A Phase 3 Randomized, Double-Blind, Active-Controlled Study of Palazestrant With Ribociclib Versus Letrozole With Ribociclib for the First-Line Treatment of ER+, HER2- Advanced Breast Cancer (OPERA-02)

This phase 3 clinical trial compares the efficacy and safety of palazestrant with ribociclib to letrozole and ribociclib in women and men who have not received prior systemic anti-cancer treatment for advanced breast cancer.

开始日期2025-11-03

申办/合作机构

Olema Pharmaceuticals, Inc.

[+1]

NCT06784193

/ Recruiting临床1期

A Phase 1 First-in-Human, Open-Label, Multicenter Study of OP-3136 in Adult Participants With Advanced or Metastatic Solid Tumors

This is a first-in-human, open-label, multicenter phase 1 study to evaluate safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary efficacy of OP-3136, a lysine acetyltransferases 6A and 6B (KAT6A/B) inhibitor, as monotherapy and in combination with other anticancer agents in participants with advanced solid tumors.
This study consists of 2 parts: a dose escalation part (Part 1) and dose expansion part (Part 2).

开始日期2024-12-16

申办/合作机构

Olema Pharmaceuticals, Inc.

NCT06016738

/ Active, not recruiting临床3期

A Phase 3 Randomized, Open-Label Study of OP-1250 Monotherapy vs Standard of Care for the Treatment of ER+, HER2- Advanced or Metastatic Breast Cancer Following Endocrine and CDK 4/6 Inhibitor Therapy (OPERA-01)

This phase 3 clinical trial compares the safety and efficacy of palazestrant (OP-1250) to the standard-of-care options of fulvestrant or an aromatase inhibitor in women and men with breast cancer whose disease has advanced on one endocrine therapy in combination with a CDK4/6 inhibitor.

开始日期2023-11-16

申办/合作机构

Olema Pharmaceuticals, Inc.

100 项与 Palazestrant 相关的临床结果

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100 项与 Palazestrant 相关的转化医学

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100 项与 Palazestrant 相关的专利（医药）

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项与 Palazestrant 相关的文献（医药）

2026-01-14·Future Oncology

OPERA-01: a phase III study of palazestrant for ER+, HER2– advanced breast cancer after CDK4/6 inhibitor therapy

Article

作者: Chan, Arlene ; Schmid, Peter ; Sohn, Joohyuk ; McArthur, Heather ; Bellet Ezquerra, Meritxell ; Pistilli, Barbara ; de Kermadec, Elisabeth ; Del Mastro, Lucia ; Meisel, Jane ; Zheng, Lianqing

Endocrine therapy (ET) resistance is a major concern when treating estrogen receptor-positive (ER+) human epidermal growth factor receptor 2-negative (HER2-) breast cancer. A combination of cyclin-dependent kinase 4/6 inhibitors (CDK4/6i) and ET is the current first-line standard of care (SOC) for patients with ER+, HER2- advanced breast cancer. Despite the benefits of ET plus a CDK4/6i, disease progression due to endocrine resistance remains a significant challenge. More effective ETs that can overcome resistance are needed to improve clinical outcomes and maintain quality of life by delaying chemotherapy. Palazestrant is a novel oral, complete estrogen receptor antagonist (CERAN) and selective estrogen receptor degrader (SERD) that blocks both transcriptional activation function domains, AF1 and AF2, resulting in complete inhibition of ER-driven transcription, regardless of estrogen receptor 1 (ESR1) mutation status. As monotherapy, palazestrant showed tolerable safety, favorable pharmacokinetics, and antitumor efficacy in heavily pretreated patients during phase I/II studies. OPERA-01 (NCT06016738) is a phase III study designed to evaluate the safety and efficacy of palazestrant monotherapy compared to SOC ET in patients with ER+, HER2- locally advanced or metastatic breast cancer, regardless of ESR1 mutation status, whose disease advanced following treatment with at least one ET in combination with a CDK4/6i.Clinical Trial Registration: Clinicaltrials.gov NCT06016738. Registered 17 August 2023.

2025-06-10·ACS Omega

Discovery of Palazestrant (OP-1250), a Potent and Orally Bioavailable Complete Estrogen Receptor Antagonist (CERAN) and Selective Estrogen Receptor Degrader (SERD)

Article

作者: Rich, Brian ; Yu, Guijun ; Kushner, Peter J. ; Peña, Guadalupe ; Phukan, Samiron ; Hodges-Gallagher, Leslie ; Sapugay, Judevin ; Chawla, Reena ; Andersen, Samuel E. ; Millikin, Robert ; Sun, Richard ; Parisian, Alison ; Zhou, Fei ; Duncan, Alexis ; Zak, David R. ; Wang, Chenbo ; Hearn, Brian R. ; Barratt, Susanna ; Ng, Raymond A. ; Satish Kher, Samir ; Fanning, Sean W. ; Watanabe, Teruki ; Myles, David C. ; Palanisamy, Gopinath S. ; Yeghikyan, David ; Thangathirupathy, Srinivasan ; Robello, Brandon ; Greene, Geoffrey ; Harmon, Cyrus L. ; Heerding, Dirk A.

Metastatic breast cancer (mBC) is a leading cause of cancer death in women. Most breast cancer patients are administered estrogen-receptor-targeted endocrine therapies to treat or prevent progressive metastatic disease. Development of endocrine resistance through acquisition of mutations in the estrogen receptor gene, ESR1, that constitutively activate the estrogen receptor leads to relapse. Complete antagonism of both WT and mutant ESR1 (mutESR1) with an oral therapeutic that persistently antagonizes ER-driven oncogenic transcriptional activities is a requirement for efficacy. Here, we describe our discovery of the investigational drug OP-1250 (palazestrant). OP-1250 is a potent complete estrogen receptor antagonist (CERAN) and selective estrogen receptor degrader (SERD) that is active in both WT and mutESR1 breast cancer tumors. OP-1250's effective induction of tumor regression either as a single agent or in combination with a CDK4/6 inhibitor has led to the rapid advancement of this compound into a Phase 3 clinical trial (OPERA-01).

