| SELLAS Life Sciences Announces First Pediatric AML Patient Dosed in the Ongoing Phase 2 Trial of SLS009 r/r AML |
- First ASXL1 Pediatric Acute Myeloid Leukemia (AML) Patient Dosed at MD Anderson Cancer Center: Program Supported by Rare Pediatric Disease Designation (RPDD) - First ASXL1 Pediatric Acute Myeloid Leukemia (AML) Patient Dosed at MD Anderson Cancer Center: Program Supported by Rare Pediatric Disease Designation (RPDD) |
globenewswire.com |
2025-05-15 12:45:00 |
Czytaj oryginał (ang.) |
| SELLAS Life Sciences Reports First Quarter 2025 Financial Results and Provides Corporate Update |
– Announced Positive Overall Survival in Cohort 3 from the Ongoing Phase 2 Trial of SLS009 (tambiciclib) in Relapsed/Refractory (r/r) Acute Myeloid Leukemia (AML) Demonstrating 8.9 mOS in AML-MRC and 8.8 mOS in All r/r to Venetoclax-Based Regimens Patients – |
globenewswire.com |
2025-05-13 20:05:00 |
Czytaj oryginał (ang.) |
| SELLAS Unveils Breakthrough Preclinical Data Highlighting Efficacy of SLS009 in TP53 Mutated AML at the 2025 AACR Conference |
New Data Suggest SLS009 (tambiciclib) May Overcome Resistance to Azacitidine-Venetoclax Regimen and Trigger Apoptosis of TP53 Mutated AML Cells New Data Suggest SLS009 (tambiciclib) May Overcome Resistance to Azacitidine-Venetoclax Regimen and Trigger Apoptosis of TP53 Mutated AML Cells |
globenewswire.com |
2025-04-28 12:45:00 |
Czytaj oryginał (ang.) |
| SELLAS to Present at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting |
- ASCO Presentation to Highlight Preclinical Efficacy of SLS009 (tambiciclib) in ASXL1 Mutated Colorectal Cancer - - ASCO Presentation to Highlight Preclinical Efficacy of SLS009 (tambiciclib) in ASXL1 Mutated Colorectal Cancer - |
globenewswire.com |
2025-04-23 14:23:00 |
Czytaj oryginał (ang.) |
| SELLAS Announces Positive Overall Survival in Cohort 3 from the Ongoing Phase 2 Trial of SLS009 in r/r AML |
- 8.9 Months Median Overall Survival (mOS) in Patients with AML-Myelodysplasia-Related Changes (AML-MRC) and 8.8 mOS in All Relapsed or Refractory to Venetoclax-Based Regimens Patients; Surpassing Historical Benchmark of 2.5 Months - |
globenewswire.com |
2025-04-08 12:45:00 |
Czytaj oryginał (ang.) |
| Sellas Life Sciences: A Hold For Now With Huge, But Uncertain, Near-Term Catalyst |
Sellas Life Sciences Group, Inc.'s stock has dropped significantly, with a Hold rating due to uncertainty around the final Phase 3 trial data for GPS in AML. Interim results for GPS are promising but inconclusive; the trial continues until 80 patients die, creating investment uncertainty and ongoing cash burn. The company raised $25M in January 2025, extending its runway to late 2025, but may need more funds for regulatory and commercial plans. |
seekingalpha.com |
2025-03-31 19:03:48 |
Czytaj oryginał (ang.) |
| SELLAS Life Sciences Reports Full Year 2024 Financial Results and Provides Corporate Update |
– Announced Positive Outcome of Interim Analysis for its Pivotal Phase 3 REGAL Trial of Galinpepimut-S (GPS) in Acute Myeloid Leukemia (AML) with Next and Final Analysis Planned Upon Reaching 80 Events, Anticipated in 2025 – |
globenewswire.com |
2025-03-20 18:05:00 |
Czytaj oryginał (ang.) |
| SELLAS Announces Positive Data from Phase 2a Trial of SLS009 in Combination with Zanubrutinib in DLBCL |
- Combination Achieved a 67% of Overall Response Rate, More than Double that of Zanubrutinib Alone; 83% Disease Control Rate in Difficult-to-Treat Non-GCB DLBCL (ABC DLBCL) Patients - |
globenewswire.com |
2025-02-20 10:45:00 |
Czytaj oryginał (ang.) |
| SELLAS Life Sciences Group Announces $25 Million Registered Direct Offering Priced At-the-Market Under Nasdaq Rules |
