| 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 |
| Praxis Precision Medicines, Inc.: Praxis Precision Medicines Announces Extension Period for Relutrigine for Treatment of SCN2A and SCN8A Developmental and Epileptic Encephalopathies | FDA sets updated PDUFA date of December 27, 2026 BOSTON, June 29, 2026 (GLOBE NEWSWIRE) -- Praxis Precision Medicines, Inc. (NASDAQ: PRAX), a fully integrated, leading central nervous system (CNS)... ► Artikel lesen |
| Praxis Precision Medicines, Inc.: Praxis Precision Medicines Provides Vormatrigine Program Update | POWER1 Study in highly refractory patients with focal onset seizures did not meet its primary success measure Secondary measure, the 50% response rate, was met and seizure reduction during the second... ► Artikel lesen |
| Praxis Precision Medicines, Inc.: Praxis Precision Medicines Provides Corporate Update and Reports First Quarter 2026 Financial Results | FDA accepted the new drug application (NDA) for ulixacaltamide in Essential Tremor with a PDUFA target action date of January 29, 2027, and the NDA for relutrigine, with priority review, in SCN2A... ► Artikel lesen |