2024-11-01·LANCET ONCOLOGY

The state of the science of oral selective oestrogen receptor degraders

Article

作者: Mayer, Erica L ; Fanucci, Kristina

148

项与 Palazestrant 相关的新闻（医药）

2026-08-13

·BioSpace

Olema Oncology Appoints Jason O’Byrne as Chief Financial Officer

SAN FRANCISCO, Aug. 13, 2026 (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 breast cancer and beyond, today announced the appointment of Jason O’Byrne, MBA, as Chief Financial Officer. “We are very pleased to welcome Jason to Olema at an important time for the Company,” said Sean P. Bohen, M.D., Ph.D., President and Chief Executive Officer of Olema Oncology. “As we approach pivotal data from OPERA-01 and prepare for our first potential commercial launch, the breadth and depth of Jason’s expertise in corporate strategy, capital markets, business development, and financial management and operations will be essential as we continue Olema’s transformation into a fully integrated oncology company.” Mr. O’Byrne brings more than two decades of finance and global operations leadership across high-growth biotechnology and pharmaceutical organizations. He joins Olema from Vir Biotechnology, where he served as Executive Vice President and Chief Financial Officer, leading the Finance, Investor Relations, and Information Technology functions. Previously, Mr. O’Byrne was Chief Financial Officer of Caribou Biosciences. Across both organizations, he led a wide range of financial and capital markets initiatives, including Caribou’s initial public offering. Prior to Caribou, he served as Senior Vice President of Finance at Audentes Therapeutics, where he oversaw financial due diligence and integration for its $3 billion acquisition by Astellas Pharma. Earlier in his career, Mr. O’Byrne spent over a decade at Genentech and Roche in finance leadership roles of increasing responsibility, spanning clinical development, commercial, and global operations. He holds an MBA in Finance, with distinction, from New York University’s Stern School of Business and a Bachelor of Applied Science in Mechanical Engineering from the University of British Columbia. "I am thrilled to join Olema at such an exciting stage in its evolution and believe palazestrant and OP-3136 have the potential to meaningfully improve the lives of people living with breast cancer and beyond,” said Mr. O'Byrne. “With a strong balance sheet and a series of important milestones ahead, I look forward to working with Sean and the executive team to help scale Olema through this next chapter and deliver durable benefit to patients and long-term value to shareholders." About Olema Oncology Olema Oncology is a clinical-stage biopharmaceutical company committed to transforming the standard of care and improving outcomes for patients living with breast cancer and beyond. Olema is advancing a pipeline of novel therapies by leveraging our deep understanding of endocrine-driven cancers, nuclear receptors, and mechanisms of acquired resistance. Our lead product candidate, palazestrant (OP-1250), is a proprietary, orally available complete estrogen receptor antagonist (CERAN) and a selective estrogen receptor degrader (SERD), currently in two Phase 3 clinical trials. In addition, Olema is developing OP-3136, a potent lysine acetyltransferase 6 (KAT6) inhibitor, now in a Phase 1 clinical study. Olema is headquartered in San Francisco and has operations in Cambridge, Massachusetts. For more information, please visit . Forward-Looking Statements Statements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Words such as “anticipate,” “believe,” “could,” “expect,” “goal,” “intend,” “may,” “on track,” “potential,” “upcoming,” “will” and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. These statements include those related to the expected timing of data readouts, including from OPERA-01; the potential timing for commercial launch; the anticipated contributions of new members of executive leadership; Olema’s plans to evolve into a fully integrated oncology company; the potential of palazestrant and OP-3136 to meaningfully improve patient lives; the sufficiency of Olema’s cash; the potential timing of upcoming milestones at Olema; and Olema’s potential to deliver durable, long-term value for patients and shareholders. Because such statements deal with future events and are based on Olema’s current expectations, they are subject to various risks and uncertainties, and actual results, performance, or achievements of Olema could differ materially from those described in or implied by the statements in this press release. These forward-looking statements are subject to risks and uncertainties, including, without limitation, those discussed in the section titled “Risk Factors” in Olema’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2026, and future filings and reports that Olema makes from time to time with the U.S. Securities and Exchange Commission. Except as required by law, Olema assumes no obligation to update these forward-looking statements, including in the event that actual results differ materially from those anticipated in the forward-looking statements. Media and Investor Relations Contact Courtney O’Konek Vice President, Corporate Communications Olema Oncology media@olema.com

临床1期高管变更临床3期并购临床2期

2026-08-11

·药研前瞻

生物科技每日资讯 (2026-08-11)

