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Bezuclastinib Trials Progress as Cogent Biosciences Inc. Strengthens Cash Position
• SUMMIT Part 2 registration-directed study of bezuclastinib in NonAdvSM patients initiated and actively enrolling at 40 sites globally; once-daily 100 mg selected as RP2D; topline results expected by YE 2025• PEAK Phase 3 study of bezuclastinib + sunitinib in 2nd-line GIST patients on track to complete enrollment by end of 2024; topline results expected by YE 2025• APEX Part 2 registration-directed study of bezuclastinib in AdvSM patients on track to complete enrollment by end of 2024; topline
Registration-enabling SUMMIT Part 2 initiated and actively enrolling at 40 sites globally; RP2D selected at 100 mg once-daily optimized formulation based on: 51% week 12 mean change in Total Symptom Score (TSS), including 70% of patients achieving ≥50% reduction in TSS at week 12 49% week 12 mean improvement in quality-of-life (McQoL)Safety and tolerability profile generally similar to placebo with no grade 3/4 events; no bleeding, edema or cognitive events; no dose reductions and no discontinua
Pro-forma cash, cash equivalents and marketable securities expected to fund the Company into 2027 and through clinical readouts from ongoing SUMMIT, PEAK and APEX registration-directed trials Cogent to host investor webcast at 8:00 a.m. ET on February 23 to review the SUMMIT Part 1b data with bezuclastinib at AAAAI annual meeting WALTHAM, Mass. and BOULDER, Colo., Feb. 14, 2024 (GLOBE NEWSWIRE) -- Cogent Biosciences, Inc. (Nasdaq: COGT), a biotechnology company focused on developing precision th
Company to Host Virtual Investor Webcast on Friday, February 23 at 8:00 a.m. ETWALTHAM, Mass. and BOULDER, Colo., Feb. 05, 2024 (GLOBE NEWSWIRE) -- Cogent Biosciences, Inc. (Nasdaq: COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases, today announced its upcoming posters for bezuclastinib at the 2024 American Academy of Allergy Asthma & Immunology Annual Meeting (AAAAI) being held in Washington, D.C. from February 23-26, 2024. The company wil
Plan to initiate global, registration-directed SUMMIT Part 2 study of bezuclastinib in NonAdvSM patients during 1H 2024; present results from complete SUMMIT Part 1 at 2024 AAAAI annual conference in Q1 2024On track to complete enrollment in global, pivotal Phase 3 PEAK study of bezuclastinib + sunitinib in 2nd-line GIST patients by end of 2024On track to complete enrollment in registration-directed Phase 2 APEX study of bezuclastinib in AdvSM patients by end of 2024Plan to initiate Phase 1 tria
WALTHAM, Mass. and BOULDER, Colo., Jan. 02, 2024 (GLOBE NEWSWIRE) -- Cogent Biosciences, Inc. (Nasdaq: COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases, today announced that Andrew Robbins, President and Chief Executive Officer, will present at the 42nd Annual J.P. Morgan Healthcare Conference in San Francisco on Tuesday, January 9, 2024 at 4:30 p.m. PT/7:30 p.m. ET. A live webcast will be available on the Investors & Media page of Cogent’
56% ORR in TKI-naïve patients, including 86% ORR by PPR criteria and 100% ORR in APEX patients treated at 100 mg BID with exposures consistent with go-forward dose Nearly all patients achieved at least 50% improvement in key biomarkers of disease burden: serum tryptase reduction (94%), KIT D816V VAF reduction (93%), and bone marrow mast cell burden (97%) Encouraging safety and tolerability profile with no related cognitive impairment or bleeding events reported Cogent to host investor webcast to
Rapid and ongoing improvement in patient symptoms, with 57% median best improvement on MC-QoL and 78% of patients reporting ≥1 point improvement on PGIS by week 20 100% of bezuclastinib treated patients achieved at least 50% improvement across all relevant biomarker measures, including serum tryptase, KIT D816V VAF, and mast cell burden; Placebo patients, after cross-over to bezuclastinib, also demonstrated rapid symptomatic improvement, with 75% median best improvement on MC-QoL, and 67% of pat
Novel EGFR-sparing, brain-penetrant ErbB2 inhibitor demonstrates superior efficacy profile reaching 80% brain penetrance with potent coverage of key mutations inadequately addressed by currently approved therapies Novel, H1047R mutant-selective PI3Kα inhibitor, disclosed as third Cogent discovery stage program, demonstrates high clinical target engagement without metabolic dysfunction commonly associated with molecules in the class WALTHAM, Mass. and BOULDER, Colo., Dec. 07, 2023 (GLOBE NEWSWIRE