SELLAS Updates on REGAL Trial Progress with 72 Events Recorded
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Dec 29 2025
0mins
Should l Buy SLS?
Source: Newsfilter
- Trial Progress Update: As of December 26, 2025, SELLAS has recorded 72 events in the REGAL trial, just 8 events away from the 80 required to trigger the final analysis, indicating smooth trial progress and potential completion of analysis by year-end.
- Blinded Status Maintained: SELLAS remains blinded to trial outcomes, ensuring the validity and reliability of future statistical analyses and avoiding any statistical penalties that could arise from premature data disclosure.
- Survival Expectations: The REGAL trial aims to evaluate GPS as a maintenance therapy for AML patients, with researchers hoping to observe longer survival than the current treatment options, which have an expected median survival of around 8 months, addressing urgent patient needs.
- Clinical Trial Significance: The REGAL trial is viewed as a crucial effort to assess GPS as a novel therapeutic approach in AML patients, demonstrating SELLAS's commitment to addressing significant unmet medical needs.
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Analyst Views on SLS
Wall Street analysts forecast SLS stock price to rise
2 Analyst Rating
2 Buy
0 Hold
0 Sell
Moderate Buy
Current: 3.550
Low
7.00
Averages
7.25
High
7.50
Current: 3.550
Low
7.00
Averages
7.25
High
7.50
About SLS
SELLAS Life Sciences Group, Inc. is a late-stage clinical biopharmaceutical company. The Company is focused on the development of therapeutics for a range of cancer indications. The Company's product candidates are galinpepimut-S (GPS), a peptide immunotherapy directed against the Wilms tumor 1 (WT1), antigen, and SLS009, a selective small molecule cyclin-dependent kinase 9 (CDK9) inhibitor. GPS is a cancer immunotherapeutic agent licensed by Memorial Sloan Kettering Cancer Center (MSK), that targets the WT1 protein, which is present in an array of tumor types. GPS has potential as a monotherapy or in combination with other immunotherapeutic agents to address a broad spectrum of hematologic malignancies and solid tumor indications. The Company is developing SLS009, which is licensed by GenFleet Therapeutics (Shanghai), Inc., for all therapeutic and diagnostic uses in the world outside of mainland China, Hong Kong, Macau, and Taiwan.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
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- U.S. Enrollment Plans: The U.S. clinical trial is expected to begin in Q1 2026, with European enrollment anticipated in Q2 2026, demonstrating the company's commitment to advancing SLS009 on a global scale.
- Market Performance Decline: SLS stock has ended in the red in five of the last seven sessions, with the latest trading down 3.2%, as investors booked profits amid dilution concerns, putting pressure on the stock price.
- Investor Sentiment: Despite the stock's decline, retail sentiment on Stocktwits remains bullish, with investors believing that validating SLS009 in both the U.S. and EU simultaneously will attract global buyers like Novartis.
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- Drug Combination Evaluation: SLS009 will be evaluated in combination with azacitidine (AZA) and venetoclax (VEN), aiming to enhance treatment outcomes for newly diagnosed AML patients, which is expected to significantly improve clinical results.
- International Collaboration Network: The IMPACT-AML project connects multiple European clinical institutions, allowing SELLAS to accelerate clinical research in a cost-effective manner, thereby enhancing the market potential of SLS009.
- Strategic Significance: This collaboration not only provides strong external validation for SELLAS but also reflects the potential of SLS009 in addressing critical unmet needs in AML, further solidifying SELLAS's market position in cancer treatment.
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- Clinical Study Expansion: SELLAS Life Sciences has signed an agreement with IMPACT-AML to expand the clinical development of SLS009 into Europe, with plans to enroll 40 newly diagnosed AML patients, aiming to accelerate patient enrollment and broaden drug accessibility.
- U.S. Enrollment Plans: The U.S. clinical trial is expected to begin in Q1 2026, with European enrollment anticipated in Q2 2026, demonstrating the company's commitment to advancing SLS009 on a global scale.
- Market Performance Decline: SLS stock has ended in the red in five of the last seven sessions, with the latest trading down 3.2%, as investors booked profits amid dilution concerns, putting pressure on the stock price.
- Investor Sentiment: Despite the stock's decline, retail sentiment on Stocktwits remains bullish, with investors believing that validating SLS009 in both the U.S. and EU simultaneously will attract global buyers like Novartis.
