[8-K] Stoke Therapeutics, Inc. Reports Material Event
Stoke Therapeutics and Biogen issued a joint press release announcing that the first patient has been dosed in the global Phase 3 EMPEROR study of zorevunersen for the treatment of Dravet syndrome. The company furnished that press release as Exhibit 99.1 to this Form 8-K and also included the cover page interactive XBRL file.
The filing states the furnished information, including Exhibit 99.1, is not deemed "filed" for purposes of Section 18 of the Exchange Act and is not incorporated by reference into other filings unless expressly stated. The report is executed on behalf of Stoke by Chief Financial Officer Thomas E. Leggett.
Stoke Therapeutics e Biogen hanno pubblicato un comunicato stampa congiunto annunciando che il primo paziente 猫 stato dosato nello studio globale di Fase 3 EMPEROR su zorevunersen per il trattamento della sindrome di Dravet. La societ脿 ha fornito quel comunicato come Allegato 99.1 a questo Form 8-K e ha incluso anche il file XBRL interattivo della pagina di copertina.
Il deposito dichiara che le informazioni fornite, incluso l'Allegato 99.1, non sono considerate 'depositate' ai fini della Sezione 18 dell'Exchange Act e non sono incorporate per riferimento in altri depositi, salvo diversa indicazione esplicita. Il rapporto 猫 firmato per conto di Stoke dal direttore finanziario Thomas E. Leggett.
Stoke Therapeutics y Biogen emitieron un comunicado de prensa conjunto anunciando que se ha dosificado al primer paciente en el estudio global de Fase 3 EMPEROR de zorevunersen para el tratamiento del s铆ndrome de Dravet. La compa帽铆a adjunt贸 ese comunicado como Anexo 99.1 a este Form 8-K y tambi茅n incluy贸 el archivo XBRL interactivo de la portada.
La presentaci贸n se帽ala que la informaci贸n suministrada, incluido el Anexo 99.1, no se considera 'presentada' a efectos de la Secci贸n 18 del Exchange Act y no se incorpora por referencia en otras presentaciones, salvo que se indique expresamente lo contrario. El informe se firma en nombre de Stoke por el director financiero Thomas E. Leggett.
Stoke Therapeutics鞕� Biogen鞚� 瓿惦彊 氤措弰鞛愲毳� 氚滍憸頃橃棳 鞝� 靹戈硠 3靸� EMPEROR 鞐瓣惮鞐愳劀 zorevunersen鞙茧 霌滊澕氩� 歃濏泟甑� 旃橂毳� 鞙勴暅 觳� 頇橃瀽鞐愱矊 鞎诫鞚� 韴棳霅橃棃鞚岇潉 鞎岆牳鞀惦媹雼�. 須岇偓電� 頃措嫻 氤措弰鞛愲毳� 鞚� Form 8-K鞐� Exhibit 99.1搿� 鞝滉车頃橁碃 響滌 韼橃澊歆�鞚� 雽�頇旐槙 XBRL 韺岇澕霃� 韽暔頄堨姷雼堧嫟.
頃措嫻 鞝滌稖靹滊電� 鞝滉车霅� 鞝曤炒(Exhibit 99.1 韽暔)臧� 歃濌秾瓯半灅氩�(Exchange Act) 鞝�18臁办潣 氇╈爜靸� '鞝滌稖霅�' 瓴冹溂搿� 臧勳＜霅橃 鞎婌溂氅�, 氇呾嫓鞝侅溂搿� 鞏戈笁霅橃 鞎婋姅 頃� 雼るジ 鞝滌稖靹滊鞐� 彀胳“搿� 韽暔霅橃 鞎婋姅雼り碃 氇呾嫓頃橁碃 鞛堨姷雼堧嫟. 鞚� 氤搓碃靹滊姅 Stoke毳� 雽�鞁犿晿鞐� 斓滉碃鞛毂呾瀯鞛� Thomas E. Leggett臧� 鞛戩劚路靹滊獏頄堨姷雼堧嫟.
