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Wednesday, February 24, 2021 7:04:20 AM
1) We had a top-line beat. For a company like Halo, revenue beat is more important than bottomline beat.
2) Something new that Helen mentioned in the Q&A regarding Efgartigimod’s phase 3 in Myasthenia Gravis; Argenix is seeking approval based on IgG levels instead of the traditional disease (in this case MH) outcome non-inferiority. See below for primary and secondary outcome measures in the new clinical trial posted this month.
This is quite significant as it will pave the way for other already approved IV therapeutics to get approval much faster and at lower cost. (i.e. pharmacokinetics markers as a surrogate for disease efficacy). This will make partnering up with Halo so much more attractive, since it’s the partners that pay for the trials.
https://clinicaltrials.gov/ct2/show/NCT04735432?cond=Efgartigimod&draw=2&rank=11
“Primary Outcome Measures :
Percent change from baseline in total Immunoglobulin (IgG) levels at day 29 [ Time Frame: at day 29 ]
Secondary Outcome Measures :
Absolute values in total immunoglobulin (IgG) levels over time [ Time Frame: up to 12 weeks ]
Change from baseline in total immunoglobulin (IgG) levels over time [ Time Frame: up to 12 weeks ]
Percent change from baseline in total immunoglobulin (IgG) levels over time [ Time Frame: up to 12 weeks ]”
3) likely to see analyst upgrades and new initiations.
4) The debt/note issuance was a smart move. It pays off an existing debt and allows for more share buybacks (per press release). It rewards the current investor.
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