Regeneron Pharmaceuticals Inc REGN said Wednesday that it requested emergency use authorization from the FDA for its investigational coronavirus antibody cocktail.
The experimental drug, named REGN-COV2, was in news last week after it was administered to President Donald Trump.
What Is REGN-COV2? REGN-COV2 is a combination of two monoclonal antibodies: REGN10933 and REGN10987.
The company said it has doses 50,000 patients and hopes to make available doses for 300,000 patients in the months ahead.
Regeneron's early data — and perhaps the Trump news — have led to the FDA being supportive of the company filing, Cantor Fitzgerald analyst Alethia Young said in a Thursday note.
Patient Access In Q4? The filing means that patients could obtain access to the drug in the fourth quarter, Young said.
The analyst's base case assumes COVID-19 sales of $1.8 billion in 2021 for Regeneron, with a 50% probability of success.
Assuming 100% success on Cantor's revenue forecasts for 2021-2023, $18 per share would be added to Regeneron's valuation, she said.
Going by the urgency with which Gilead Sciences, Inc.'s GILD remdesivir was approved, REGN-COV2 could be approved in the coming weeks — especially as COVID-19 remains an urgent issue in the U.S., Young said.
"Our positive thesis on REGN is more than REGN-COV2, but certainly we think commercial sales from REGN-COV2 could be a near-term positive earnings driver for 2021."
Dupixent is likely to be another earnings growth driver for Regeneron, the analyst said.
Regeneron Vs. Lilly: The coronavirus antibodies from Regeneron and Eli Lilly And Co LLY, which submitted an emergency use application Wednesday, have similar efficacy and safety, Canaccord Genuity analyst John Newman said in a note.
The lack of baseline viral load data for Lilly is not helpful, the analyst said.
Regeneron's antibody cocktail showed better efficacy for higher viral loads or in patients who were likely more ill, while Lilly did not disclose any such data, he said.
Hospitalization or medical visits for both were similar, with Lilly holding a slight edge, Newman said.
"Importantly, Regeneron illustrated faster symptom resolutions in patients with higher viral load at baseline."
Cantor Fitzgerald has an Overweight rating on Regeneron with a $690 price target.
Canaccord Genuity maintained a Buy rating and $700 price target.
REGN Price Action: At last check, Regeneron shares were rising 2.14% to $604.34.
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