Sorrento Therapeutics (SRNE) surges over 50% on the FDA approval of their COVID-19 antibody trial. The biotechnology firm received FDA clearance to proceed with a phase I clinical trial evaluating STI-1499, also known as COVI-GUARD, a “neutralizing” antibody for patients who tested positive for COVID-19.
Shares traded up as much as 27% to $10.60 in Thursday trades.
Sorrento expects a quick enrollment phase for the clinical trial and expects this trial to be followed by large trials targeting a potential emergency use authorization submission to the FDA as early as the end of this year.
The firm has initiated manufacturing processes to produce 50,000 doses in anticipation of receiving emergency use authorization for the COVID-19 antibody.
According to Sorrento, its COVID-19 antibody “has been 100% effective against the highly contagious D614G variant strain,” which is a mutation variant of SARS-CoV-2.
“The potentially high potency of STI-1499 antibody may allow for rapid scaling up of manufacturing operations,” Sorrento said.
Sorrento said it submitted data generated from testing on Syrian Golden hamsters infected with SARS-CoV-2 to the FDA in support of its antibody testing trial.
The main goal of this initial trial is to lay the groundwork for larger clinical studies, which can subsequently be used to apply for emergency use authorization (EUA). What appears to have grabbed investors’ collective attention this morning is that Sorrento noted in its press release that an EUA submission could be in the hands of the FDA before year’s end.
That’s a big deal because Sorrento is well behind both Eli Lilly and Regeneron Pharmaceuticals in the COVID-19 neutralizing antibody race. Lilly, for instance, has already launched a phase 3 trial for its COVID-19 antibody candidate LY-CoV555. Pivotal data from that ongoing study is expected by next March.
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Shares of Sorrento Therapeutics (SRNE) appear to be a very good investment option, the Money Midnight Indicator is expecting its price to increase considerably in the next several months. The majority of the metrics point to this investment being highly attractive.