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SELLAS Life Sciences Group Inc - SLS STOCK NEWS

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

Our selection of high-quality news articles is accompanied by an expert summary from Rhea-AI, detailing the impact and sentiment surrounding the news at the time of release, providing a deeper understanding of how each news could potentially affect SELLAS Life Sciences Group's stock performance. The page also features a concise end-of-day stock performance summary, highlighting the actual market reaction to each news event. The list of tags makes it easy to classify and navigate through different types of news, whether you're interested in earnings reports, stock offerings, stock splits, clinical trials, fda approvals, dividends or buybacks.

Designed with both novice traders and seasoned investors in mind, our page aims to simplify the complex world of stock market news. By combining real-time updates, Rhea-AI's analytical insights, and historical stock performance data, we provide a holistic view of SELLAS Life Sciences Group's position in the market.

News
SELLAS Life Sciences Announces Positive Recommendation from REGAL Independent Data Monitoring Committee of Galinpepimut-S in Acute Myeloid Leukemia
Rhea-AI Summary
SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) announced that the Independent Data Monitoring Committee (IDMC) recommended the continuation of the Phase 3 REGAL trial for galinpepimut-S (GPS) in acute myeloid leukemia (AML) without any modifications. The IDMC expressed satisfaction with the speed of enrollment and high study integrity, and will review the most current survival data at the next scheduled meeting in Q1 2024.
Rhea-AI Impact
Rhea-AI Sentiment
End-of-Day
0.93%
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none
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News
SELLAS Life Sciences Reaches Target Enrollment ex-China in Phase 3 REGAL Trial of Galinpepimut-S in Acute Myeloid Leukemia
Rhea-AI Summary
SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) has reached target patient enrollment outside of mainland China in the ongoing Phase 3 REGAL trial of galinpepimut-S (GPS) in patients with acute myeloid leukemia (AML) who have achieved complete remission following second-line salvage therapy. The trial is designed to compare GPS monotherapy to the best available treatment in AML patients who are ineligible for or unable to undergo allogeneic stem-cell transplantation. The primary endpoint is overall survival, with secondary endpoints including leukemia-free survival, antigen-specific T-cell immune response dynamics, measurable residual disease, and assessments of AML clonal evolution and inflammasome molecular signatures in the tumor microenvironment. The interim analysis is expected by late 2023 or early 2024, with the final analysis on track to occur by the end of 2024. GPS has received Fast Track Designation in the United States and Orphan Drug Designation in both the United States and the European Union for AML.
Rhea-AI Impact
Rhea-AI Sentiment
End-of-Day
-0.94%
Tags
clinical trial
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News
SELLAS Life Sciences Receives Favorable FDA Type C Meeting Feedback on Chemistry, Manufacturing, and Controls (CMC) Biologics License Application (BLA) Filing Strategy for Galinpepimut-S (GPS)
Rhea-AI Summary
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.
Rhea-AI Impact
Rhea-AI Sentiment
End-of-Day
-3.3%
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none
News
SELLAS Provides Business Update and Reports Third Quarter 2023 Financial Results
Rhea-AI Summary
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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End-of-Day
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earnings
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News
SELLAS Life Sciences Presents Positive Key Immunobiological and Clinical Data from Phase 1/2 Trial of Galinpepimut-S (GPS) in Combination with Keytruda® in WT1+ Platinum-Resistant Advanced Ovarian Cancer at the International Gynecologic Cancer Society 2023 Annual Global Meeting
Rhea-AI Summary
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.
Rhea-AI Impact
Rhea-AI Sentiment
End-of-Day
1.04%
Tags
clinical trial
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News
SELLAS Life Sciences Announces $4 Million Registered Direct Offering Priced At-the-Market Under Nasdaq Rules
Rhea-AI Summary
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.
Rhea-AI Impact
Rhea-AI Sentiment
End-of-Day
-16.38%
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offering
News
SELLAS Life Sciences Receives Fast Track Designation from FDA for SLS009 for Treatment of Relapsed/Refractory Peripheral T-cell Lymphomas
Rhea-AI Summary
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.
Rhea-AI Impact
Rhea-AI Sentiment
End-of-Day
23.4%
Tags
clinical trial
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News
SELLAS Life Sciences to Present Final Data from Phase 1/2 Study of Galinpepimut-S in Combination with Keytruda® (pembrolizumab) in Patients with WT1+ Platinum-Resistant Advanced Ovarian Cancer at the International Gynecologic Cancer Society 2023 Annual Global Meeting
Rhea-AI Summary
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.
Rhea-AI Impact
Rhea-AI Sentiment
End-of-Day
-7.87%
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conferences clinical trial
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News
SELLAS Life Sciences Provides Update on Phase 3 REGAL Clinical Trial for Galinpepimut-S in Acute Myeloid Leukemia
Rhea-AI Summary
SELLAS Life Sciences provides update on Phase 3 clinical trial for galinpepimut-S
Rhea-AI Impact
Rhea-AI Sentiment
End-of-Day
20.37%
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clinical trial
News
SELLAS Announces First Patient Dosed in Phase Ib/II Trial of SLS009 (GFH009) in Relapsed/Refractory Peripheral T-cell Lymphomas
Rhea-AI Summary
SELLAS Life Sciences announces initiation of Phase Ib/II trial for SLS009 in PTCL
Rhea-AI Impact
Rhea-AI Sentiment
End-of-Day
-15.49%
Tags
clinical trial
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SELLAS Life Sciences Group Inc

Nasdaq:SLS

SLS Rankings

#4423 Ranked by Market Cap
#5312 Ranked by Stock Gains
N/A Ranked by Dividends

SLS Stock Data

75.40M
55.63M
0.5%
10.45%
9.37%
Pharmaceutical Preparation Manufacturing
Manufacturing
Link
US
Camden

About SLS

σellas life sciences is a healthcare-oriented global group of companies with a unique and innovative vision, which is ambitious, yet clear: to practice the medicine of tomorrow, today. in other words, we incorporate innovation throughout all our activities aiming at breakthroughs that will have a significant impact on the thinking and practicing of healthcare worldwide. our international team of acknowledged scientists, doctors and health professionals along with a seasoned and highly experienced pharmaceutical executive management form the core of σellas. we strive to improve patients' quality of life through developing and commercializing cutting-edge drugs, medical devices and innovative therapies.