Dance Inhaled Insulin Data; EASD 2019 Day 4

On the fourth day of EASD, 3 key press releases were observed including new inhaled insulin data from MannKind and Dance. Additionally, Xeris announced the initiation of its Ph2 pramlintide+insulin fixed-ratio combination trial. In case you missed it earlier today, FENIX also provided coverage of Novo’s Ph3b CONCLUDE data presentation (H2H Tresiba vs. Toujeo T2DM basal-only trial). Below FENIX provides insights and context from each respective announcement.

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