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[8-K] Cogent Biosciences, Inc. Reports Material Event

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(Neutral)
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Form Type
8-K
Rhea-AI Filing Summary

Cogent Biosciences (NASDAQ: COGT) filed an 8-K announcing positive top-line results from Part 2 of its registration-directed SUMMIT Phase 2/3 trial evaluating bezuclastinib in non-advanced systemic mastocytosis (NonAdvSM).

Efficacy: The study met its primary endpoint—mean change in Total Symptom Score (TSS) at 24 weeks—with a placebo-adjusted improvement of 8.91 points (24.3-point reduction bezuclastinib vs. 15.4-point reduction placebo, p = 0.0002). All key secondary endpoints were highly significant, including â‰�50 % reduction in serum tryptase (87.4 % vs. 0 %; p < 0.0001), KIT D816V variant allele frequency, bone-marrow mast-cell aggregates, and additional TSS thresholds (p-values 0.0142â€�0.0001).

Safety: The majority of treatment-emergent adverse events (TEAEs) were low grade (98.3 % bezuclastinib; 88.3 % placebo). The most common TEAEs in the active arm were hair-color change (69.5 %), altered taste (23.7 %), nausea (22 %), and ALT/AST elevations (22 %; >Grade 3, 5.9 %). Serious adverse events occurred in 4.2 % of bezuclastinib patients vs. 5.0 % placebo. Discontinuations due to ALT/AST elevations were 5.9 %; all cases resolved.

Regulatory path: Based on these data, the company plans to submit its first NDA for bezuclastinib in NonAdvSM to the U.S. FDA by year-end 2025. A detailed dataset will be presented at a medical meeting later in 2025.

Pipeline read-outs: Cogent reiterated that top-line results from the PEAK Phase 3 trial (bezuclastinib + sunitinib in GIST) and the APEX registration-directed trial in advanced systemic mastocytosis remain on track for the second half of 2025.

The filing contains customary forward-looking-statement disclaimers and does not include financial figures.

Cogent Biosciences (NASDAQ: COGT) ha presentato un modulo 8-K annunciando risultati positivi preliminari dalla Parte 2 del suo studio registrativo SUMMIT Fase 2/3 che valuta bezuclastinib nella mastocitosi sistemica non avanzata (NonAdvSM).

Efficacia: Lo studio ha raggiunto il suo end-point primario—variazione media del Total Symptom Score (TSS) a 24 settimane—con un miglioramento aggiustato rispetto al placebo di 8,91 punti (riduzione di 24,3 punti con bezuclastinib contro 15,4 punti con placebo, p = 0,0002). Tutti i principali end-point secondari sono risultati altamente significativi, inclusa una riduzione â‰�50% della tripsina sierica (87,4% vs. 0%; p < 0,0001), frequenza dell'allele variante KIT D816V, aggregati di mastociti nel midollo osseo e soglie aggiuntive del TSS (valori p da 0,0142 a 0,0001).

Sicurezza: La maggior parte degli eventi avversi emergenti dal trattamento (TEAE) erano di grado lieve (98,3% bezuclastinib; 88,3% placebo). Gli eventi avversi più comuni nel braccio attivo erano cambiamento del colore dei capelli (69,5%), alterazione del gusto (23,7%), nausea (22%) e aumento degli enzimi ALT/AST (22%; >Grado 3, 5,9%). Eventi avversi gravi si sono verificati nel 4,2% dei pazienti trattati con bezuclastinib contro il 5,0% con placebo. Le interruzioni del trattamento dovute all’aumento di ALT/AST sono state il 5,9%; tutti i casi si sono risolti.

Percorso regolatorio: Sulla base di questi dati, l’azienda prevede di presentare la sua prima NDA per bezuclastinib nel NonAdvSM alla FDA statunitense entro la fine del 2025. Un dataset dettagliato sarà presentato in un convegno medico nel corso del 2025.

Risultati pipeline: Cogent ha ribadito che i risultati preliminari dello studio PEAK Fase 3 (bezuclastinib + sunitinib nel GIST) e dello studio APEX registrativo nella mastocitosi sistemica avanzata sono confermati per la seconda metà del 2025.

Il documento include le consuete dichiarazioni di non responsabilità riguardo alle previsioni future e non contiene dati finanziari.

Cogent Biosciences (NASDAQ: COGT) presentó un formulario 8-K anunciando resultados positivos preliminares de la Parte 2 de su ensayo registratorio SUMMIT Fase 2/3 que evalúa bezuclastinib en mastocitosis sistémica no avanzada (NonAdvSM).

Eficacia: El estudio cumplió su objetivo primario—cambio medio en la Puntuación Total de Síntomas (TSS) a las 24 semanas—con una mejoría ajustada por placebo de 8.91 puntos (reducción de 24.3 puntos con bezuclastinib frente a 15.4 puntos con placebo, p = 0.0002). Todos los objetivos secundarios clave fueron altamente significativos, incluyendo una reducción â‰�50% en tripsina sérica (87.4% vs. 0%; p < 0.0001), frecuencia del alelo variante KIT D816V, agregados de mastocitos en médula ósea y umbrales adicionales de TSS (valores p entre 0.0142 y 0.0001).