NEW YORK, Jan. 28, 2025 (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 healthcare-focused institutional investor for the purchase and sale of 19,685,040 shares of its common stock (or common stock equivalents in lieu thereof) and warrants to purchase up to an aggregate of 19,685,040 shares of common stock in a registered direct offering (the "Offering") at a combined purchase price of $1.27 per share and accompanying warrant, priced at-the-market under Nasdaq rules. The warrants will have an exercise price of $1.20 per share, will be immediately exercisable upon issuance and will expire 5 years from issuance. |
globenewswire.com |
2025-01-28 17:11:00 |
Czytaj oryginał (ang.) |
| SELLAS Life Sciences Announces Positive Outcome of Interim Analysis for its Pivotal Phase 3 REGAL Trial of GPS in Acute Myeloid Leukemia |
- REGAL Successfully Passes Event-Driven (60 Deaths) Interim Analysis for Efficacy, Futility, and Safety: The Independent Data Monitoring Committee (IDMC) Recommended Continuation of the Clinical Trial Without Modification – |
globenewswire.com |
2025-01-23 10:10:00 |
Czytaj oryginał (ang.) |
| SELLAS Announces Key Business Objectives for 2025 |
- Independent Data Monitoring Committee to Perform Interim Analysis of Phase 3 REGAL Study in January 2025 - - SLS009: Full Topline Phase 2 Data in Acute Myeloid Leukemia and FDA Regulatory Review Expected in 1H 2025 - - Approval of “tambiciclib” as Recommended International Nonproprietary Name for SLS009 - - Applied for Non-Dilutive Grant Funding to Expand SLS009 Development Into Frontline Setting in AML - - Developing SLS009 Pediatric Programs in Hematological and Potentially Other Malignancies - - Company to Host Corporate Update Webinar Today, January 8, 2025, at 9:00 am ET - NEW YORK, Jan. 08, 2025 (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 provided a business update and will host a webinar at 9:00 am ET. “We believe that 2025 will be a pivotal year for SELLAS as we continue to advance our clinical stage portfolio of novel therapeutics for hematologic malignancies,” said Angelos Stergiou, MD, ScD h.c. |
globenewswire.com |
2025-01-08 10:20:00 |
Czytaj oryginał (ang.) |
| SELLAS Life Sciences Triggers Interim Analysis in Phase 3 REGAL Trial of GPS in Acute Myeloid Leukemia |
- Study Reaches Pre-Specified Threshold of 60 Events (Deaths) Initiating the Interim Analysis – - REGAL Independent Data Monitoring Committee to Perform Interim Analysis in January 2025 - - Company to Host Webcast Call Today at 9:00 am ET NEW YORK, Dec. 10, 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 pre-specified threshold of 60 events (deaths) has been reached in its ongoing Phase 3 REGAL clinical trial of galinpepimut-S (GPS) in acute myeloid leukemia (AML), triggering the interim analysis to be conducted by the Independent Data Monitoring Committee (IDMC). The IDMC will conduct a thorough review of the current REGAL data, and the interim analysis will provide an assessment of efficacy, futility as well as safety of GPS. |
globenewswire.com |
2024-12-10 10:30:00 |
Czytaj oryginał (ang.) |
| SELLAS Announces Positive Overall Survival and Overall Response Rate Data from the Phase 2 Trial of SLS009 in r/r AML |
- Median Overall Survival (mOS) Not Yet Reached, Now Exceeds 7.7. Months at Latest Follow-Up in the 30 mg BIW Cohort in Patients Relapsed or Refractory to Venetoclax-Based Regimens - |
globenewswire.com |
2024-12-09 10:45:00 |
Czytaj oryginał (ang.) |
| SELLAS Announces Positive Data from Preclinical Studies Indicating ASXL1 Mutations as Predictor of Response to SLS009 in Solid Cancers |
- Preselection Method for Cancers Responding to SLS009: High Efficacy of SLS009 Observed in 67% of ASXL1 Mutated Solid Cancers vs 0% in Non-ASXL1 Mutated Cancers – |
globenewswire.com |
2024-11-27 10:45:00 |
Czytaj oryginał (ang.) |
