Austrian and Dutch forecasts point to potential GPS approval or registration in November and August 2027, respectively.
- Regal’s final analysis awaits its 80th death, with the latest disclosed count at 78 as of May 11.
- Positive Regal results could support a potential FDA filing, while Sellas remains blinded to efficacy and survival outcomes.
- Sellas also expects Q4 topline results from its Phase 2 SLS009 study and has reported preclinical pancreatic-cancer findings.
Sellas Life Sciences Group (SLS) is in the spotlight on Wednesday after BlackRock disclosed a 7.9% stake, while retail bulls circulated European forecasts pointing to possible 2027 approval of its leukemia immunotherapy ahead of its Phase 3 results.
SLS stock closed Tuesday up 7% at $12.17,
In a Tuesday filing, BlackRock revealed that it owned 15.87 million SLS shares as of Sept.30, which is about 31% above its March-end holding of 12.14 million shares.
GPS Approval Estimates Put 2027 On SLS Traders’ Radar
Meanwhile, an Austrian health-tech assessment report lists Nov.1, 2027 as expected European Commission approval for GPS in its pipeline appendix.
On the other hand, a Dutch Medicines Horizon Scan entry lists April 2027 as expected registration. “Changes in expected regulatory timelines, development status, and the emergence or discontinuation of medicinal products contribute to both data-related and inherent uncertainty,” the Austrian report cautions.
All Eyes On Sellas Regal’s 80th Event
GPS targets WT1, a protein found in multiple cancers. The randomized Phase 3 Regal trial compares it with investigators’ choice of best available therapy in acute myeloid leukemia (AML) patients who achieved a second complete remission following salvage treatment. Overall survival is the primary endpoint.
Final analysis is triggered by the 80th death across the treatment groups. The latest disclosed count was 78 events as of May 11. Sellas will announce the 80th event before proceeding through database lock, blinded review, statistical analysis and unblinding ahead of topline disclosure.
“For GPS, we are approaching the pre-specified 80th event in the Phase 3 REGAL trial marking a critical step toward the final efficacy analysis and, if successful, a potential BLA submission to the FDA,” CEO Angelos Stergiou said in August. However, Sellas is blinded to efficacy and survival outcomes.
SLS009 Marks Another Catalyst For Sellas
Sellas is also advancing SLS009, or Tambiciclib, its selective CDK9 inhibitor. In August, it reported 28 patients enrolled in an 80-patient randomized Phase 2 study. The trial includes newly diagnosed AML patients unlikely to benefit from Azacitidine and Venetoclax, as well as those showing early resistance after two treatment cycles. Topline results are guided for this fourth quarter.
The company also presented pancreatic-cancer findings last month, showing SLS009 activity in patient-derived laboratory models resistant to the RAS inhibitor Daraxonrasib, with stronger effects when combined.
How Do Retail Traders Feel About SLS?
On Stocktwits, retail sentiment for SLS slipped to ‘neutral’ from ‘bullish’ levels a week ago amid ‘extremely high’ message volume.
The European forecasts sparked debate over what the dates mean for GPS. “Noob question, but what is exactly the significance of this? That they expect the trial to be over soon?” one user asked.
Another user stressed the planning. “The expected date is advisory so that EU healthcare systems can prepare for a potentially disruptive drug,” the user said.
A separate user was skeptical. “Sorry, but it seems like much ado about nothing,” the user wrote, questioning the report’s significance. Others wanted the discussion to reach more traders. “This needs to be seen during market hours,” another user wrote.
SLS stock has surged 223% year-to-date.
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