Keros to Start Rinvatercept DMD Trial in Q1 2026, Plans ALS Regulatory Talks
Keros Therapeutics plans a phase II DMD trial of rinvatercept in Q1 2026 and regulatory talks for ALS in H2 2026. Cash stands at $383 million with runway into H1 2028.
Myelodysplastic Syndromes
DiseaseRelated News
FDA Approves Tregzi Cell Therapy to Prevent Chronic GVHD in Blood Cancer Patients
The FDA has approved Tregzi, a donor-derived T-cell immunotherapy, to reduce the risk of chronic graft-versus-host disease following stem cell transplant in adults with high-risk blood cancers. In a pivotal trial, 78% of recipients were alive and free of severe chronic GVHD at one year versus 38.4% with standard transplant.
iPSC-derived NK cell pipeline shows 12-plus active players and 15-plus drugs
The iPSC-derived NK cells pipeline includes 12+ active players and 15+ drugs in development. FT522 is in Phase I, while CNTY-101 and NCR300 are among other programs in the clinic.
Myelofibrosis Pipeline Expands with Over 40 Candidates from 35+ Companies
The myelofibrosis therapeutic pipeline now includes over 40 candidates from more than 35 companies, with recent developments including Orphan Drug Designation for CK0804 and multiple Phase III trial initiations. Key clinical milestones include completed enrollment in Karyopharm's SENTRY trial and upcoming Phase I data from Incyte's combination therapy studies.
FDA Drug Approval Decisions Expected in April 2026
The FDA is set to make decisions on four drug applications in April 2026, including Orca-T for hematological malignancies, orforglipron for obesity, sparsentan for kidney disease, and a doravirine/islatravir combination for HIV-1.
Faron's Bexmarilimab Data Accepted for BSH Presentation; New AML Study Launched
Faron Pharmaceuticals announces acceptance of bexmarilimab Phase I/II data for poster presentation at BSH 2026, while launching a new Phase II BEAM-X study evaluating the drug in AML patients post-stem cell transplantation.
Zemcelpro Receives NUB Status 1 in Germany, Enabling Hospital Reimbursement Applications
ExCellThera's cell therapy Zemcelpro (dorocubicel) has been granted NUB Status 1 in Germany, allowing hospitals to apply for temporary supplementary reimbursement. 220 German hospitals have expressed interest in offering the therapy in 2026.
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TERMINATED | |
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