SLS 最新10-Q变化

相对上期新增的文字 · 来源:10-Q · 2026-05-12

• SLS009, or Tambiciclib: Highly Selective Next Generation CDK9 Inhibitor

• In July 2025, we announced that the Phase 2 trial of SLS009 in r/r AML met all primary endpoints and received FDA guidance to advance into a first-line therapy study. The overall response rate, or ORR, in 54 evaluable patients was 33% across all cohorts and dose levels, 40% for the 30 mg BIW dose le…

• Following a productive end of Phase 2 meeting, the FDA recommended that we proceed into a clinical trial to include newly diagnosed, first-line AML patients eligible for aza/ven therapy, where the FDA noted clinical benefit might be greatest. The randomized 80-patient Phase 2 clinical trial is curre…

• In January 2026, we announced that we entered into an agreement with IMPACT-AML, a European collaborative initiative dedicated to advancing innovative treatments for patients with AML. Under the agreement, the IMPACT-AML network will conduct a clinical study evaluating SLS009, enabling access to mul…

• For SLS009, the FDA granted Orphan Drug Product designations in AML and peripheral T-cell lymphoma, or PTCL, and Fast Track designations for r/r AML and r/r PTCL. The FDA granted RPD designation to SLS009 for the treatment of pediatric acute lymphoblastic leukemia, or ALL, in June 2024 and the FDA g…

相对上期删除的文字 · 来源:10-Q · 2025-11-12

• In the fourth quarter of 2023, we completed enrollment in the 45 mg (safety) dose cohort in the Phase 2a study and reported positive initial topline data. At that time, we also commenced enrollment in the 60 mg dose cohort with patients randomized to one of two groups, 60 mg fixed dose once weekly o…

• During the trial, we identified potential biomarkers currently undergoing testing as predictive markers in the most recent portion of the study. In May 2024, we announced additional preliminary data from the Phase 2a trial of SLS009 in r/r AML and successful filing of a provisional patent applicatio…

• In July 2025, we announced that the Phase 2 trial of SLS009 in r/r AML met all primary endpoints and received FDA guidance to advance our first-line therapy study. The overall response rate, or ORR, in 54 evaluable patients was 33% across all cohorts and dose levels, 40% for the 30 mg BIW dose level…

• MR with Myelomonocytic/Myelomonoblastic, or M4/M5, patients with an ORR of 50% (6/12). The median overall survival, or mOS, reached 8.9 months in patients with AML MR and 8.8 months in patients r/r to venetoclax-based regimens at a 30 mg BIW dose level, surpassing the historical benchmark of ~2.4 mo…

• In addition, following a productive end of Phase 2 meeting, the FDA recommended that we proceed into a trial to include newly diagnosed, first-line AML patients eligible for aza/ven therapy, where the FDA noted clinical benefit might be greatest. The randomized 80-patient trial is currently in prepa…

相对上期新增的文字 · 来源:10-Q · 2026-05-12

• •changes in applicable laws, regulatory actions, judicial decisions, accounting standards, and tariffs or trade restrictions;

相对上期新增的文字 · 来源:10-Q · 2026-05-12

• •changes in applicable laws, regulatory actions, judicial decisions, accounting standards, and tariffs or trade restrictions;

相对上期新增的文字 · 来源:10-Q · 2026-05-12

• •changes in applicable laws, regulatory actions, judicial decisions, accounting standards, and tariffs or trade restrictions;

相对上期新增的文字 · 来源:10-Q · 2026-05-12

• •changes in applicable laws, regulatory actions, judicial decisions, accounting standards, and tariffs or trade restrictions;

相对上期新增的文字 · 来源:10-Q · 2026-05-12

• •changes in applicable laws, regulatory actions, judicial decisions, accounting standards, and tariffs or trade restrictions;