R289 Granted Orphan Drug Designation by the FDA for MDS
“Receiving Orphan Drug designation for R289 supports the development of this therapeutic candidate for the treatment of MDS and highlights the significant unmet medical need that exists for these patients,” said Raul Rodriguez, Rigel’s president and CEO. “Orphan Drug and Fast Track designations, along with encouraging initial data from our ongoing Phase 1b study in patients with lower-risk MDS, represent significant milestones in the advancement of R289 as a potential new treatment option.”
Share:
More News
“This research collaboration with AbCellera directly aligns with Jazz’s rare disease strategy, expanding our focus on GI cancers and building on our existing expertise in oncology,” said Josh Allen, Ph.D., chief scientific officer, oncology, Jazz Pharmaceuticals. “We look forward to collaborating with AbCellera to progress potential best-in-class TCE multispecific antibodies
AIM Chief Executive Officer Thomas K. Equels stated: “AIM hopes to utilize the exploratory biomarker data generated through DURIPANC to design a Phase 3 study involving Ampligen in the treatment of pancreatic cancer. We are particularly interested in evaluating whether specific biomarkers may help to identify ‘super-responder’ patient subsets most
“We are committed to improving the treatment of glioblastoma and are grateful to our investigators and the patients and families who made the TRIDENT trial possible,” said Uri Weinberg, MD, PhD, Chief Medical and Innovation Officer, Novocure. “The study did not meet its primary endpoint, but the results from TRIDENT
“Fast Track Designation is a valuable step forward for givastomig and for patients with first-line HER2-negative metastatic gastric cancer,” said Phillip Dennis, MD, PhD, Chief Medical Officer of NovaBridge. “Phase 1b results demonstrate robust efficacy and favorable overall tolerability in combination with immunochemotherapy. Responses were deep and durable across a