Darovasertib

IDEAYA Biosciences, Inc. (IDYA) is a precision medicine oncology firm with a $1.2 billion cash reserve and a strong pipeline, including darovasertib in Phase 2/3 trials. Despite a $492.5 million deficit and reliance on external financing, collaborations with GSK and Pfizer bolster its position. The company focuses on synthetic lethality and molecular diagnostics for targeted therapies, facing challenges in revenue generation and regulatory approvals.

IDEAYA Biosciences reports Q3 2024 financial results and business update, including successful FDA Type C meeting for darovasertib in neoadjuvant UM, exceeding 150 patients enrolled in darovasertib + crizotinib 1L HLA-A2+ MUM trial, and targeting Phase 3 registration-enabling trial initiation in H1 2025. IDE397 shows confirmed ORR by RECIST 1.1 of 40%, 38%, and 22% in MTAP-deletion UC, SqNSCLC, and AdenoNSCLC, respectively, presented at ENA 2024. IDEAYA targets expansion of IDE397 + AMG 193 in MTAP-deletion NSCLC and IDE397 + Trodelvy in MTAP-deletion UC in Q4 2024. IDEAYA also targets Phase 1/2 expansion for IDE161 and FPI in combination with KEYTRUDA in MSI-High and MSS EC in Q4 2024, and IDE705 (GSK 101) Pol Theta Helicase Phase 1 dose escalation ongoing in HRD solid tumors. Received IND clearance for IDE275 (GSK959) Werner Helicase for Phase 1 trial in MSI-High solid tumors, targeting DC nomination for MTAP-deletion, KAT6 pathway, and B7H3/PTK7 Topo-Payload Bispecific-ADC programs in Q4 2024. IDEAYA plans Investor R&D Day on December 16, 2024, to highlight pipeline. Cash, cash equivalents, and marketable securities total $1.2 billion as of September 30, 2024, anticipated to fund operations into at least 2028.

IDEAYA Biosciences to present Phase 1 expansion results of IDE397, a MAT2A inhibitor, at EORTC-NCI-AACR Symposium in Barcelona, focusing on MTAP-deletion urothelial and NSCLC. The company also showcases preclinical data for MAT2A and PARG programs. IDEAYA's financial metrics indicate a market cap of $2.47B, strong liquidity, but negative P/E ratio and revenue decline, reflecting a transitional phase.

Ideaya Biosciences announced positive phase 2 data for darovasertib in neoadjuvant uveal melanoma, showing 49% tumor shrinkage and 61% eye preservation. The FDA Type C meeting supported eye preservation and time to vision loss as primary endpoints, paving the way for a potential registrational phase 3 trial.

IDEAYA Biosciences reports positive Phase II data for darovasertib in neoadjuvant uveal melanoma, with 49% of patients showing >30% tumor shrinkage and a favorable adverse event profile. The company plans a Phase III trial with 400 patients, focusing on eye preservation and time to vision loss as primary endpoints.

IDEAYA Bioscience's darovasertib, a PKC inhibitor for neoadjuvant uveal melanoma, showed 30% tumor shrinkage in half of patients and 61% eye preservation rate in Phase II trial. The company plans a Phase III trial enrolling 400 patients, with FDA guidance on potential endpoints and broad indication label for high-risk metastatic disease.

IDEAYA Biosciences reports positive Phase 2 darovasertib data in neoadjuvant uveal melanoma, with ~49% tumor shrinkage and ~61% eye preservation. A Phase 3 registrational trial is planned following FDA guidance, targeting ~400 patients. Annual incidence of primary UM in North America, Europe, and Australia is ~12k, with no FDA-approved therapies.

Ideaya Biosciences Inc. released interim Phase 2 data on darovasertib in neoadjuvant uveal melanoma, showing 49% tumor shrinkage >30% and 61% eye preservation. A Phase 3 trial is planned with FDA guidance.

IDEAYA Biosciences reports positive Phase 2 data for darovasertib in neoadjuvant uveal melanoma, with ~49% tumor shrinkage and ~61% eye preservation. A Phase 3 registrational trial is planned following FDA guidance, targeting ~400 patients with potential broad indication for low, intermediate, and high-risk metastatic disease.