📌 今日要点速览 🧬 SION — SION-719 囊性纤维化 IIa 期试验失败，汗液氯化物仅降 -1.0 mmol/L（p=0.7），股价暴跌约 90% 至。竞争威胁解除，当日 530.83 💊 TENAX — 口服左西孟旦（TNX-103）III 期 LEVEL 试验未达主要终点，股价 -84% 至 $2，计划寻求 FDA Type C 会议 🤝 JAZZ — 以亿首付 5 亿里程碑收购 Actio Biosciences，获得 KCNT1 癫痫管线 ABS-1230 📊 BBIO — Q2 营收亿（ 2.224 亿，三个管线 PDUFA 日期确定（11/27、5/8/27、待定） 🎯 COGT — Q2 财报，bezuclastinib GIST PDUFA 11/30，AdvSM NDA 已提交（6/30），现金 $8.659 亿 🧠 BHVN — Q2 财报，BHV-1300 Graves' 病关键试验启动，MoDE/TRAP 平台多管线推进 💰 APGE — Q2 净亏万，收购待完成（135.11/股，约 $109 亿），APEX IIb 期阳性 🔬 SANA — Q2 现金 $1.605 亿，SC451 IND 年内申报，SG293 首次人体数据年内读出 🎯 ORKA — Q2 净亏 $4120 万，EVERLAST-A Week 28 数据 Q3 末读出，III 期计划 2027 H1 🧬 VERA — Q2 净亏 $1.095 亿，IgAN ORIGIN 3 最终分析 Q3，sBLA Q4 申报 💊 OLMA — Q2 净亏 $6320 万，palazestrant III 期推进中，OP-3136 I 期进行 📊 CATX — Q2 财报，VMT-α-NET III 期 site activation 目标年底，现金 $2.37 亿 📊 板块总览指标数值 XBI 收盘价 $158.03 日涨跌幅 +$0.66 (+0.42%) ▲ 日内区间 158.55 成交量 ~745 万股 XBI 周一微涨 0.42%，连续第六个交易日收阳。板块内部呈现"财报驱动分化"格局：Q2 财报密集发布带动多只中市值股波动，同时 SION 和 TENAX 两只临床失败股暴跌形成鲜明对比。JAZZ 收购 Actio 标志着私有生物科技 M&A 浪潮延续。 💡 市场影响分析：8/10 是 XBI 财报季最密集的交易日之一，12 家成分股同日发布 Q2 业绩或重大事件。SION 临床失败释放的资金和注意力部分流向 VRTX（+7%）和其他 CF 领域，板块整体保持稳健但个股分化加剧。新闻总表公司事件影响 SION SION-719 IIa 期 CF 试验失败 ▲▼ 股价 -90%+ TENAX TNX-103 III 期 LEVEL 试验失败 ▼ 股价 -84% JAZZ 收购 Actio Biosciences 500M M&A BBIO Q2 营收 $243.7M (+120%) 财报 COGT Q2 财报 + bezuclastinib PDUFA 11/30 财报+催化 VERA Q2 财报 + ORIGIN 3 最终分析 Q3 财报+催化 OLMA Q2 财报 + palazestrant III 期推进财报 BHVN Q2 财报 + BHV-1300 关键试验启动财报+管线 SANA Q2 财报 + SC451/SG293 IND 即将财报+管线 APGE Q2 财报 + AbbVie 收购待完成财报+M&A ORKA Q2 财报 + III 期 2027 H1 财报+催化 CATX Q2 财报 + III 期 site activation 财报+管线逐家公司详情 🧬 Sionna Therapeutics (SION) — SION-719 IIa 期 CF 试验失败，股价崩塌 Sionna 公布 SION-719（下一代 CFTR 补充剂）IIa 期临床试验结果，主要终点汗液氯化物仅降低 -1.0 mmol/L，统计学上无意义（p=0.7）。该药物与 Vertex 的 Trikafta 联合使用时未显示出有意义的附加效果。试验设计：SION-719 联合 Trikafta 治疗 CF 患者，评估汗液氯化物改善结果：-1.0 mmol/L（远低于有临床意义的阈值），p=0.7 市场反应：股价暴跌约 90% 至 $4.19 对 VRTX 影响：竞争威胁解除，Vertex 当日 +7% 至 $530.83 分析师评论：结果"出人意料"，此前市场预期 SION-719 有潜力成为 Trikafta 的补充疗法 💡 市场影响分析：SION 的失败是 Vertex 在 CF 领域垄断地位的又一确认。Vertex 目前控制全球 CF 市场约 90% 份额，SION-719 是少数几个有潜力挑战其地位的在研药物之一。试验失败后，Vertex 的竞争护城河进一步加深。对 SION 而言，公司尚有其他 CF 管线（SION-619、SION-919），但核心资产受挫将严重影响融资能力。 💊 Tenax Therapeutics (TENAX) — 口服左西孟旦 III 期失败 Tenax 公布 TNX-103（口服左西孟旦）III 期 LEVEL 试验结果，未达到主要终点。该试验评估口服左西孟旦治疗肺动脉高压合并右心衰竭患者的疗效。试验设计：口服左西孟旦 vs 安慰剂，主要终点为临床恶化时间结果：未达到主要终点市场反应：股价暴跌 -84% 至约 $2 后续计划：计划寻求 FDA Type C 会议讨论后续路径背景：左西孟旦为钙增敏剂，静脉制剂已在海外获批用于急性心衰 💡 市场影响分析：TENAX 是典型的微市值生物科技股（失败前市值约 $5000 万），临床失败后几乎面临存亡危机。口服左西孟旦是公司唯一临床阶段资产，III 期失败意味着需要重新评估整个开发策略。这也提醒投资者微市值单资产公司的极端风险。 🤝 Jazz Pharmaceuticals (JAZZ) — $13 亿收购 Actio Biosciences Jazz 宣布收购私有生物科技公司 Actio Biosciences，交易对价包括 $8.2 亿首付 + 最高 $5 亿里程碑，总交易价值可达 $13 亿。核心资产：ABS-1230，靶向 KCNT1 通道的罕见癫痫药物适应症：KCNT1 基因突变相关的罕见癫痫（包括 EIIEE 和 MMPSI）当前阶段：临床前/早期临床战略意义：扩展 Jazz 神经科学管线，补充现有睡眠/癫痫产品组合行业背景：2026 年私有生物科技 M&A 浪潮加速，多家大型药企通过收购补充管线 💡 市场影响分析：JAZZ 以神经科学为核心，此次收购进一步深化在罕见癫痫领域的布局。KCNT1 癫痫是高度未满足需求的适应症，目前无获批的靶向疗法。$8.2 亿首付对于早期资产而言偏高，反映 Jazz 对罕见神经科学资产的强烈需求。M&A 浪潮对 XBI 成分股中的中市值公司估值有正面溢出效应。 📊 BridgeBio Pharma (BBIO) — Q2 营收暴增 120%，三管线齐发 BridgeBio 公布 2026 年 Q2 财报，营收 $2.437 亿，同比增长 +120%。 Attruby 单药：Q2 收入 $2.224 亿，ATTR 淀粉样变性市场持续放量 BBP-418：PDUFA 目标日 11/27（LMNA 心肌病） Encaleret：PDUFA 目标日 5/8/2027（ADH1 低钙血症）第三管线：第三个 PDUFA 待确定现金：融资后约 $17 亿，跑道至 2028 年后战略：从单产品向多产品商业化转型 💡 市场影响分析：BBIO 是 2026 年生物科技商业化成功的标杆案例。Attruby 单药季度收入突破亿，验证了淀粉样变性市场的巨大潜力。三个日期确定意味着年将迎来密集催化。17 亿现金为持续研发和商业化提供保障，公司正从"单一产品生物科技"向"多产品生物制药公司"转型。 🎯 Cogent Biosciences (COGT) — Q2 财报 + bezuclastinib 双适应症推进 Cogent 公布 Q2 财报，同时更新 bezuclastinib 管线进展。 Q2 财报：具体数据待补充 Bezuclastinib GIST：PDUFA 目标日 11/30（胃肠道间质瘤） AdvSM NDA：已提交（6/30），系统性肥大细胞增多症现金（pro forma）：$8.659 亿管线策略：bezuclastinib 双适应症（GIST + AdvSM）同步推进 💡 市场影响分析：COGT 的 bezuclastinib 是 KIT D816V 抑制剂，同时瞄准 GIST 和 AdvSM 两个适应症。