FDA grants Priority Review for Gilead's bictegravir/lenacapavir single-tablet HIV regimen. The NDA is supported by ARTISTRY-1 and ARTISTRY-2 trials showing noninferiority. A PDUFA target date of August 27, 2026 has been set.
Altesa BioSciences closed an oversubscribed $75 million Series B financing led by Forbion with participation from Sanofi to advance vapendavir, a first-in-class oral antiviral targeting rhinovirus infections in COPD patients.
A once-daily single-tablet combination of bictegravir and lenacapavir demonstrated non-inferiority to existing HIV treatments in Phase 3 trials, offering simplified treatment for people living with HIV who are virologically suppressed.
