This section highlights FDA-related milestones and regulatory updates for drugs developed by Olema Pharmaceuticals (OLMA).
Over the past two years, Olema Pharmaceuticals has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
OP-1250, OP-3136, and palazestrant. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
OP-1250 - FDA Regulatory Timeline and Events
OP-1250 is a drug developed by Olema Pharmaceuticals for the following indication: Metastatic, ER+ / HER2- breast cancer.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- OP-1250
- Announced Date:
- November 25, 2024
- Indication:
- Metastatic, ER+ / HER2- breast cancer
Announcement
Olema Pharmaceuticals, announced that it will present new data from the Phase 1b/2 clinical study of palazestrant (OP-1250) in combination with CDK4/6 inhibitor ribociclib at the San Antonio Breast Cancer Symposium (SABCS 2024) being held December 10-13, 2024, at the Henry B. Gonzalez Convention Center in San Antonio, Texas.
AI Summary
Olema Pharmaceuticals announced it will share new data at the San Antonio Breast Cancer Symposium (SABCS 2024). The company will present findings from its Phase 1b/2 clinical study, which looks at the use of palazestrant (OP-1250) combined with the CDK4/6 inhibitor ribociclib. This study targets patients with estrogen receptor-positive, HER2-negative advanced or metastatic breast cancer. The poster presentation is scheduled for December 11, 2024, from 5:30 to 7:00 p.m. CT at the Henry B. Gonzalez Convention Center in San Antonio, Texas. Olema’s new data explore the potential of this oral therapy combination to improve outcomes for patients, highlighting its effectiveness and safety profile. The presentation at SABCS 2024 aims to offer important insights into a promising treatment strategy for this specific breast cancer group.
Read Announcement- Drug:
- OP-1250
- Announced Date:
- May 15, 2024
- Indication:
- Metastatic, ER+ / HER2- breast cancer
Announcement
Olema Pharmaceuticals, announced interim results from an ongoing Phase 1b/2 clinical study of palazestrant (OP-1250) in combination with CDK4/6 inhibitor ribociclib for the treatment of ER+/HER2- metastatic breast cancer.
AI Summary
Olema Pharmaceuticals recently announced interim results from its ongoing Phase 1b/2 clinical study. The trial is testing palazestrant (OP-1250) in combination with the CDK4/6 inhibitor ribociclib. This study focuses on treating patients with ER+/HER2- metastatic breast cancer. The innovative therapy aims to provide a new treatment option for those who often have limited choices after standard treatments. Early findings from this trial are promising and could lead to improvements in managing this aggressive form of breast cancer.
Palazestrant works as a selective estrogen receptor degrader, while ribociclib helps slow down cancer cell growth by targeting specific proteins in the cell cycle. The combination represents a modern approach to cancer treatment, and ongoing research will determine the full potential of this therapy. These results mark a significant step in developing new treatments to benefit patients with advanced breast cancer.
Read Announcement- Drug:
- OP-1250
- Announced Date:
- May 8, 2024
- Indication:
- Metastatic, ER+ / HER2- breast cancer
Announcement
Olema Pharmaceuticals 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.
AI Summary
Olema Pharmaceuticals announced that it will present new clinical data at the upcoming European Society for Medical Oncology (ESMO) Breast Cancer Annual Congress. The data comes from the Company’s ongoing Phase 1b/2 study, which investigates the combination of palazestrant and the CDK4/6 inhibitor ribociclib in breast cancer patients. The results, set to be shared in a poster presentation, highlight the potential benefits and safety profile of using this combination therapy to treat advanced breast cancer.
This poster session, scheduled for May 15-17, 2023, in Berlin, Germany, offers an excellent opportunity for medical professionals and researchers to review emerging clinical findings. The presentation is expected to spark discussions on optimizing endocrine and targeted therapies in breast cancer care, contributing to a deeper understanding of treatment strategies and potential improvements in patient outcomes.
