[8-K] Stoke Therapeutics, Inc. Reports Material Event
Stoke Therapeutics reported financial results for the quarter ended June 30, 2025 and provided business updates, including new data from ongoing open label extension (OLE) studies of zorevunersen extending out to three years and the initiation of a Phase 1 clinical study of STK-002 in patients with Autosomal Dominant Optic Atrophy (ADOA).
The company furnished a press release and an investor presentation as Exhibits 99.1 and 99.2, with the presentation including certain key findings from an analysis of the OLE studies; the company states these materials are furnished, not filed, and are not incorporated by reference into other filings.
Stoke Therapeutics ha comunicato i risultati finanziari per il trimestre chiuso il 30 giugno 2025 e ha fornito aggiornamenti aziendali, tra cui nuovi dati dagli studi in estensione open-label (OLE) su zorevunersen che arrivano fino a tre anni e l'avvio di uno studio clinico di Fase 1 su STK-002 in pazienti con atrofia ottica autosomica dominante (ADOA).
La societ脿 ha messo a disposizione un comunicato stampa e una presentazione per gli investitori come Allegati 99.1 e 99.2; la presentazione contiene alcuni risultati chiave dell'analisi degli studi OLE. La societ脿 precisa che tali materiali sono forniti e non depositati, e non sono incorporati per riferimento in altri documenti.
Stoke Therapeutics inform贸 los resultados financieros del trimestre finalizado el 30 de junio de 2025 y ofreci贸 actualizaciones comerciales, incluyendo nuevos datos de los estudios de extensi贸n en abierto (OLE) de zorevunersen con seguimiento de hasta tres a帽os y el inicio de un estudio cl铆nico de Fase 1 de STK-002 en pacientes con atrofia 贸ptica autos贸mica dominante (ADOA).
La compa帽铆a proporcion贸 un comunicado de prensa y una presentaci贸n para inversores como Anexos 99.1 y 99.2; la presentaci贸n incluye algunos hallazgos clave del an谩lisis de los estudios OLE. La empresa indica que estos materiales se facilitan pero no se presentan oficialmente, y no se incorporan por referencia en otras presentaciones.
Stoke Therapeutics電� 2025雲� 6鞗� 30鞚茧 膦呺霅� 攵勱赴 鞁れ爜鞚� 氚滍憸頃橁碃 牍勳雼堨姢 鞐呺嵃鞚错姼毳� 鞝滉车頄堨溂氅�, 鞐赴鞐愲姅 zorevunersen鞚� 鞓ろ攬霛茧波 鞐办灔(OLE) 鞐瓣惮鞐愳劀 3雲勱箤歆� 鞐办灔霅� 靸堧鞖� 雿办澊韯办檧 靸侅椉靸夓泊 鞖办劚 鞁滌嫚瓴� 鞙勳稌歃�(ADOA) 頇橃瀽毳� 雽�靸侅溂搿� 頃� STK-002鞚� 1靸� 鞛勳儊鞁滍棙 臧滌嫓臧� 韽暔霅橃柎 鞛堨姷雼堧嫟.
須岇偓電� 氤措弰鞛愲鞕� 韴瀽鞛� 氚滍憸鞛愲毳� 歃濍箼鞛愲 99.1 氚� 99.2搿� 鞝滉车頄堨溂氅�, 氚滍憸鞛愲鞐愲姅 OLE 鞐瓣惮 攵勳劃鞚� 鞚茧秬 欤检殧 瓴瓣臣臧� 韽暔霅橃柎 鞛堨姷雼堧嫟. 須岇偓電� 鞚� 鞛愲霌れ澊 '鞝滉车(furnished)'霅� 瓴冹澊瓿� '鞝滌稖(filed)'霅� 瓴冹潃 鞎勲媹氅� 雼るジ 鞝滌稖靹滊鞐� 彀胳“搿� 韽暔霅橃 鞎婋姅雼り碃 氇呾嫓頄堨姷雼堧嫟.
Stoke Therapeutics a publi茅 ses r茅sultats financiers pour le trimestre clos le 30 juin 2025 et a communiqu茅 des informations op茅rationnelles, y compris de nouvelles donn茅es provenant des 茅tudes d'extension en ouvert (OLE) de zorevunersen couvrant jusqu'脿 trois ans et le lancement d'une 茅tude clinique de phase 1 de STK-002 chez des patients atteints d'atrophie optique autosomique dominante (ADOA).