GIST PDUFA 11/30 是近期关键催化，AdvSM NDA 已提交意味着双适应症商业化在即。$8.659 亿 pro forma 现金为公司提供了充足的商业化资金。 🧬 Vera Therapeutics (VERA) — Q2 财报 + IgAN 关键催化临近 Vera 公布 Q2 财报，更新 atacicept 管线进展。 Q2 净亏损：$1.095 亿现金：$4.992 亿 ORIGIN 3 最终分析：预计 Q3 2026 读出 sBLA 申报：预计 Q4 2026 Atacicept：靶向 BAFF/APRIL 的融合蛋白，IgA 肾病适应症商业化准备：加速布局 💡 市场影响分析：VERA 的 atacicept 是 IgA 肾病领域的有力竞争者。ORIGIN 3 最终分析 Q3 读出是公司最大催化事件，阳性结果将支撑 sBLA 申报。IgA 肾病赛道竞争激烈（Travere、Calliditas 等），atacicept 的差异化定位至关重要。$4.992 亿现金为商业化启动提供保障。 💊 Olema Pharmaceuticals (OLMA) — Q2 财报 + palazestrant III 期推进 Olema 公布 Q2 财报，更新选择性雌激素受体降解剂（SERD）管线进展。 Q2 净亏损：$6320 万现金：$4.611 亿 Palazestrant：III 期临床试验推进中（ER+ HER2- 乳腺癌） OP-3136：I 期临床试验进行中（下一代 SERD）管线策略：palazestrant 单药 + 联合方案双轨推进 💡 市场影响分析：OLMA 的 palazestrant 是乳腺癌 SERD 赛道的后来者，面临 elacestrant（Stemline）和 camizestrant（AstraZeneca）的竞争。III 期数据读出将决定其市场地位。$4.611 亿现金为完成 III 期提供保障，但商业化竞争将是更大挑战。 🧠 Biohaven (BHVN) — Q2 财报 + BHV-1300 关键试验启动 Biohaven 公布 Q2 财报，更新多管线进展。 Q2 财报：具体数据待补充 BHV-1300：Graves' 病关键试验已启动 MoDE（分子降解引擎）平台：多管线推进 TRAP（靶向受体衰减蛋白）平台：多管线推进管线布局：神经科学 + 免疫/炎症双轮驱动 💡 市场影响分析：BHVN 从偏头痛起家后正快速扩展至自免领域。BHV-1300 是 MoDE 平台的首个关键试验，Graves' 病适应症进入后期开发是平台验证的重要里程碑。MoDE/TRAP 双平台策略如果成功，将打开多个适应症的大门。 🔬 Sana Biotechnology (SANA) — Q2 财报 + IND 申报临近 Sana 公布 Q2 财报，更新细胞疗法管线进展。 Q2 现金：$1.605 亿 SC451：IND 申报预计年内提交（1 型糖尿病） SG293：首次人体数据预计年内读出（CD19 CAR-T） UP421：NEJM 随访数据更新技术平台：fusogen 平台驱动细胞疗法创新 💡 市场影响分析：SANA 的 fusogen 平台是细胞疗法领域的创新方向，SC451 和 SG293 的 IND/临床数据将是关键验证点。$1.605 亿现金相对紧张，IND 申报和临床数据读出将决定融资能力。UP421 在 NEJM 的数据更新有助提升市场关注度。 💰 Apogee Pharmaceuticals (APGE) — Q2 财报 + AbbVie 收购待完成 Apogee 公布 Q2 财报，AbbVie 收购交易正在进行中。 Q2 净亏损：$8590 万现金：$13 亿 AbbVie 收购：$135.11/股，总交易价值约 $109 亿，预计近期完成 APEX IIb 期：Part B 阳性结果（肥胖适应症）战略：收购完成后将成为 AbbVie 肥胖管线核心 💡 市场影响分析：APGE 被 AbbVie 以 109 亿收购是 2026 年肥胖赛道最大 M&A 之一。135.11/股的收购价较公告前有显著溢价。APEX IIb 期 Part B 阳性结果进一步验证了 APGE 的差异化 GLP-1/GIP 双激动剂在肥胖领域的潜力。收购完成后，AbbVie 将在肥胖赛道与 Lilly/Novo 竞争。 🎯 Oruka Therapeutics (ORKA) — Q2 财报 + III 期 2027 H1 启动 Oruka 公布 Q2 财报，更新银屑病管线进展。 Q2 净亏损：$4120 万现金：$11 亿 EVERLAST-A：Week 28 数据预计 Q3 末读出（银屑病） EVERLAST-B：已入组完成 III 期计划：2027 H1 启动 ORKA-004：TL1A 靶向，Q4 进入临床 💡 市场影响分析：ORKA 的银屑病长效抗体方案如果成功，将挑战现有 IL-23 抑制剂的市场地位。EVERLAST-A Week 28 数据是近期关键催化。$11 亿现金为 III 期开发提供充足跑道。TL1A 靶向的 ORKA-004 进入临床标志着公司向炎症性肠病扩展。 📊 Caribou Biosciences (CATX) — Q2 财报 + III 期 site activation 年底 Caribou 公布 Q2 财报，更新 CAR-T 细胞疗法管线进展。 Q2 财报：具体数据待补充 VMT-α-NET：III 期 site activation 目标年底（神经内分泌肿瘤）现金：$2.37 亿技术平台：CRISPR 基因编辑驱动下一代 CAR-T 管线策略：同种异体 CAR-T 差异化定位 💡 市场影响分析：CATX 的 VMT-α-NET 是同种异体 CAR-T 在神经内分泌肿瘤领域的探索，III 期 site activation 年底完成是重要里程碑。$2.37 亿现金需要精打细算，III 期启动后的融资压力值得关注。同种异体 CAR-T 领域竞争激烈（Allogene、Cellectis 等），VMT-α-NET 的差异化定位至关重要。 📅 催化剂日历日期公司事件 8/13 ANNX Q2 财报预期发布 8/17 BMY Iberdomide PDUFA（首个 CELMoD） 8/22 CAPR Deramiocel PDUFA（DMD，高风险） 8/27 GILD BIC/LEN HIV 治疗 PDUFA 8/28 CYTK ESC ACACIA-HCM 完整结果 Q3 末 ORKA EVERLAST-A Week 28 数据 Q3 VERA ORIGIN 3 最终分析 9/30 SRRK Apitegromab PDUFA 11/1 AGIO Mitapivat SCD sNDA PDUFA 11/27 BBIO BBP-418 PDUFA（LMNA 心肌病） 11/30 COGT Bezuclastinib GIST PDUFA Q4 VERA sBLA 申报 Q4 ORKA ORKA-004 TL1A 进入临床年内 SANA SC451 IND 申报年内 SANA SG293 首次人体数据 2027 H1 ORKA III 期启动行业动态（非 XBI 成分股） 🔬 Silence Therapeutics (SLN) — Divesiran II 期 SANRECO 试验阳性 Silence Therapeutics（非 XBI 成分股）公布 divesiran（siRNA 靶向 POLRIMA）II 期 SANRECO 试验阳性结果。主要终点：88% vs 19%（治疗 vs 安慰剂），p<0.001 适应症：真性红细胞增多症（PV）机制：siRNA 靶向 POLRIMA，抑制异常红细胞生成市场反应：股价 +39% 意义：验证 siRNA 在血液疾病中的治疗潜力 ⚠️ FDA 拒绝 ITM-11 放射性药物 FDA 拒绝 ITM Isotope Technologies Munich 的放射性药物 ITM-11（Lu-177 标记放射性配体），原因是生产质量问题。 ITM-11 定位为 Novartis Pluvicto 的竞争对手适应症：胃肠胰神经内分泌肿瘤（GEP-NET）拒绝原因：CMC（化学制造控制）问题，非疗效/安全性行业影响：放射性药物赛道生产壁垒凸显 ⚠️ 免责声明：本日数据来源于公开市场信息，不构成任何投资建议。

