Category Archives: Topics

Farxiga Positive Topline DAPA-HF Results

AstraZeneca announced positive topline results from the DAPA-HF trial which evaluated the effect of dapagliflozin on the composite of CV death or worsening heart failure (HF). AZ did not provide any details (e.g. hazard ratios) for DAPA-HF; however, the company is likely looking to present the trial at the 2019 AHA conference (November 16-18). Below, FENIX provides insight into the positive DAPA-HF results including potential readthrough to BI/Lilly, Janssen, and Lexicon.

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Medtronic CY Q2 ’19 (FY Q1 ’20) Earnings Update

Medtronic hosted its CY Q2 ’19 (FY Q1 ’20) earnings call and provided a brief update to its diabetes business including the projected launch of its 780G advanced hybrid closed-loop system in FY H2 ’20 (CY late 2020/early 2021). Below, FENIX provides highlights and insights from the call.

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Medtronic Extended Wear Infusion Set

Medtronic announced it received Investigational Device Exemption (IDE) from FDA to initiate in-human studies of a new extended wear infusion set. According to the press release, the trial will evaluate the new infusion set for up to 7 days in 150 T1DM subjects using the 670G hybrid closed-loop system. The trial has not yet been observed on CT.gov. Below, FENIX provides thoughts on the new Medtronic infusion set initiative.

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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.

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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.

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Two New Lilly Ph1 Tirzepatide Trials

Two new Ph1 trials for Lilly’s tirzepatide have been observed on CT.gov, including a T2DM counter-regulatory response trial to hypoglycemia and another trial evaluating multiple injection sites in subjects with various BMIs. Below, FENIX provides thoughts on the respective trials.

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Novo: REDUCE-IT Adcom Readthrough to Oral Sema? MYL Generic Victoza Filed; Q2 ’19 Earnings Update

Novo Nordisk hosted its Q2 ’19 earnings call and provided updates to its diabetes business including the recent initiation of the first-in-human study of its novel basal insulin FSI965 as well as Ph2 completion of its anti-IL 21+liraglutide Ph2 trial in new-onset T1DM. Additionally, Novo disclosed that Mylan notified Novo of an ANDA Paragraph IV filing for generic Victoza. Below, FENIX provides highlights and insights from the call including potential readthrough from the recently scheduled Amarin REDUCE-IT adcom (and likely PDUFA delay) to the ongoing oral semaglutide FDA review.

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MannKind and Senseonics Q2 ’19 Earnings Updates

MannKind and Senseonics hosted their Q2 ’19 earnings calls and provided updates to their respective diabetes businesses. Below, FENIX provides highlights and insights from the calls.

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Xeris Q2 ’19 Earnings Update

Yesterday, Xeris published its Q2 ’19 earnings press release highlighting the September 10, 2019 PDUFA for its hypoglycemia rescue product ‘Gvoke.’ Gvoke launch is anticipated in Q4 ’19. Furthermore, the company disclosed utilizing the additional data from the fourth Ph3 trial to file an MAA to EMA by YE 2019. Below, FENIX provides additional thoughts on Gvoke in the context of its additional Ph3 data, and other novel glucagon rescue products.

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