Seguridad: La mayoría de los eventos adversos emergentes del tratamiento (TEAEs) fueron de grado bajo (98.3% bezuclastinib; 88.3% placebo). Los TEAEs más comunes en el brazo activo fueron cambio de color del cabello (69.5%), alteración del gusto (23.7%), náuseas (22%) y elevaciones de ALT/AST (22%; >Grado 3, 5.9%). Eventos adversos graves ocurrieron en el 4.2% de los pacientes con bezuclastinib frente al 5.0% con placebo. Las discontinuaciones por elevación de ALT/AST fueron del 5.9%; todos los casos se resolvieron.

Camino regulatorio: Basándose en estos datos, la compañía planea presentar su primera NDA para bezuclastinib en NonAdvSM ante la FDA de EE.UU. antes de finales de 2025. Un conjunto de datos detallado será presentado en una reunión médica durante 2025.

Resultados de la pipeline: Cogent reiteró que los resultados preliminares del ensayo PEAK Fase 3 (bezuclastinib + sunitinib en GIST) y del ensayo APEX registratorio en mastocitosis sistémica avanzada siguen previstos para la segunda mitad de 2025.

El documento incluye las habituales declaraciones de exención de responsabilidad sobre proyecciones futuras y no contiene cifras financieras.

Cogent Biosciences (NASDAQ: COGT)ëŠ� 비진행성 ì „ì‹  비만세í¬ì¦�(NonAdvSM)ì—서 bezuclastinibë¥� í‰ê°€í•˜ëŠ” ë“±ë¡ ì§€í–� SUMMIT 2/3ìƒ� 시험 2ë¶¶Äì� ê¸ì •ì ì¸ 주요 ê²°ê³¼ë¥� 발표하는 8-Kë¥� 제출했습니다.

Ðë¨ëŠ¥: 연구ëŠ� 24주차 ì´� ì¦ìƒ ì ìˆ˜(TSS)ì� í‰ê·  변화ë¼ëŠ� 주요 í‰ê°€ ë³€ìˆ�ë¥� 충족했으ë©�, 위약 대ë¹� ì¡°ì •ë� 개선 í­ì€ 8.91ì �ì´ì—ˆìŠµë‹ˆë‹�(베주í´ë¼ìŠ¤í‹°ë‹� 24.3ì � ê°ì†Œ vs. 위약 15.4ì � ê°ì†Œ, p = 0.0002). 주요 2ì°� í‰ê°€ ë³€ìˆ�ë� ëª¨ë‘ ë§¤ìš° 유ì˜ë¯¸í–ˆìœ¼ë©°, 혈청 트립타ì � 50% ì´ìƒ ê°ì†Œ(87.4% vs. 0%; p < 0.0001), KIT D816V ë³€ì� 대ë¦� 유전ìž� 빈ë„, 골수 ë¹„ë§Œì„¸í¬ ì§‘í•©ì²�, 추가 TSS 기준ì¹�(pê°� 0.0142~0.0001)ê°€ í¬í•¨ë©ë‹ˆë‹�.

안전ì„�: 치료 ì¤� ë°œìƒí•� ì´ìƒë°˜ì‘(TEAE)ì� ëŒ€ë¶€ë¶„ì€ ê²½ì¦ì´ì—ˆìœ¼ë©°(베주í´ë¼ìŠ¤í‹°ë‹� 98.3%, 위약 88.3%), 활성군ì—ì„� ê°€ìž� í”한 TEAEëŠ� 모발 ìƒ� ë³€í™�(69.5%), ë¯¸ê° ë³€í™�(23.7%), 구역(22%), ALT/AST ìƒìй(22%; 3등급 초과, 5.9%)ì´ì—ˆìŠµë‹ˆë‹�. 심ê°í•� ì´ìƒë°˜ì‘ì€ ë² ì£¼í´ë¼ìŠ¤í‹°ë‹� í™˜ìž 4.2%ì—서, 위약êµ� 5.0%ì—서 ë°œìƒí–ˆìŠµë‹ˆë‹¤. ALT/AST ìƒìŠ¹ìœ¼ë¡œ ì¸í•œ ì¤‘ë‹¨ì€ 5.9%였으며 모든 경우가 í•´ê²°ë˜ì—ˆìŠµë‹ˆë‹�.

규제 경로: ì� ë°ì´í„°ë¥¼ 바탕으로 회사ëŠ� 2025ë…� ë§ê¹Œì§€ 미국 FDAì—� NonAdvSMì—� 대í•� bezuclastinibì� ì²� NDA 제출ì� 계íší•˜ê³  있습니다. ìžì„¸í•� ë°ì´í„� 세트ëŠ� 2025ë…� 후반 ì˜ë£Œ 회ì˜ì—서 발표ë� 예정입니ë‹�.

