Every 8-K that Quoin Pharmaceuticals, Ltd. American (QNRX) has filed with the SEC in the last 24 months is listed below, newest first, and each one links through to the document itself with the summary and the scores our analysis gives it.
A 8-K covers material events a company has to report between its quarterly reports, so if you follow QNRX and want that one kind of document rather than the whole filing history, this is the page to keep. The company's other filings, of every form, are on the full QNRX filings page.
Quoin Pharmaceuticals Ltd. (QNRX) reported that the U.S. FDA has granted Rare Pediatric Disease (RPD) Designation to its lead asset, QRX003, for the treatment of Peeling Skin Syndrome (PSS). This is the second RPD designation for QRX003, following an earlier RPD designation for Netherton Syndrome.
The RPD program is intended to support development of therapies for serious diseases that primarily affect individuals under 18 years of age. If a New Drug Application for QRX003 is eventually approved, Quoin may qualify to receive a transferable Priority Review Voucher. Quoin also stated that, with an IND cleared by the FDA, it is preparing to initiate a Phase 2 clinical study of QRX003 in PSS before the end of 2026, with plans to enroll up to 12 pediatric and adult patients in the U.S. and Europe.
Quoin Pharmaceuticals Ltd. (QNRX) entered into a private placement securities purchase agreement with institutional and accredited investors for gross proceeds of up to $50.0 million, including approximately $30.8 million upfront and up to $19.2 million on potential cash exercise of accompanying ordinary warrants. Quoin will issue 6,305,300 ADSs (or pre-funded warrants) and ordinary warrants to purchase up to 3,152,650 ADSs, and expects upfront net proceeds of about $29.0 million, intended for general corporate purposes and completion of QRX003 development, with aggregate net proceeds expected to fund operations into the second half of 2029.
The company also entered exchange agreements issuing 222,574 ADSs to settle approximately $1.146 million of historical note interest. Separately, interim data from the Phase 2/3 CL-QRX003-004 trial in Netherton Syndrome showed 4 of 6 patients (66.67%) achieved the primary IGA endpoint at Week 12 (p=0.0087), significant improvement on a key secondary GIC endpoint (mean change -1.5; p=0.007), and a favorable safety profile with no treatment-related serious adverse events.
Quoin Pharmaceuticals Ltd. (QNRX) reported results of its 2026 Annual General Meeting held on August 20, 2026. Shareholders approved changes to the Company’s 401(k) plan matching contributions, including for U.S.-based executive officers, as described in the Company’s July 16, 2026 proxy statement.
Shareholders also approved amendments to the non-employee directors’ compensation program, increasing the annual base cash retainer to up to $250,000, with the exact amount to be set each year by the Compensation Committee and the Board. The annual option award value range was set between $20,000 and $200,000, also determined annually at their discretion. Other terms of the program remain unchanged. As of the July 15, 2026 record date, there were 70,294,615 ordinary shares outstanding, represented by 2,008,418 ADSs, entitled to vote at the meeting.
Quoin Pharmaceuticals Ltd. reported second quarter 2026 results and multiple clinical and regulatory milestones across its rare dermatology pipeline. QRX003 for Netherton Syndrome received FDA conditional approval of the proposed brand name QYLEKI™, continued in pivotal-path development, and is supported by a new U.S. Notice of Allowance covering a combination treatment patent. The company also submitted the first-ever IND for Peeling Skin Syndrome, which the FDA subsequently cleared, enabling a planned Phase 2/3 study in pediatric and adult patients in the United States and Europe in the second half of 2026. Quoin’s topical rapamycin platform QRX009 is advancing toward clinical testing with planned investigator-led studies in several additional indications.
Quoin held approximately $10.8 million in cash, cash equivalents, and marketable securities as of June 30, 2026 and expects this to fund operations into 2027. Net loss for the quarter was about $5.4 million, compared with $3.7 million in the prior-year quarter, driven mainly by higher research and development spending.
Quoin Pharmaceuticals announced that the U.S. Food and Drug Administration has conditionally approved QYLEKI™ as the proposed brand name for QRX003, its investigational lotion for treating the rare skin disorder Netherton Syndrome. Final approval of the brand name would come only with FDA marketing approval of QRX003.
QRX003 (QYLEKI 4% lotion) is in Phase 2 whole-body clinical trials, with a pivotal Phase 3 study expected to start in the second half of 2026 and a potential New Drug Application filing anticipated in 2027. The product has Orphan Drug Designation in the U.S., European Union, and Japan, and has also received Fast Track and Rare Pediatric Disease designations from the FDA, in an area where there is currently no approved treatment.
Quoin Pharmaceuticals reports that Japan’s Ministry of Health, Labour and Welfare has granted Orphan Drug Designation to QRX003 lotion (4%) for treating Netherton Syndrome, a rare genetic skin disorder with no approved treatments.
The Japanese designation covers diseases affecting fewer than 50,000 patients and provides prioritized consultation, reduced fees, tax incentives, priority review, and up to 10 years of market exclusivity upon approval.
