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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 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 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 ...
SELLAS Life Sciences Announces Positive Recommendation from the Independent Data Monitoring Committee of the Phase 3 REGAL Trial in Acute Myeloid Leukemia
GlobeNewswire News Room· 2024-06-17 13:05
– The Independent Data Monitoring Committee (IDMC) Recommends Continuation of Phase 3 REGAL Trial Without Any Modifications – – No Safety or Futility Concerns Were Raised Based on the Efficacy and Safety Assessment of All REGAL Patients – – Interim Analysis Anticipated by Q4 2024 – 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 ra ...
SELLAS Announces Completion of Enrollment and Initial Positive Data in Phase 2a Trial of SLS009 in r/r AML
Newsfilter· 2024-06-10 12:40
- Trial Continues with Two Expansion Cohorts of Patients with ASXL1 Mutations and Myelodysplasia-Related Molecular Mutations Other Than ASXL1; Additional Update Expected in Q3 2024 - Thirty heavily pretreated patients were recruited in 5 centers across the US, reflecting the high unmet need of this refractory/relapsed patient population. Except for one, all patients in this Phase 2a trial had unfavorable/poor cytogenetic and/or molecular genetics risk (97%) and were treated with continued venetoclax – azacy ...
SELLAS Announces Completion of Enrollment and Initial Positive Data in Phase 2a Trial of SLS009 in r/r AML
GlobeNewswire News Room· 2024-06-10 12:40
- Overall Response Rate (ORR) of 33% and 50% Achieved to Date in 60 mg QW and 30 mg BIW Cohorts, Respectively - The Phase 2a clinical trial of SLS009 is an open-label, single-arm, multi-center study designed to evaluate the safety, tolerability, and efficacy of SLS009 in combination with venetoclax and azacitidine at two dose levels, 45 and 60 mg. In the 60 mg dose cohort patients were randomized into either a 60 mg dose once per week or a 30 mg dose two times per week. The target response rate at the optim ...
Galena Biopharma (SLS) Upgraded to Buy: Here's What You Should Know
zacks.com· 2024-05-20 17:01
As such, the Zacks rating upgrade for Galena Biopharma is essentially a positive comment on its earnings outlook that could have a favorable impact on its stock price. Most Powerful Force Impacting Stock Prices The change in a company's future earnings potential, as reflected in earnings estimate revisions, has proven to be strongly correlated with the near-term price movement of its stock. The influence of institutional investors has a partial contribution to this relationship, as these big professionals u ...
SEELAS Life Sciences (SLS) - 2024 Q1 - Quarterly Results
2024-05-14 20:06
Exhibit 99.1 SELLAS Life Sciences Reports First Quarter 2024 Financial Results and Provides Corporate Update - Announced Independent Data Monitoring Committee's (IDMC) Recommendation to Continue the Phase 3 REGAL Study in Patients with Acute Myeloid Leukemia (AML) Without Modifications: IDMC to Reconvene in June - - Completed Enrollment in Phase 3 REGAL Study of Galinpepimut-S - - Announced Positive Phase 2 Data of SLS009 Demonstrating 100% Response Rate in r/r AML Patients with ASXL1 Mutation at 30 mg BIW ...