파ì´í”„ë¼ì� ê²°ê³¼: CogentëŠ� GISTì—서 bezuclastinib + 수니티닙ì� í‰ê°€í•˜ëŠ” PEAK 3ìƒ� 시험ê³� ì§„í–‰ì„� ì „ì‹  비만세í¬ì¦ì—ì„œì˜ APEX ë“±ë¡ ì§€í–� 시험ì� 주요 결과가 2025ë…� 하반ê¸�ì—� 예정대ë¡� 발표ë� 것임ì� 재확ì¸í–ˆìŠµë‹ˆë‹�.

제출 문서ì—는 ì¼ë°˜ì ì¸ 미래 예측 ê´€ë � ë©´ì±… ì¡°í•­ì� í¬í•¨ë˜ì–´ 있으ë©� 재무 수치ëŠ� í¬í•¨ë˜ì–´ 있지 않습니다.

Cogent Biosciences (NASDAQ : COGT) a déposé un formulaire 8-K annonçant des résultats positifs préliminaires de la partie 2 de son essai d’enregistrement SUMMIT Phase 2/3 évaluant le bezuclastinib dans la mastocytose systémique non avancée (NonAdvSM).

Efficacité : L’étude a atteint son critère principal—le changement moyen du Total Symptom Score (TSS) à 24 semaines—avec une amélioration ajustée par rapport au placebo de 8,91 points (réduction de 24,3 points avec bezuclastinib contre 15,4 points avec placebo, p = 0,0002). Tous les critères secondaires clés étaient très significatifs, incluant une réduction â‰�50 % de la tryptase sérique (87,4 % vs. 0 % ; p < 0,0001), la fréquence allélique de la variante KIT D816V, les agrégats de mastocytes dans la moelle osseuse, et d’autres seuils de TSS (valeurs p de 0,0142 à 0,0001).

Sécurité : La majorité des événements indésirables survenant durant le traitement (TEAEs) étaient de faible grade (98,3 % bezuclastinib ; 88,3 % placebo). Les TEAEs les plus fréquents dans le groupe actif étaient le changement de couleur des cheveux (69,5 %), l’altération du goût (23,7 %), les nausées (22 %) et les élévations des transaminases ALT/AST (22 % ; >Grade 3, 5,9 %). Les événements indésirables graves sont survenus chez 4,2 % des patients sous bezuclastinib contre 5,0 % sous placebo. Les arrêts de traitement dus aux élévations d’ALT/AST étaient de 5,9 % ; tous les cas se sont résolus.

Voie réglementaire : Sur la base de ces données, la société prévoyait de soumettre sa première NDA pour le bezuclastinib dans le NonAdvSM à la FDA américaine d’ici la fin de l’année 2025. Un ensemble de données détaillé sera présenté lors d’une réunion médicale plus tard en 2025.

Résultats de la pipeline : Cogent a réitéré que les résultats préliminaires de l’essai PEAK Phase 3 (bezuclastinib + sunitinib dans le GIST) et de l’essai APEX d’enregistrement dans la mastocytose systémique avancée restent prévus pour la deuxième moitié de 2025.

Le dépôt contient les clauses habituelles de non-responsabilité relatives aux déclarations prospectives et ne comprend pas de chiffres financiers.

Cogent Biosciences (NASDAQ: COGT) hat eine 8-K-Meldung eingereicht, in der positive vorläufige Ergebnisse aus Teil 2 der registrierungsgerichteten SUMMIT Phase 2/3-Studie zur Bewertung von Bezuclastinib bei nicht-weiter fortgeschrittener systemischer Mastozytose (NonAdvSM) bekannt gegeben wurden.

Wirksamkeit: Die Studie erreichte ihren primären Endpunkt â€� die mittlere Veränderung des Total Symptom Score (TSS) nach 24 Wochen â€� mit einer placebo-adjustierten Verbesserung von 8,91 Punkten (24,3 Punkte Reduktion mit Bezuclastinib vs. 15,4 Punkte Reduktion mit Placebo, p = 0,0002). Alle wichtigen sekundären Endpunkte waren hochsignifikant, einschließlich einer â‰�50 % Reduktion des Serum-Tryptase-Spiegels (87,4 % vs. 0 %; p < 0,0001), der KIT D816V Variantenallelfrequenz, der Knochenmark-Mastzellaggregate und weiterer TSS-Schwellenwerte (p-Werte 0,0142â€�0,0001).

Sicherheit: Die Mehrheit der behandlungsbedingten unerwünschten Ereignisse (TEAEs) war geringgradig (98,3 % Bezuclastinib; 88,3 % Placebo). Die häufigsten TEAEs in der aktiven Behandlungsgruppe waren Haarfarbenveränderungen (69,5 %), veränderter Geschmack (23,7 %), Übelkeit (22 %) und ALT/AST-Erhöhungen (22 %; >Grad 3, 5,9 %). Schwere Nebenwirkungen traten bei 4,2 % der Behandlungsgruppe vs. 5,0 % der Placebogruppe auf. Abbrüche aufgrund von ALT/AST-Erhöhungen betrugen 5,9 %; alle Fälle wurden behoben.