QRX003 already holds Orphan Drug, Pediatric Rare Disease, and Fast Track designations from the U.S. FDA and Orphan Drug status from the European Medicines Agency. The drug is in Phase 2 trials, with a pivotal Phase 3 study expected in the second half of 2026 and potential NDA filing in 2027.
Quoin Pharmaceuticals Ltd. reported a wider first quarter 2026 net loss while highlighting major regulatory progress for its rare-disease pipeline. Net loss was about $5.0 million for the quarter ended March 31, 2026, compared with roughly $3.8 million a year earlier. Cash, cash equivalents and investments totaled approximately $14 million at March 31, 2026, which the company believes will fund operations into 2027.
Regulatory momentum centered on lead candidate QRX003 for Netherton Syndrome. The U.S. FDA granted Fast Track Designation, and a Type C meeting indicated a single Phase 3 study may support U.S. approval, potentially without a traditional placebo or vehicle control. Quoin filed for Breakthrough Medicine Designation in Saudi Arabia and submitted an Orphan Drug Designation application in Japan, where authorities confirmed QRX003 qualifies for both Orphan Drug and Fast Track review. Quoin aims to complete Phase 3 recruitment by the end of 2026 and potentially file an NDA in 2027.
The company also advanced its QRX009 topical rapamycin platform, planning investigator-led studies in Pachyonychia Congenita, Gorlin Syndrome and Tuberous Sclerosis Complex, and targeting an additional U.S. IND filing in the third quarter of 2026.
Quoin Pharmaceuticals reported fourth quarter and full-year 2025 results alongside a substantial corporate and regulatory update. For the year ended December 31, 2025, net loss was approximately $15.8 million compared to $9.0 million in 2024, reflecting higher research and development and general and administrative spending. Net loss for the quarter ended December 31, 2025 was about $4.3 million versus $2.3 million a year earlier. Quoin held roughly $18.7 million in cash, cash equivalents and marketable securities at year-end and believes this will fund operations into 2027.
Strategically, Quoin closed a private placement financing of up to $104.5 million in October 2025, including $16.5 million at closing and up to $88.0 million from potential warrant exercises. The company secured Orphan Drug Designations for lead candidate QRX003 for Netherton Syndrome in the U.S. and Europe and obtained U.S. Fast Track Designation in March 2026. A recent Type C meeting indicated that a single Phase 3 trial may support U.S. approval, with Phase 3 initiation and full enrollment targeted for 2026 and a potential NDA filing in 2027. Quoin is also expanding studies in Peeling Skin Syndrome and advancing topical rapamycin programs with proof-of-concept trials planned for the second half of 2026.
Quoin Pharmaceuticals Ltd. filed a report describing that the U.S. Food and Drug Administration has granted Fast Track Designation to its investigational QRX003 lotion (4%) for the treatment of Netherton Syndrome, a rare and severe genetic skin disease with no approved therapies.
The company explains that Fast Track status is intended to speed development and review of drugs for serious conditions with unmet medical need. QRX003 is already in two late-stage whole-body clinical trials and has previously received Orphan Drug and Pediatric Rare Disease designations in the U.S., as well as Orphan Drug Designation in Europe.
Quoin Pharmaceuticals Ltd. filed a Form 8-K describing a key regulatory step for its lead drug candidate QRX003, a late-stage topical treatment for the rare skin disorder Netherton Syndrome. The company has submitted an application to the Saudi Food and Drug Authority for Breakthrough Medicine Designation, a program intended to speed development, review and potential availability of medicines for serious conditions with high unmet need. Quoin believes QRX003 meets all SFDA eligibility criteria and states that, if the designation is granted, regulatory review could be accelerated and patient access in Saudi Arabia could begin as early as the second half of 2026. QRX003 already holds Orphan Drug and Pediatric Rare Disease designations from the U.S. FDA and Orphan Drug Designation from the European Medicines Agency. The drug is being tested in two late-stage pivotal whole-body clinical trials, with enrollment expected to complete in the first half of 2026 and top-line data anticipated in the second half of 2026. Subject to successful results, Quoin plans to submit a New Drug Application in the United States and other territories in late 2026 or early 2027. The company also reports that, as of January 20, 2026, it had 1,616,179 American Depositary Shares outstanding, each representing thirty-five ordinary shares.
Quoin Pharmaceuticals Ltd. reported that its Compensation Committee approved new standard forms of stock option award agreements for directors and executive officers under the company’s 2025 Equity Incentive Plan. These agreements are designed to allow a range of vesting schedules and terms within what the plan permits. If a grantee dies or becomes disabled, unvested options are forfeited, while vested options may be exercised for up to one year, subject to their stated expiration date. If a grantee is terminated for cause, all options, whether vested or unvested, are terminated and may be subject to recoupment by the company. For terminations for other reasons, unvested options are forfeited and vested options generally remain exercisable for up to three months, but not beyond their original expiration date.
