SEELAS Life Sciences (SLS)
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SELLAS Receives European Medicines Agency Orphan Drug Designation for SLS009 for the Treatment of Acute Myeloid Leukemia
GlobeNewswire News Room· 2024-07-08 20:45
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 21:05
- 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 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 21:05
- 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 clinical biopharmaceutical company focused ...
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 21:05
– 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 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 21:05
– 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 20:40
- 30 Patients Relapsed or Refractory to Venetoclax-Based Regimens Enrolled Ahead of Schedule - - Overall Response Rate (ORR) of 33% and 50% Achieved to Date in 60 mg QW and 30 mg BIW Cohorts, Respectively - - 45 mg (Safety Dose) Once a Week of SLS009 Showed a Median Overall Survival (OS) of 5.4 Months vs. 2.5 Months with Standard of Care; 60 mg Once a Week and 30 mg Twice a Week Median OS Have Not Been Reached Yet - - 100% Overall Response Rate in Patients with ASXL1 Mutation in the 30 mg BIW Cohort to Date ...
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 20:40
- 30 Patients Relapsed or Refractory to Venetoclax-Based Regimens Enrolled Ahead of Schedule - - Overall Response Rate (ORR) of 33% and 50% Achieved to Date in 60 mg QW and 30 mg BIW Cohorts, Respectively - - 45 mg (Safety Dose) Once a Week of SLS009 Showed a Median Overall Survival (OS) of 5.4 Months vs. 2.5 Months with Standard of Care; 60 mg Once a Week and 30 mg Twice a Week Median OS Have Not Been Reached Yet - - 100% Overall Response Rate in Patients with ASXL1 Mutation in the 30 mg BIW Cohort to Date ...
Galena Biopharma (SLS) Upgraded to Buy: Here's What You Should Know
zacks.com· 2024-05-21 01:01
Investors might want to bet on Galena Biopharma, Inc. (SLS) , as it has been recently upgraded to a Zacks Rank #2 (Buy). An upward trend in earnings estimates -- one of the most powerful forces impacting stock prices -- has triggered this rating change. The Zacks rating relies solely on a company's changing earnings picture. It tracks EPS estimates for the current and following years from the sell-side analysts covering the stock through a consensus measure -- the Zacks Consensus Estimate. The power of a ch ...
SEELAS Life Sciences (SLS) - 2024 Q1 - Quarterly Results
2024-05-15 04:06
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 ...
SEELAS Life Sciences (SLS) - 2024 Q1 - Quarterly Report
2024-05-15 04:01
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 ________________________________ FORM 10-Q ________________________________ ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Commission File Number: 001-33958 SELLAS Life Sciences Group, Inc. (Exact name of registrant as specified in its charter) Delaware 20- ...