Menarini Group et Ryvu Therapeutics annoncent les premières données cliniques de l'étude de phase II JASPIS-01 sur le dapolsertib (MEN1703, SEL24)

Menarini and Ryvu reported preliminary clinical activity and an acceptable safety profile for dapolsertib monotherapy in the Phase II JASPIS-01 study of heavily pretreated patients with relapsed/refractory aggressive B-cell non-Hodgkin lymphoma. Patients had a median of four prior treatment lines; 53% had received CAR-T therapy and 60% CD3×CD20 bispecific antibodies. The investigational oral PIM/FLT3 inhibitor is dosed at 125 mg daily on days 1–14 of 21-day cycles, and data are scheduled for presentation at ASH on December 13, 2026; no response-rate figures were provided.

Analysis

The key valuation question is not whether preliminary activity is described as encouraging, but whether it converts into durable responses in patients who have already failed CAR-T or CD3×CD20 bispecifics. The release gives no response rate, response duration, cohort size, or subgroup breakdown, so it does not yet establish clinical differentiation. A positive poster could support dapolsertib’s option value; it should not be capitalized as a near-term earnings driver.

For RVU, the direct economics are partly insulated from development spending because Menarini funds the trial, while Ryvu retains licensed-asset economics whose milestone and royalty terms are not disclosed. Consequently, the data may matter more as validation of Ryvu’s discovery platform and pipeline credibility than as a measurable revenue revision today. Menarini’s funding also means this program’s trial costs are not the obvious near-term cash-burn transmission to RVU.

The next catalyst is the ASH poster on December 13. The 1–3 month repricing risk is asymmetric around the missing efficacy detail; over 6–18 months, durability, tolerability, and progress in the separate glofitamab combination cohort matter more than an initial response signal. The contrarian point: a highly pretreated population creates meaningful unmet need, but also makes small, uncontrolled early cohorts especially vulnerable to selection effects and unstable response estimates. No immediate trade is justified from this release alone.

Key Decisions for Investors

• Do not chase RVU on the announcement. Treat the December 13 poster as the first decision point; verify cohort size, ORR, complete responses, duration of response, follow-up, discontinuations, and results specifically after CAR-T or bispecific failure.
• Keep RVU on a catalyst watch rather than initiating an event position now. Consider a measured long only if the poster shows credible, durable activity with interpretable safety in the post-CAR-T/bispecific subgroup; position size should reflect early-stage binary risk and confirm current liquidity before execution.
• Falsify the efficacy thesis if responses are sparse or short-lived, the relevant post-cellular/bispecific subgroup shows little activity, or tolerability prevents sustained dosing. Also verify Ryvu’s actual milestone/royalty terms before translating clinical progress into revenue or valuation assumptions.