Regulatorischer Weg: Basierend auf diesen Daten plant das Unternehmen, bis Ende 2025 den ersten NDA-Antrag für Bezuclastinib bei NonAdvSM bei der US-amerikanischen FDA einzureichen. Ein detaillierter Datensatz wird auf einer medizinischen Tagung im Laufe des Jahres 2025 vorgestellt.

Pipeline-Ergebnisse: Cogent bekräftigte, dass die vorläufigen Ergebnisse der PEAK Phase 3-Studie (Bezuclastinib + Sunitinib bei GIST) und der APEX registrierungsgerichteten Studie bei fortgeschrittener systemischer Mastozytose für die zweite Hälfte 2025 planmäßig erwartet werden.

Die Einreichung enthält die üblichen Haftungsausschlüsse zu zukunftsgerichteten Aussagen und enthält keine finanziellen Zahlen.

Positive
  • Primary endpoint met with highly significant p = 0.0002 and clinically meaningful 8.91-point placebo-adjusted TSS improvement.
  • All key secondary endpoints reached statistical significance, including 87.4 % vs. 0 % â‰�50 % serum-tryptase reduction.
  • NDA filing targeted for YE 2025, indicating regulatory confidence and potential near-term commercialization.
  • Manageable safety profile: mostly low-grade TEAEs; serious AEs lower than placebo (4.2 % vs. 5.0 %).
  • Additional catalysts (PEAK and APEX top-line data) scheduled for 2H 2025, providing pipeline momentum.
Negative
  • ALT/AST elevations led to 5.9 % treatment discontinuations, highlighting a liver-safety signal requiring monitoring.
  • No financial metrics disclosed, limiting immediate assessment of funding runway for NDA filing and commercialization.

Insights

TL;DR: Statistically strong SUMMIT data de-risks bezuclastinib and positions COGT for NDA filing by YE-25; safety manageable.

The p = 0.0002 result on TSS and clean sweeps on all secondary endpoints provide a compelling efficacy package for a rare-disease NDA. The 87.4 % tryptase reduction demonstrates biologic activity well beyond placebo. ALT/AST elevations are monitorable, and serious AEs were lower than placebo, supporting chronic use claims. With PEAK and APEX catalysts also due in 2H 25, Cogent gains multiple shots on goal. Absence of financial details limits immediate valuation work, but clinical risk is clearly reduced, supporting a positive bias.

TL;DR: Efficacy robust; liver-enzyme signals bear watching but do not outweigh benefit.

The high percentage of low-grade TEAEs and comparable serious-AE rates vs. placebo mitigate safety concerns. However, 5.9 % discontinuations from ALT/AST elevations warrant hepatic monitoring language in the eventual label. Endpoint multiplicity appears controlled with strong p-values, reducing statistical risk. Overall, data support regulatory submission timelines.

Cogent Biosciences (NASDAQ: COGT) ha presentato un modulo 8-K annunciando risultati positivi preliminari dalla Parte 2 del suo studio registrativo SUMMIT Fase 2/3 che valuta bezuclastinib nella mastocitosi sistemica non avanzata (NonAdvSM).

Efficacia: Lo studio ha raggiunto il suo end-point primario—variazione media del Total Symptom Score (TSS) a 24 settimane—con un miglioramento aggiustato rispetto al placebo di 8,91 punti (riduzione di 24,3 punti con bezuclastinib contro 15,4 punti con placebo, p = 0,0002). Tutti i principali end-point secondari sono risultati altamente significativi, inclusa una riduzione â‰�50% della tripsina sierica (87,4% vs. 0%; p < 0,0001), frequenza dell'allele variante KIT D816V, aggregati di mastociti nel midollo osseo e soglie aggiuntive del TSS (valori p da 0,0142 a 0,0001).

Sicurezza: La maggior parte degli eventi avversi emergenti dal trattamento (TEAE) erano di grado lieve (98,3% bezuclastinib; 88,3% placebo). Gli eventi avversi più comuni nel braccio attivo erano cambiamento del colore dei capelli (69,5%), alterazione del gusto (23,7%), nausea (22%) e aumento degli enzimi ALT/AST (22%; >Grado 3, 5,9%). Eventi avversi gravi si sono verificati nel 4,2% dei pazienti trattati con bezuclastinib contro il 5,0% con placebo. Le interruzioni del trattamento dovute all’aumento di ALT/AST sono state il 5,9%; tutti i casi si sono risolti.

Percorso regolatorio: Sulla base di questi dati, l’azienda prevede di presentare la sua prima NDA per bezuclastinib nel NonAdvSM alla FDA statunitense entro la fine del 2025. Un dataset dettagliato sarà presentato in un convegno medico nel corso del 2025.