2026-08-10

·ir.olema.com

Olema Oncology Reports Second Quarter 2026 Financial and Operating Results

Completed enrollment in the pivotal Phase 3 OPERA-01 trial; top-line data are now expected in the first quarter of 2027 Presented initial Phase 1 clinical data for OP-3136 at the 2026 ASCO Annual Meeting Announced a clinical trial collaboration and supply agreement with Bayer to evaluate darolutamide in combination with OP-3136 in metastatic castration-resistant prostate cancer Ended the second quarter with $461.1 million in cash, cash equivalents, and marketable securities SAN FRANCISCO, Aug. 10, 2026 (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 breast cancer and beyond, today reported financial and operating results for the second quarter ended June 30, 2026. “Our commitment to transforming the metastatic breast cancer treatment paradigm remains resolute as we continue to advance palazestrant as a potentially differentiated endocrine therapy across multiple regimens. Importantly, enrollment in our pivotal OPERA-01 Phase 3 trial is complete and we now expect to report top-line data in the first quarter of 2027,” said Sean P. Bohen, M.D., Ph.D., President and Chief Executive Officer of Olema Oncology. “Beyond palazestrant, we made significant progress with OP-3136, our novel KAT6 inhibitor. The initial monotherapy Phase 1 data, presented at ASCO, demonstrated that OP-3136 was well-tolerated and showed evidence of anti-tumor activity across multiple dose levels and various tumor types. These data, taken together with our first clinical collaboration for OP-3136, established with Bayer to evaluate OP-3136 in combination with darolutamide in metastatic castration-resistant prostate cancer, reinforce our confidence in its potential as a best-in-class, differentiated option for patients with advanced solid tumors.” Bohen continued, “Supported by a strong balance sheet, we are intently focused on execution in the second half of the year as we ramp preparations for our first potential commercial launch of palazestrant as a monotherapy, work to establish palazestrant as a potential combination agent of choice in breast cancer, and continue our transformation into a fully integrated oncology company.” Recent Progress Completed enrollment in the pivotal Phase 3 OPERA-01 trial of palazestrant as a monotherapy in patients with second or third-line estrogen receptor-positive (ER+), human epidermal growth factor receptor 2-negative (HER2-) advanced or metastatic breast cancer (MBC). Presented initial Phase 1 clinical data for OP-3136 as a monotherapy in multiple solid tumor types and a trial-in-progress poster for the pivotal Phase 3 OPERA-02 trial evaluating palazestrant in combination with ribociclib in frontline ER+/HER2- MBC at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting. Announced a clinical trial collaboration and supply agreement with Bayer to evaluate OP-3136 in combination with darolutamide, Bayer's androgen receptor inhibitor, in patients with metastatic castration-resistant prostate cancer (mCRPC). Completed enrollment in the Phase 1b/2 study of palazestrant in combination with atirmociclib in ER+/HER2- MBC. Advanced enrollment in the pivotal Phase 3 OPERA-02 trial and the Phase 1 study of OP-3136 as a monotherapy and in combination with fulvestrant and palazestrant in ER+/HER2- MBC. Anticipated Upcoming Events Initiate enrollment in the Phase 1b/2 study evaluating OP-3136 in combination with darolutamide in mCRPC in collaboration with Bayer in the fourth quarter of 2026. Report top-line data from the pivotal Phase 3 OPERA-01 trial in the first quarter of 2027. Second Quarter 2026 Financial Results Cash, cash equivalents, and marketable securities as of June 30, 2026, were $461.1 million. Net loss for the quarter ended June 30, 2026 was $63.2 million, as compared to $43.8 million for the quarter ended June 30, 2025. The increase in net loss for the second quarter was related to higher spending on clinical development and research and corporate-related activities related to late-stage clinical trials for palazestrant and the advancement of OP-3136. GAAP research and development (R&D) expenses were $57.8 million for the quarter ended June 30, 2026, as compared to $43.9 million for the quarter ended June 30, 2025. The increase in R&D expenses was primarily related to increased spending on clinical development-related activities as we continue to advance palazestrant through late-stage clinical trials and OP-3136 in early-stage clinical studies, and increased personnel-related costs to support expanding development activities, including an increase in non-cash stock-based compensation expense of $5.2 million, mainly due to higher grant prices in 2026 and higher headcount. These increases were partially offset by the $10.0 million milestone expense related to the Aurigene agreement that was recognized in the same period in 2025. Non-GAAP R&D expenses were $48.9 million for the quarter ended June 30, 2026, excluding $8.9 million non-cash stock-based compensation expense. Non-GAAP R&D expenses were $40.2 million for the quarter ended June 30, 2025, excluding $3.7 million non-cash stock-based compensation expense. A reconciliation of GAAP to non-GAAP financial measures used in this press release can be found at the end of this press release. GAAP G&A expenses were $9.4 million for the quarter ended June 30, 2026, as compared to $4.0 million for the quarter ended June 30, 2025. The increase in G&A expenses was primarily due to higher corporate-related costs that reflect continued investment in personnel and corporate infrastructure to support our expanding late-stage clinical development activities and anticipated future commercial operations, including an increase in non-cash stock-based compensation expense of $3.0 million, mainly due to higher grant prices in 2026, and an increase in professional fees of $1.8 million. Non-GAAP G&A expenses were $5.4 million for the quarter ended June 30, 2026, excluding $4.0 million non-cash stock-based compensation expense. Non-GAAP G&A expenses were $3.0 million for the quarter ended June 30, 2025, excluding $1.0 million non-cash stock-based compensation expense. A reconciliation of GAAP to non-GAAP financial measures used in this press release can be found at the end of this press release. About Olema Oncology Olema Oncology is a clinical-stage biopharmaceutical company committed to transforming the standard of care and improving outcomes for patients living with breast cancer and beyond. Olema is advancing a pipeline of novel therapies by leveraging our deep understanding of endocrine-driven cancers, nuclear receptors, and mechanisms of acquired resistance. Our lead product candidate, palazestrant (OP-1250), is a proprietary, orally available complete estrogen receptor antagonist (CERAN) and a selective estrogen receptor degrader (SERD), currently in two Phase 3 clinical trials. In addition, Olema is developing OP-3136, a potent lysine acetyltransferase 6 (KAT6) inhibitor, now in a Phase 1 clinical study. Olema is headquartered in San Francisco and has operations in Cambridge, Massachusetts. For more information, please visit www.