La soci茅t茅 a fourni un communiqu茅 de presse et une pr茅sentation aux investisseurs en tant qu'Annexes 99.1 et 99.2 ; la pr茅sentation inclut certains r茅sultats cl茅s d'une analyse des 茅tudes OLE. La soci茅t茅 pr茅cise que ces documents sont fournis et non d茅pos茅s, et ne sont pas incorpor茅s par renvoi dans d'autres d茅p么ts.
Stoke Therapeutics meldete die Finanzergebnisse f眉r das Quartal zum 30. Juni 2025 und gab gesch盲ftliche Neuigkeiten bekannt, darunter neue Daten aus laufenden Open-Label-Extension-(OLE)-Studien zu zorevunersen mit einer Beobachtungsdauer von bis zu drei Jahren sowie den Beginn einer Phase-1-Studie von STK-002 bei Patienten mit autosomal-dominanter optischer Atrophie (ADOA).
Das Unternehmen stellte eine Pressemitteilung und eine Investorenpr盲sentation als Anh盲nge 99.1 und 99.2 zur Verf眉gung; die Pr盲sentation enth盲lt bestimmte Schl眉sselergebnisse aus der Analyse der OLE-Studien. Das Unternehmen weist darauf hin, dass diese Unterlagen zur Verf眉gung gestellt, nicht eingereicht wurden und nicht durch Verweis in andere Einreichungen aufgenommen sind.
- New OLE data for zorevunersen extending out to three years, indicating continued long-term follow-up
- Initiation of a Phase 1 clinical study of STK-002 in patients with Autosomal Dominant Optic Atrophy (ADOA)
- Quarterly financial results and business updates were publicly announced and accompanied by a furnished press release and investor presentation
- None.
Insights
TL;DR: Announcement contains potentially material clinical updates鈥攖hree-year OLE data disclosure and a new Phase 1 start鈥攖hough no trial results are included here.
The filing signals continued clinical progress: ongoing OLE data for zorevunersen reaching three years suggests longer-term follow-up is underway, and initiation of a Phase 1 study for STK-002 broadens the pipeline into ADOA. From an R&D perspective, these are material program milestones because they support development continuity and future data flow. However, the 8-K itself provides no efficacy, safety, enrollment, or endpoint outcomes, so definitive assessment of clinical or commercial impact is not possible from this filing alone.
TL;DR: Furnishing of presentation and press release is actionable for investors but lacks detailed clinical data; the Phase 1 initiation is a clear operational milestone.
Initiating a first-in-patient or Phase 1 study for STK-002 is an operationally important event that typically increases program visibility and starts the clock on early human safety and pharmacology data generation. The mention of three-year OLE follow-up for zorevunersen indicates longer-term surveillance of treated patients, which can inform durability and safety profiles. The filing does not disclose numerical results, safety signals, or timelines for upcoming data releases, limiting the ability to judge near-term valuation impact.
Stoke Therapeutics ha comunicato i risultati finanziari per il trimestre chiuso il 30 giugno 2025 e ha fornito aggiornamenti aziendali, tra cui nuovi dati dagli studi in estensione open-label (OLE) su zorevunersen che arrivano fino a tre anni e l'avvio di uno studio clinico di Fase 1 su STK-002 in pazienti con atrofia ottica autosomica dominante (ADOA).
La societ脿 ha messo a disposizione un comunicato stampa e una presentazione per gli investitori come Allegati 99.1 e 99.2; la presentazione contiene alcuni risultati chiave dell'analisi degli studi OLE. La societ脿 precisa che tali materiali sono forniti e non depositati, e non sono incorporati per riferimento in altri documenti.
Stoke Therapeutics inform贸 los resultados financieros del trimestre finalizado el 30 de junio de 2025 y ofreci贸 actualizaciones comerciales, incluyendo nuevos datos de los estudios de extensi贸n en abierto (OLE) de zorevunersen con seguimiento de hasta tres a帽os y el inicio de un estudio cl铆nico de Fase 1 de STK-002 en pacientes con atrofia 贸ptica autos贸mica dominante (ADOA).
