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| Praxis Precision Medicines, Inc.: Praxis Precision Medicines Announces Plans to File an NDA for Relutrigine in SCN2A and SCN8A Developmental and Epileptic Encephalopathies in Early 2026 | BOSTON, Dec. 11, 2025 (GLOBE NEWSWIRE) -- Praxis Precision Medicines, Inc. (NASDAQ: PRAX), a clinical-stage biopharmaceutical company translating genetic insights into the development of therapies... ► Artikel lesen |
| Praxis Precision Medicines, Inc.: Praxis Precision Medicines Announces Alignment with FDA on Simplified and Accelerated Registrational Pathway for Elsunersen in Early Onset SCN2A Developmental and Epileptic Encephalopathy | Clear recognition of high unmet need and urgency for the SCN2A community and plausibility of the mechanism of elsunersen FDA agreed to proposed changes to the EMBRAVE3 trial design to be a single-arm... ► Artikel lesen |
| Morning Market Movers: SMX, Praxis Precision Medicines, Polyrizon, Rubrik, Inc. See Big Swings | HONG KONG (dpa-AFX) - At 7:50 a.m. ET on Friday, premarket trading is seeing notable activity in several stocks, with early price movements signaling potential opportunities before the opening... ► Artikel lesen |
| Royalty Pharma plc: Royalty Pharma Acquires Royalty Interest in Nuvalent's Neladalkib and Zidesamtinib for Up to $315 Million | NEW YORK, Dec. 16, 2025 (GLOBE NEWSWIRE) -- Royalty Pharma plc (Nasdaq: RPRX) today announced that it has acquired a pre-existing royalty interest in Nuvalent's neladalkib and zidesamtinib from an... ► Artikel lesen |
| Nuvalent, Inc.: Nuvalent Announces FDA Acceptance of New Drug Application for Zidesamtinib for the Treatment of TKI Pre-treated Patients with Advanced ROS1-positive NSCLC | NDA based on data from global ARROS-1 Phase 1/2 clinical trial
FDA assigns PDUFA target action date of September 18, 2026
CAMBRIDGE, Mass., Nov. 19, 2025 /PRNewswire/... ► Artikel lesen |
| Nuvalent, Inc.: Nuvalent Announces Positive Topline Pivotal Data from ALKOVE-1 Clinical Trial of Neladalkib for TKI Pre-treated Patients with Advanced ALK-positive NSCLC | In 253 ALK TKI pre-treated patients, ORR by BICR was 31% (95% CI: 26, 37), with initial estimated durability of response of 64% and 53% at the 12-month and 18-month... ► Artikel lesen |
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