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 antagonist (CERAN) and selective estrogen receptor 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, central nervous system penetration, and combinability with cyclin-dependent kinase 4/6 (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 as a single agent in the ongoing pivotal Phase 3 clinical trial, OPERA-01, and in combination with ribociclib in the ongoing pivotal Phase 3 clinical trial, OPERA-02. Palazestrant is also being evaluated in multiple Phase 1/2 studies in combination with ribociclib, palbociclib, alpelisib, everolimus, and atirmociclib. About OP-3136 OP-3136 is a novel, orally available small molecule that potently and selectively inhibits lysine acetyltransferase 6 (KAT6), an epigenetic target that is dysregulated in breast and other cancers. In preclinical studies, OP-3136 has demonstrated significant anti-proliferative activity in ER+ breast cancer models and is combinable and synergistic with endocrine therapies including palazestrant and cyclin-dependent kinase 4/6 (CDK4/6) inhibitors. The Investigational New Drug (IND) application for OP-3136 was cleared by the U.S. Food and Drug Administration (FDA) in December 2024 and patients are currently enrolling in the Phase 1 clinical study. Non-GAAP Financial Information The results presented in this press release include both GAAP information and non-GAAP information. As used in this release, non-GAAP R&D expense is defined by Olema as GAAP R&D expense excluding stock-based compensation expense, and non-GAAP G&A expense is defined by Olema as GAAP G&A expense excluding stock-based compensation expense. We use these non-GAAP financial measures to evaluate our ongoing operations and for internal planning and forecasting purposes. We believe that non-GAAP financial information, when taken collectively, may be helpful to investors because it provides consistency and comparability with past financial performance. However, non-GAAP financial information is presented for supplemental informational purposes only, has limitations as an analytical tool, and should not be considered in isolation or as a substitute for financial information presented in accordance with GAAP. Other companies, including companies in our industry, may calculate similarly titled non-GAAP measures differently or may use other measures to evaluate their performance, all of which could reduce the usefulness of our non-GAAP financial measures as tools for comparison. Investors are encouraged to review the related GAAP financial measures and the reconciliation of these non-GAAP financial measures to their most directly comparable GAAP financial measures and not rely on any single financial measure to evaluate our business. Forward-Looking Statements Statements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Words such as “anticipate,” “believe,” “could,” “expect,” “goal,” “intend,” “may,” “on track,” “potential,” “upcoming,” “will” and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. These statements include those related to the continued advancement of Olema’s pipeline of product candidates, including palazestrant and OP-3136; the progress, timing, and results of Olema’s clinical trials, including the Phase 3 OPERA-01 and OPERA-02 trials and ongoing Phase 1/2 studies; the expected timing of data readouts, including top-line data from OPERA-01; the potential therapeutic effects and benefits of palazestrant and OP-3136, alone or in combination with each other or with other agents; the potential for palazestrant to serve as a differentiated endocrine therapy across multiple regimens and to transform the metastatic breast cancer treatment paradigm; the potential for OP-3136 to be a best-in-class, differentiated option for patients with advanced solid tumors; the expected benefits of Olema's collaboration with Bayer; Olema’s plans to become a fully integrated oncology company; and Olema’s commercial launch preparations. These forward-looking statements are subject to risks and uncertainties, including, without limitation, those discussed in the section titled “Risk Factors” in Olema’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2026, and future filings and reports that Olema makes from time to time with the U.S. Securities and Exchange Commission. Except as required by law, Olema assumes no obligation to update these forward-looking statements, including in the event that actual results differ materially from those anticipated in the forward-looking statements. Media and Investor Relations Contact Courtney O’Konek Vice President, Corporate Communications Olema Oncology media@olema.com Olema Pharmaceuticals, Inc. Condensed Consolidated Balance Sheets Data (Unaudited) (In thousands) June 30,December 31, 2026 2025 Cash, cash equivalents and marketable securities $461,070$505,437 Total assets 486,578 533,430 Total current liabilities 53,014 51,802 Total liabilities 56,014 54,871 Total stockholders’ equity 430,564 478,559 Total liabilities and stockholders’ equity $486,578$533,430 Olema Pharmaceuticals, Inc. Condensed Consolidated Statements of Operations (Unaudited) (In thousands, except for share and per share data) Three Months Ended June 30, Six Months Ended June 30, 2026 2025 2026 2025 Operating expenses: Research and development (1)$57,785 $43,902 $107,017 $74,526 General and administrative (2) 9,394 3,962 18,148 8,211 Total operating expenses 67,179 47,864 125,165 82,737 Loss from operations (67,179) (47,864) (125,165) (82,737) Other income: Interest income 4,507 4,042 9,283 8,566 Other (loss) income (528) 38 (407) (2) Total other income 3,979 4,080 8,876 8,564 Net loss$(63,200)$(43,784) $(116,289)$(74,173) Net loss per share, basic and diluted$(0.61)$(0.51) $(1.12)$(0.87) Weighted average shares used to compute net loss per share, basic and diluted (3) 104,453,732 85,497,426 103,631,483 85,462,021 (1) Research and development expenses for the three- and six-months ended June 30, 2025 include a $10.0 million milestone payment in connection with the Aurigene Agreement. (1) and (2) Used to reference to the table below. (3) The weighted average shares used to compute net loss per share, basic and diluted include the effect from the pre-funded warrants. Reconciliation of GAAP to Non-GAAP Information (In thousands) Three Months Ended June 30, Six Months Ended June 30, 2026 2025 2026 2025 (1) Research and development reconciliation GAAP research and development$ 57,785 $ 43,902 $ 107,017 $ 74,526 Less: stock-based compensation expense 8,891 3,709 15,462 7,010 Non-GAAP research and development$ 48,894 $ 40,193 $ 91,555 $ 67,516 (2) General and administrative reconciliation GAAP general and administrative$ 9,394 $ 3,962 $ 18,148 $ 8,211 Less: stock-based compensation expense 4,012 983 7,589 2,060 Non-GAAP general and administrative$ 5,382 $ 2,979 $ 10,559 $ 6,151