Read Announcement
OP-3136 - FDA Regulatory Timeline and Events
OP-3136 is a drug developed by Olema Pharmaceuticals for the following indication: Bioavailable KAT6 Inhibitor.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- OP-3136
- Announced Date:
- April 25, 2025
- Indication:
- Bioavailable KAT6 Inhibitor
Announcement
- Olema Pharmaceuticals, announced preclinical data demonstrating the anti-tumor activity of OP-3136, a novel small molecule that potently and selectively inhibits lysine acetyltransferase 6 (KAT6), in prostate, ovarian, and non-small cell lung cancer (NSCLC) models.
AI Summary
Olema Pharmaceuticals has shared new preclinical data showing that its small-molecule drug, OP-3136, can effectively slow tumor growth. The drug is a potent and selective inhibitor of lysine acetyltransferase 6 (KAT6), an enzyme linked to cancer development. Studies in prostate, ovarian, and non-small cell lung cancer models reveal strong anti-tumor activity. In ovarian cancer tests, OP-3136 as a single treatment resulted in sustained tumor shrinkage, while in other models it reliably slowed tumor growth. The findings indicate that the drug may work independently of KAT6 expression levels. Olema Oncology is now testing OP-3136 in a Phase 1 clinical trial for multiple solid tumors. These preclinical results suggest that OP-3136 may become a valuable treatment option for patients with difficult cancers.
Read Announcement- Drug:
- OP-3136
- Announced Date:
- March 25, 2025
- Indication:
- Bioavailable KAT6 Inhibitor
Announcement
Olema Pharmaceuticals, announced it will present a poster highlighting preclinical anti-tumor activity of OP-3136, a novel small molecule that potently and selectively inhibits lysine acetyltransferase 6 (KAT6), in prostate, ovarian, and non-small cell lung cancer models in a late-breaking session at the American Association for Cancer Research (AACR) Annual Meeting taking place April 25-30 in Chicago, Illinois.
AI Summary
Olema Pharmaceuticals will present a late-breaking poster at the AACR Annual Meeting in Chicago from April 25-30, 2025. The poster will show preclinical data on OP-3136, a new small molecule designed to target and inhibit lysine acetyltransferase 6 (KAT6). This enzyme is linked to cancer growth, and its inhibition could delay or stop tumor development. The study highlights significant anti-tumor activity in prostate, ovarian, and non-small cell lung cancer models.
Dr. Gopinath S. Palanisamy will present the findings on April 28 during the Tumor Biology 2 session. The research underlines that OP-3136 is a potent and selective KAT6 inhibitor with promising potential as a targeted therapy. These early results add valuable insight into the development of novel cancer treatments that could improve patient outcomes.
Read Announcement- Drug:
- OP-3136
- Announced Date:
- December 9, 2024
- Indication:
- Bioavailable KAT6 Inhibitor
Announcement
Olema Pharmaceuticals announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for OP-3136, a novel small molecule that potently and selectively inhibits KAT6, a validated epigenetic target that is dysregulated in breast and other cancers.
AI Summary
Olema Pharmaceuticals recently announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for OP-3136. OP-3136 is an innovative small molecule designed to potently and selectively inhibit KAT6, an epigenetic target known to be dysregulated in breast and other cancers. This milestone allows Olema to move forward with clinical testing, with plans to start a Phase 1 trial in early 2025. Preclinical studies have shown that OP-3136 works effectively on its own and in combination with other drugs, generating strong interest among researchers. The FDA's clearance supports Olema's commitment to developing targeted therapies that have the potential to improve treatment options and outcomes for patients with breast cancer and beyond.
Read Announcement- Drug:
- OP-3136
- Announced Date:
- December 9, 2024
- Indication:
- Bioavailable KAT6 Inhibitor
Announcement
Olema Pharmaceuticals, announced that Phase 1 clinical trial for OP-3136 to initiate in early 2025
AI Summary
Olema Pharmaceuticals recently announced plans to start a Phase 1 clinical trial for its experimental drug OP-3136 in early 2025. OP-3136 is a novel small molecule that acts as a potent and selective inhibitor of KAT6, a protein involved in breast cancer and other malignancies. Preclinical studies have shown that the drug works well on its own and in combination with palazestrant, sparking strong interest among investigators.
