palazestrant — Topline data
Q1 2027
• Completed enrollment in the pivotal Phase 3 OPERA-01 trial; top-line data are now expected in the first quarter of 2027Source filing
OLMA biotech catalysts & pipeline
OLEMA PHARMACEUTICALS INC · Data as of 2026-09-08
Upcoming catalysts
palazestrant — NDA/BLA submission
2027
We have completed enrollment and anticipate top-line results for this trial in the first quarter of 2027, expect to submit the new drug application (NDA) in 2027, and, if successful, anticipate potential U.S. Food and Drug Administration (FDA) approval and commercial launch in 2028.Source filing
OP-3136 — Initial data
mid-2027
We anticipate presenting initial combination data from the Phase 1 clinical study of OP-3136 in combination with fulvestrant or palazestrant in mid-2027.Source filing
palazestrant — PDUFA
in late 2027
We anticipate top-line results for this trial in the fall of 2026, expect to submit the NDA in 2027, and , if successful, anticipate potential U.S. Food and Drug Administration (FDA) approval and commercial launch in late 2027.Source filing
palazestrant — Topline data
2028
We anticipate top-line data from this trial in 2028 and, if successful, anticipate potential FDA approval and commercial launch in the frontline MBC setting in the United States in 2029.Source filing
palazestrant — Regulatory decision
2028
We have completed enrollment and anticipate top-line results for this trial in the first quarter of 2027, expect to submit the new drug application (NDA) in 2027, and, if successful, anticipate potential U.S. Food and Drug Administration (FDA) approval and commercial launch in 2028.Source filing
palazestrant — PDUFA
in 2029
We anticipate top-line data in 2028 and, if successful, anticipate potential FDA approval and commercial launch in the frontline MBC setting in the United States in 2029.Source filing
palazestrant — Regulatory decision
2029
We anticipate top-line data from this trial in 2028 and, if successful, anticipate potential FDA approval and commercial launch in the frontline MBC setting in the United States in 2029.Source filing