Risultati pipeline: Cogent ha ribadito che i risultati preliminari dello studio PEAK Fase 3 (bezuclastinib + sunitinib nel GIST) e dello studio APEX registrativo nella mastocitosi sistemica avanzata sono confermati per la seconda metà del 2025.

Il documento include le consuete dichiarazioni di non responsabilità riguardo alle previsioni future e non contiene dati finanziari.

Cogent Biosciences (NASDAQ: COGT) presentó un formulario 8-K anunciando resultados positivos preliminares de la Parte 2 de su ensayo registratorio SUMMIT Fase 2/3 que evalúa bezuclastinib en mastocitosis sistémica no avanzada (NonAdvSM).

Eficacia: El estudio cumplió su objetivo primario—cambio medio en la Puntuación Total de Síntomas (TSS) a las 24 semanas—con una mejoría ajustada por placebo de 8.91 puntos (reducción de 24.3 puntos con bezuclastinib frente a 15.4 puntos con placebo, p = 0.0002). Todos los objetivos secundarios clave fueron altamente significativos, incluyendo una reducción â‰�50% en tripsina sérica (87.4% vs. 0%; p < 0.0001), frecuencia del alelo variante KIT D816V, agregados de mastocitos en médula ósea y umbrales adicionales de TSS (valores p entre 0.0142 y 0.0001).

Seguridad: La mayoría de los eventos adversos emergentes del tratamiento (TEAEs) fueron de grado bajo (98.3% bezuclastinib; 88.3% placebo). Los TEAEs más comunes en el brazo activo fueron cambio de color del cabello (69.5%), alteración del gusto (23.7%), náuseas (22%) y elevaciones de ALT/AST (22%; >Grado 3, 5.9%). Eventos adversos graves ocurrieron en el 4.2% de los pacientes con bezuclastinib frente al 5.0% con placebo. Las discontinuaciones por elevación de ALT/AST fueron del 5.9%; todos los casos se resolvieron.

Camino regulatorio: Basándose en estos datos, la compañía planea presentar su primera NDA para bezuclastinib en NonAdvSM ante la FDA de EE.UU. antes de finales de 2025. Un conjunto de datos detallado será presentado en una reunión médica durante 2025.

Resultados de la pipeline: Cogent reiteró que los resultados preliminares del ensayo PEAK Fase 3 (bezuclastinib + sunitinib en GIST) y del ensayo APEX registratorio en mastocitosis sistémica avanzada siguen previstos para la segunda mitad de 2025.

El documento incluye las habituales declaraciones de exención de responsabilidad sobre proyecciones futuras y no contiene cifras financieras.

Cogent Biosciences (NASDAQ: COGT)ëŠ� 비진행성 ì „ì‹  비만세í¬ì¦�(NonAdvSM)ì—서 bezuclastinibë¥� í‰ê°€í•˜ëŠ” ë“±ë¡ ì§€í–� SUMMIT 2/3ìƒ� 시험 2ë¶¶Äì� ê¸ì •ì ì¸ 주요 ê²°ê³¼ë¥� 발표하는 8-Kë¥� 제출했습니다.

Ðë¨ëŠ¥: 연구ëŠ� 24주차 ì´� ì¦ìƒ ì ìˆ˜(TSS)ì� í‰ê·  변화ë¼ëŠ� 주요 í‰ê°€ ë³€ìˆ�ë¥� 충족했으ë©�, 위약 대ë¹� ì¡°ì •ë� 개선 í­ì€ 8.91ì �ì´ì—ˆìŠµë‹ˆë‹�(베주í´ë¼ìŠ¤í‹°ë‹� 24.3ì � ê°ì†Œ vs. 위약 15.4ì � ê°ì†Œ, p = 0.0002). 주요 2ì°� í‰ê°€ ë³€ìˆ�ë� ëª¨ë‘ ë§¤ìš° 유ì˜ë¯¸í–ˆìœ¼ë©°, 혈청 트립타ì � 50% ì´ìƒ ê°ì†Œ(87.4% vs. 0%; p < 0.0001), KIT D816V ë³€ì� 대ë¦� 유전ìž� 빈ë„, 골수 ë¹„ë§Œì„¸í¬ ì§‘í•©ì²�, 추가 TSS 기준ì¹�(pê°� 0.0142~0.0001)ê°€ í¬í•¨ë©ë‹ˆë‹�.

