Category Archives: Topics

Lyumjev Approved for Insulin Pump Use; Dario and Nemaura Q2 ’21 Earnings Updates; CHMP Agenda August 16-19

A series of cardiometabolic-related news items have been observed: Lilly announced FDA approved Lyumjev for pump compatibility; Dario hosted its Q2 ’21 earnings call (press release); Nemaura Medical published its CY Q2 ’21 (FY Q1 ’22) business update (press release); and the CHMP agenda for this month’s meeting (August 16-19) has been released. Below, FENIX highlights and insights for the respective new items.

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Xeris Expanded Payor Coverage; Movano Q2 ’21 Earnings Update

Xeris announced it has reached a milestone for Gvoke payor coverage and Movano hosted its Q2 ’21 earnings update. Of note, Gvoke Medicare access has reached 91% and commercial insurance access is at 88%. Below, FENIX provides highlights and insights for the respective news items.

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New Non-invasive CGM Startup Raises $11.7M in Series B; Zealand, Mannkind, and Metacrine Q2 ’21 Earnings Updates; Integrity Applications Reverse Stock Split

A series of cardiometabolic-related news items have been observed: Hagar announced it has raised $11.7M in Series B financing for the clinical development of a non-invasive CGM; Zealand, Mannkind, and Metacrine hosted their Q2 ’21 earnings calls; and Integrity Applications announced it has implemented a 1-for-13 reverse stock split. Below, FENIX provides highlights and insights for the respective news items.

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AZ/Fibrogen Receive Roxadustat CRL

AstraZeneca and Fibrogen announced FDA issued a CRL regarding the roxadustat NDA for the treatment of anemia due to CKD in non-dialysis dependent (NDD) and dialysis-dependent (DD) adults. Recall, in July 2021, FDA held an advisory committee that voted 1-13 and 2-14 against the approval of roxadustat for the NDD and DD populations, respectively (previous FENIX insight). According to the press release, FDA is requesting additional clinical study be performed prior to resubmitting the roxadustat application. AZ and Fibrogen are working with FDA to evaluate next steps.

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Lifescan and Fitbit Diabetes Collaboration; Sigilon Q2 ’21 Earnings Update

Two cardiometabolic-related news items have been observed: Lifescan and Fitbit announced a multi-year collaboration for data integration into each other’s apps; and Sigilon announced its Q2 ’21 earnings. Below, FENIX provides highlights and insights for the respective news items.

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Viatris and Senseonics Q2 ’21 Earnings Updates; Forxiga CKD EU Approval; GoodRx and BI Patient Access Initiative; Diamyd EU Patent Granted; New Glooko CTO

A series of cardiometabolic-related news items have been observed: Viatris and Senseonics hosted their respective Q2 ’21 earnings calls; AstraZeneca announced EU approval of Forxiga for the treatment of CKD in adults with and without T2DM; GoodRx and BI announced an initiative to increase access to cost-savings programs for patients with T2DM and COPD; Diamyd announced the European Patent Office has granted the Diamyd’s recent patent application for treatment using GAD; and Glooko announced Prakash Menon has been appointed as the company’s Chief Technology Officer. Below, FENIX provides highlights and insights for the respective news items.

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Xeris, Amarin, Regeneron, and BD Q2 ’21 Earnings Updates

Xeris, Amarin, Regeneron, and BD hosted their respective Q2 ’21 earnings calls, Below, FENIX provides highlights and insights from the events.

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Novo Q2 ’21 Post-earnings Event

Novo Nordisk hosted its post-Q2 ’21 earnings event and provided further details on the obesity market and Wegovy launch. Below, FENIX provides an overview of the commentary from senior management beyond what was discussed during the Q2 ’21 earnings call as well as insights from the call.

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Omnipod 5 Delayed; Insulet, Provention Bio, and Bayer Q2 ’21 Earnings Updates

Insulet (press release), Provention Bio (press release), and Bayer (press release; slides) hosted their respective Q2 ’21 earnings calls. Importantly, Insulet disclosed the projected Omnipod 5 FDA clearance and launch have been delayed. Below, FENIX provides highlights and insights from the calls.

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Tandem, Ionis, Esperion, and Amgen Q2 ’21 Earnings Updates; Dario Gains National Digital Behavioral Health Contract

Five cardiometabolic-related news items have recently been observed: Tandem, Ionis, Esperion, and Amgen hosted their respective Q2 ‘21 earnings calls; and Dario Health announced it was selected as the digital behavioral health provider for an undisclosed national professional services company. Below, FENIX provides highlights and insights for the respective news items.

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