SELLAS Receives IMPD Approval from the French Regulatory Authority for its Pivotal Phase 3 REGAL Study of Galinpepimut-S in Patients with Acute Myeloid Leukemia
SELLAS Life Sciences Group, Inc. (SLS)
Last sellas life sciences group, inc. earnings: 11/14 04:41 pm
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Source: GlobeNewswire
NEW YORK, Sept. 09, 2020 (GLOBE NEWSWIRE) -- SELLAS Life Sciences Group, Inc. (Nasdaq: SLS) (“SELLAS” or the “Company”), a late-stage clinical biopharmaceutical company focused on the development of novel cancer immunotherapies for a broad range of cancer indications, today announced that it has received approval of its Investigational Medicinal Product Dossier (IMPD) from the French regulatory authority, Agence Nationale de Sécurité du Médicament et des Produits de Santé (ANSM), to advance in France its pivotal Phase 3 REGAL study of galinpepimut-S (GPS) in patients with Acute Myeloid Leukemia (AML) who have achieved complete remission after second-line anti-leukemic therapy (CR2). “This clearance marks an important milestone for SELLAS, as the IMPD allows us to expand AML patient enrollment for our pivotal Phase 3 REGAL study of GPS in France,” commented Angelos M. Stergiou, MD, ScD h.c., President and Chief Executive Officer of SELLAS. “Obtaining IMPD clearance is a stringen
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SLS
Sec Filings
- 3/29/24 - Form D
- 3/28/24 - Form S-3
- 3/28/24 - Form S-3
- SLS's page on the SEC website