안전ì„�: 치료 ì¤� ë°œìƒí•� ì´ìƒë°˜ì‘(TEAE)ì� ëŒ€ë¶€ë¶„ì€ ê²½ì¦ì´ì—ˆìœ¼ë©°(베주í´ë¼ìŠ¤í‹°ë‹� 98.3%, 위약 88.3%), 활성군ì—ì„� ê°€ìž� í”한 TEAEëŠ� 모발 ìƒ� ë³€í™�(69.5%), ë¯¸ê° ë³€í™�(23.7%), 구역(22%), ALT/AST ìƒìй(22%; 3등급 초과, 5.9%)ì´ì—ˆìŠµë‹ˆë‹�. 심ê°í•� ì´ìƒë°˜ì‘ì€ ë² ì£¼í´ë¼ìŠ¤í‹°ë‹� í™˜ìž 4.2%ì—서, 위약êµ� 5.0%ì—서 ë°œìƒí–ˆìŠµë‹ˆë‹¤. ALT/AST ìƒìŠ¹ìœ¼ë¡œ ì¸í•œ ì¤‘ë‹¨ì€ 5.9%였으며 모든 경우가 í•´ê²°ë˜ì—ˆìŠµë‹ˆë‹�.

규제 경로: ì� ë°ì´í„°ë¥¼ 바탕으로 회사ëŠ� 2025ë…� ë§ê¹Œì§€ 미국 FDAì—� NonAdvSMì—� 대í•� bezuclastinibì� ì²� NDA 제출ì� 계íší•˜ê³  있습니다. ìžì„¸í•� ë°ì´í„� 세트ëŠ� 2025ë…� 후반 ì˜ë£Œ 회ì˜ì—서 발표ë� 예정입니ë‹�.

파ì´í”„ë¼ì� ê²°ê³¼: CogentëŠ� GISTì—서 bezuclastinib + 수니티닙ì� í‰ê°€í•˜ëŠ” PEAK 3ìƒ� 시험ê³� ì§„í–‰ì„� ì „ì‹  비만세í¬ì¦ì—ì„œì˜ APEX ë“±ë¡ ì§€í–� 시험ì� 주요 결과가 2025ë…� 하반ê¸�ì—� 예정대ë¡� 발표ë� 것임ì� 재확ì¸í–ˆìŠµë‹ˆë‹�.

제출 문서ì—는 ì¼ë°˜ì ì¸ 미래 예측 ê´€ë � ë©´ì±… ì¡°í•­ì� í¬í•¨ë˜ì–´ 있으ë©� 재무 수치ëŠ� í¬í•¨ë˜ì–´ 있지 않습니다.

Cogent Biosciences (NASDAQ : COGT) a déposé un formulaire 8-K annonçant des résultats positifs préliminaires de la partie 2 de son essai d’enregistrement SUMMIT Phase 2/3 évaluant le bezuclastinib dans la mastocytose systémique non avancée (NonAdvSM).

Efficacité : L’étude a atteint son critère principal—le changement moyen du Total Symptom Score (TSS) à 24 semaines—avec une amélioration ajustée par rapport au placebo de 8,91 points (réduction de 24,3 points avec bezuclastinib contre 15,4 points avec placebo, p = 0,0002). Tous les critères secondaires clés étaient très significatifs, incluant une réduction â‰�50 % de la tryptase sérique (87,4 % vs. 0 % ; p < 0,0001), la fréquence allélique de la variante KIT D816V, les agrégats de mastocytes dans la moelle osseuse, et d’autres seuils de TSS (valeurs p de 0,0142 à 0,0001).

Sécurité : La majorité des événements indésirables survenant durant le traitement (TEAEs) étaient de faible grade (98,3 % bezuclastinib ; 88,3 % placebo). Les TEAEs les plus fréquents dans le groupe actif étaient le changement de couleur des cheveux (69,5 %), l’altération du goût (23,7 %), les nausées (22 %) et les élévations des transaminases ALT/AST (22 % ; >Grade 3, 5,9 %). Les événements indésirables graves sont survenus chez 4,2 % des patients sous bezuclastinib contre 5,0 % sous placebo. Les arrêts de traitement dus aux élévations d’ALT/AST étaient de 5,9 % ; tous les cas se sont résolus.

Voie réglementaire : Sur la base de ces données, la société prévoyait de soumettre sa première NDA pour le bezuclastinib dans le NonAdvSM à la FDA américaine d’ici la fin de l’année 2025. Un ensemble de données détaillé sera présenté lors d’une réunion médicale plus tard en 2025.

Résultats de la pipeline : Cogent a réitéré que les résultats préliminaires de l’essai PEAK Phase 3 (bezuclastinib + sunitinib dans le GIST) et de l’essai APEX d’enregistrement dans la mastocytose systémique avancée restent prévus pour la deuxième moitié de 2025.

Le dépôt contient les clauses habituelles de non-responsabilité relatives aux déclarations prospectives et ne comprend pas de chiffres financiers.

Cogent Biosciences (NASDAQ: COGT) hat eine 8-K-Meldung eingereicht, in der positive vorläufige Ergebnisse aus Teil 2 der registrierungsgerichteten SUMMIT Phase 2/3-Studie zur Bewertung von Bezuclastinib bei nicht-weiter fortgeschrittener systemischer Mastozytose (NonAdvSM) bekannt gegeben wurden.

