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| Disc Medicine Inc: Disc Medicine Reports Second Quarter 2026 Financial Results and Provides Business Update | Completed Type A meeting with the FDA on bitopertin and aligned that the Phase 3 APOLLO study, if successful, can serve as the basis for CRL response; topline data expected in Q4 2026Launched Expanded... ► Artikel lesen |
| Disc Medicine Inc: Disc Medicine Provides Update from FDA Type A Meeting for Bitopertin in Erythropoietic Protoporphyria | Aligned with the FDA that the Phase 3 APOLLO study, if successful, can serve as the basis for CRL response and could potentially support a traditional approvalOn track for expected CRL response submission... ► Artikel lesen |
| Cogent Biosciences, Inc.: Cogent Biosciences Announces FDA Acceptance of New Drug Application (NDA) for Bezuclastinib in Patients with Advanced Systemic Mastocytosis (AdvSM) | NDA supported by positive results from the APEX pivotal trial demonstrating clinically meaningful responses and evidence of disease modification in patients with AdvSM PDUFA target action date set... ► Artikel lesen |
| Cogent Biosciences, Inc.: Cogent Biosciences Announces Submission of New Drug Application (NDA) for Bezuclastinib in Advanced Systemic Mastocytosis (AdvSM) | Submission based on results of APEX pivotal trial which demonstrated bezuclastinib objective response rate (CR+CRh+PR+CI) of 65% per mIWG criteria and 81% ORR per PPR criteria with a well-tolerated... ► Artikel lesen |
| Cogent Biosciences, Inc.: Cogent Biosciences Announces Detailed Data from APEX Pivotal Trial of Bezuclastinib in Patients with Advanced Systemic Mastocytosis at the 2026 European Hematology Association (EHA) Congress | -- Bezuclastinib demonstrated rapid and deep clinical benefit in AdvSM patients resulting in an updated objective response rate (CR+CRh+PR+CI) of 65% per mIWG criteria and 81% ORR per PPR criteria... ► Artikel lesen |
| CG Oncology Inc.: CG Oncology Reports Second Quarter 2026 Financial Results and Provides Business Updates | PIVOT-006 Phase 3 topline data evaluating cretostimogene monotherapy as an adjuvant therapy in intermediate-risk NMIBC anticipated in the near-termBLA completion for HR BCG-unresponsive NMIBC expected... ► Artikel lesen |
| ANI Pharmaceuticals, Inc.: ANI Pharmaceuticals Announces Intent to Appeal Rulings in CG Oncology Matter | Trial court denied Company's motion for a new trial and judgment as a matter of law for unjust enrichmentANI intends to appeal rulings to the Delaware Supreme Court and continue to seek to recover... ► Artikel lesen |
| CG Oncology Inc.: CG Oncology Reports Positive First Results from CORE-008 Cohort CX Phase 2 Trial Evaluating Intravesical Combination Therapy in High-Risk BCG-Exposed and BCG-Unresponsive Patients | - High CR rates at any time observed in the CIS-containing population with 85.7% and 92.3% in the ITT population and Efficacy Evaluable population, respectively - High-Grade - EFS in the overall intention-to-treat... ► Artikel lesen |
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