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Olema Pharmaceuticals, Inc. (Nasdaq: OLMA), also known as Olema Oncology, is a clinical-stage biopharmaceutical company committed to the discovery, development, and commercialization of targeted therapies for women's cancers. Headquartered in San Francisco with operations in Cambridge, Massachusetts, Olema is advancing a pipeline of novel therapies aimed at improving treatment options for women living with cancer. The core focus of the company centers on endocrine-driven cancers, nuclear receptors, and mechanisms of acquired resistance.
Olema's lead product candidate, palazestrant (OP-1250), is a proprietary, orally-available small molecule with dual activity as both a complete estrogen receptor (ER) antagonist (CERAN) and a selective ER degrader (SERD). Palazestrant is currently in Phase 3 clinical trials under the OPERA-01 study for patients with recurrent, locally advanced, or metastatic ER-positive (ER+), human epidermal growth factor receptor 2-negative (HER2-) breast cancer. This innovative therapy has demonstrated significant potential by completely blocking ER-driven transcriptional activity in both wild-type and mutant forms of metastatic ER+ breast cancer, showing anti-tumor efficacy, favorable pharmacokinetics, CNS penetration, and combinability with CDK4/6 inhibitors.
In addition to palazestrant, Olema is developing a potent KAT6 inhibitor (OP-3136), which addresses an epigenetic target implicated in breast cancer and other cancers. This compound has shown promise in preclinical studies and is expected to move into clinical trials by the end of 2024.
Olema's financial health remains robust, with cash, cash equivalents, and marketable securities totaling $249.0 million as of March 31, 2024. The company reported a net loss of $31.0 million for the first quarter of 2024, primarily driven by increased spending on research and clinical development activities. However, Olema continues to make significant strides in advancing its clinical programs, supported by experienced scientists, healthcare investors, and partnerships with innovative pharmaceutical companies.
Recent corporate highlights include the initiation of a Phase 1/2 dose-escalation and expansion clinical trial of OP-1250, and the selection of a development candidate for the KAT6 program. Olema's commitment to transforming the standard of care for women's cancers is evident in its ongoing clinical studies and presentations at major oncology conferences such as the ESMO Breast Cancer Annual Congress.
For more information about Olema Pharmaceuticals, visit their website at www.olema.com.
Olema Oncology announced updated clinical results for palazestrant combined with ribociclib in treating ER+/HER2- advanced or metastatic breast cancer. With a 12-month median follow-up, the study showed promising results with median progression-free survival (PFS) not yet reached. The 6-month PFS rate was 73% overall, with 81% in ESR1 mutation patients and 70% in ESR1 wild-type patients.
The Phase 1b/2 study included 62 patients, with 56 receiving the recommended Phase 2 dose. The combination demonstrated favorable tolerability and safety profile consistent with ribociclib and endocrine therapy. Notable outcomes include a 76% clinical benefit rate across all patients and 27% objective response rate in patients with measurable disease.
Olema Pharmaceuticals (Nasdaq: OLMA) announced FDA clearance of its Investigational New Drug (IND) application for OP-3136, a novel small molecule that inhibits KAT6, an epigenetic target involved in breast and other cancers. The company plans to initiate a Phase 1 clinical trial in early 2025. OP-3136 has shown promising preclinical activity both as a standalone treatment and in combination with palazestrant. The drug development represents Olema's continued focus on targeted therapies for breast cancer and other oncology indications.
Olema Pharmaceuticals (Nasdaq: OLMA), a clinical-stage biopharmaceutical company focused on targeted therapies for breast cancer, has granted stock options to two new employees. The grants, approved by the Compensation Committee, total 60,000 shares under the company's 2022 Inducement Plan.
The options have a 10-year term with an exercise price of $10.21 per share, matching Nasdaq's reported sale price on December 2, 2024. The vesting schedule includes 25% after one year, with the remaining 75% vesting monthly over three years, contingent on continued employment.
