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SELLAS Life Sciences Group, Inc. - SLS STOCK NEWS

Welcome to our dedicated page for SELLAS Life Sciences Group news (Ticker: SLS), a resource for investors and traders seeking the latest updates and insights on SELLAS Life Sciences Group stock.

SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) is a late-stage clinical biopharmaceutical company dedicated to the development of novel therapeutics aimed at addressing a broad range of cancer indications. The company's core mission is to practice the medicine of tomorrow, today, by integrating innovative approaches that significantly impact the global healthcare landscape.

SELLAS' leading product candidate is galinpepimut-S (GPS), a peptide immunotherapy targeting the Wilms Tumor 1 (WT1) antigen. Licensed from Memorial Sloan Kettering Cancer Center, GPS is designed to treat various hematologic malignancies and solid tumors. Notably, GPS is currently undergoing a Phase 3 REGAL clinical trial for acute myeloid leukemia (AML), with promising safety and efficacy data observed so far.

Another pivotal asset in SELLAS' pipeline is SLS009 (formerly GFH009), a highly selective cyclin-dependent kinase 9 (CDK9) inhibitor. Licensed from GenFleet Therapeutics (Shanghai), Inc., SLS009 is being explored for its potential to treat relapsed/refractory acute myeloid leukemia (r/r AML) and other cancer types. Recent Phase 2a trial results show that SLS009 exhibits strong anti-leukemic activity, with favorable safety profiles and significant response rates, particularly in patients with identified biomarkers such as the ASXL1 mutation.

SELLAS is committed to advancing these therapeutics through rigorous clinical trials and strategic partnerships. The company collaborates with renowned scientists, healthcare professionals, and pharmaceutical executives to bring cutting-edge treatments to market. Recent collaborations include a clinical trial agreement with BeiGene Switzerland GmbH to study the combination of GFH009 and BRUKINSA® (zanubrutinib) in treating diffuse large B cell lymphoma (DLBCL).

Financially, SELLAS has shown resilience and growth, as evidenced by a successful $20 million registered direct offering in March 2024, bolstering their cash reserves for ongoing R&D activities. The company continues to report sound financial health, marked by a focused approach on strategic developments and clinical milestones.

For more information on SELLAS Life Sciences Group, Inc. and its innovative therapies, visit their official website at www.sellaslifesciences.com.

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SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) announced positive feedback from the FDA regarding their Chemistry, Manufacturing, and Controls (CMC) sections in a potential biologics license application (BLA) for their lead product candidate, galinpepimut-S (GPS). The FDA's favorable guidance is a crucial step in the approval pathway for GPS, a potential immunotherapy cancer vaccine for acute myeloid leukemia (AML). The Company has successfully completed various clinical development and CMC objectives, including manufacturing, process qualification, method validation, and stability monitoring. The FDA also agreed on the Company’s proposed stability data generation plan for the commercial presentation of GPS, making it more accessible for end-users.
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NASDAQ: SLS - SELLAS Life Sciences Group, Inc. reports positive Phase 2a data of SLS009 in AML patients and regulatory milestones. Fast Track Designation by FDA for PTCL and Orphan Drug Designation for AML. Phase 3 REGAL Trial of Galinpepimut-S on track to complete enrollment ex-China in November 2023.
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SELLAS Life Sciences Group, Inc. announced final clinical and immunobiological data from the Phase 1/2 clinical trial of galinpepimut-S (GPS) in combination with pembrolizumab (Keytruda®) in Wilms’ tumor-1 (WT1)-positive platinum-resistant ovarian cancer. The combination showed a median overall survival of 18.4 months compared to 13.8 months with pembrolizumab alone. The combination also resulted in a 41% longer progression-free survival and a statistically significant difference. The trial included 16 evaluable patients.
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SELLAS Life Sciences Group, Inc. has entered into a securities purchase agreement with a U.S. institutional investor for the purchase and sale of 3,652,300 shares of common stock at a price of $1.0952 per share. The registered direct offering will result in total gross proceeds of approximately $4 million. The investor will also receive warrants to purchase up to an aggregate of 3,652,300 shares of common stock with an exercise price of $0.9702.
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SELLAS Life Sciences Group, Inc. has received Fast Track Designation from the FDA for SLS009, its CDK9 inhibitor, for the treatment of relapsed/refractory Peripheral T-cell Lymphomas (PTCL). In the Phase 1 study, SLS009 demonstrated a 36.4% clinical response rate in PTCL patients, compared to the standard of care response rate of 25.8%. The company is actively pursuing Breakthrough Therapy designation and has an ongoing Phase 1b/2 trial in China.
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SELLAS Life Sciences Group, Inc. to present topline clinical data from Phase 1/2 trial of galinpepimut-S in combination with pembrolizumab at the 2023 IGCS Annual Global Meeting.
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SELLAS Life Sciences provides update on Phase 3 clinical trial for galinpepimut-S
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SELLAS Life Sciences announces initiation of Phase Ib/II trial for SLS009 in PTCL
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SELLAS Life Sciences receives Orphan Drug Designation for SLS009 in the treatment of acute myeloid leukemia
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GenFleet Therapeutics announces the dosing of the first subject in a phase Ib/II trial of GFH009, a CDK9 inhibitor, for relapsed/refractory PTCL patients. Preliminary results show promising clinical efficacy.
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FAQ

