Group 1 - IDEAYA Biosciences, Inc. (IDYA) shares increased by 15.3% to close at $39.51, following a notable trading volume compared to typical sessions, contrasting with a 9.9% loss over the past four weeks [1][2] - The stock price surge was driven by positive clinical data from a phase II study of IDE397, which targets MTAP-deletion urothelial and non-small cell lung cancer (NSCLC) patients, showing promising responses and durability of treatment [2] - The phase II clinical data involved 18 evaluable patients, including seven with urothelial cancer, four with adenocarcinoma NSCLC, and seven with squamous NSCLC, indicating significant clinical proof-of-concept for IDE397 [2] Group 2 - The consensus EPS estimate for IDEAYA has remained unchanged over the last 30 days, suggesting that stock price movements may not sustain without trends in earnings estimate revisions [4] - The stock is part of the Zacks Medical - Biomedical and Genetics industry, where another company, Lexicon Pharmaceuticals (LXRX), experienced a 4.2% decline, reflecting a -4.6% return over the past month [7]

Key Takeaways IDEAYA 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 announc ...

Loading... Loading... Monday, IDEAYA Biosciences Inc IDYA released clinical data for the IDE397 Phase 2 monotherapy expansion dose in methylthioadenosine phosphorylase-deletion urothelial and non-small cell lung cancer patients (NSCLC). "IDE397 is a potential first-in-class MAT2A inhibitor, that is being advanced as a monotherapy agent in priority MTAP-deletion solid tumor types and in high conviction rational combinations, including with Amgen's investigational MTA-cooperative protein arginine methytranfer ...

~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 ...

Core Viewpoint - IDEAYA Biosciences has initiated a Phase 1 clinical trial to evaluate the combination of IDE397, a MAT2A inhibitor, and Trodelvy, targeting patients with MTAP-deletion bladder cancer [12][5]. Group 1: Clinical Trial Details - The Phase 1 trial will assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of the IDE397 and Trodelvy combination [5][12]. - MTAP-deletion is present in approximately 26% of bladder cancer patients, indicating a significant target population for this treatment [5]. - The trial is part of a broader clinical program that includes a Phase 2 expansion arm for IDE397 monotherapy in MTAP-deletion solid tumors [1][5]. Group 2: Product Information - Trodelvy is currently approved in nearly 50 countries for second-line metastatic triple-negative breast cancer and in over 30 countries for pre-treated HR+/HER2- metastatic breast cancer [5]. - In the U.S., Trodelvy has received accelerated approval for treating locally advanced or metastatic urothelial cancer in patients who have previously undergone platinum-containing chemotherapy and anti-PD-(L)1 therapy [5]. Group 3: Future Developments - IDEAYA plans to provide a clinical data update for the IDE397 Phase 2 monotherapy expansion in MTAP-deletion bladder and lung cancer in the second half of 2024 [9]. - The company is also advancing multiple preclinical stage MTAP-deletion programs to enable wholly-owned combinations with IDE397, targeting a Development Candidate nomination in the second half of 2024 [9].

SOUTH SAN FRANCISCO, Calif., June 24, 2024 /PRNewswire/ -- IDEAYA Biosciences, Inc. (Nasdaq:IDYA), a precision medicine oncology company committed to the discovery and development of targeted therapeutics, today announced clinical program updates for IDE397, a potential first-in-class Phase 2 MAT2A inhibitor targeting MTAP-deletion solid tumors. There is an ongoing Phase 2 expansion of IDE397 monotherapy in MTAP-deletion solid tumors (NCT04794699), and an Amgen-sponsored Phase 1/2 trial of IDE397 and AMG 19 ...

Core Insights - IDEAYA Biosciences announced updated clinical results for darovasertib, a first-in-class oral small molecular inhibitor of protein kinase C (PKC), in the treatment of uveal melanoma (UM) [1][2] Clinical Trial Results - The ongoing Phase 2 trial of darovasertib showed promising results, with 75% of enucleation patients preserving their eyes and approximately 67% experiencing over 30% tumor shrinkage after 6 months [3][6] - Median tumor shrinkage was reported at approximately 47% for enucleation patients after 6 months [3][6] - In a separate cohort of 8 patients treated for 4 months or more, median tumor shrinkage was approximately 72% [5][6] Safety Profile - Darovasertib demonstrated a manageable adverse event (AE) profile, with no drug-related serious adverse events reported [4][7] - Drug-related AEs were primarily Grade 1 or Grade 2, with about 20% of patients experiencing at least one drug-related Grade 3 AE [4][7] Regulatory Plans - The company is targeting a Type C meeting with the FDA in H2 2024 to discuss a potential registrational trial for darovasertib in the neoadjuvant UM setting [5][6] - The Phase 2 company-sponsored trial has activated over 14 sites globally and enrolled over 40 patients as of May 24, 2024 [5][6] Market Potential - The projected global annual incidence of primary uveal melanoma is approximately 8,000 to 10,000 patients, indicating a significant market opportunity for darovasertib [6][8]

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. About IDEAYA Biosciences IDEAYA is a precision medicine oncology company committed to the discovery and development of targeted therapeutics for patient populations selected using molecular diagnostics. IDEAYA's approach integrates cap ...

Over 18-years at leading life sciences and strategy consulting companies, including Revolution Medicines, Guardant Health, Onyx Pharmaceuticals, and McKinsey & Company SOUTH SAN FRANCISCO, Calif., May 28, 2024 /PRNewswire/ -- IDEAYA Biosciences, Inc. (NASDAQ: IDYA), a precision medicine oncology company committed to the discovery and development of targeted therapeutics, today announced that Daniel A. Simon, will join the company as its Chief Business Officer in August 2024. "We are thrilled to welcome Dani ...

Core Insights - IDEAYA Biosciences announced preliminary clinical results for darovasertib, a first-in-class oral small molecular inhibitor of protein kinase C (PKC), in a Phase 2 trial for uveal melanoma at the 2024 ASCO Annual Meeting [1][5] Group 1: Clinical Trial Details - The Phase 2 trial involved 15 patients with localized uveal melanoma, treated with darovasertib 300mg twice daily [2] - An initial safety cohort of 3 patients was treated for one month, followed by 12 patients in an expansion cohort for up to six months [2] - As of the database lock, 11 patients completed primary treatment, with 4 remaining on neoadjuvant treatment and 6 receiving adjuvant darovasertib [3] Group 2: Efficacy and Safety Results - Approximately 67% (6 of 9 patients) had confirmed eye preservation, converting to plaque brachytherapy or external beam radiotherapy [3][8] - Median tumor shrinkage was approximately 39% after six months of treatment [3][8] - Darovasertib was generally well tolerated, with drug-related adverse events primarily Grade 1 or Grade 2; 13% reported at least one Grade 3 adverse event, with no serious adverse events observed [4][8] Group 3: Upcoming Presentation - Additional clinical data and follow-up will be presented at the ASCO 2024 oral presentation scheduled for June 3, 2024 [5][9] - The presentation will focus on the safety and efficacy of darovasertib for localized ocular melanoma [9]