文章核心观点 - IDEAYA Biosciences公司的股价在最近一个交易日上涨15.3%,这可归因于交易量的显著增加[1] - IDEAYA公司宣布其IDE397单药治疗MTAP缺失尿路上皮癌和非小细胞肺癌患者的II期临床试验数据呈现积极结果[2] - IDEAYA公司预计在即将发布的财报中将录得每股亏损0.56美元,同比下降12%,但营收将同比增长80.8%至6.4亿美元[3] 行业和公司研究 IDEAYA Biosciences公司 - IDEAYA公司股价的上涨与其最近公布的积极临床试验数据有关,该数据显示IDE397在MTAP缺失实体瘤患者中可产生有意义的疗效反应,且初步疗效持续时间令人鼓舞[2] - 尽管IDEAYA公司的每股收益预期在过去30天内保持不变,但股价通常会随着收益预期趋势而波动,因此需密切关注该公司未来的表现[4][5] - IDEAYA公司目前被评为中性评级(Zacks Rank 3),同行业公司Lexicon Pharmaceuticals在过去一个月内下跌4.6%[6][7] 医疗-生物医药行业 - IDEAYA公司属于医疗-生物医药行业,该行业另一家公司Lexicon Pharmaceuticals在最近一个交易日下跌4.2%[6] - Lexicon公司预计在即将发布的财报中每股亏损将同比减少18.2%至0.18美元[7]

Key TakeawaysIDEAYA Biosciences reported positive results from a Phase 2 trial of its experimental drug to treat certain bladder and small-cell lung cancers on Monday, and shares soared in intraday trading.The once-a-day tablet IDE397 helped patients with MTAP-deletion solid cancers.The company noted there are no Food and Drug Administration (FDA)-approved drugs for those who have MTAP-deletion solid tumors. Shares of IDEAYA Biosciences (IDYA) took off in intraday trading Monday after the biotech announced ...

~39% Overall Response Rate (ORR): 1 CR and 6 PRs (2 awaiting confirmation) by RECIST 1.1 out of 18 evaluable MTAP-deletion urothelial and NSCLC patients ~94% Disease Control Rate (DCR): 1 CR and 6 PRs and 10 SD by RECIST 1.1 ~78% of Patients with Tumor Shrinkage: 14 patients observed tumor shrinkage ~81% ctDNA Molecular Response Rate (MRR): 13 of 16 patients with > 50% ctDNA reduction AE Profile: ~5.6% drug-related grade >3 AEs and no drug-related SAEs or discontinuations at 30 mg once-a-day expansion dose ...

First-Patient-In (FPI) for Phase 1 combination treatment with IDE397, IDEAYA's MAT2A inhibitor, and Trodelvy®, Gilead's Trop-2 directed antibody-drug conjugate (ADC) The global Phase 1 clinical trial will evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and efficacy of IDE397 in combination with Trodelvy MTAP-deletion is found in approximately 26% of patients with bladder cancer SOUTH SAN FRANCISCO, Calif., June 25, 2024 /PRNewswire/ -- IDEAYA Biosciences, Inc. (Nasdaq:IDYA), a precisio ...

Targeting IDE397 Phase 2 monotherapy expansion dose clinical data update in over ~15 evaluable MTAP lung and bladder cancer patients in H2 2024, including RECIST 1.1 clinical efficacy waterfall, swim-lane plot, ctDNA molecular response analysis, AE profile, PK and pharmacodynamics Initiating IDE397 Phase 2 monotherapy expansion in MTAP bladder cancer, in addition to the earlier reported Phase 2 expansion in MTAP squamous lung cancer Activated over 35 clinical trial sites globally across the U.S., Canada, Eu ...

文章核心观点 - 公司的首创口服小分子抑制剂darovasertib在治疗眼部黑色素瘤(UM)方面显示出良好的疗效和安全性[1][2][3] - 公司正在积极推进darovasertib在UM适应症的临床开发,包括计划与FDA进行I型会议以就潜在的注册性试验征求指导[3][8] - 公司自主赞助的UM新辅助治疗试验也取得了积极的初步结果,体现了darovasertib在该领域的应用前景[9] 根据目录分别总结 临床试验结果 - 在公司赞助的UM新辅助治疗试验中,8例患者中位肿瘤缩小率达72%,大部分原计划切除眼球的患者最终得以保眼[9] - 在独立研究者发起的UM新辅助/辅助治疗试验中,75%的计划切除眼球的患者最终得以保眼,67%的患者肿瘤缩小超过30%,中位肿瘤缩小率为47%[6] - 上述临床试验中darovasertib的安全性良好,主要不良反应为1-2级,3级不良反应发生率较低[7][10] 公司临床开发计划 - 公司计划于2024年下半年与FDA进行I型会议,就darovasertib在UM新辅助治疗适应症的潜在注册性试验征求指导[8] - 公司自主赞助的UM新辅助治疗试验目前已在全球14个中心启动,入组超过40例患者[8] - 公司还在推进darovasertib在转移性UM一线治疗和HLA-A2阳性转移性UM适应症的临床开发[11] 市场机会分析 - 公司预计全球原发性UM的年发病率约为8,000-10,000例,主要集中在美国和欧洲[11] - 新辅助和辅助治疗UM是一个高未满足医疗需求的适应症,是darovasertib潜在的一线治疗机会,可显著扩大其适用人群[2]

SOUTH SAN FRANCISCO, Calif., May 29, 2024 /PRNewswire/ -- IDEAYA Biosciences, Inc. (NASDAQ: IDYA), a precision medicine oncology company committed to the discovery and development of targeted therapeutics, announced its participation in the upcoming investor relations events. 2024 Jefferies Global Healthcare Conference Wednesday, June 5th, 2024 at 9:00 AM ET Fireside chat with Yujiro S. Hata, Chief Executive Officer, hosted by Maury Raycroft, Ph.D. Equity Research Analyst, Biotechnology Goldman Sachs 45th A ...

~67% eye preservation rate (6 of 9 enucleation patients) with darovasertib monotherapy neoadjuvant uveal melanoma treatment Median tumor shrinkage (maximum volume change) of ~39% after 6 months Clinical data on additional enucleation patients and with further follow-up from the abstract-summary cut-off date will be presented at ASCO 2024 Darovasertib was generally well tolerated with no drug-related serious adverse events Oral presentation at ASCO 2024 scheduled for Monday, June 3, 2024 at 9:51am CDT SOUTH ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES AND EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES AND EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-38915 IDEAYA Biosciences, Inc. (Exact name of registrant as specified in its charter) Delaware 47-4268251 (State or oth ...

Exhibit 99.1 IDEAYA Biosciences, Inc. Reports First Quarter 2024 Financial Results and Provides Business Update • ASCO 2024 oral presentation of darovasertib neoadjuvant UM Phase 2 investigator-sponsored trial on June 3rd, and targeting neoadjuvant UM update in over 30 patients from Phase 2 company-sponsored trial and regulatory guidance both in H2 2024 • Selected move-forward Phase 2 dose for IDE397 in MTAP squamous NSCLC, based on clinical efficacy observed in this indication, including multiple PRs by RE ...