See More
SELLAS Life Sciences Partners with IMPACT-AML to Advance SLS009 Clinical Trials
- Clinical Trial Expansion: SELLAS Life Sciences has entered into an agreement with IMPACT-AML to recruit approximately 40 newly diagnosed high-risk acute myeloid leukemia (AML) patients in the U.S. by Q1 2026, leveraging existing infrastructure for efficient European patient enrollment.
- Drug Combination Evaluation: SLS009 will be evaluated in combination with azacitidine (AZA) and venetoclax (VEN), aiming to enhance treatment outcomes for newly diagnosed AML patients, which is expected to significantly improve clinical results.
- International Collaboration Network: The IMPACT-AML project connects multiple European clinical institutions, allowing SELLAS to accelerate clinical research in a cost-effective manner, thereby enhancing the market potential of SLS009.
- Strategic Significance: This collaboration not only provides strong external validation for SELLAS but also reflects the potential of SLS009 in addressing critical unmet needs in AML, further solidifying SELLAS's market position in cancer treatment.
See More
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- IP Expansion: Oncolytics Biotech filed a Track 1 prioritized examination patent application with the USPTO in Q3 2025 for manufacturing innovations related to pelareorep, which, if granted, could extend its commercial protection to 2044, thereby enhancing its competitive market position.
- Significant Clinical Results: Pelareorep achieved a 33% objective response rate in second-line KRAS-mutant microsatellite-stable metastatic colorectal cancer patients, significantly higher than the 6-11% response rate for chemotherapy alone, potentially driving a $20 billion market growth.
- Expert Team Expansion: Oncolytics Biotech expanded its Gastrointestinal Tumor Scientific Advisory Board by adding three globally recognized experts from leading cancer centers, enhancing academic support for its clinical research and further elevating the company's reputation in the industry.
- Successful FDA Alignment: The company secured FDA alignment on its Phase 3 study design for pelareorep in first-line metastatic pancreatic cancer, marking the imminent launch of the only immunotherapy registration trial planned for this disease in the market.
See More
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- Capital Raising Announcement: Intelligent Bio Solutions revealed plans to raise $10 million through a private placement, which led to a sharp 19.7% decline in its stock price during Friday's session, indicating a negative impact on investor confidence and market performance.
- Stock Price Reaction: Following the announcement, shares of Intelligent Bio fell to $7.65, reflecting market concerns regarding the company's future financial health and potentially affecting its ability to secure further funding.
- Market Dynamics: While Intelligent Bio's stock plummeted, other stocks such as Lavoro Limited and Ironwood Pharmaceuticals surged by 181% and 57.7% respectively, highlighting a divergence in market performance among different companies.
- Investor Focus: The announcement of this capital raising plan may prompt investors to reassess Intelligent Bio's strategic direction, particularly in the current market environment where the necessity and timing of fundraising are critically important.
See More
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- Sales Guidance Boost: Ironwood Pharmaceuticals anticipates 2026 US net sales for Linzess to reach between $1.125 billion and $1.175 billion, indicating strong market demand that is expected to drive future revenue growth.
- Revenue Expectations Rise: The company projects total revenue for 2026 to be between $450 million and $475 million, which is likely to enhance investor confidence and attract more capital inflow.
- Strong EBITDA Forecast: Ironwood expects adjusted EBITDA to exceed $300 million in 2026, indicating ongoing improvements in profitability that could elevate its market valuation.
- Significant Stock Surge: Following the announcement, Ironwood's shares surged 57.7% to $5.32, reflecting a positive market reaction to its growth potential.
See More
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- Market Breakthrough: ARS Pharma's neffy has received approval from China's NMPA, becoming the first needle-free epinephrine nasal spray for emergency allergy treatment, with commercial availability expected in spring 2026, addressing the growing demand for allergy treatments and further expanding the company's global market presence.
- Market Potential: Neffy generated $31.3 million in U.S. sales in Q3 2025, demonstrating strong market adoption, and the upcoming launch in China is anticipated to significantly boost overall revenue and enhance brand influence.
- Strategic Positioning: This approval marks neffy's successful entry into multiple global markets, including the U.S., U.K., E.U., Japan, and Australia, underscoring the company's leadership in the global allergy treatment sector.
- Future Outlook: With the product's commercialization in China, ARS Pharma plans to strengthen its collaboration with Pediatrix Therapeutics, leveraging its marketing rights in China to drive sales growth and increase market share.
See More
