Last mentioned: Mar 14, 2026
Artemis III
Planned mission to land the first humans on the lunar South Pole.
APOLLO Data Readout
Expected release of Phase 2 data which will support the traditional NDA filing.
APOLLO Trial Data
Expected top-line results from the Phase 2/3 APOLLO trial in Q4 2026.
Artemis II Launch
Target window for the first crewed flight of the SLS and Orion.
FDA CRL Issued
Disc Medicine receives a Complete Response Letter for bitopertin's accelerated approval application.
Strategic Pivot
Company announces shift to traditional approval pathway for EPP indication.
Regulatory Pivot
Disc Medicine announces shift to traditional approval pathway.
FDA CRL Issued
FDA rejects accelerated approval pathway for bitopertin in EPP.
Technical Reviews
NASA conducts extensive testing on Orion heat shield and life support systems.
Artemis I Success
Uncrewed Orion capsule successfully orbits the Moon and returns to Earth.
NASA has officially set an April 2026 target for the Artemis II mission, marking the first time humans will return to the lunar vicinity since 1972. The mission will send a crew of four on a high-stakes flyby to validate the Space Launch System and Orion spacecraft for future deep-space exploration.
Disc Medicine has shifted its regulatory strategy for bitopertin in erythropoietic protoporphyria (EPP) following an FDA Complete Response Letter regarding its accelerated approval bid. The company will now focus on a traditional approval route, with pivotal Phase 2/3 APOLLO trial data expected in Q4 2026.
Disc Medicine is shifting its regulatory strategy for bitopertin in erythropoietic protoporphyria (EPP) after receiving a Complete Response Letter from the FDA. The company will now pursue a traditional approval pathway, with critical Phase 2 APOLLO trial data expected in the fourth quarter of 2026.