Browsing Tag
FDA Fast Track
18 posts
Radiopharm Theranostics RAD 101 hits primary endpoint in 90% of brain metastasis patients at second Phase 2b interim analysis
Radiopharm Theranostics RAD 101 achieves 90% PET-MRI concordance in brain metastases Phase 2b trial. Full data due June 2026. Read more.
JNJ’s pasritamig plus docetaxel advances to Phase 3 after strong early results in metastatic castration-resistant prostate cancer
Johnson & Johnson's pasritamig hits 75% PSA response in taxane-naive prostate cancer patients. What Phase 3 means for JNJ's oncology strategy. Read more.
Sangamo Therapeutics wins FDA fast-track status for gene therapy ST-503 targeting small fiber neuropathy
Find out how Sangamo Therapeutics’ FDA fast-track win for ST-503 could reshape small fiber neuropathy treatment and shift biotech investor sentiment.
Will ST‑503 be the non‑opioid breakthrough in pain therapy? Sangamo gets Fast Track nod
Sangamo Therapeutics gains FDA Fast Track for ST-503, a gene therapy targeting chronic neuropathic pain. Find out what this means for non-opioid innovation.
Investors eye Plus Therapeutics after promising ReSPECT-LM results and FDA fast-track push for REYOBIQ in brain metastases
See how Plus Therapeutics’ REYOBIQ delivered >75 percent benefit and no toxicity in its ReSPECT-LM trial—discover what this means for CNS cancer treatment and investors.
Can Moleculin’s MIRACLE trial redefine AML treatment? Company to showcase study at leukemia event
Find out how Moleculin’s MIRACLE phase 3 trial could reshape AML treatment as the company presents its latest progress at the Madrid leukemia meeting.
Neuren Pharmaceuticals secures third FDA Fast Track for NNZ-2591 as shares rise 4.21%
Find out how Neuren Pharmaceuticals is expanding FDA Fast Track coverage for NNZ‑2591 across rare disorders like PMS, AS, and Pitt Hopkins.
Alterity Therapeutics stock surges 33% after ATH434 momentum and FDA fast track designation
Alterity Therapeutics surged 33% after highlighting ATH434’s Phase 2 gains and FDA Fast Track status. Find out why investors are piling in now.
Schrödinger earns FDA Fast Track for SGR-1505 in Waldenström macroglobulinemia amid rising therapeutic demand
Schrödinger’s SGR-1505 receives FDA Fast Track designation for Waldenström macroglobulinemia, highlighting a novel MALT1-targeted approach.
X4 Pharmaceuticals (NASDAQ: XFOR) gets FDA fast track for mavorixafor in chronic neutropenia
X4 Pharmaceuticals (XFOR) secures FDA Fast Track for mavorixafor in chronic neutropenia, targeting trial completion in 2025 and results in 2026.