| SELLAS Life Sciences Reports Third Quarter 2024 Financial Results and Provides Corporate Update |
– Pre-specified Events to Trigger Interim Analysis of Phase 3 REGAL Study in Patients with Acute Myeloid Leukemia (AML) Remains on Track for Q4 2024 – |
globenewswire.com |
2024-11-13 18:15:00 |
Czytaj oryginał (ang.) |
| voxeljet, Dressler Group GmbH, Fraunhofer IPA and the University of Bayreuth Collaborate in Re-Processing of Discarded PA12 Powder for 3D Printing via High-Speed Sintering (HSS) |
FRIEDBERG, Germany--(BUSINESS WIRE)--voxeljet AG (OTCMKTS: VJTTY) (the ‘Company', ‘voxeljet', or ‘we'), a provider of high-speed, large-format 3D printers and on-demand parts services to industrial and commercial customers, Dressler Group GmbH, and Fraunhofer IPA today announced the successful completion of a material study for waste PA12 powder from laser-based 3D printing systems. In the study, waste powder from Selective Laser Sintering systems was successfully recycled by Dressler Group and. |
businesswire.com |
2024-11-13 10:00:00 |
Czytaj oryginał (ang.) |
| SELLAS Life Sciences to Present at the 66th American Society of Hematology (ASH) Annual Meeting & Exposition 2024 |
- Presentation at ASH will Feature Results from the Phase 2a Trial of SLS009 in Relapsed/Refractory Acute Myeloid Leukemia After Venetoclax Failure – |
globenewswire.com |
2024-11-05 11:55:00 |
Czytaj oryginał (ang.) |
| SELLAS Announces U.S. FDA Rare Pediatric Disease Designation (RPDD) Granted to Galinpepimut-S (GPS) for the Treatment of Pediatric Acute Myeloid Leukemia |
- GPS Currently Investigated in Phase 3 REGAL Trial in Adult AML Patients – Interim Analysis Anticipated in Q4 2024 - - RPDD Provides Eligibility for GPS to Receive a Priority Review Voucher (PRV) Upon Marketing Approval that can be Transferred/Sold to Other Parties – - Recent Valuations for PRVs Remain Attractive (~$100 million/each) – NEW YORK, Oct. 15, 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 Galinpepimut-S (GPS), an immunotherapeutic targeting Wilms Tumor-1 (WT1), for the treatment of pediatric acute myeloid leukemia (AML). “GPS has already demonstrated promise in clinical settings for AML, and we believe its potential could extend to pediatric patients,” said Angelos Stergiou, MD, ScD h.c. |
globenewswire.com |
2024-10-15 12:45:00 |
Czytaj oryginał (ang.) |
| SELLAS Life Sciences to Participate in Fireside Chat at the 2024 Maxim Healthcare Virtual Summit |
NEW YORK, Oct. 10, 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 Dr. Angelos Stergiou, President and Chief Executive Officer of SELLAS, will participate in a fireside chat at the 2024 Maxim Healthcare Virtual Summit on Tuesday, October 15, 2024 at 9:00 am EDT. |
globenewswire.com |
2024-10-10 20:05:00 |
Czytaj oryginał (ang.) |
| Seelos Therapeutics announces the signing of a Material Transfer Agreement with U.S. Army Medical Materiel Development Activity (USAMMDA) to evaluate SLS-002 for treatment of PTSD |
-Dosing of the SLS-002 cohort is expected to commence in 4Q2024 NEW YORK , Sept. 24, 2024 /PRNewswire/ -- Seelos Therapeutics, Inc. (Nasdaq: SEEL) ("Seelos"), a clinical-stage biopharmaceutical company focused on the development of therapies for central nervous system disorders and rare diseases, today announced the signing of a Material Transfer Agreement (MTA) with the U.S. Army Medical Materiel Development Activity (USAMMDA) to supply SLS-002 (intranasal racemic ketamine) for the U.S. Department of Defense's (DOD) Military and Veterans Adaptive Platform Clinical Trial ("M-PACT") to evaluate its potential for treatment of post-traumatic stress disorder (PTSD). |
prnewswire.com |
2024-09-24 12:00:00 |
Czytaj oryginał (ang.) |
| Galena Biopharma (SLS) Upgraded to Buy: Here's Why |