Stoke Therapeutics et Biogen ont publi茅 un communiqu茅 de presse conjoint annon莽ant que le premier patient a 茅t茅 trait茅 dans l'茅tude mondiale de phase 3 EMPEROR portant sur zorevunersen pour le traitement du syndrome de Dravet. La soci茅t茅 a fourni ce communiqu茅 comme Annexe 99.1 脿 ce formulaire 8-K et a 茅galement inclus le fichier XBRL interactif de la page de couverture.
Le d茅p么t indique que les informations fournies, y compris l'Annexe 99.1, ne sont pas consid茅r茅es comme 'd茅pos茅es' au sens de la section 18 de l'Exchange Act et ne sont pas incorpor茅es par r茅f茅rence dans d'autres d茅p么ts, sauf indication expresse contraire. Le rapport est sign茅 au nom de Stoke par le directeur financier Thomas E. Leggett.
Stoke Therapeutics und Biogen gaben eine gemeinsame Pressemitteilung heraus, in der bekanntgegeben wird, dass der erste Patient in der globalen Phase-3-Studie EMPEROR mit zorevunersen zur Behandlung des Dravet-Syndroms dosiert wurde. Das Unternehmen hat diese Pressemitteilung als Anlage 99.1 zu diesem Formular 8-K beigef眉gt und auch die interaktive XBRL-Datei der Titelseite eingereicht.
Die Einreichung stellt fest, dass die bereitgestellten Informationen, einschlie脽lich Anlage 99.1, nicht als 'eingereicht' im Sinne von Section 18 des Exchange Act gelten und nicht durch Verweis in andere Einreichungen aufgenommen werden, es sei denn, dies wird ausdr眉cklich angegeben. Der Bericht wurde im Namen von Stoke vom Finanzchef Thomas E. Leggett unterzeichnet.
- First patient dosed in the global Phase 3 EMPEROR study of zorevunersen for Dravet syndrome
- Joint announcement with Biogen International GmbH, indicating partner collaboration on the program
- Press release furnished as Exhibit 99.1, creating an official public disclosure of the event
- None.
Insights
TL;DR: First patient dosing in a global Phase 3 trial is a clear clinical progression for zorevunersen and confirms active enrollment.
The announcement that the first patient has been dosed in the global Phase 3 EMPEROR study confirms transition of zorevunersen into a late-stage, global clinical evaluation for Dravet syndrome. This filing furnishes the partner joint press release with Biogen as Exhibit 99.1, establishing public record of trial initiation activity. From a development standpoint, first-dose announcements typically indicate protocol activation and initial site readiness, which are observable program milestones for investors and stakeholders.
TL;DR: The joint release with Biogen about Phase 3 dosing is materially positive as evidence of program advancement and partner alignment.
Stoke Therapeutics publicly disclosed that the first patient was dosed in the global Phase 3 EMPEROR trial for zorevunersen and furnished the press release as Exhibit 99.1. The joint nature of the announcement with Biogen International GmbH reinforces the ongoing collaboration. The Form 8-K clarifies the press release is furnished (not filed), which is standard practice for corporate communications while preserving certain legal protections.
Stoke Therapeutics e Biogen hanno pubblicato un comunicato stampa congiunto annunciando che il primo paziente 猫 stato dosato nello studio globale di Fase 3 EMPEROR su zorevunersen per il trattamento della sindrome di Dravet. La societ脿 ha fornito quel comunicato come Allegato 99.1 a questo Form 8-K e ha incluso anche il file XBRL interattivo della pagina di copertina.
Il deposito dichiara che le informazioni fornite, incluso l'Allegato 99.1, non sono considerate 'depositate' ai fini della Sezione 18 dell'Exchange Act e non sono incorporate per riferimento in altri depositi, salvo diversa indicazione esplicita. Il rapporto 猫 firmato per conto di Stoke dal direttore finanziario Thomas E. Leggett.
Stoke Therapeutics y Biogen emitieron un comunicado de prensa conjunto anunciando que se ha dosificado al primer paciente en el estudio global de Fase 3 EMPEROR de zorevunersen para el tratamiento del s铆ndrome de Dravet. La compa帽铆a adjunt贸 ese comunicado como Anexo 99.1 a este Form 8-K y tambi茅n incluy贸 el archivo XBRL interactivo de la portada.
