On Thursday, May 7, Autolus held their Q1 2020 earnings call (press release/slides), highlighting their current clinical progress, enrollment, and potential initiation of their pivotal trial AUTO1-AL1 in adult R/R ALL. Below, FENIX provides thoughts on Autolus’s cell therapy program, particularly in the context of the ongoing health emergency.
On Wednesday, May 6, Allogene held their Q1 2020 earnings call (webcast/press release/ slides), highlighting the off-the-shelf benefits allogeneic products have over autologous products, particularly during the COVID-19 pandemic. Below, FENIX provides thoughts on Allogene’s cell therapy program in the context of the ongoing health emergency.
Yescarta sales continued to grow versus the previous quarter (Q4 2019), seemingly with little initial impact from COVID-19, in contrast to Kymriah which reported a slight dip in Q1 2020 sales (see previous FENIX insight). Below, FENIX provides thoughts on published revenues and possible factors influencing HCPs’ CAR-T prescribing preferences.
On Thursday, April 30, Gilead held their Q1 2020 earnings call (press release / financial report / slides). Of note, Yescarta sales continued to grow versus the previous quarter (Q4 2019), seemingly with little initial impact from COVID-19, in contrast to Kymriah which saw a slight dip in Q1 2020 sales. Below, FENIX provides thoughts on Gilead’s cell therapy program, particularly in the context of the ongoing COVID-19 pandemic.
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.
Novo Nordisk announced plans to initiate a new US insulin savings program starting on January 2, 2020. Under the new plan, Novo will offer a $99 Cash Card Program for a select volume of any of its insulin analog products as well as the launch of NovoLog and NovoLog Mix Authorized Generics (AG). Below, FENIX provides thoughts on the New Novo insulin program in the context of similar programs by Lilly and Sanofi.
Zafgen announced that it is planning to “strategic options to maximize shareholder value,” including a merger, acquisition, or in-licensing opportunity. Following preliminary data from a new animal study, Zafgen believes that in the short-term, there is a low probability of resolving the clinical hold placed on ZGN-1061. Below, FENIX provides brief thoughts on potential outcomes for Zafgen and ZGN-1061.
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.
Insulet hosted its Q4 ’18 earnings call and provided updates to its Omnipod business including the development of the Omnipod Horizon hybrid closed-loop. Of note, this is believed to be the first time that Insulet disclosed it received Breakthrough Device Designation for Omnipod Horizon. Below are highlights and insights from the call.
AstraZeneca’s Farxiga franchise labels (Farxiga and Xigduo) have been updated to reduce the eGFR cutoff from 60 to 45 mL/min/1.73m2. Additionally, AZ announced positive topline results from the Brilinta Ph3 THEMIS study in patients with established CAD and T2DM. Below, FENIX provides insight into the lower Farxiga eGFR as well as thoughts on AZ’s strengthening CV protection market position.