Kinselby (resminostat)

Where it stands

Kinselby (resminostat), from 4Sc AG, has been refused EU marketing authorisation. The records show the status as Refused and carry an official milestone, "EU refusal: Kinselby (resminostat): EU marketing authorisation refused", dated 2026-08-21. No approval date is recorded.

The proposed indication was treatment of patients with advanced-stage mycosis fungoides (MF) and Sézary syndrome (SS), both forms of cutaneous T-cell lymphoma. The records list the therapeutic area as MF and SS.

The records give a CHMP opinion date of 2025-05-22 but do not state what the opinion concluded. The refusal milestone is dated about fifteen months later. The records do not explain the interval, so I cannot say whether it reflects a re-examination, a procedural pause or a data-entry issue. Readers should check the dates against the primary EMA and European Commission sources before relying on them.

Regulatory pathway and designations

The record is for the EU, and a CHMP opinion is involved, which is consistent with the centralised procedure. In general, the CHMP issues a scientific opinion and the European Commission then adopts the legally binding decision. An applicant that receives a negative opinion can ask for a re-examination within a short statutory window. The records do not say whether this happened here.

Kinselby holds an Orphan designation. In general, orphan designation gives incentives such as protocol assistance and, once a product is authorised, market exclusivity. It does not lower the evidentiary standard for a positive benefit-risk conclusion. With the authorisation refused, no orphan market exclusivity would arise from this product in the EU. The records do not cover the designation date, the sponsor of record or the orphan maintenance status.

Safety and pharmacovigilance

The records contain no safety data, risk management information or pharmacovigilance commitments for Kinselby, and they do not state the grounds for refusal.

What to watch

The key unknown is the stated basis for the refusal. The EMA normally publishes a refusal assessment report and a Q&A document setting out the CHMP's reasoning, and these will show whether the concerns were about efficacy, benefit-risk, or data quality. The records do not contain them.

Also watch for any sign of re-examination, resubmission or a revised application from 4Sc AG, and for how the orphan designation is treated in the EU Community Register. The records say nothing about these.

Finally, reconcile the timeline between the 2025-05-22 CHMP opinion date and the 2026-08-21 refusal milestone against the primary sources. The records cover only the EU, so any status in other regions, such as the US, cannot be inferred from them.