Darovasertib Drug Asset Due Diligence Report 2026

This Darovasertib Drug Asset Due Diligence Report was built with PatSnap Life Sciences MCP workflows. Drug & Asset MCP establishes identity, ownership and stage; Clinical Trials MCP checks design, endpoints and readouts; Company & Deal Intelligence MCP reconstructs transaction precedent. Explore the MCP servers used in this report.

Decision date: 20 July 2026. Currency fields are presented in US$ millions as returned by the deal dataset. This is a screening memorandum, not legal, medical, patent or investment advice.

Phase 3

Highest phase

Registered trials

Result records

Matched deals

Executive recommendation: GO

Decision memo

Advance diligence: development maturity and available evidence support continued investment, subject to indication-specific safety, IP, and commercial gates.

The central underwriting question is whether Darovasertib can convert its Small molecule drug profile and Not disclosed biology into clinically meaningful differentiation while preserving an investable safety, IP and commercial position.

1. Asset identity and development status

Asset	Darovasertib (query alias: Darovasertib)
Modality / target	Small molecule drug; Not disclosed; Not disclosed
Highest global status	Phase 3
Originator	Not disclosed
Active developers	Not disclosed

The MCP disease footprint includes no disclosed indication. The highest-phase flag is a useful orientation point, but the licensing case depends on indication-level evidence and rights, not the global label alone.

2. Clinical program: design and endpoint audit

Phase	Status	Enrollment	Lead primary endpoint
Phase 3	Recruiting	Not disclosed	Not disclosed
Phase 2/3	Active, not recruiting	Not disclosed	Not disclosed
Phase 2	Active, not recruiting	Not disclosed	Not disclosed

The trial set should be diligenced for randomization, comparator relevance, endpoint hierarchy, analysis population, multiplicity, geographic mix and readout timing. For early-stage studies, safety and dose selection can be as decision-critical as response rate.

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3. Clinical readouts: what is known

1139TiP - IDE196 (darovasertib) in combination with crizotinib versus investigator’s choice of treatment as first-line therapy in HLA-A2 negative metastatic uveal melanoma

Phase 2/3; n=not disclosed; evaluation: Positive. Reported fields: No quantitative result field returned

A phase 2 safety and efficacy study of neoadjuvant/adjuvant darovasertib for localized ocular melanoma.

Phase 2; n=not disclosed; evaluation: Positive. Reported fields: No quantitative result field returned

ctDNA reduction and clinical efficacy of the darovasertib + crizotinib (daro + crizo) combination in metastatic uveal melanoma (MUM)

Phase 1/2; n=not disclosed; evaluation: Positive. Reported fields: No quantitative result field returned

These fields are structured evidence signals, not a substitute for statistical review. The next diligence pass should reconcile denominators, confidence intervals, follow-up, censoring, dose cohorts and treatment-emergent toxicity against the original abstract, registry and protocol.

4. Market and competitive position

Darovasertib addresses its disclosed development indications. Commercial attractiveness rests on addressable biomarker-positive patients, treatment-line placement, duration, administration burden, pricing and displacement of entrenched standards. The modality—Small molecule drug—must demonstrate a benefit large enough to offset class-specific safety and operational costs.

The strongest market-validation signal in this screen is partner behavior: 4 matched transaction record(s) indicate that sophisticated counterparties have assigned strategic value to the asset or its rights. That does not establish net present value; probability of success, remaining R&D spend, royalties, cost sharing and territorial scope still need modeling.

5. Transaction precedent and economics

Date	Transaction	Phase at deal	Disclosed economics
2025-09-02	Servier and IDEAYA Biosciences Partner to Bring Darovasertib, a Promising Uveal Melanoma Treatment, to Patients Worldwide	Not disclosed	US$210.0M upfront; US$320.0M milestones
2020-03-11	IDEAYA and Pfizer Enter Clinical Trial Collaboration and Supply Agreement to Evaluate Clinical Combination of IDE196 and Binimetinib in Solid Tumors Harboring GNAQ or GNA11 Hotspot Mutations	Not disclosed	Financial terms not disclosed
2019-10-08	IDEAYA Announces First Patient Dosing of IDE196 for Solid Tumors outside of Uveal Melanoma and a Collaboration with Foundation Medicine in support of its Tumor-Agnostic GNAQ/11 Basket Trial	Not disclosed	Financial terms not disclosed

Headline values are not directly comparable. Diligence should normalize upfront cash, equity, development and sales milestones, tiered royalties, opt-in mechanics, cost sharing, change-of-control clauses and geography.

6. IP and freedom-to-operate screen

No asset-specific patent-application milestone appeared in the returned milestone slice. That absence is not a freedom-to-operate conclusion; a dedicated family, claim, ownership, expiry, and legal-status search remains mandatory before signing.

The claim chart should separately test composition or sequence coverage, formulation and dosing, indication and biomarker claims, combinations, manufacturing know-how, prosecution history, term extensions and third-party blocking rights. Confirm that licensed patents, data and know-how track every granted territory and field.

7. Principal risks and diligence gates

Therapeutic index across KRAS/BRAF mutation subgroups
On-target toxicity and adaptive MAPK resistance
Lack of matched efficacy results in the current MCP result set

Cross-functional diligence should also test CMC comparability, supply chain, pharmacovigilance, regulatory correspondence, data integrity, investigator concentration, partner obligations and change-of-control restrictions.

8. Final go/no-go memorandum

GO