临床1期临床3期财报快速通道ASCO会议

100 项与 Palazestrant 相关的药物交易

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研发状态

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适应症	最高研发状态	国家/地区	公司	日期
ER阳性乳腺癌	临床3期	美国	Olema Pharmaceuticals, Inc.	2025-11-03
ER阳性乳腺癌	临床3期	澳大利亚	Olema Pharmaceuticals, Inc.	2025-11-03
ER阳性乳腺癌	临床3期	奥地利	Olema Pharmaceuticals, Inc.	2025-11-03
ER阳性乳腺癌	临床3期	比利时	Olema Pharmaceuticals, Inc.	2025-11-03
ER阳性乳腺癌	临床3期	加拿大	Olema Pharmaceuticals, Inc.	2025-11-03
ER阳性乳腺癌	临床3期	捷克	Olema Pharmaceuticals, Inc.	2025-11-03
ER阳性乳腺癌	临床3期	法国	Olema Pharmaceuticals, Inc.	2025-11-03
ER阳性乳腺癌	临床3期	德国	Olema Pharmaceuticals, Inc.	2025-11-03
ER阳性乳腺癌	临床3期	希腊	Olema Pharmaceuticals, Inc.	2025-11-03
ER阳性乳腺癌	临床3期	中国香港	Olema Pharmaceuticals, Inc.	2025-11-03