Wirksamkeit: Die Studie erreichte ihren primären Endpunkt â€� die mittlere Veränderung des Total Symptom Score (TSS) nach 24 Wochen â€� mit einer placebo-adjustierten Verbesserung von 8,91 Punkten (24,3 Punkte Reduktion mit Bezuclastinib vs. 15,4 Punkte Reduktion mit Placebo, p = 0,0002). Alle wichtigen sekundären Endpunkte waren hochsignifikant, einschließlich einer â‰�50 % Reduktion des Serum-Tryptase-Spiegels (87,4 % vs. 0 %; p < 0,0001), der KIT D816V Variantenallelfrequenz, der Knochenmark-Mastzellaggregate und weiterer TSS-Schwellenwerte (p-Werte 0,0142â€�0,0001).

Sicherheit: Die Mehrheit der behandlungsbedingten unerwünschten Ereignisse (TEAEs) war geringgradig (98,3 % Bezuclastinib; 88,3 % Placebo). Die häufigsten TEAEs in der aktiven Behandlungsgruppe waren Haarfarbenveränderungen (69,5 %), veränderter Geschmack (23,7 %), Übelkeit (22 %) und ALT/AST-Erhöhungen (22 %; >Grad 3, 5,9 %). Schwere Nebenwirkungen traten bei 4,2 % der Behandlungsgruppe vs. 5,0 % der Placebogruppe auf. Abbrüche aufgrund von ALT/AST-Erhöhungen betrugen 5,9 %; alle Fälle wurden behoben.

Regulatorischer Weg: Basierend auf diesen Daten plant das Unternehmen, bis Ende 2025 den ersten NDA-Antrag für Bezuclastinib bei NonAdvSM bei der US-amerikanischen FDA einzureichen. Ein detaillierter Datensatz wird auf einer medizinischen Tagung im Laufe des Jahres 2025 vorgestellt.

Pipeline-Ergebnisse: Cogent bekräftigte, dass die vorläufigen Ergebnisse der PEAK Phase 3-Studie (Bezuclastinib + Sunitinib bei GIST) und der APEX registrierungsgerichteten Studie bei fortgeschrittener systemischer Mastozytose für die zweite Hälfte 2025 planmäßig erwartet werden.

Die Einreichung enthält die üblichen Haftungsausschlüsse zu zukunftsgerichteten Aussagen und enthält keine finanziellen Zahlen.

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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

 

FORM 8-K

 

 

CURRENT REPORT

Pursuant to Section 13 or 15(d)

of The Securities Exchange Act of 1934

Date of Report (Date of Earliest Event Reported): July 7, 2025

 

 

COGENT BIOSCIENCES, INC.

(Exact name of registrant as specified in its charter)

 

 

 

Delaware   001-38443   46-5308248

(State or other jurisdiction

of incorporation)

 

(Commission

File Number)

 

(I.R.S. Employer

Identification No.)

 

275 Wyman Street, 3rd Floor

Waltham, Massachusetts

  02451
(Address of principal executive offices)   (Zip Code)

Registrant’s telephone number, including area code: (617) 945-5576

Not Applicable

(Former name or former address, if changed since last report)

 

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

 

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

 

Title of each class

 

Trading
Symbol(s)

 

Name of each exchange

on which registered

Common stock, $0.001 Par Value   COGT   The Nasdaq Global Select Market

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 or Rule 12b-2 of the Securities Exchange Act of 1934.

Emerging growth company  

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.  ☐

 

 
 


Item 8.01

Other Events

On July 7, 2025, Cogent Biosciences, Inc. (the “Company”) announced positive top-line results from the registration-directed Part 2 of the SUMMIT clinical trial of bezuclastinib in patients with non-advanced systemic mastocytosis (“NonAdvSM”) demonstrating clinically meaningful and highly statistically significant improvements across the primary and all key secondary endpoints, including patient-reported symptoms and objective measures of mast cell burden. Based on these data, the Company is on track to submit its first new drug application (“NDA”) to the U.S. Food and Drug Administration (“FDA”) for bezuclastinib in NonAdvSM by the end of 2025. In addition, the Company plans to present detailed results from the SUMMIT trial at an upcoming medical meeting later this year.

The SUMMIT trial, which was designed to assess the clinical benefit of bezuclastinib versus placebo, achieved its primary endpoint with a highly statistically significant difference in the mean change in total symptom score (“TSS”) at 24 weeks (p=0.0002). TSS was assessed by the Mastocytosis Symptom Severity Daily Diary. The bezuclastinib arm had a mean reduction of 24.3 points in TSS at 24 weeks, versus the placebo arm which had a mean reduction of 15.4 points in TSS, resulting in a placebo-adjusted TSS improvement of 8.91 points. In addition, the SUMMIT trial demonstrated highly statistically significant benefit across all key secondary endpoints, including reduction of serum tryptase on which 87.4% of bezuclastinib-treated patients had ≥50% reduction, compared to no patients in the control arm (87.4% vs. 0%; p<0.0001).

