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Olema Pharmaceuticals Inc

Olema Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company focused on the discovery, development, and commercialization of therapies for women's cancers. Its lead product candidate is palazestrant, an estrogen receptor (ER) antagonist and selective ER degrader, which is in a pivotal Phase 3 trial (OPERA-01) as a monotherapy for second/third-line ER-positive, HER2-negative metastatic breast cancer, and is also being studied in combination with CDK4/6 inhibitors, the PI3K alpha inhibitor alpelisib, an mTOR inhibitor, and a CDK4 inhibitor in a Phase 1b/2 trial for ER-positive, HER2-negative advanced or metastatic breast cancer. The company also develops OP-3136, an orally available small molecule that potently and selectively inhibits KAT6, in Phase 1 trials for breast and other solid tumors. Formerly known as CombiThera, Inc., it changed its name to Olema Pharmaceuticals, Inc. in March 2009, was incorporated in 2006, and is headquartered in San Francisco, California.

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Olema Pharmaceuticals Shares Fall 15.1% After AstraZeneca SERENA-4 Trial Miss

Olema Pharmaceuticals shares fell 15.1% in pre-market trading to $8.68 after AstraZeneca reported that its Phase 3 SERENA-4 trial of camizestrant did not meet its primary endpoint. AstraZeneca said on Friday that camizestrant, in combination with palbociclib, did not demonstrate a statistically significant improvement in progression-free survival as a first-line treatment for patients with ER-positive, HER2-negative advanced breast cancer. Investors were assessing the result in relation to Olema's lead candidate, palazestrant, also known as OP-1250, which is being evaluated in the pivotal Phase 3 OPERA-01 trial; palazestrant is an oral selective estrogen receptor degrader and complete estrogen receptor antagonist, or SERD/CERAN, giving it mechanistic similarities to camizestrant, although AstraZeneca's trial outcome does not determine the results of Olema's separate clinical programme. Following the AstraZeneca results, Stifel reduced its price target for Olema to $30 from $48 while maintaining a Buy rating. Olema shares were trading above their 52-week low of $6.65 following Monday's decline, compared with a 52-week high of $36.26, as the broader US market also moved lower, with the Nasdaq falling 1.7% and the S&P 500 declining 0.7%.
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AI Stocks Slide Premarket as Executives Urge Slower Development

U.S. stock index futures fell sharply on Monday, with technology shares under pressure after several leading artificial intelligence executives called for a slower pace of AI development. By 05:52 ET, Dow futures had fallen 150 points, or 0.3%, S&P 500 futures had dropped 63 points, or 0.8%, and Nasdaq 100 futures had slumped 531 points, or 1.8%. Rumble shares surged as much as 28% in premarket trading after reports that Anthropic had agreed to a $13.7 billion computing contract with the company, a deal Rumble had disclosed in an August securities filing without identifying the customer. Anthropic CEO Dario Amodei called on AI companies to slow the advancement of model capabilities in an essay posted on X on Saturday, warning that increasingly capable AI agents could create significant economic damage if misused, and OpenAI CEO Sam Altman and xAI chief Elon Musk said they agree with his concerns. Nvidia fell more than 2% in premarket trading, while Meta and Amazon each dropped more than 1%, and chipmakers Intel, AMD and Marvell Technology fell nearly 6%, 5% and 6%, respectively, even as software names ServiceNow, Adobe and Workday rose about 3%, 2.5% and 2.5%. Scholar Rock shares surged 9.1% to $60.45 after the FDA approved ISEMBYLD, also known as apitegromab-mstn, as the first and only muscle-targeted treatment for spinal muscular atrophy in patients aged two and older receiving an SMN2-targeted therapy, ahead of the September 30, 2026 PDUFA deadline. Elmet Group shares jumped 30.8% after announcing a $450 million committed investment from the U.S. Department of War to accelerate domestic tungsten manufacturing, while Olema Pharmaceuticals slid 15.1% to $8.68 after AstraZeneca said its Phase 3 SERENA-4 trial of camizestrant failed to show a statistically significant improvement in progression-free survival, and MARA Holdings fell 5.7% to $11.30 after JPMorgan double-downgraded the bitcoin miner to Underweight from Neutral and cut its price target to $11 from $13.
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Biotech & Genomic Medicine

Olema Oncology completes enrollment in pivotal Phase 3 OPERA-01 trial, top-line data expected in Q1 2027

Olema Oncology has completed enrollment in its pivotal Phase 3 OPERA-01 trial of palazestrant as a monotherapy for ER+/HER2- advanced or metastatic breast cancer, with top-line data now expected in the first quarter of 2027. The company also presented initial Phase 1 clinical data for OP-3136, its novel KAT6 inhibitor, at the 2026 ASCO Annual Meeting, showing the drug was well-tolerated with evidence of anti-tumor activity across multiple dose levels and tumor types. Additionally, Olema announced a clinical trial collaboration and supply agreement with Bayer to evaluate OP-3136 in combination with darolutamide in metastatic castration-resistant prostate cancer. For the second quarter of 2026, Olema reported a net loss of $63.2 million, compared to $43.8 million in the same period last year, and ended the quarter with $461.1 million in cash, cash equivalents, and marketable securities.
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Biotech & Genomic Medicine

Olema Pharmaceuticals reports initial Phase 1 data for KAT6 inhibitor OP-3136 at ASCO 2026

Olema Pharmaceuticals reported initial Phase 1 clinical data for its KAT6 inhibitor OP-3136 at the 2026 ASCO Annual Meeting on May 21. The monotherapy was well-tolerated with no dose-limiting toxicities or discontinuations due to treatment-related adverse events, and showed evidence of anti-tumor activity across multiple solid tumor types. This adds an earlier-stage asset behind Olema's main palazestrant program, where the more immediate valuation catalyst remains the OPERA-01 trial. Topline data from the Phase 3 OPERA-01 trial of palazestrant as a monotherapy in second- and third-line ER+/HER2- metastatic breast cancer are expected in fall 2026. The company ended the first quarter with $505.3 million in cash, cash equivalents, and marketable securities.
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