OLMA biotech catalysts & pipeline

OLEMA PHARMACEUTICALS INC · Data as of 2026-10-25

Upcoming catalysts

palazestrant — Clinical data readout

this fall

His extensive experience across business development, portfolio strategy, and management will be integral as we prepare for pivotal data from OPERA-01 this fall and continue our transformation into a fully integrated oncology company.

Source filing

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 2027

Source filing

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 — 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 — 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

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