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT07085767 (OPERA-02, ASCO2026)	临床3期	ER阳性/HER2阴性乳腺癌一线 ER+ \| HER2-	1,000	Palazestrant plus Ribociclib	顧築築網壓糧積餘顧壓(衊艱網艱遞膚簾製遞鏇) = 餘襯築築築觸淵窪獵襯衊積鏇選願繭醖壓範淵 (觸構鹹醖構鬱選窪醖窪, 0.59 ~ NR) 更多	积极	2026-05-29
				Letrozole plus Ribociclib	糧鏇築選齋網願衊糧遞(範廠鹹鬱顧遞網蓋窪鹽) = 衊餘壓鑰觸鬱餘繭夢鬱窪鬱膚積鑰夢築艱衊製 (憲蓋餘觸蓋醖齋衊選遞, 10.1 ~ NR) 更多
NCT06016738 (OPERA-01, Pubmed \| Future Oncol)	临床3期	ER+ \| HER2-	368	Palazestrant	築醖醖鬱網築鹽鏇艱願(願獵膚繭築範襯簾鹽鹹) = 網鏇憲齋蓋製簾構齋獵膚願膚顧遞網餘顧窪壓 (醖選鑰鏇網蓋艱鹹鹹衊 ) 更多	积极	2025-12-29
				fulvestrant	淵糧鹹鏇窪糧構淵衊夢(衊築觸遞製顧蓋簾觸蓋) = 淵築願鹽淵顧築觸願膚製獵願襯蓋鑰鑰壓簾積 (鬱襯醖糧網簾觸築築膚, 1 ~ 9) 更多
NCT05508906 (ESMO2025)	临床1/2期	ER阳性/HER2阴性乳腺癌 ER+ \| HER2-	72	Palazestrant 120 mg plus ribociclib	製範膚獵範醖願膚艱積(遞獵遞選淵艱廠範網網) = 35% 淵選製壓齋製築衊獵鏇 (範鹹壓膚膚顧簾衊遞憲 ) 更多	积极	2025-10-17
				Palazestrant 120 mg plus ribociclib (prior CDK4/6i)
NCT04505826 (phase 1/2 study, Pubmed \| Breast Cancer Res)	临床1/2期	HR阳性乳腺腺癌 \| HER2 阴性乳腺癌 \| HR阳性/HER2阴性乳腺癌 ESR1 mutations	146	Palazestrant 60 mg/day	蓋窪鹽遞範觸壓鏇鹽積(構餘範淵糧夢糧簾淵醖) = 25.6% 範鬱鏇觸遞淵鏇築積壓 (構淵齋窪鬱廠獵夢觸淵 ) 更多	积极	2025-07-01
				Palazestrant 120 mg/day
NCT05508906 (Company_Website) 人工标引	临床1/2期	ER阳性/HER2阴性乳腺癌一线	63	Palazestrant + Ribociclib	願醖獵顧淵夢艱鑰醖獵(廠蓋積淵齋夢壓願網艱) = 夢積範餘築鬱窪糧夢鏇觸艱衊鏇壓積獵壓蓋繭 (蓋糧觸鏇膚鏇淵繭築願 ) 更多	积极	2024-12-10
				Palazestrant + Ribociclib (prior treatment with a CDK4/6i plus an endocrine therapy)	願醖獵顧淵夢艱鑰醖獵(廠蓋積淵齋夢壓願網艱) = 願願鬱壓艱餘淵餘膚積觸艱衊鏇壓積獵壓蓋繭 (蓋糧觸鏇膚鏇淵繭築願 ) 更多
NCT05508906 (ESMO_BC2024) 人工标引	临床1/2期	ER阳性/HER2阴性乳腺癌一线 HER2 Negative \| ER Positive	33	palazestrant+ribociclib	願襯製網膚鬱淵願積糧(願衊壓艱餘遞範壓構蓋) = The most common (≥25%) were nausea, neutropenia (G4: 2 pts; 6%), WBC count decreased, fatigue, anemia, and diarrhea. Most TEAEs were grade 1-2 and consistent with the known safety profiles of each drug. 選築選艱顧衊廠簾餘齋 (顧鑰鏇顧鬱餘構憲蓋糧 )	积极	2024-05-16
GlobeNewswire 人工标引	临床1/2期	ER阳性/HER2阴性乳腺癌 ESR1 Mutation \| ER Positive \| HER2 Negative	46	palbociclib 125 mg+palazestrant 120 mg	壓選網糧鹽簾淵憲蓋鹽(願壓餘壓壓蓋觸鹽積糧) = There was no observed drug-drug interaction between palazestrant and palbociclib, and there was no induced metabolism or increase in exposure of either palbociclib or palazestrant when administered in combination. 觸鹹淵廠繭憲簾衊顧衊 (製願窪遞積觸鏇觸憲鏇 ) 更多	积极	2023-12-05
				palbociclib 125 mg+palazestrant 120 mg (ESR1 mutation)
GlobeNewswire 人工标引	临床1/2期	ER阳性/HER2阴性乳腺癌 HER2 Negative \| ER Positive	19	Ribociclib 600 mg+Palazestrant 120 mg	窪觸觸廠鹹襯願積廠衊(蓋衊築鹹艱願餘膚繭夢) = well tolerated, with no safety signals or enhancement of toxicity and an overall safety profile remains consistent with the expected safety profile of ribociclib plus an endocrine therapy. 壓積艱簾鑰網膚鏇壓窪 (獵願壓廠觸淵艱遞夢壓 ) 更多	积极	2023-12-05
NCT04505826 (ESMO 12023 \| ESMO 22023) 人工标引	临床1/2期	ER阳性/HER2阴性乳腺癌 ER Positive \| HER2 Negative	86	OP-1250 120 mg	鏇壓鬱願鏇鑰構選鏇顧(觸衊壓鏇衊淵蓋艱廠壓) = nausea, vomiting, neutropenia, fatigue, headache, constipation, and diarrhea 餘艱鑰製鬱壓鹹遞衊網 (積糧夢構觸夢憲齋選醖 ) 更多	积极	2023-10-22
				OP-1250 120 mg (ESR1 mutation)
NCT04505826 (ENA2022) 人工标引	临床1期	ER阳性/HER2阴性乳腺癌 ER positive \| HER2 negative	37	OP-1250 (60mg)	膚淵鏇淵簾淵鬱夢壓壓(鹹艱夢願鹽鑰艱鹽蓋餘) = The most common treatment emergent adverse events reported (≥10%) in Phase 1b in the 60 mg/120 mg cohorts were nausea (28%/21%), vomiting (17%/16%), fatigue (17%/5%) and headache (11%/ 11%). 膚壓顧獵蓋醖積獵鹽獵 (艱蓋廠窪遞遞膚觸窪鏇 ) 更多	积极	2022-10-28
				OP-1250 (120mg)