FDA Approval of AVMAPKI FAKZYNJA CO-PACK
Achieved FDA approval for AVMAPKI FAKZYNJA CO-PACK for KRAS-mutated recurrent LGSOC nearly 2 months ahead of schedule. This marks the first-ever truly novel/novel drug combination approved in oncology.
Successful Commercial Launch
Generated $2.1 million in net product revenue within the first 6 weeks of launch, indicating strong early traction and operational excellence.
Broad Insurance Coverage
Secured coverage from major insurers in the U.S., including the three largest PBMs, representing over 80% of lives.
Strengthened Financial Position
Completed a $75 million private placement, ending the quarter with $164.3 million in cash, cash equivalents, and investments.
Expansion of Distribution Network
Entered into multiple agreements with specialty distributors and oncology group purchasing organizations.