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| Cogent Biosciences, Inc.: Cogent Biosciences Announces Breakthrough Therapy Designation for Bezuclastinib in Combination with Sunitinib for Patients with Gastrointestinal Stromal Tumors (GIST) | - Cogent will submit the PEAK New Drug Application (NDA) under previously announced RTOR designation; on track to complete NDA submission in April 2026 WALTHAM, Mass. and BOULDER, Colo., Jan. 26... ► Artikel lesen |
| Cogent Biosciences, Inc.: Cogent Biosciences Announces Anticipated 2026 Commercial and Clinical Milestones for Bezuclastinib and Precision Therapies Portfolio | New Drug Application (NDA) for NonAdvSM submitted in December 2025, NDA submission for AdvSM on track for 1H 2026NDA submission for GIST on track for April 2026; bezuclastinib has the potential to... ► Artikel lesen |
| Cogent Biosciences, Inc.: Cogent Biosciences Announces Submission of New Drug Application for Bezuclastinib in NonAdvanced Systemic Mastocytosis | WALTHAM, Mass. and BOULDER, Colo., Dec. 30, 2025 (GLOBE NEWSWIRE) -- Cogent Biosciences, Inc. (Nasdaq: COGT), a biotechnology company focused on developing precision therapies for genetically defined... ► Artikel lesen |
| CG Oncology Inc.: CG Oncology Provides Updated Timeline for PIVOT-006 Phase 3 Topline Data in Intermediate-Risk NMIBC | - PIVOT-006 Phase 3 topline data evaluating cretostimogene monotherapy for intermediate-risk NMIBC now expected in 1H 2026, nearly one year ahead of schedule - First randomized registrational trial... ► Artikel lesen |
| CG Oncology Inc.: CG Oncology Reports Third Quarter 2025 Financial Results and Provides Business Updates | Initiated rolling Biologics License Application (BLA) submission to U.S. FDA for cretostimogene monotherapy in high-risk (HR) BCG-unresponsive non-muscle invasive bladder cancer (NMIBC)Demonstrated... ► Artikel lesen |
| CG Oncology Inc.: CG Oncology Completes Enrollment in PIVOT-006 | - Rapid enrollment underscores high unmet need in intermediate-risk non-muscle invasive bladder cancer (NMIBC) -- One of the largest randomized phase 3 studies in this patient population will encompass... ► Artikel lesen |
| Arcutis Biotherapeutics, Inc.: Arcutis Announces Positive Topline Results for INTEGUMENT-INFANT Phase 2 Trial of ZORYVE (roflumilast) Cream 0.05% in Infants with Mild to Moderate Atopic Dermatitis | 58% of participants achieved a 75% improvement in Eczema Area and Severity Index (EASI-75) with ZORYVE cream 0.05% at Week 4Investigational ZORYVE cream 0.05% was well tolerated and demonstrated a... ► Artikel lesen |
| Arcutis Biotherapeutics, Inc.: FDA Accepts Supplemental New Drug Application for Arcutis' ZORYVE (roflumilast) Cream 0.3% for the Treatment of Plaque Psoriasis in Children Ages 2 to 5 | Prescription Drug User Fee Act (PDUFA) target action date set for June 29, 2026If approved, ZORYVE cream 0.3% would be the first and only topical PDE4 inhibitor indicated for plaque psoriasis in children... ► Artikel lesen |
| Arcutis Biotherapeutics, Inc.: Arcutis Announces Publication of Positive Long-Term Safety and Efficacy Data of ZORYVE (roflumilast) Foam 0.3% in Individuals with Seborrheic Dermatitis in American Journal of Clinical Dermatology | ZORYVE foam 0.3% was safe, well-tolerated, and demonstrated durable and continuously improving efficacy in the treatment of seborrheic dermatitis up to 52 weeksOnce-daily ZORYVE foam 0.3% is approved... ► Artikel lesen |
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