Quoin Pharmaceuticals (QNRX) reported a technical milestone: it achieved the target loading concentrations for two topical rapamycin delivery technologies. The proprietary topical formulation reached a rapamycin loading concentration of 4% w/w, and a proprietary dermal patch system reached 5% w/w.
The company plans to begin manufacturing clinical trial and stability batches from at least one of these technologies this quarter, with the aim of commencing clinical testing in the first half of 2026. Initial clinical targets include Microcystic Lymphatic Malformations and Venous Malformations, areas where there are currently no FDA‑approved treatments or cures. The announcement was furnished under Regulation FD and includes forward‑looking statements subject to risks and uncertainties.
Quoin Pharmaceuticals Ltd. furnished a Form 8-K announcing its third quarter financial results. The announcement was made on November 6, 2025, with a detailed press release attached as Exhibit 99.1.
The company stated that the information provided under Item 2.02 is not deemed “filed” for purposes of Section 18 of the Exchange Act and is incorporated by reference only as specified. Quoin’s American Depositary Shares trade on Nasdaq under the symbol QNRX, with each ADS representing thirty-five ordinary shares.
Quoin Pharmaceuticals (QNRX) announced that the FDA granted Orphan Drug Designation (ODD) to its lead candidate QRX003 for treating Netherton Syndrome. This follows ODD from the EMA in May 2025.
ODD provides benefits such as tax credits for qualified clinical testing, waiver or partial payment of FDA application fees, and seven years of U.S. market exclusivity if approved. QRX003 lotion (4%) is in two late‑stage, whole‑body pivotal trials.
Quoin expects enrollment in both pivotal studies to complete in the first quarter of 2026, with top‑line data in the second half of 2026, and an NDA submission planned later in the year.
Quoin Pharmaceuticals (QNRX) closed a private placement, raising approximately $16.6 million in upfront gross proceeds and about $15 million in net proceeds. The financing included ADSs, pre-funded warrants for ADSs, and four series of accompanying warrants, each permitting purchases of up to 2,009,091 ADSs.
The unit price for ADSs and accompanying warrants was $8.25, while pre-funded warrant units were priced at $8.2499. Director Dennis Langer participated, purchasing 15,152 ADSs with accompanying warrants for roughly $128,641 at $8.49. Warrants carry a 4.99% beneficial ownership cap; pre-funded warrants are exercisable at $0.0001 per ADS and allow cashless exercise. If a resale registration is not effective six months after issuance, the ordinary warrants may be exercised cashlessly.
Quoin agreed to file a resale registration within 30 days and target effectiveness within 60 days (or 90 days on full SEC review). The company placed 180‑day financing standstills and obtained 180‑day lock-ups from directors and officers. Potential future gross proceeds from warrant cash exercises total up to about $88.0 million.
Quoin Pharmaceuticals reported the separation of an executive under a Separation Agreement that provides three key elements: a cash payment of $433,620 to be delivered in equal bi-weekly installments in lieu of 12 months' notice; a $108,405 bonus for the 2024 financial year to be paid in a lump sum on the one-year anniversary of the Separation Agreement's effective date; and an amendment to outstanding vested non-qualified stock options that extends the post-termination exercise window from 90 days to 1 year and 9 months. The filing is signed by Dr. Michael Myers, Chief Executive Officer, and includes an Inline XBRL cover page reference.
Quoin Pharmaceuticals Ltd. furnished a Form 8-K reporting corporate governance and personnel items. The filing lists several governance topics including the submission of matters to a vote of security holders, a material modification to rights of security holders, departures and elections of directors or certain officers, and compensatory arrangements for officers. The document discloses one specific executive term: Ms. Lawlor will be entitled to 28 days' annual leave in each calendar year (in addition to statutory public holidays). The Form 8-K was executed by the company's Chief Executive Officer.
Quoin Pharmaceuticals (NASDAQ:QNRX), a late clinical-stage specialty pharmaceutical company, announced that the FDA has granted Rare Pediatric Disease (RPD) Designation for their lead asset QRX003, targeting Netherton Syndrome. This significant regulatory milestone was disclosed in an 8-K filing dated June 24, 2025.
The RPD designation for QRX003 represents an important development in the company's rare and orphan disease pipeline, potentially accelerating the path to market for their Netherton Syndrome treatment.
Quoin Pharmaceuticals Ltd. (NASDAQ: QNRX) filed a Form 8-K to announce that its Board has scheduled the 2025 Annual General Meeting of Shareholders ("2025 AGM") for August 21, 2025. Because this date is more than 30 days earlier than the anniversary of the 2024 AGM, previously disclosed shareholder-proposal deadlines are no longer valid.
Revised submission windows:
- Rule 14a-8 proposals: must be received by June 30, 2025 for inclusion in the Company’s proxy materials.
- Universal proxy (Rule 14a-19) director nominations: notice must also be delivered by June 30, 2025, the 10th calendar day after this report’s public announcement.
No financial results, transactions, or strategic changes were disclosed. The filing is primarily a procedural notice affecting shareholders who intend to submit proposals or nominate directors.