The upcoming trial will focus on evaluating the safety, tolerability, and optimal dosing of OP-3136. Positive results from the study could pave the way for new targeted treatments in oncology, offering fresh hope for patients whose cancers are driven by dysregulation of key epigenetic factors. Olema’s effort marks an important step in advancing innovative cancer therapies aimed at improving patient outcomes.
Read Announcement- Drug:
- OP-3136
- Announced Date:
- October 9, 2024
- Indication:
- Bioavailable KAT6 Inhibitor
Announcement
Olema Pharmaceuticals, announced that it will be presenting multiple posters during the 36th EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics (ENA 2024) taking place October 23-25, 2024, in Barcelona, Spain.
AI Summary
Olema Pharmaceuticals, a clinical-stage biopharmaceutical company focused on women’s cancers, will present multiple posters at the 36th EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics (ENA 2024). The symposium will be held in Barcelona, Spain from October 23 to 25, 2024.
The presentations will showcase new research on combination therapies for ER+/HER2- breast cancer. One poster covers how combining palazestrant—a complete estrogen receptor antagonist and degrader—with everolimus, an mTOR inhibitor, can enhance tumor suppression. Another study details the benefits of pairing palazestrant with capivasertib, a pan-AKT inhibitor, to improve anti-tumor activity. A third poster discusses the potential of using OP-3136, a KAT6 inhibitor, alongside endocrine therapy and a CDK4/6 inhibitor to achieve greater tumor control. These findings highlight innovative approaches in targeting and treating breast cancer, promising further advancements in therapeutic strategies.
Read Announcement
palazestrant - FDA Regulatory Timeline and Events
palazestrant is a drug developed by Olema Pharmaceuticals for the following indication: CDK4/6 inhibitor.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- palazestrant
- Announced Date:
- March 18, 2025
- Indication:
- CDK4/6 inhibitor
Announcement
Olema Pharmaceuticals provided updates
AI Summary
Olema Pharmaceuticals provided exciting updates in its Q4 2024 report. The company received clearance from the FDA for its Investigational New Drug (IND) application for OP-3136, a promising small molecule targeting KAT6. With this clearance, Olema has already begun enrolling patients in a Phase 1 trial for OP-3136, marking an important step in its clinical development program. The progress of OP-3136 compliments ongoing studies across their pipeline focused on breast cancer. Additionally, Olema announced significant financial milestones, including a $250 million equity private placement and a new clinical trial collaboration with Novartis, strengthening its balance sheet and supporting future efforts. CEO Sean P. Bohen highlighted the company’s commitment to advancing its pivotal clinical trials and drug discovery programs, targeting improved outcomes for patients with metastatic breast cancer.
Read Announcement- Drug:
- palazestrant
- Announced Date:
- December 10, 2024
- Indication:
- CDK4/6 inhibitor
Announcement
Olema Pharmaceuticals, announced updated clinical results from the ongoing Phase 1b/2 study of palazestrant in combination with CDK4/6 inhibitor, ribociclib, in patients with estrogen receptor-positive, human epidermal growth factor receptor 2-negative (ER+/HER2-) advanced or metastatic breast cancer.
AI Summary
Olema Pharmaceuticals announced promising updated results from an ongoing Phase 1b/2 study evaluating palazestrant in combination with the CDK4/6 inhibitor ribociclib in patients with ER+/HER2- advanced or metastatic breast cancer. With a median follow-up of 12 months, the study has not yet reached median progression-free survival. The overall 6-month PFS rate was 73%, with rates of 81% in patients having ESR1 mutations and 70% in those with wild-type ESR1. Even among patients previously treated with a CDK4/6 inhibitor, the 6-month PFS rate was 68%.
The data show that the combination has a favorable safety profile consistent with ribociclib and endocrine therapy, along with robust clinical activity. These results support further development and are paving the way for a pivotal Phase 3 trial next year to further assess this combination therapy for metastatic breast cancer.
Read Announcement
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