Dec. 30 Quick Takes: Approval for Sinopharm vaccine, following report of 79% protection; plus Aprea, Axsome, Serum Institute, Pfizer-BioNTech, Moderna, Inotrem and Actinium
Sinopharm reveals top-line Phase III data
China’s National Medical Products Administration (NMPA) granted conditional approval late Wednesday to an inactivated SARS-CoV-2 virus vaccine from Sinopharm. Earlier on Wednesday, the vaccine developer said prime-boost vaccine administration had 79.3% efficacy in a Phase III trial to prevent COVID-19. According to the company, 99.5% of vaccinated participants had detectable neutralizing antibodies. The company did not provide detailed data.
Aprea sinks on eprenetapopt miss in pivotal trial
A Phase III miss for eprenetapopt to treat TP53 mutant myelodysplastic syndromes sent Aprea Therapeutics Inc. (NASDAQ:APRE) shares down 78% to $5.50 on Monday. The reactivator of mutant and inactivated TP53 plus azacitidine vs. azacitidine alone failed on the primary endpoint of improving complete remission rate (33% vs. 22.4%, p=0.13). Aprea shares closed Wednesday at $5.07...