La presentaci贸n se帽ala que la informaci贸n suministrada, incluido el Anexo 99.1, no se considera 'presentada' a efectos de la Secci贸n 18 del Exchange Act y no se incorpora por referencia en otras presentaciones, salvo que se indique expresamente lo contrario. El informe se firma en nombre de Stoke por el director financiero Thomas E. Leggett.
Stoke Therapeutics鞕� Biogen鞚� 瓿惦彊 氤措弰鞛愲毳� 氚滍憸頃橃棳 鞝� 靹戈硠 3靸� EMPEROR 鞐瓣惮鞐愳劀 zorevunersen鞙茧 霌滊澕氩� 歃濏泟甑� 旃橂毳� 鞙勴暅 觳� 頇橃瀽鞐愱矊 鞎诫鞚� 韴棳霅橃棃鞚岇潉 鞎岆牳鞀惦媹雼�. 須岇偓電� 頃措嫻 氤措弰鞛愲毳� 鞚� Form 8-K鞐� Exhibit 99.1搿� 鞝滉车頃橁碃 響滌 韼橃澊歆�鞚� 雽�頇旐槙 XBRL 韺岇澕霃� 韽暔頄堨姷雼堧嫟.
頃措嫻 鞝滌稖靹滊電� 鞝滉车霅� 鞝曤炒(Exhibit 99.1 韽暔)臧� 歃濌秾瓯半灅氩�(Exchange Act) 鞝�18臁办潣 氇╈爜靸� '鞝滌稖霅�' 瓴冹溂搿� 臧勳＜霅橃 鞎婌溂氅�, 氇呾嫓鞝侅溂搿� 鞏戈笁霅橃 鞎婋姅 頃� 雼るジ 鞝滌稖靹滊鞐� 彀胳“搿� 韽暔霅橃 鞎婋姅雼り碃 氇呾嫓頃橁碃 鞛堨姷雼堧嫟. 鞚� 氤搓碃靹滊姅 Stoke毳� 雽�鞁犿晿鞐� 斓滉碃鞛毂呾瀯鞛� Thomas E. Leggett臧� 鞛戩劚路靹滊獏頄堨姷雼堧嫟.
Stoke Therapeutics et Biogen ont publi茅 un communiqu茅 de presse conjoint annon莽ant que le premier patient a 茅t茅 trait茅 dans l'茅tude mondiale de phase 3 EMPEROR portant sur zorevunersen pour le traitement du syndrome de Dravet. La soci茅t茅 a fourni ce communiqu茅 comme Annexe 99.1 脿 ce formulaire 8-K et a 茅galement inclus le fichier XBRL interactif de la page de couverture.
Le d茅p么t indique que les informations fournies, y compris l'Annexe 99.1, ne sont pas consid茅r茅es comme 'd茅pos茅es' au sens de la section 18 de l'Exchange Act et ne sont pas incorpor茅es par r茅f茅rence dans d'autres d茅p么ts, sauf indication expresse contraire. Le rapport est sign茅 au nom de Stoke par le directeur financier Thomas E. Leggett.
Stoke Therapeutics und Biogen gaben eine gemeinsame Pressemitteilung heraus, in der bekanntgegeben wird, dass der erste Patient in der globalen Phase-3-Studie EMPEROR mit zorevunersen zur Behandlung des Dravet-Syndroms dosiert wurde. Das Unternehmen hat diese Pressemitteilung als Anlage 99.1 zu diesem Formular 8-K beigef眉gt und auch die interaktive XBRL-Datei der Titelseite eingereicht.
Die Einreichung stellt fest, dass die bereitgestellten Informationen, einschlie脽lich Anlage 99.1, nicht als 'eingereicht' im Sinne von Section 18 des Exchange Act gelten und nicht durch Verweis in andere Einreichungen aufgenommen werden, es sei denn, dies wird ausdr眉cklich angegeben. Der Bericht wurde im Namen von Stoke vom Finanzchef Thomas E. Leggett unterzeichnet.
FAQ
What did Stoke Therapeutics (STOK) report in this 8-K?
Which clinical study was started for zorevunersen?
Who partnered with Stoke on the announcement?
Is the press release considered formally filed with the SEC?
Who signed the Form 8-K for Stoke Therapeutics?
