8-K - Quoin Pharmaceuticals, Ltd. | StockGist

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Quoin Pharmaceuticals Ltd. announced that the FDA granted Fast Track Designation to QRX003 lotion (4%) for the treatment of Netherton Syndrome, a rare genetic skin disorder with no approved treatments. This designation facilitates development through more frequent FDA interactions, rolling review eligibility, and potential accelerated approval.

Key Takeaways

1FDA granted Fast Track Designation to QRX003 lotion (4%) for Netherton Syndrome on March 11, 2026

2QRX003 is being evaluated in two late-stage whole-body clinical trials for Netherton Syndrome

3Previous designations: FDA Orphan Drug, Pediatric Rare Disease, and EMA Orphan Drug for QRX003

4Netherton Syndrome is a rare genetic skin disorder caused by SPINK5 mutations with no FDA-approved therapies

5Fast Track benefits include more frequent FDA interactions, rolling review, Accelerated Approval, and Priority Review eligibility

Current Report Details

Event Type

Regulation Fd

Other Event

Exhibits Only

Disclosure

Voluntary

Variant

8-K

Items Reported

7.01

and Exhibit 99.1 attached hereto are furnished and shall not be deemed to be “filed” with the Securities and Exchange Commission (the “SEC”) for purposes of Sec

Regulation Fd

8.01

. Other Events. Announcement of Fast Track Designation for QRX003 lotion (4%) for the Treatment of Netherton Syndrome On March 11, 2026, the Company announced t

Other Event

9.01

. Financial Statements and Exhibits. (d) Exhibits. The following exhibits are filed or furnished, as applicable, with this Report: Exhibit Number Description 99

Exhibits Only

Source Document

Exhibits (2)

8-K

FORM 8-K

99.1

EXHIBIT 99.1