– 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 – – Data from the Phase 2a Trial of SLS009 in Relapsed/Refractory AML After Venetoclax Failure to be Presented at the Upcoming American Society of Hematology (ASH) Annual Meeting in December – – GPS Granted FDA Rare Pediatric Disease Designation (RPDD) for the Treatment of Pediatric AML – NEW YORK, Nov. 13, 2024 (GLOBE NEWSWIRE) -- SELLAS Life Sciences Group, I ...

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. Maxim Healthcare Virtual Summit Details: ...

-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 clinicalstage 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 ...

Galena Biopharma, Inc. (SLS) could be a solid choice for investors given its recent upgrade to a Zacks Rank #2 (Buy). This upgrade is essentially a reflection of an upward trend in earnings estimates -- one of the most powerful forces impacting stock prices. A company's changing earnings picture is at the core of the Zacks rating. The system tracks the Zacks Consensus Estimate -- the consensus measure of EPS estimates from the sell-side analysts covering the stock -- for the current and following years. The ...

- 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 - - Reported Positive Preliminary Data from the Phase 2a Trial of SLS009 in r/r AML Demonstrating to Date Overall Response Rate (ORR) of 33%, 50%, and 100% in 60 mg QW, 30 mg BIW and 30mg BIW with ASXL1 Mutation Cohorts Respectively - - SLS009 Granted EMA Orphan Drug Designations and U.S. FDA ...

Core Insights - SELLAS Life Sciences Group, Inc. has received Orphan Drug Designation from the European Medicines Agency for SLS009, a selective CDK9 inhibitor targeting relapsed/refractory peripheral T-cell lymphomas [1][2] - The company has previously obtained Orphan Drug and Fast Track Designations from the FDA for SLS009, indicating strong regulatory recognition [2] - SLS009 has shown a 36.4% response rate in PTCL patients during Phase 1 trials, outperforming the current standard of care, belinostat, which has a 25.8% response rate [2] Company Overview - SELLAS is a late-stage clinical biopharmaceutical company focused on developing novel therapies for various cancer indications [4] - The company’s other lead product candidate, GPS, targets the WT1 protein and has potential applications in both hematologic malignancies and solid tumors [4] - SLS009 is positioned as a potentially first and best-in-class CDK9 inhibitor, with reduced toxicity and increased potency compared to existing options [4]

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). "We are pleased t ...

NEW YORK, July 31, 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 it has entered into a securities purchase agreement with a single institutional investor for the purchase and sale of 15,849,056 shares of common stock (or common stock equivalents in lieu thereof) and warrants to purchase up to an aggr ...

Core Insights - SELLAS Life Sciences Group, Inc. has received Rare Pediatric Disease Designation (RPDD) from the FDA for SLS009, a CDK9 inhibitor aimed at treating pediatric acute myeloid leukemia (AML) [3][8] - The RPDD allows SELLAS to potentially obtain a Priority Review Voucher (PRV) upon FDA approval of SLS009, which can be sold or transferred for expedited review of future marketing applications [1][8] - The prognosis for pediatric AML remains poor, with a 5-year overall survival rate of only 33% in relapsed cases, highlighting the urgent need for effective treatments [4] Company Overview - SELLAS is a late-stage clinical biopharmaceutical company focused on developing novel therapies for various cancer indications, including AML [5] - The company is also advancing another lead product candidate, GPS, which targets the WT1 protein and has potential applications in both hematologic malignancies and solid tumors [5] Clinical Development - The ongoing Phase 2 clinical trial for SLS009 has opened enrollment for pediatric AML patients, emphasizing the company's commitment to addressing the needs of this vulnerable population [1][8] - SLS009 is positioned as a potentially first-in-class small molecule CDK9 inhibitor, demonstrating a high response rate in AML patients with unfavorable prognostic factors [5]

Core Insights - SELLAS Life Sciences Group, Inc. has received Rare Pediatric Disease Designation (RPDD) from the FDA for SLS009, a CDK9 inhibitor aimed at treating pediatric acute myeloid leukemia (AML) [1][5] - This designation follows a previous RPDD for pediatric acute lymphoblastic leukemia, highlighting the company's focus on addressing urgent needs in pediatric oncology [8] Company Overview - SELLAS is a late-stage clinical biopharmaceutical company dedicated to developing novel therapies for various cancer indications, including AML [6] - The company’s lead product candidate, GPS, targets the WT1 protein and has potential applications in both hematologic malignancies and solid tumors [6] Product Development - SLS009 is positioned as a potentially first-in-class small molecule CDK9 inhibitor, showing reduced toxicity and increased potency compared to existing CDK9 inhibitors [6] - The drug has demonstrated a high response rate in AML patients with unfavorable prognostic factors, such as ASXL1 mutations [6] Clinical Context - Acute myeloid leukemia is the second most common hematological malignancy in children, often associated with poor prognosis [5] - Current treatments for refractory and relapsed pediatric AML yield a 5-year overall survival rate of only 33%, with significantly lower rates for those with shorter remission periods [5] Regulatory Implications - If SLS009 receives FDA approval for pediatric AML, SELLAS may be eligible for a Priority Review Voucher (PRV), which can expedite the review process for future marketing applications [2][5] - PRVs have recently been valued at approximately $100 million, indicating significant financial implications for the company [2] Clinical Trials - The company has opened enrollment for pediatric AML patients in an ongoing Phase 2 clinical trial, emphasizing its commitment to developing SLS009 [8]