Quoin Pharmaceuticals (QNRX) Soars After Hitting 4%/5% Topical Rapamycin Targets; Clinical Batches This Quarter, Human Trials 1H 2026 [Nov. 11, 2025]

• Milestone achieved: Quoin reached 4% w/w rapamycin in a proprietary topical lotion and 5% w/w in a dermal patch—a formulation hurdle it says enables next steps toward human testing. 1
• Near‑term timeline:Clinical/stability batches are slated to begin in Q4 2025, with first‑in‑human studies targeted for 1H 2026 across several indications. 1
• Initial indications:Microcystic lymphatic malformations (MLM) and venous malformations (VM)—areas with no FDA‑approved therapies today. 1
• Market reaction: Financial media flagged a sharp early surge in QNRX shares following the news. 2

What happened today

Quoin Pharmaceuticals, Ltd. (NASDAQ: QNRX) announced that it has successfully achieved target loading concentrations for two topical rapamycin delivery technologies—4% in its lotion and 5% in a dermal patch. The company said it will start manufacturing clinical and stability batches this quarter and is planning clinical testing in the first half of 2026. Initial targets include MLM and VM, which currently lack any FDA‑approved treatments. 1

Quoin’s topical rapamycin program is identified on its pipeline page as QRX009, a formulation designed to improve skin penetration and local delivery—an area the company says has limited the performance of prior topical rapamycin efforts. 3

Market reaction at a glance

Coverage from financial outlets highlighted a double‑digit spike in QNRX on the announcement, including reports of pre‑market gains approaching ~66% and strong early trading momentum. 2

As of approximately 15:10 UTC on Nov. 11, QNRX traded near $10.25, with an intraday range of $8.41–$15.05.

Why this matters

• Unmet need: MLM and VM can cause significant morbidity and have no approved therapies, creating a clear clinical and regulatory rationale for novel approaches. Today’s announcement frames QRX009 as a candidate that could advance quickly if stability and scale‑up hold. 1
• Platform potential: Quoin positions the lotion and patch as proprietary delivery systems intended to optimize drug deposition at target sites—potentially differentiating from other topical rapamycin programs with similar loadings. 1

Context: pipeline and funding backdrop

Today’s milestone comes days after Quoin’s Q3 2025 update, where the company noted:

• a private placement with the potential to raise up to $105.3M (including $16.6M upfront closed in October 2025);
• plans to begin enrolling two pivotal studies of QRX003 for Netherton syndrome in Q4 2025;
• and an FDA Orphan Drug Designation for QRX003.
  Management also indicated its cash position, combined with recent financing, supports operations into 2027. 4

Against that backdrop, QRX009—the topical rapamycin program highlighted today—sits alongside late‑stage dermatology assets QRX003 (Netherton syndrome) and programs in Peeling Skin Syndrome and Scleroderma, underscoring Quoin’s rare‑disease dermatology focus. 4

What’s next (near‑term catalysts)

• Q4 2025: Completion of clinical/stability batch manufacturing for at least one of the two rapamycin delivery technologies. 1
• 1H 2026:First‑in‑human clinical testing in MLM, VM and potentially other indications. 1
• Q4 2025:Enrollment start for QRX003 pivotal studies (Netherton syndrome). 4

How the Street is covering it

Multiple outlets amplified the news and the stock move this morning, including Investing.com, StreetInsider, GuruFocus, and Yahoo Finance (syndicating the press release). Expect continued volatility as traders handicap formulation progress versus clinical execution and regulatory timelines. 2

Risks to monitor

• Formulation ≠ efficacy: Hitting target drug load is a necessary step, but stability, skin penetration, and clinical efficacy/safety must still be demonstrated in trials. 5
• Execution and regulatory risk: Timelines depend on successful batch manufacture, IND/IRB clearances, and trial enrollment—all standard friction points cited in the company’s forward‑looking caution. 1
• Financing and volatility: As a clinical‑stage biotech, Quoin’s shares can be highly volatile around data and financing events; the company’s recent financing helps runway, but outcomes remain data‑dependent. 4

Sources (Nov. 11, 2025)

• Company press release: “Quoin Pharmaceuticals Announces Achievement of Topical Rapamycin Target Loadings…” (details on 4%/5% loadings, indications, and timelines). 1
• Market coverage: Investing.com (premarket spike and recap of key facts); StreetInsider (price reaction at/near the open). 2
• Syndicated PR: Yahoo Finance posting of the Nov. 11 release. 6
• Pipeline context: Company pipeline and QRX009 program description. 3
• Q3 2025 update: Financing, ODD for QRX003, pivotal start timing, and runway commentary. 4

Editor’s note: This article is for informational purposes only and does not constitute investment advice. Always do your own research and consider consulting a licensed financial advisor.