Recent 8-K filings for QNRX
Highest-materiality recent filing
Quoin Pharma gets FDA clearance to start second pivotal Netherton Syndrome study for QRX003
- FDA cleared Study CL-QRX003-002, testing whole-body QRX003 (~80% BSA) with off-label systemic therapy in ~12-15 subjects.
- Complements monotherapy pivotal study CL-QRX003-003 led by Dr. Amy Paller at Northwestern with up to 6 international sites.
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Quoin Pharma gets Japan MHLW Orphan Drug Designation for QRX003 in Netherton Syndrome
Japan MHLW granted Orphan Drug Designation to QRX003 lotion (4%) for Netherton Syndrome, a rare genetic skin disorder with no approved treatments.
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Quoin Q1 net loss $5M; FDA says single Phase 3 may suffice for QRX003
Net loss $5.0M in Q1 2026 vs $3.8M in Q1 2025; cash $14M expected to fund operations into 2027.
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Quoin raises up to $104.5M, advances QRX003 regulatory path, reports 2025 net loss $15.8M
Closed private placement for up to $104.5M ($16.5M at closing, $88M warrant potential).
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FDA grants Fast Track Designation to Quoin's QRX003 for Netherton Syndrome
Fast Track Designation granted to QRX003 lotion (4%) for Netherton Syndrome, a rare genetic skin disorder with no approved treatments.
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Filed application with Saudi FDA for Breakthrough Medicine Designation for QRX003 for Netherton Syndrome.
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Quoin achieves 4% and 5% rapamycin loadings in topical and patch; clinical testing planned H1 2026
Rapamycin loading 4% w/w in proprietary topical formulation; 5% w/w in dermal patch system.
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Quoin Pharma reports Q3 net loss of $3.9M, raises up to $105.3M in private placement
Net loss of $3.9M for Q3 2025 ($11.5M YTD) vs $2.3M and $6.7M in prior-year periods; R&D spend increased to $2.3M for Q3.
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Quoin Pharmaceuticals receives FDA Orphan Drug Designation for QRX003 in Netherton Syndrome
FDA grants Orphan Drug Designation to QRX003 for Netherton Syndrome; 7-year US exclusivity if approved.
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Quoin raises $16.6M upfront in PIPE; up to $104.6M total with milestone warrants
Upfront gross proceeds of $16.6M ($15M net) from private placement; proceeds for QRX003 development and general corporate.
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Quoin finalizes CFO exit: $433K lieu of notice, $108K bonus, extended options
Separation agreement signed August 21; effective August 15, 2025.
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Quoin shareholders approve increase in shares from 100M to 5B; Sally Lawlor named new CFO
Shareholders approved amendment to increase authorized ordinary shares from 100,000,000 to 5,000,000,000 (50x).
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Quoin Pharma Q2 net loss $3.7M; QRX003 advances with FDA/EMA designations
Net loss Q2 2025 $3.7M vs $2.0M YoY; cash $7.8M supports operations into Q1 2026.
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Quoin Pharma receives FDA Rare Pediatric Disease Designation for QRX003 in Netherton Syndrome
FDA granted Rare Pediatric Disease Designation (RPDD) on June 24, 2025 for QRX003.
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Quoin Pharma gets FDA clearance to start second pivotal Netherton Syndrome study for QRX003
FDA cleared Study CL-QRX003-002, testing whole-body QRX003 (~80% BSA) with off-label systemic therapy in ~12-15 subjects.
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Quoin Pharma gets EMA Orphan Drug Designation for QRX003 for Netherton Syndrome
EMA grants Orphan Drug Designation for QRX003, a topical treatment for Netherton Syndrome, a rare disease with no approved therapies.
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Quoin Pharma Q1 net loss $3.8M; positive QRX003 data and patent expansion
Cash of $11.6M at March 31, 2025; expected to fund operations into Q1 2026.
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Quoin Pharma regains Nasdaq minimum bid price compliance; delisting risk removed
Received Nasdaq Compliance Notice on April 29, 2025 confirming minimum bid price compliance.
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Quoin Pharma announces 1-for-20 reverse ADS split to regain Nasdaq compliance
ADS ratio changed from 1:1 to 1:20 (one ADS now represents 20 ordinary shares) effective April 8, 2025.
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After 6 weeks of daily whole-body QRX003, the pediatric Netherton patient's skin is almost completely healed.
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Quoin reports FY2024 net loss $9.0M; cash $14.1M; positive QRX003 whole-body data in Netherton
Cash of $14.1M at Dec 31, 2024 expected to fund operations into Q2 2026.
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IGA score improved from 7 to 1-2 (0-10 scale) after two weeks of whole-body QRX003 treatment.
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IGA score improved from 'severe' at baseline to 'mild' after six weeks of twice-daily QRX003 dosing.
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M-IASI score improved from 18 to 3; WINRS from 7 to 2; IGA from Moderate to Almost Clear after 12 weeks.
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Quoin Pharmaceuticals prices $6.8M public offering of ADSs and warrants
Gross proceeds ~$6.8M from offering of 15,111,110 ADSs (or pre-funded warrants) and Series F/G warrants at $0.45 per unit.
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Quoin Pharma gets FDA clearance for whole-body QRX003 study in Netherton Syndrome
FDA clearance for new Netherton Syndrome study of QRX003 applied to >80% BSA twice daily for 12 weeks in up to 8 patients.
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Quoin Q3 net loss $2.3M; initiates Peeling Skin Syndrome study; management buys shares
Net loss of $2.3M for Q3 2024 vs $1.9M in Q3 2023; nine-month net loss $6.7M vs $6.6M.
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Quoin Pharma reports Q4/FY2023 net loss $8.7M; cash runway to H2 2025; positive QRX003 data
Net loss Q4 2023 $2.0M (flat YoY); FY2023 $8.7M vs $9.4M in 2022.
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Raised $6.5M gross from public offering of ADSs, pre-funded and Series D/E warrants at $1.60 combined per unit.
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Agreement allows Quoin to sell up to $8M of ADSs to Alumni Capital at discounts of 2% to 10% to market.
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FDA cleared protocol amendments for both ongoing QRX003 trials for Netherton Syndrome.
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Quoin reports positive Phase 2 data for QRX003 in Netherton Syndrome; cash $14M
Five of six evaluable subjects showed negligible/absent pruritus after QRX003 treatment in open-label study.
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Quoin to effect 1-for-60,000 reverse stock split on Nov 8; ADS ratio changes to 1:1
Reverse split of ordinary shares at 1-for-60,000 ratio effective November 8, 2023.
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Quoin shareholders approve 12x authorized share increase and 1:60,000 reverse split
Shareholders approved increasing authorized ordinary shares from 500 billion to 6 trillion.
Materiality & sentiment trend
Max materiality 0.85 · Median 0.60 · Most common event other_material