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Top 20 biopharmaceutical companies saw a 2% market cap increase to $4.3trn in Q3 2024, driven by FDA approvals and strategic alliances, despite some declines.

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.

The Cancer Antibody Drug Conjugates Market report highlights the transformative potential of ADCs in cancer treatment, with 16 approved products and sales exceeding $10B in 2023. The market is projected to surpass $50B by 2030, driven by ongoing clinical trials and increased R&D efforts. Key players include Padcev, Kadcyla, and Enhertu, with significant development activity in lung and breast cancer. The market is led by the US and China, with major pharmaceutical companies driving innovation.

IDE397, a MAT2A inhibitor, demonstrated antitumor activity and a manageable safety profile in MTAP-deletion urothelial cancer and NSCLC patients, with 33% achieving a confirmed overall response at the 30 mg RP2D. The study also showed a 93% disease control rate and 81% ctDNA molecular response rate, supporting further combination therapy development.

The biopharmaceutical industry saw a 2% upturn in aggregate market capitalization to $4.3 trillion in Q3 2024, driven by FDA approvals and interest rate cuts. Bristol-Myers Squibb, Gilead Sciences, Sanofi, AbbVie, and Alnylam Pharmaceuticals led with over 10% growth. Novo Nordisk and Merck faced declines due to FDA rejections and sales drops.

IDE397, a MAT2A inhibitor, showed 33% ORR and 93% DCR in NSCLC and urothelial cancer patients with MTAP deletions, with no treatment-related discontinuations. Plans for combination studies with sacituzumab govitecan-hziy and AMG 193 are underway.

Ideaya Biosciences presents phase 1 expansion data for IDE397, a potential first-in-class MAT2A inhibitor, in MTAP-deletion urothelial cancer and non-small cell lung cancer at ENA 2024, showing clinical efficacy and a manageable safety profile. The company plans to advance IDE397 as a monotherapy and in combinations, including with Trodelvy in urothelial cancer and AMG 193 in NSCLC.

Gilead Sciences withdrew FDA accelerated approval of Trodelvy for locally advanced or metastatic urothelial carcinoma, based on TROPiCS-04 study not meeting primary endpoint of overall survival. This withdrawal does not affect other Trodelvy indications.