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
Pfizer Inc (NYSE: PFE) and BioNTech SE (NASDAQ: BNTX) have announced results from a Phase 2/3 trial of a 10 µg booster (third) dose of COVID-19 vaccine in children 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.
FDA Intends To Revoke Protagonist Therapeutics’ Rusfertide Breakthrough Tag In Rare Form Of Blood Cancer
Protagonist Therapeutics Inc (NASDAQ: PTGX) received a letter from the FDA indicating the agency’s intent to rescind Breakthrough …
