Clinical Trials
11
3 active
Approvals
0
Total approvals
Agencies
0
Regulatory bodies
Founded
2007
Active, not recruiting
3
27.3%
Completed
1
9.1%
Recruiting
7
63.6%
No approval data available
- Olema Oncology has appointed Jason O'Byrne, MBA, as Chief Financial Officer as the company approaches pivotal data from its OPERA-01 study and a potential first commercial launch. - O'Byrne joins from Vir Biotechnology, where he served as Executive Vice President and CFO, and previously held CFO roles at Caribou Biosciences and Audentes Therapeutics. - His background spans corporate strategy, capital markets, business development, and financial management, including leadership of Caribou's IPO and the $3 billion Astellas acquisition of Audentes. - Olema highlighted its strong balance sheet as it advances palazestrant (OP-1250) and OP-3136 toward multiple upcoming milestones in breast cancer and beyond.
- Olema Pharmaceuticals announced the departure of Chief Financial Officer Shane Kovacs, with CEO Sean P. Bohen assuming interim financial responsibilities during a critical clinical development phase. - The company's lead drug candidate Palazestrant (OP-1250) for metastatic breast cancer is currently being evaluated in two separate Phase 3 trials, with initial Opera-01 study data expected in the second half of 2026. - Olema maintains strong financial positioning with $329.0 million in cash and equivalents as of September 30, 2025, supporting continued operations and clinical trial advancement. - The leadership change occurs amid external challenges including SEC action related to alleged market manipulation schemes involving fabricated clinical trial data from December 2025.
- Olema Pharmaceuticals shares dropped 6.9-7.2% in after-hours trading following the announcement of a public offering of common stock and pre-funded warrants. - The company plans to use proceeds to advance its breast cancer treatment pipeline, including palazestrant (OP-1250) in Phase 3 trials and OP-3136, a KAT6 inhibitor in Phase 1. - Despite recent positive developments in the SERD market and 81% stock gains over six months, investor concerns about dilution overshadowed the fundraising announcement. - Analysts maintain positive outlooks with H.C. Wainwright reaffirming a Buy rating with $28 price target and Guggenheim initiating coverage with a Buy rating at $20 target.
- CDK4/6 inhibitors are establishing new standards in early-stage HR+ breast cancer, with abemaciclib and ribociclib showing significant improvements in disease-free survival in adjuvant settings. - The second-line HR+ metastatic setting has become highly fragmented with multiple targeted therapies, including oral SERDs like giredestrant showing 44-62% reduction in disease progression risk. - Triple-negative breast cancer treatment paradigm is shifting with TROP2-directed ADCs, as sacituzumab govitecan and datopotamab deruxtecan demonstrate substantial survival benefits in first-line metastatic disease. - HER2+ breast cancer continues to be transformed by ADCs, with trastuzumab deruxtecan achieving 70% progression-free survival at two years and 67% pathological complete response rates in neoadjuvant settings.
- Olema Oncology and Pfizer have announced a new clinical trial collaboration to evaluate the combination of palazestrant and atirmociclib in approximately 35 patients with ER+/HER2- metastatic breast cancer. - The Phase 1b/2 study will assess the safety and combinability of palazestrant with Pfizer's investigational highly selective CDK4 inhibitor atirmociclib, with initiation anticipated in H2 2025. - Results from this combination study will inform a potential pivotal Phase 3 trial in the frontline metastatic breast cancer setting. - This represents Olema's second clinical trial agreement with Pfizer, building on their previous collaboration established in November 2020 to evaluate palazestrant with palbociclib.
- Olema Oncology has aligned with the FDA to select 90mg once-daily palazestrant as the dose for Part 2 of the Phase 3 OPERA-01 monotherapy trial in second- and third-line ER+/HER2- metastatic breast cancer. - The same 90mg dose will be used in combination with ribociclib for the pivotal Phase 3 OPERA-02 trial in frontline ER+/HER2- metastatic breast cancer. - Top-line data from OPERA-01 is anticipated in 2026 with a potential commercial launch in 2027, as the company advances its novel dual-mechanism estrogen receptor antagonist and degrader. - Palazestrant has demonstrated anti-tumor efficacy across ESR1 mutant and wild-type ER+ breast cancer tumors and has received FDA Fast Track designation for this indication.
• Olema Oncology's novel KAT6 inhibitor OP-3136 demonstrated potent anti-tumor activity in preclinical models of ovarian, prostate, and non-small cell lung cancer, expanding its potential beyond breast cancer. • In ovarian cancer models, OP-3136 achieved sustained tumor regression over 28 days, while showing comparable efficacy to ribociclib in lung cancer models and dose-dependent tumor inhibition in prostate cancer. • The compound exhibited enhanced anti-tumor activity when combined with standard therapies like ribociclib and docetaxel, with patient recruitment currently ongoing in Phase 1 clinical trials.
- Olema Oncology is progressing its pivotal Phase 3 OPERA-01 trial of palazestrant monotherapy in second/third-line metastatic breast cancer, with top-line data anticipated in 2026. - The company is preparing to initiate the Phase 3 OPERA-02 trial of palazestrant in combination with ribociclib for frontline metastatic breast cancer in 2025, supported by promising efficacy data showing 13.8 months median progression-free survival. - With $392.7 million in cash reserves as of Q1 2025, Olema is well-positioned to advance its clinical pipeline, including the ongoing Phase 1 trial of KAT6 inhibitor OP-3136 for multiple solid tumor applications.
• Olema Oncology has received FDA clearance for its Investigational New Drug (IND) application for OP-3136, a novel KAT6 inhibitor, marking a key regulatory milestone. • OP-3136, a small molecule, has demonstrated compelling preclinical activity as a monotherapy and in combination with palazestrant for breast cancer. • A Phase 1 clinical trial is scheduled to begin in early 2025 to assess the safety and initial efficacy of OP-3136 in patients with breast and other cancers. • This regulatory advancement diversifies Olema's oncology pipeline and strengthens its focus on targeted therapies for endocrine-driven cancers.
• Olema Oncology has secured a $250 million private placement to advance its clinical programs, including the Phase 3 OPERA-02 trial. • A collaboration with Novartis will provide ribociclib for the OPERA-02 trial, evaluating palazestrant in combination for ER+/HER2- metastatic breast cancer. • The OPERA-02 trial is expected to begin in mid-2025, with approximately 1,000 patients, and Olema retains global commercial rights to palazestrant. • Olema's funding supports multiple clinical milestones, including OPERA-01 Phase 3 data in 2026 and OP-3136 Phase 1/2 data, strengthening its development pipeline.