Olema Oncology has announced two major developments: a clinical trial collaboration with Novartis and a $250 million private placement. The Novartis agreement will provide ribociclib drug supply for the planned Phase 3 OPERA-02 trial in frontline ER+/HER2- metastatic breast cancer, expected to start mid-2025. The private placement involves issuing shares at $9.08 and pre-funded warrants, with participation from notable investors including Adage Capital Partners, Bain Capital Life Sciences, and others. The funding will support OPERA-02, the ongoing Phase 3 OPERA-01 trial (with top-line data expected in 2026), and Phase 1/2 study of OP-3136.
Olema Oncology (Nasdaq: OLMA) announced it will present new data from its Phase 1b/2 clinical study at the San Antonio Breast Cancer Symposium (SABCS 2024). The study focuses on palazestrant (OP-1250) combined with CDK4/6 inhibitor ribociclib for treating ER+/HER2- advanced or metastatic breast cancer.
The poster presentation (ID: P2-09-16) is scheduled for December 11, 2024, from 5:30 to 7:00 p.m. CT in Halls 2-3. Olema will host an investor conference call on December 10, 2024, at 8:00 a.m. ET to discuss the findings. The poster will be available on Olema's website following the symposium's embargo policy.
Olema Oncology (OLMA) reported Q3 2024 financial results with a cash position of $214.8 million as of September 30, 2024. The company recorded a net loss of $34.6 million, up from $21.5 million in Q3 2023, primarily due to increased R&D expenses of $33.2 million. The company presented new preclinical data for OP-3136, their KAT6 inhibitor, and continues enrollment in the OPERA-01 Phase 3 trial of palazestrant. Olema plans to submit an IND application for OP-3136 before year-end and initiate Phase 1 trials in early 2025.
Olema Oncology (Nasdaq: OLMA), a clinical-stage biopharmaceutical company focused on targeted therapies for breast cancer, has announced its participation in three upcoming investor conferences. The company will attend the Jefferies London Healthcare Conference on November 20, 2024, at 1:30 p.m. GMT, the Evercore HealthCONx Conference on December 3, 2024, at 2:10 p.m. ET, and Citi's Global Healthcare Conference on December 3, 2024, at 3:15 p.m. ET. The events will feature various presentation formats including fireside chats and panel discussions. Live webcasts will be available on Olema's investor relations website and archived for at least 30 days.
Olema Pharmaceuticals (Nasdaq: OLMA) has granted stock options to one new employee as part of its inducement program. The grant includes options to purchase 2,500 shares of common stock at an exercise price of $11.62 per share. The options vest over four years, with 25% vesting after the first year and the remainder vesting monthly over three years. The options have a 10-year term and were granted under the company's 2022 Inducement Plan in accordance with Nasdaq Listing Rule 5635(c)(4).
Olema Oncology presented preclinical data at ENA 2024 showcasing anti-tumor activity of their drug candidates. OP-3136, a KAT6 inhibitor, demonstrated strong anti-tumor activity alone and enhanced effects when combined with palazestrant. The company plans to submit an IND application for OP-3136 by year-end. Additionally, palazestrant showed improved tumor suppression when combined with everolimus and capivasertib in ER+/HER2- breast cancer models. The studies revealed synergistic effects and significant tumor regression, particularly when palazestrant was combined with these agents, showing superior results compared to fulvestrant combinations.
Olema Oncology (Nasdaq: OLMA) announced upcoming poster presentations at the 36th EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics (ENA 2024) in Barcelona, Spain, from October 23-25, 2024. The presentations will showcase new preclinical data on combination therapies for ER+/HER2- breast cancer.
Three posters will be presented on October 24, 2024:
- Combining palazestrant (CERAN) with everolimus (mTOR inhibitor)
- Combining palazestrant with capivasertib (pan-AKT inhibitor)
- Combining OP-3136 (KAT6 inhibitor) with endocrine therapy and CDK4/6 inhibitor
These studies demonstrate enhanced tumor suppression and anti-tumor activity in ER+/HER2- breast cancer models. Abstracts and posters will be available on the ENA website and Olema's website, respectively.
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