What is the current stock price of SELLAS Life Sciences Group (SLS)?

The current stock price of SELLAS Life Sciences Group (SLS) is $1.01 as of December 26, 2024.

What is the market cap of SELLAS Life Sciences Group (SLS)?

The market cap of SELLAS Life Sciences Group (SLS) is approximately 66.9M.

What does SELLAS Life Sciences Group, Inc. specialize in?

SELLAS Life Sciences Group, Inc. focuses on the development of novel therapeutics for a broad range of cancer indications.

What is GPS in SELLAS' product pipeline?

GPS, or galinpepimut-S, is a peptide immunotherapy targeting the WT1 antigen, designed to treat various cancers and currently in a Phase 3 clinical trial for AML.

What is SLS009?

SLS009 is a highly selective CDK9 inhibitor licensed from GenFleet Therapeutics, being tested for effectiveness in treating relapsed/refractory AML and other cancers.

How is SELLAS contributing to cancer research?

SELLAS advances cancer research through clinical trials of innovative therapies like GPS and SLS009, aiming to address unmet medical needs in oncology.

Who are SELLAS' key partners?

SELLAS collaborates with Memorial Sloan Kettering Cancer Center, GenFleet Therapeutics, and BeiGene Switzerland GmbH for its clinical trials and therapeutic developments.

What financial milestone did SELLAS achieve in 2024?

In March 2024, SELLAS completed a $20 million registered direct offering, enhancing their financial position for ongoing research and development activities.

What recent clinical trial advancements has SELLAS made?

SELLAS recently completed enrollment in the Phase 3 REGAL trial for GPS in AML and reported positive Phase 2a results for SLS009 in r/r AML.

What is the significance of the ASXL1 mutation in SELLAS' research?

The ASXL1 mutation is linked to poor prognosis in myeloid diseases, and SELLAS' SLS009 has shown promising response rates in patients with this mutation, indicating potential for targeted therapy.

Where can I get more information about SELLAS Life Sciences Group, Inc.?

For more details, visit SELLAS Life Sciences Group, Inc.'s official website at www.sellaslifesciences.com.

What is the focus of the collaboration between SELLAS and BeiGene Switzerland GmbH?

The collaboration focuses on a clinical trial combining GFH009 (CDK9 inhibitor) and BRUKINSA® (zanubrutinib, BTK inhibitor) to treat diffuse large B cell lymphoma.

SELLAS Life Sciences Group, Inc.

Nasdaq:SLS

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66.87M
70.26M
0.24%
7.36%
13.39%
Biotechnology
Pharmaceutical Preparations
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United States of America
NEW YORK