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SELLAS Receives EMA Orphan Drug Designation for SLS009 for Treatment of Peripheral T-cell Lymphomas
Newsfilter· 2024-08-06 12:45
NEW YORK, Aug. 06, 2024 (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 therapies for a broad range of cancer indications, today announced that the European Medicines Agency (EMA) has granted Orphan Drug Designation (ODD) for SLS009, a novel, and highly selective CDK9 inhibitor, for the treatment of relapsed/refractory (r/r) peripheral T-cell lymphomas (PTCL). "We are pleased t ...
SELLAS Receives EMA Orphan Drug Designation for SLS009 for Treatment of Peripheral T-cell Lymphomas
GlobeNewswire News Room· 2024-08-06 12:45
NEW YORK, Aug. 06, 2024 (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 therapies for a broad range of cancer indications, today announced that the European Medicines Agency (EMA) has granted Orphan Drug Designation (ODD) for SLS009, a novel, and highly selective CDK9 inhibitor, for the treatment of relapsed/refractory (r/r) peripheral T-cell lymphomas (PTCL). "We are pleased t ...
SELLAS Life Sciences Announces $21.0 Million Registered Direct Offering Priced at a Premium to Market
Newsfilter· 2024-07-31 12:30
NEW YORK, July 31, 2024 (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 therapies for a broad range of cancer indications, today announced that it has entered into a securities purchase agreement with a single institutional investor for the purchase and sale of 15,849,056 shares of common stock (or common stock equivalents in lieu thereof) and warrants to purchase up to an aggr ...
SELLAS Announces U.S. FDA Rare Pediatric Disease Designation (RPDD) Granted to SLS009 for the Treatment of Pediatric Acute Myeloid Leukemia
GlobeNewswire News Room· 2024-07-16 13:05
- Opened Enrollment for Pediatric AML Patients in Ongoing Phase 2 Clinical Trial - Rare Pediatric Disease (RPD) Designation is granted by the FDA for serious or life-threatening diseases that affect fewer than 200,000 people in the United States and in which the serious or life-threatening manifestations primarily affect individuals less than 18 years of age. If, in the future, a New Drug Application (NDA) for SLS009 for the treatment of pediatric AML is approved by the FDA, SELLAS might be eligible to rece ...
SELLAS Announces U.S. FDA Rare Pediatric Disease Designation (RPDD) Granted to SLS009 for the Treatment of Pediatric Acute Myeloid Leukemia
Newsfilter· 2024-07-16 13:05
- This Recognition Marks SELLAS' Second RPDD Following the Designation for ALL Received Last Month - NEW YORK, July 16, 2024 (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 therapies for a broad range of cancer indications, today announced that the U.S. Food and Drug Administration (FDA) has granted Rare Pediatric Disease Designation (RPDD) to SLS009, a highly selective CDK9 in ...
SELLAS Receives European Medicines Agency Orphan Drug Designation for SLS009 for the Treatment of Acute Myeloid Leukemia
GlobeNewswire News Room· 2024-07-08 12:45
NEW YORK, July 08, 2024 (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 therapies for a broad range of cancer indications, today announced that the European Commission, based on a positive opinion issued by the European Medicines Agency (EMA), has granted Orphan Drug Designation (ODD) for SLS009, a novel, and highly selective CDK9 inhibitor, for the treatment of acute myeloid ...
SELLAS Receives European Medicines Agency Orphan Drug Designation for SLS009 for the Treatment of Acute Myeloid Leukemia
Newsfilter· 2024-07-08 12:45
NEW YORK, July 08, 2024 (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 therapies for a broad range of cancer indications, today announced that the European Commission, based on a positive opinion issued by the European Medicines Agency (EMA), has granted Orphan Drug Designation (ODD) for SLS009, a novel, and highly selective CDK9 inhibitor, for the treatment of acute myeloid ...
SELLAS Announces U.S. FDA Rare Pediatric Disease Designation Granted to SLS009 for the Treatment of Pediatric Acute Lymphoblastic Leukemia
GlobeNewswire News Room· 2024-06-24 13:05
- Rare Pediatric Disease Designation (RPDD) Provides Eligibility for SLS009 to Receive a Priority Review Voucher (PRV) Upon Marketing Approval that can be Transferred/Sold to Other Parties – - Acute Lymphoblastic Leukemia (ALL) is the Most Common Type of Cancer in Children – - Past Sales of PRVs Have Averaged More Than $100 Million - NEW YORK, June 24, 2024 (GLOBE NEWSWIRE) -- SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) ("SELLAS" or the "Company"), a late-stage clinical biopharmaceutical company focused ...
SELLAS Announces U.S. FDA Rare Pediatric Disease Designation Granted to SLS009 for the Treatment of Pediatric Acute Lymphoblastic Leukemia
Newsfilter· 2024-06-24 13:05
Managing Director LifeSci Advisors, LLC - Acute Lymphoblastic Leukemia (ALL) is the Most Common Type of Cancer in Children – - Rare Pediatric Disease Designation (RPDD) Provides Eligibility for SLS009 to Receive a Priority Review Voucher (PRV) Upon Marketing Approval that can be Transferred/Sold to Other Parties – - Past Sales of PRVs Have Averaged More Than $100 Million - NEW YORK, June 24, 2024 (GLOBE NEWSWIRE) -- SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) ("SELLAS" or the "Company"), a late-stage cli ...
SELLAS Life Sciences Announces Positive Recommendation from the Independent Data Monitoring Committee of the Phase 3 REGAL Trial in Acute Myeloid Leukemia
Newsfilter· 2024-06-17 13:05
– No Safety or Futility Concerns Were Raised Based on the Efficacy and Safety Assessment of All REGAL Patients – NEW YORK, June 17, 2024 (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 therapies for a broad range of cancer indications, today announced a positive review of the ongoing Phase 3 REGAL clinical trial of galinpepimut-S (GPS) in acute myeloid leukemia (AML) by the In ...