ABM Therapeutics' ABM-1310 Granted Fast Track Designation by the FDA Following Orphan Drug Designation
26 Sep 2023
Fast TrackOrphan Drug
SAN DIEGO and SHANGHAI, Sept. 26, 2023 /PRNewswire/ -- ABM Therapeutics is pleased to announce today that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for the investigation of ABM-1310 for the treatment of Glioblastoma (GBM) patients carrying BRAF V600E mutation, following the Orphan Drug Designation for ABM-1310 to treat malignant gliomas including GBM received in July.
The FDA grants Fast Track Designation to facilitate the development and expedite the review of medicines to treat serious conditions and fill an unmet medical need. Fast Track Designation is intended to bring promising medicines to patients sooner.
ABM-1310 is an investigational therapeutic candidate currently undergoing clinical development for BRAF V600E mutant solid tumorsBRAF V600E mutant solid tumors. The Fast Track Designation paves the potential path of ABM-1310 to have a significant impact on patients with BRAF V600E mutant GlioblastomaBRAF V600E mutant Glioblastoma. The Fast Track Designation also reinforces ABM's commitment to advancing this target therapy for Glioblastoma patients. ABM is ready to work closely with the FDA to expedite its development.
"We are very grateful to the FDA for recognizing the potential of our novel next-generation investigational drug ABM-1310 to help patients with brain tumors," said Zane Yang, M.D., CMO of ABM Therapeutics. "This offers ABM an interactive collaboration with the FDA to ensure ABM-1310 clinical development expeditiously with the highest standards of safety and quality."
ABM Therapeutics acknowledges the contributions of our team, partners, and investors who have played a vital role in reaching this milestone. Our mission remains to focus on developing innovative therapies for patients.
About ABM Therapeutics
ABM Therapeutics, a clinical-stage biopharmaceutical company with a mission to focus on small molecule research and development of novel drugs for the treatment of cancer, brain cancer and cancer metastases. ABM has been building a broad and robust proprietary pipeline to construct a brain medicine R&D platform. ABM's pipeline includes several programs in various stages of discovery and development, most of which have improved brain permeability to address the unmet needs of treating cancers and metastases in the brain.
SOURCE ABM Therapeutics
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