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Olema Oncology Announces New Clinical Data for Palazestrant in Combination with Ribociclib to be Presented at the 2024 ESMO Breast Cancer Annual Congress

Key Takeaway: Olema Oncology has announced that it will present new clinical data regarding palazestrant in combination with ribociclib at the 2024 ESMO Breast Cancer Annual Congress. This data comes from an ongoing Phase 1b/2 clinical study targeting patients with ER+, HER2- advanced breast cancer. Palazestrant has already shown promise in clinical trials and received FDA Fast Track designation for its potential. The presentation will take place on May 16, 2024, and a copy of the poster will be available on Olema's website.
Price reaction · baseline $11.24 (2024-05-07 close) · hit after-hours · clean, no other OLMA news in the window
day 0 close · peak
-3.5%

Market Sentiment Analysis

POSITIVE FACTORS

  • Olema is presenting new clinical data at a prominent congress.
  • Palazestrant shows anti-tumor efficacy in advanced breast cancer.
  • The drug has received FDA Fast Track designation.
  • Olema is advancing a pipeline of novel therapies for women's cancers.

CONCERNS & RISKS

  • The clinical data are still under investigation and not finalized.
  • The efficacy and safety data from ongoing trials are yet to be fully established.

BiopharmaWatch Analysis

From our catalyst data and publicly available data · not financial advice
Best trade, last catalyst
+73%
120-day peak, hindsight
Typical move
8%
average across 7 past catalysts
Cash runway
~30 mo
Minimal dilution risk
Lead asset
Palazestrant
Phase 3 · Breast Cancer

Full Press Release Details

SAN FRANCISCO, May 08, 2024 (GLOBE NEWSWIRE) -- Olema Pharmaceuticals, Inc. (“Olema” or “Olema Oncology,” Nasdaq: OLMA), a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of targeted therapies for women’s cancers, today announced that it will present new clinical data from the Company’s ongoing Phase 1b/2 clinical study of palazestrant in combination with CDK4/6 inhibitor ribociclib in a poster presentation at the upcoming European Society for Medical Oncology (ESMO) Breast Cancer Annual Congress 2024 taking place May 15-17, 2023, in Berlin, Germany.
Details of the ESMO Breast Cancer Annual Congress 2024 poster presentation are:
Title : A Phase 1b/2 study of palazestrant (OP-1250) in combination with ribociclib in patients with estrogen receptor-positive, human epidermal growth factor receptor 2-negative (ER+, HER2-), advanced and/or metastatic breast cancer (ID 407)
Presentation # : 212P
Date : Thursday, May 16, 2024
Time : 12:00 p.m. CEST (6:00 a.m. ET)
A copy of the poster will be made available on Olema’s website under the Science section when it is presented at the congress. Abstracts for the posters will be found on the ESMO Breast Cancer Annual Congress website here.
Company Investor Webcast and Conference Call
Olema will host a webcast and conference call for analysts and investors to review the data being presented at ESMO Breast Cancer Annual Congress 2024 on Wednesday, May 15, 2024, at 8:00 a.m. ET (2:00 p.m. CEST). Please register for the webcast by visiting the Investors & Media section of Olema’s website at olema.com.
About Palazestrant (OP-1250)
Palazestrant (OP-1250) is a novel, orally-available small molecule with dual activity as both a complete estrogen receptor (ER) antagonist (CERAN) and selective ER degrader (SERD). It is currently being investigated in patients with recurrent, locally advanced or metastatic ER-positive (ER+), human epidermal growth factor receptor 2-negative (HER2-) breast cancer. In clinical studies, palazestrant completely blocks ER-driven transcriptional activity in both wild-type and mutant forms of metastatic ER+ breast cancer and has demonstrated anti-tumor efficacy along with attractive pharmacokinetics and exposure, favorable tolerability, CNS penetration, and combinability with CDK4/6 inhibitors. Palazestrant has been granted U.S. Food and Drug Administration (FDA) Fast Track designation for the treatment of ER+/HER2- metastatic breast cancer that has progressed following one or more lines of endocrine therapy with at least one line given in combination with a CDK4/6 inhibitor. It is being evaluated both as a single agent in an ongoing Phase 3 clinical trial, OPERA-01, and in Phase 1/2 combination studies with CDK4/6 inhibitors (palbociclib and ribociclib), a PI3Ka inhibitor (alpelisib), and an mTOR inhibitor (everolimus). For more information, please visit www.opera01study.com.
About Olema Oncology
Olema Oncology is a clinical-stage biopharmaceutical company committed to transforming the standard of care and improving outcomes for women living with cancer. Olema is advancing a pipeline of novel therapies by leveraging our deep understanding of endocrine-driven cancers, nuclear receptors, and mechanisms of acquired resistance. In addition to our lead product candidate, palazestrant (OP-1250), a proprietary, orally-available complete estrogen receptor (ER) antagonist (CERAN) and a selective ER degrader (SERD), Olema is developing a potent KAT6 inhibitor (OP-3136). Olema is headquartered in San Francisco and has operations in Cambridge, Massachusetts. For more information, please visit us at www.olema.com.
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Frequently Asked Questions

What will Olema present at ESMO Breast Cancer Congress 2024?

Olema will present clinical data on palazestrant combined with ribociclib.

When does Olema's presentation take place at the congress?

Olema's presentation is scheduled for May 16, 2024, at 12:00 p.m. CEST.

What is palazestrant used for?

Palazestrant is investigated for treating ER+/HER2- metastatic breast cancer.

What designation has palazestrant received from the FDA?

Palazestrant has received FDA Fast Track designation for specific breast cancer.

Where can I find more information about Olema?

Visit Olema's website at www.olema.com for more information.

Last updated: May 8, 2024