Here’s a roundup of top developments in the biotech space over the last 24 hours:
Stocks In Focus
Pfizer-BioNTech’s COVID-19 Vaccine Booster Shows High Immune Response In Kids Ages 5-11
Data from a subanalysis of 30 sera indicate that serum antibodies induced by a third dose neutralize the omicron variant. The shot demonstrated a 36-fold increase in neutralizing antibody titers compared to levels seen after two vaccine doses.
PFE shares are down 0.15% at $53.02 and BNTX stock is down 0.65% at $178.21 during premarket trading.
FDA Extends Review Period For Regeneron’s COVID-19 Therapy
The FDA has extended the review of Regeneron Pharmaceuticals Inc’s (NASDAQ: REGN) marketing application of REGEN-COV (casirivimab and imdevimab) in non-hospitalized COVID-19 patients and as prophylaxis in certain individuals.
The extension is due to ongoing discussions with the FDA on pre-exposure prophylactic use, for which Regeneron has submitted additional data. The new target action date is July 13.
The FDA has not requested any further studies.
Valneva’s COVID-19 Vaccine Scores Conditional UK Approval
The Medicines and Healthcare products Regulatory Agency (MHRA) of the U.K. has granted Conditional Marketing Authorization for Valneva SE’s (NASDAQ: VALN) COVID-19 vaccine candidate in adults 18 to 50 years of age.
MHRA found that VLA2001 meets safety, quality and effectiveness standards.