La compa帽铆a proporcion贸 un comunicado de prensa y una presentaci贸n para inversores como Anexos 99.1 y 99.2; la presentaci贸n incluye algunos hallazgos clave del an谩lisis de los estudios OLE. La empresa indica que estos materiales se facilitan pero no se presentan oficialmente, y no se incorporan por referencia en otras presentaciones.
Stoke Therapeutics電� 2025雲� 6鞗� 30鞚茧 膦呺霅� 攵勱赴 鞁れ爜鞚� 氚滍憸頃橁碃 牍勳雼堨姢 鞐呺嵃鞚错姼毳� 鞝滉车頄堨溂氅�, 鞐赴鞐愲姅 zorevunersen鞚� 鞓ろ攬霛茧波 鞐办灔(OLE) 鞐瓣惮鞐愳劀 3雲勱箤歆� 鞐办灔霅� 靸堧鞖� 雿办澊韯办檧 靸侅椉靸夓泊 鞖办劚 鞁滌嫚瓴� 鞙勳稌歃�(ADOA) 頇橃瀽毳� 雽�靸侅溂搿� 頃� STK-002鞚� 1靸� 鞛勳儊鞁滍棙 臧滌嫓臧� 韽暔霅橃柎 鞛堨姷雼堧嫟.
須岇偓電� 氤措弰鞛愲鞕� 韴瀽鞛� 氚滍憸鞛愲毳� 歃濍箼鞛愲 99.1 氚� 99.2搿� 鞝滉车頄堨溂氅�, 氚滍憸鞛愲鞐愲姅 OLE 鞐瓣惮 攵勳劃鞚� 鞚茧秬 欤检殧 瓴瓣臣臧� 韽暔霅橃柎 鞛堨姷雼堧嫟. 須岇偓電� 鞚� 鞛愲霌れ澊 '鞝滉车(furnished)'霅� 瓴冹澊瓿� '鞝滌稖(filed)'霅� 瓴冹潃 鞎勲媹氅� 雼るジ 鞝滌稖靹滊鞐� 彀胳“搿� 韽暔霅橃 鞎婋姅雼り碃 氇呾嫓頄堨姷雼堧嫟.
Stoke Therapeutics a publi茅 ses r茅sultats financiers pour le trimestre clos le 30 juin 2025 et a communiqu茅 des informations op茅rationnelles, y compris de nouvelles donn茅es provenant des 茅tudes d'extension en ouvert (OLE) de zorevunersen couvrant jusqu'脿 trois ans et le lancement d'une 茅tude clinique de phase 1 de STK-002 chez des patients atteints d'atrophie optique autosomique dominante (ADOA).
La soci茅t茅 a fourni un communiqu茅 de presse et une pr茅sentation aux investisseurs en tant qu'Annexes 99.1 et 99.2 ; la pr茅sentation inclut certains r茅sultats cl茅s d'une analyse des 茅tudes OLE. La soci茅t茅 pr茅cise que ces documents sont fournis et non d茅pos茅s, et ne sont pas incorpor茅s par renvoi dans d'autres d茅p么ts.
Stoke Therapeutics meldete die Finanzergebnisse f眉r das Quartal zum 30. Juni 2025 und gab gesch盲ftliche Neuigkeiten bekannt, darunter neue Daten aus laufenden Open-Label-Extension-(OLE)-Studien zu zorevunersen mit einer Beobachtungsdauer von bis zu drei Jahren sowie den Beginn einer Phase-1-Studie von STK-002 bei Patienten mit autosomal-dominanter optischer Atrophie (ADOA).
Das Unternehmen stellte eine Pressemitteilung und eine Investorenpr盲sentation als Anh盲nge 99.1 und 99.2 zur Verf眉gung; die Pr盲sentation enth盲lt bestimmte Schl眉sselergebnisse aus der Analyse der OLE-Studien. Das Unternehmen weist darauf hin, dass diese Unterlagen zur Verf眉gung gestellt, nicht eingereicht wurden und nicht durch Verweis in andere Einreichungen aufgenommen sind.
FAQ
What did Stoke Therapeutics (STOK) announce in this 8-K?
Are the press release and investor presentation included with the filing?
Does the filing provide clinical results for the zorevunersen OLE data?
Is the information in the 8-K considered filed with the SEC?
Who signed the report on behalf of Stoke Therapeutics?
