Novo Nordisk recently announced positive top-line results of its 72-week Ph2b NASH trial for semaglutide. Below, FENIX has conducted a winners-and-losers analysis in the context of Lilly, Sanofi, AZ, BI, and Lexicon, relative to the sema NASH results.
Novo Nordisk hosted its post-Q1 ’20 earnings roadshow event. Additionally, Xeris, Teva, and Becton Dickinson held their respective Q1 ’20 earnings calls. Teva did not discuss its generic liraglutide nor did BD discuss the status of its T2DM patch pump. Below, FENIX provides highlights and insights from the respective earnings calls.
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.
Yesterday, FDA approved Farxiga as the first SGLT2i for the treatment of HFrEF (NYHA class II-IV) in both T2DM and non-T2DM patients. The approval was based on results from the DAPA-HF study which demonstrated a 26% RRR in hospitalization for heart failure or CV death. Below, FENIX provides thoughts on the new Farxiga HF indication, including read-through to Jardiance and the SGLT2i class, and a brief overview of the updated Farxiga HCP website.
Novo Nordisk hosted its Q1 ’20 earnings call (press release; slides) and provided updates to its diabetes business including the ongoing launch of Rybelsus (oral semaglutide) and new Ph2 semaglutide NASH topline data. Unsurprisingly, much of the Q1 ’20 prepared remarks and Q&A were focused on NASH. Below, FENIX provides highlights from the call and additional thoughts on Novo’s PCSK9i/basal insulin hybrid approach.
FDA has approved Farxiga to reduce the risk of CV death and hospitalization for heart failure in T2DM and non-T2DM patients based on results from the DAPA-HF outcomes trial (view FDA press release). The DAPA-HF approval comes just one day after FENIX’s estimated date of May 4, 2020. AstraZeneca has not issued a press release nor is the updated label available at the time of this publication. FENIX will be conducting an analysis of the new Farxiga HF indication once the updated label is available.
On Tuesday, April 28, Novartis held their Q1 2020 earnings call (press release / financial report / slides). Of note, Kymriah sales fell slightly versus the previous quarter (Q4 2019), possibly due to the impact of COVID-19. However, Novartis underlined its confidence in the oncology field’s “resilience” and the company’s full-year sales outlook. Below, FENIX provides thoughts on Novartis’s cell therapy program, particularly in the context of the ongoing COVID-19 pandemic.
A series of diabetes-related news has been observed: Ypsomed announced a partnership with Dexcom to integrate CGM data with the YpsoPump and develop a hybrid closed-loop system; Dexcom announced Health Canada has authorized use of the G6 CGM to be used in hospitals during the COVID-19 pandemic; and Diamyd announced positive preliminary results from the first part of the Ph1/2 ReGenerate-1 trial evaluating Remygen in T1DM. Below, FENIX provides highlights and insights from the respective news items.
A new Dexcom G6 CGM TV commercial called, “Diabetes Didn’t Come Up,” has recently been observed. Of note, this is believed to be the first time that Dexcom has created a commercial solely focused on the G6 CGM pediatric indication. Below, FENIX provides analysis of the messaging used in the TV commercial, thoughts on why the pediatric TV DTC hasn’t occurred until ~2 years after launch, and Dexcom’s peds positioning vs. Abbott Libre.
According to the CHMP meeting highlights, Sanofi’s bs-aspart has received a positive CHMP opinion. Of note, the Invokana/Vokanamet renal protection indication (CREDENCE) was not mentioned in the meeting highlights, suggesting additional questions were asked to the sponsor. Below, FENIX provides brief thoughts on the positive CHMP opinion for Sanofi’s bs-aspart.