Welcome to our dedicated page for Cogent Biosciences SEC filings (Ticker: COGT), a comprehensive resource for investors and traders seeking official regulatory documents including 10-K annual reports, 10-Q quarterly earnings, 8-K material events, and insider trading forms.
Tracking a clinical-stage biotech can feel like decoding lab notes. Cogent Biosciences files dense 10-Ks packed with bezuclastinib trial data, surprise 8-Ks announcing secondary offerings, and Form 4s that hint at insider conviction. Missing a single update could mean overlooking a pivotal KIT D816V milestone.
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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 �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 0.0142�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.
The Form 4 filing reports that Chemours Company (CC) director Courtney Mather was awarded 2,292 deferred stock units (DSUs) on 30 June 2025. Each DSU equals one share of common stock and will be settled in the first month after the director leaves the board. The award is recorded at a reference price of $11.45 per unit. After the grant, Mather directly owns 2,292 derivative securities; no sales or additional purchases of common stock were disclosed. Apart from this routine director compensation grant, the filing contains no other material transactions or changes in ownership.
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