SELLAS Life Sciences Announces Expedited Development Path for Galinpepimut-S (GPS) in Acute Myeloid Leukemia (AML) Following Feedback from FDA
SELLAS Life Sciences Group, Inc. (SLS)
Last sellas life sciences group, inc. earnings: 11/14 04:41 pm
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Source: GlobeNewswire
Agreement on new open-label randomized registrational Phase 3 study in patients in second complete remission (CR2) poised to reduce sample size, time to primary endpoint and costs Fast-Track and Orphan Drug designations for GPS in AML continue to apply NEW YORK, Nov. 28, 2018 (GLOBE NEWSWIRE) -- SELLAS Life Sciences Group, Inc. (Nasdaq: SLS) (“SELLAS” or the “Company”), a clinical-stage biopharmaceutical company focused on the development of novel cancer immunotherapies for a broad range of cancer indications, today provided an update on its late-stage clinical development program for the Company’s proprietary galinpepimut-S (GPS) in patients with acute myeloid leukemia (AML). Following a clinical and regulatory strategy defining Type C dialogue with the U.S. Food and Drug Administration (FDA), the Company plans to proceed with a clinical study design and biostatistical plan to support a Phase 3 registrational study for maintenance therapy for AML patients who have achieved compl
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- 3/29/24 - Form D
- 3/28/24 - Form S-3
- 3/28/24 - Form S-3
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