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| 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 |
| CG Oncology Inc.: CG Oncology Reports First Quarter 2026 Financial Results and Provides Business Updates | Following alignment discussions with FDA, BLA completion for HR BCG-unresponsive NMIBC is expected fourth quarter 2026 PIVOT-006 Phase 3 topline data evaluating cretostimogene monotherapy as an adjuvant... ► Artikel lesen |
| ArriVent BioPharma, Inc.: ArriVent BioPharma Reports First Quarter 2026 Financial Results | Topline global pivotal Phase 3 data for firmonertinib in first-line EGFR exon 20 insertion mutant NSCLC expected mid-2026IND clearance of ARR-002, ArriVent's dual-targeting MUC16/NaPi2b tetravalent... ► Artikel lesen |
| ArriVent BioPharma, Inc.: ArriVent Announces IND Clearance for Novel Tetravalent MUC16/NaPi2b Targeting ADC ARR-002 with Initial Focus in Ovarian and Endometrial Cancers | Superior efficacy and favorable tolerability in animal models support the potential of ARR-002 to overcome limitations of single-target approachesPhase 1 initiation expected in the second half of... ► Artikel lesen |
| 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 |
| Disc Medicine Inc: Disc Medicine Announces Completion of Enrollment of Phase 3 APOLLO Trial of Bitopertin in Erythropoietic Protoporphyria | Last participant has been randomized and dosed in the Phase 3 APOLLO study of bitopertin in erythropoietic protoporphyria (EPP)The study size was expanded to 183 participants due to patient and physician... ► Artikel lesen |
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