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| 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 |
| Erasca, Inc.: Erasca Announces Updated Preliminary Phase 1 Data and Registration-Enabling Plans for Potentially Best-in-Class Pan-RAS Molecular Glue ERAS-0015 in KRAS-Mutant Solid Tumors | At RDE of 32 mg QD, encouraging monotherapy responses with 57% uORR in 2L+ KRAS G12X pancreatic cancer in U.S. trial and median relative dose intensity of 100% Monotherapy has been generally well-tolerated... ► Artikel lesen |
| Erasca, Inc.: Erasca Reports First Quarter 2026 Business Updates and Financial Results | Robust monotherapy efficacy and generally well-tolerated safety results observed during dose escalation for ERAS-0015 in both KRAS G12X NSCLC and PDAC reinforce best-in-class potential across RAS-targeted... ► Artikel lesen |
| Erasca, Inc.: Erasca Announces Clinical Trial Collaboration and Supply Agreement with Merck to Evaluate ERAS-0015 in Combination with KEYTRUDA (Pembrolizumab) | SAN DIEGO, May 11, 2026 (GLOBE NEWSWIRE) -- Erasca, Inc. (Nasdaq: ERAS), a clinical-stage precision oncology company singularly focused on discovering, developing, and commercializing therapies for... ► 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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