Galena Biopharma (SLS) might move higher on growing optimism about its earnings prospects, which is reflected by its upgrade to a Zacks Rank #2 (Buy). |
zacks.com |
2024-08-20 17:00:26 |
Czytaj oryginał (ang.) |
| SELLAS Life Sciences Reports Second 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: Interim Analysis Anticipated by Q4 2024 - |
globenewswire.com |
2024-08-13 20:10:00 |
Czytaj oryginał (ang.) |
| SELLAS Receives EMA Orphan Drug Designation for SLS009 for Treatment of Peripheral T-cell Lymphomas |
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). |
globenewswire.com |
2024-08-06 12:45:00 |
Czytaj oryginał (ang.) |
| SELLAS Announces U.S. FDA Rare Pediatric Disease Designation (RPDD) Granted to SLS009 for the Treatment of Pediatric Acute Myeloid Leukemia |
- Acute Myeloid Leukemia (AML) is the Second Most Common Hematological Malignancy in Children Often Associated with Poorer Prognosis Compared to Other Pediatric Cancers – |
globenewswire.com |
2024-07-16 13:05:00 |
Czytaj oryginał (ang.) |
| SELLAS Receives European Medicines Agency Orphan Drug Designation for SLS009 for the Treatment of Acute Myeloid Leukemia |
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 leukemia (AML). |
globenewswire.com |
2024-07-08 12:45:00 |
Czytaj oryginał (ang.) |
| SELLAS Announces U.S. FDA Rare Pediatric Disease Designation Granted to SLS009 for the Treatment of Pediatric Acute Lymphoblastic Leukemia |
- 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 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 inhibitor, for the treatment of pediatric acute lymphoblastic leukemia (ALL). “We are pleased that the FDA has granted Rare Pediatric Disease Designation to SLS009 for the treatment of pediatric ALL, the most common cancer diagnosed in children,” said Angelos Stergiou, MD, ScD h.c. |
globenewswire.com |
2024-06-24 13:05:00 |
Czytaj oryginał (ang.) |
| SELLAS Life Sciences Announces Positive Recommendation from the Independent Data Monitoring Committee of the Phase 3 REGAL Trial in Acute Myeloid Leukemia |
– The Independent Data Monitoring Committee (IDMC) Recommends Continuation of Phase 3 REGAL Trial Without Any Modifications – |
globenewswire.com |
2024-06-17 13:05:00 |
Czytaj oryginał (ang.) |
| SELLAS Announces Completion of Enrollment and Initial Positive Data in Phase 2a Trial of SLS009 in r/r AML |
- 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 - - 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 - NEW YORK, June 10, 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 the completion of enrollment as well as positive initial data from the ongoing Phase 2a trial of SLS009, a highly selective CDK9 inhibitor, in relapsed/refractory acute myeloid leukemia (r/r AML). |
globenewswire.com |
2024-06-10 12:40:00 |
Czytaj oryginał (ang.) |
| 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 - |
globenewswire.com |
2024-05-14 20:05:00 |
Czytaj oryginał (ang.) |
| SELLAS Announces Positive Phase 2 Preliminary Data of SLS009 in r/r AML Achieving a 100% Response Rate in Patients with ASXL1 Mutation At the Optimal Dose Level |
- The Company Filed IP Protection Related to the ASXL1 Mutation, a Highly Prevalent Gene Mutation in Myeloid Malignancies and Solid Tumors With Significant Market Potential – |
globenewswire.com |
2024-05-01 12:35:00 |
Czytaj oryginał (ang.) |
| SELLAS Life Sciences Announces Positive Recommendation of Independent Data Monitoring Committee Following Completion of Enrollment in REGAL Phase 3 Study |
– Based on the Efficacy and Safety Data Assessed, the Independent Data Monitoring Committee (IDMC) Recommends Continuation of Phase 3 REGAL Trial Patients Treatment and Follow-Up Without Any Modifications – |
globenewswire.com |
2024-04-29 12:45:00 |
Czytaj oryginał (ang.) |