Olema Pharmaceuticals Inc. (NASDAQ:OLMA) stock is trading higher on Tuesday, with a session volume of 45.12 million compared to the average volume of 1.171 million as per data from Benzinga Pro.
Olema Pharmaceuticals' stock surged over 200% in reaction to Roche Holdings AG's (OTC:RHHBY) phase 3 results from the lidERA Breast Cancer study of giredestrant in early-stage breast cancer.
The trial evaluated giredestrant as an adjuvant (refers to treatments given after the main treatment) endocrine treatment for oestrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative.
The study met its primary endpoint at a pre-planned interim analysis, showing a statistically significant and clinically meaningful improvement in invasive disease-free survival with giredestrant versus standard-of-care endocrine therapy.
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Roche's Trial Redefines Breast Cancer Treatment
Roche on Tuesday said that lidERA is the first phase 3 trial of a selective oestrogen receptor degrader (SERD) to demonstrate a significant benefit in the adjuvant setting. The majority of breast cancer cases are diagnosed at an early stage.
Overall survival data were immature at the time of interim analysis, but a clear positive trend was observed.
Giredestrant was well tolerated, and adverse events were consistent with its known safety profile, with no unexpected safety findings observed. Data from lidERA will be presented at an upcoming medical meeting.
lidERA is the second positive phase 3 readout for giredestrant following evERA Breast Cancer, which was presented at the European Society for Medical Oncology Congress 2025.
Analyst Take
Oppenheimer analyst said in a note that it's the first trial ever to show a clinical benefit head-to-head against an aromatase inhibitor.
"We were not expecting this readout as the entire narrative has been around Roche's evERA and persevERA trials. Nonetheless, the data are a welcome surprise. Early breast cancer is a multi-billion dollar market, and one we did not have in our model," Oppenheimer wrote.
The analyst also added that the data also incrementally derisks Roche's persevERA Phase 3 trial, which is testing oral SERDS against aromatase inhibitors in the frontline metastatic setting.
Olema's lead drug candidate, palazestrant, is a proprietary, orally available complete estrogen receptor antagonist and a SERD, currently in two Phase 3 clinical trials.
The company initiated the OPERA-02 Phase 3 trial of palazestrant in combination with ribociclib in frontline ER+/HER2 metastatic breast cancer.
It continues enrollment in the OPERA-01 Phase 3 trial of palazestrant as a monotherapy in second- and third-line ER+/HER2- metastatic breast cancer.
Oppenheimer increased the estimated probability of success for palazestrant in reaction. It raised the price forecast from $22 to $45.
Price Action: Olema Pharmaceuticals shares were up 166.65% at $22.71, and Roche Holding shares were up 8.33% at $48.29 at the time of publication on Tuesday, according to Benzinga Pro data.
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