All primary and secondary endpoints demonstrated statistically significant comparisons in favor of bezuclastinib over placebo:

 

    

SUMMIT Endpoints

   P-Value
(two-sided)
 
Primary Endpoint    Mean Change TSS at 24 weeks      0.0002  
Secondary Endpoints    > 50% Reduction in Serum Tryptase      <0.0001  
   > 50% Reduction in KIT D816V VAF      <0.0001  
   > 50% Reduction in TSS      0.0142  
   > 50% Reduction in Bone Marrow MC Aggregates      < 0.0001  
   > 30% Reduction in TSS      0.0004  
   Mean Change in Most Severe Symptom at Baseline      0.0001  

The majority of treatment emergent adverse events (“TEAEs”) (98.3% in bezuclastinib arm vs. 88.3% in placebo arm) were of low grade. The most frequent TEAEs reported on bezuclastinib treatment were hair color change (69.5% bezuclastinib vs. 5.0% placebo), altered taste (23.7% bezuclastinib vs. 0% placebo), nausea (22.0% bezuclastinib vs. 13.3% placebo) and alanine transaminase (“ALT”)/aspartate transaminase (“AST”) elevations (22.0% bezuclastinib vs. 6.6% placebo; >Gr 3, 5.9% vs. 0%). Serious adverse events occurred in 4.2% of patients treated with bezuclastinib, compared to 5.0% of patients treated with placebo. Discontinuations due to treatment-related adverse events occurred in 5.9% of patients treated with bezuclastinib, all due to ALT/AST elevations and all patients fully resolved. There were no hepatic adverse events reported in any patient other than transient and manageable lab abnormalities.

Complete analysis of the full SUMMIT Part 2 data are ongoing, and the Company plans to present detailed results at an upcoming major medical conference later this year.

 


The Company remains on track to provide top-line results from both PEAK, a Phase 3 trial of bezuclastinib in combination with sunitinib in patients with gastrointestinal stromal tumors, and APEX, a registration-directed trial of bezuclastinib in advanced systemic mastocytosis patients, during the second half of 2025.

Forward Looking Statements

This Current Report on Form 8-K contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding: the Company’s expectation to submit an NDA to the FDA for bezuclastinib in patients with NonAdvSM by the end of 2025; plans to present top-line results from the PEAK and APEX trials in the second half of 2025; plans to present a detailed data set from the SUMMIT trial at an upcoming medical meeting later in 2025; the potential for bezuclastinib to become a new standard of care for patients with NonAdvSM; and the expectation that bezuclastinib’s safety and tolerability profile support chronic dosing. The use of words such as, but not limited to, “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “might,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” or “would” and similar words or expressions are intended to identify forward-looking statements. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based on the Company’s current beliefs, expectations and assumptions regarding the future of the Company’s business, future plans and strategies, the Company’s clinical results, the rate of enrollment in the Company’s clinical trials and other future conditions. New risks and uncertainties may emerge from time to time, and it is not possible to predict all risks and uncertainties. No representations or warranties (expressed or implied) are made about the accuracy of any such forward-looking statements. The Company may not actually achieve the forecasts or milestones disclosed in its forward-looking statements, and you should not place undue reliance on its forward-looking statements. Such forward-looking statements are subject to a number of material risks and uncertainties including but not limited to those set forth under the caption “Risk Factors” in the Company’s most recent Annual Report on Form 10-K, Quarterly Report on Form 10-Q and subsequent filings made with the Securities and Exchange Commission. Any forward-looking statement speaks only as of the date on which it was made. Neither the Company’s, nor its affiliates, advisors or representatives, undertake any obligation to publicly update or revise any forward-looking statement, whether as result of new information, future events or otherwise, except as required by law. These forward-looking statements should not be relied upon as representing the Company’s views as of any date subsequent to the date hereof.

 


SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

Date: July 7, 2025   COGENT BIOSCIENCES, INC.
    By:  

/s/ Evan Kearns

      Evan Kearns
      Chief Legal Officer and Corporate Secretary

FAQ

What primary endpoint did Cogent Biosciences (COGT) meet in the SUMMIT trial?

The trial achieved a highly significant improvement in mean Total Symptom Score at 24 weeks (p = 0.0002).

How effective was bezuclastinib at reducing serum tryptase levels?

87.4 % of patients on bezuclastinib achieved �50 % serum-tryptase reduction versus 0 % on placebo.

When does Cogent plan to submit the NDA for bezuclastinib in NonAdvSM?

The company aims to file the NDA with the FDA by the end of 2025.

What were the most common treatment-emergent adverse events observed?

Hair-color change (69.5 %), altered taste (23.7 %), nausea (22 %), and ALT/AST elevations (22 %) in the bezuclastinib arm.

What upcoming catalysts could affect COGT’s valuation in 2025?

Top-line data from the PEAK Phase 3 GIST study and the APEX advanced mastocytosis trial, both expected in 2H 2025.
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