Ideaya Biosciences SEC Filings

IDEAYA Biosciences (IDYA) reported new Phase 2 clinical outcomes for its darovasertib plus crizotinib combination in first-line metastatic uveal melanoma. In 44 patients with a median follow-up of 25 months (cut-off May 28, 2025), the trial observed a median overall survival of 21.1 months and median progression-free survival of 7.0 months. Among 41 efficacy-evaluable patients, the confirmed overall response rate was 34% (14/41) with a 9.0‑month median duration of response, and disease control reached 90% (37/41). Historical median overall survival in treatment‑naïve mUM is approximately 12 months.

The regimen showed manageable tolerability; the most common treatment‑related adverse events (>30%) were diarrhea, nausea, edema, vomiting, dermatitis, hypoalbuminemia and fatigue, with grade ≥3 events of iron‑deficiency anemia and pulmonary embolism (both 5%). IDEAYA is running a registration‑enabling Phase 2/3 trial (OptimUM‑02) targeting median PFS readout by year‑end 2025 to Q1 2026, and a Phase 3 neoadjuvant trial (OptimUM‑10) in primary uveal melanoma. Pfizer is supplying defined quantities of crizotinib under a collaboration and supply agreement.

IDEAYA Biosciences filed an Form 8-K reporting material event updates tied to its OptimUM-10 trial of darovasertib. The company states that all efficacy-evaluable patients had received three or more cycles of treatment and had both baseline and on-treatment tumor assessments, paired dosimetry, and visual acuity score data available as of the stated cut-off. A median or representative follow-up duration of 3.5 months is reported for post-baseline scans, and the filing notes the study has not yet achieved a fully mature confirmed overall response rate (ORR%). The 8-K references the company’s 10-K and other SEC reports and is signed by Yujiro Hata, President and CEO.

IDEAYA Biosciences, Inc. disclosed that an upfront payment together with expected cost savings from an agreement are expected to extend the company’s cash runway by at least twelve months and, based on the company’s current operating plan, fund planned operations into 2030. The filing references mid-teens to low-twenties percentages in the text but does not provide further detail on what those percentages measure. The company also notes its 10-K was filed with the SEC on February 18, 2025. The report is signed by Yujiro Hata, President and Chief Executive Officer, dated September 2, 2025.

Janus Henderson Group plc filed Amendment No. 4 to a Schedule 13G reporting its beneficial ownership of IDEAYA BIOSCIENCES, INC. common stock (CUSIP 45166A102). The filing lists an aggregate beneficial ownership of 6,206,238 shares, representing 6.9% of the class, tied to an event date of 06/30/2025. The report shows no sole voting or dispositive power and shared voting and dispositive power of 6,206,238 shares, while Item 4 separately notes that JHIUS may be deemed beneficial owner of 6,080,532 shares. The reporting person is identified as an investment adviser/holding company (IA, HC). The statement is signed by Kristin Mariani on 08/14/2025 and includes a Power of Attorney exhibit dated 12/09/2022.

Capital Research Global Investors reports beneficial ownership of 6,552,691 shares of IDEAYA Biosciences common stock, representing 7.5% of the 87,581,963 shares the filing states are outstanding. The disclosure is made on a Schedule 13G and includes a certification that the securities were acquired and are held in the ordinary course of business and were not acquired to change or influence control of the issuer.

The filing shows CRGI has sole voting and sole dispositive power over the reported shares and names SMALLCAP World Fund, Inc. as an account on whose behalf shares are held. No group affiliation or intent to seek control is indicated in the statement.