Regeneron Pharmaceuticals, Inc. ( REGN Quick Quote REGN - Free Report) announced positive results from the RECOVERY trial in the U.K. on antibody cocktail, REGEN-COV (casirivimab and imdevimab), for COVID-19.
The phase III trial results showed that REGEN-COV reduced the risk of death by 20% in patients hospitalized with COVID-19 who had not mounted their own immune response (primary outcome for the primary analysis population). The trial was conducted at a time when most patients had not been fully vaccinated.
RECOVERY is the first study large enough to definitively determine whether REGEN-COV reduces mortality in patients hospitalized with severe COVID-19.
Earlier, late-stage studies in non-hospitalized COVID-19 patients showed that REGEN-COV reduced viral levels, shortened the time to resolution of symptoms and significantly reduced the risk of hospitalization or death.
Additionally, in a phase I/II study in hospitalized patients, REGEN-COV rapidly reduced viral levels with preliminary evidence suggesting that it lowered the risk of death or receipt of mechanical ventilation even for the patients who entered the trial without having mounted a natural antibody response of their own (seronegative).
Further, in the absence of the REGEN-COV treatment, seronegative patients had higher mortality rates than patients who had already mounted their own immune response (seropositive). Hence, the RECOVERY study prospectively focused on seronegative patients.
Patients in RECOVERY who received usual care alone had doubled the mortality rate at day 28, if they were seronegative, compared to seropositive (15%). Among seronegative patients in the RECOVERY trial, the median duration of hospital stay was 4 days shorter in the REGEN-COV group and the proportion of patients discharged alive by day 28 was greater.
Results from all these phase III studies showed that REGEN-COV can alter the course of COVID-19 infection from prevention to very early infection, all the way through when patients are on ventilators in hospitals.
The FDA has granted an Emergency Use Authorization (EUA) to REGEN-COV to treat mild-to-moderate COVID-19 in adults and pediatric patients (12 years of age and older weighing ≥40 g) with positive results of direct SARS-CoV-2 viral testing, and those at high risk of progression to severe COVID-19, including hospitalization or death.
Earlier this month, the FDA updated the EUA for REGEN-COV, lowering the dose to 1,200 mg (600 mg casirivimab and 600 mg imdevimab), which is half the dose originally authorized.
Regeneron is in discussions with the FDA to expand the current EUA to other populations, including prevention and hospitalized patient settings. The company also plans to submit a full Biologics License Application (BLA) for REGEN-COV.
The company's shares have gained 11.6% in the year so far against the
industry’s decline of 0.7%. Image Source: Zacks Investment Research
Last month, the FDA granted an EUA to
GlaxoSmithKline plc ( GSK Quick Quote GSK - Free Report) and Vir Biotechnology, Inc. ( VIR Quick Quote VIR - Free Report) ’s sotrovimab, an investigational single-dose monoclonal antibody, for the treatment of mild-to-moderate COVID-19 in adults and pediatric patients (12 years of age and older weighing at least 40 kg).
Regeneron currently carries a Zacks Rank #3 (Hold). A better-ranked stock in the biotech sector is
Repligen Corporation ( RGEN Quick Quote RGEN - Free Report) , which carries a Zacks Rank #2 (Buy). You can see . the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here
Repligen’s earnings estimates for 2021 have increased to $2.21 from $1.91 in the past 60 days.
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