Femasys is trading 11.72% up now at $3.05 after the FDA approved a modular PMA pathway for investigational FemBloc.

  • The pathway lets the FDA review completed application sections before final clinical data, reducing regulatory uncertainty while the pivotal trial continues.
  • The decision advances potential U.S. approval but does not authorize FemBloc marketing.
  • Broader biotech strength provides additional supportive context.