IDYA · IDEAYA Biosciences, Inc.

The thesis

IDEAYA Biosciences is now less likely than not to beat the S&P 500 over the next three months, even though its darovasertib application is filed. The 3 November 2026 report disclosed the closure of a Phase 3 trial, three analyst firms then cut their targets, and the shares closed at $30.65 on 5 November 2026, just above the $30 invalidation level. FDA acceptance of the filing and the two IDE849 Phase 3 starts guided for year-end settle it.

The filing risk that framed the previous note has eased. IDEAYA's third-quarter release says it submitted the new drug application (NDA) for darovasertib plus crizotinib in metastatic uveal melanoma, an eye cancer that has spread. The open questions are now the FDA's response and how much the drug will earn.

An FDA acceptance with priority review, paired with a close back above $33.96 (the 28 October 2026 close), would reverse this view.

Bullish and bearish views on IDEAYA Biosciences, Inc.

The bull case on IDEAYA Biosciences, Inc. (IDYA), in brief: The application is now submitted. The bear case: A Phase 3 trial failed to enroll.

Bull case

• The application is now submitted. IDEAYA's 3 November 2026 release says the NDA went in under the FDA's Real-Time Oncology Review program during the third quarter. William Blair, which initiated with an Outperform rating on 16 October 2026, cited a possible first-half 2027 approval, according to Investing.com.
• Randomized results support the filing. At the 1 June 2026 American Society of Clinical Oncology presentation, OptimUM-02 reported median progression-free survival of 6.9 months versus 3.1 months for investigator's choice. The hazard ratio was 0.42 and the p-value was below 0.0001.
• IDE849 has a registrational plan. After FDA Type C meetings, IDEAYA's 3 November 2026 release targets two Phase 3 starts by year-end 2026, in extensive-stage small cell lung cancer and neuroendocrine carcinoma. The lung trial plans 400 patients previously treated with tarlatamab, and partner Hengrui's Phase 1 study showed a 72.5% response rate (37 of 51 patients) at a 21 August 2026 cutoff.
• A darovasertib Phase 3 is still running. The 3 November 2026 release says OptimUM-011, an adjuvant uveal melanoma trial of about 450 patients with partner Servier, has started.
• Cash reaches well past the next events. IDEAYA reported about $1.15 billion in cash, cash equivalents and marketable securities at 30 September 2026 and left its runway guidance into 2030 unchanged. It expects $100-125 million of savings from the closed trial, to be reallocated to other programs.
• Two firms raised targets after the report. Citi raised its target to $66 on 5 November 2026, and Wedbush moved to $63 from $60 on 3 November 2026.

Bear case

• A Phase 3 trial failed to enroll. IDEAYA's 3 November 2026 release says it has ended enrollment and is closing OptimUM-010 because of site activation and enrollment challenges. This confirms the enrollment risk named in the previous note, and the release does not say how the closure bears on darovasertib's later uses.
• Three firms cut targets in one day. On 4 November 2026 RBC lowered its target to $45, Guggenheim to $52 (it had raised to $57 on 9 September 2026) and Truist to $57 from $59. Investing.com reports that Truist's cut reflected lower darovasertib uveal melanoma revenue estimates, partly offset by a higher success probability for IDE849's target, DLL3.
• Spending is rising ahead of any product sales. Third-quarter net loss was $125.7 million against $112.5 million in the second quarter, and research and development expense was $121.6 million against $108.7 million. Loss per share of $1.22 missed the $1.18 estimate, according to Benzinga, while collaboration revenue of $10.242 million beat the $6.857 million estimate.
• Share count has grown. Weighted-average shares reached 102.9 million in the third quarter, up from 92.1 million in the second, after the June 2026 offering priced at $27.00 and netted $323.4 million.
• OptimUM-01 remains a mixed picture. IDEAYA's 19 October 2026 release shows a 22.1% response rate (19 of 86 evaluable), median progression-free survival of 5.4 months and median overall survival of 13.4 months at a 23 March 2026 cutoff.

Price setup

The shares closed at $30.65 on 5 November 2026, according to adjusted daily closes. That is 27.8% below the 52-week high of $42.48 and 16.6% lower over three months. The 14-day relative strength index (a momentum gauge) is 41.5.

Closes have stepped lower for two months: $39.86 on 4 September 2026, $37.36 on 2 October 2026, $33.96 on 28 October 2026 and $30.65 on 5 November 2026. The European cancer congress in late October did not lift them, and the third-quarter report came in the final stretch of that decline. The next reference points below are $30 and the $27.00 June offering price.

The narrative is maturing: the filing story is well known and was delivered in the 3 November 2026 report, and attention has moved to FDA acceptance and IDE849. Crowding evidence is limited. The momentum reading and the distance from the high show no stretched price, and the quarterly report has passed, so no earnings date is imminent. The last public offering in company news priced on 9 June 2026.

Catalysts, next 30 days

• 16 November 2026: Investor R&D Day in London, 5:00 PM GMT. IDEAYA's 3 November 2026 release says it will present preclinical work on MTAP/CDKN2A deficiency in KRAS-mutant cancers. It is a pipeline event, so it speaks to the early programs more than to darovasertib.
• By ~31 December 2026, est.: FDA acceptance of the darovasertib NDA. The company has disclosed no acceptance or decision date, and this estimate rests on the FDA's usual filing review period. Acceptance would bring the first dated regulatory milestone.
• By 31 December 2026: two IDE849 Phase 3 starts. Company guidance also targets a Phase 1 start of IDE892 with Roche's RG6505 by year-end. First results from the global IDE849 Phase 1/2 trial are guided for the end of 2026 or early 2027.

What would change the view

The case breaks if the FDA refuses to file the application or places darovasertib on clinical hold. A slip of the IDE849 Phase 3 starts into 2027, or a new equity offering at or below the $27.00 June price, would weaken it further. On price, a daily close below $30 would end the thesis, putting the shares back near that offering price.

The more cautious view would be wrong if the FDA accepts the NDA with priority review and a near-term decision date, and the shares close back above $33.96. First global IDE849 results that match the 72.5% response rate in Hengrui's study would also argue for a stronger reading.

What it trades with

The recent price path follows company events: the shares were flat through the October congress and lower across the third-quarter report. No measured correlation figure is cited in this note.

Read-across comes mainly from partners. Servier shares darovasertib, with $139.8 million of collaboration revenue from its license still to be recognized at 30 September 2026. Hengrui originated IDE849, and Roche's RG6505 is the planned partner drug for IDE892. Results or timetable changes from those programs bear directly on IDEAYA.