Allogene Therapeutics, Inc. (ALLO) has seen a decrease of 32.73% in the aftermarket when the company reported FDA Clinical Hold of AlloCAR Trials. However, the last trading session closed at $24.38 with an increase of 1.71.
ALLO Reports FDA Clinical Hold of AlloCAR Trials Based on a Single Patient Case in ALPHA2 Trial
On 7th October 2021, The US Food and Drug Administration (FDA) has imposed a pause on the Company’s AlloCAR clinical trials. Following the discussions with the FDA, the company plans to offer more information in the coming weeks. The FDA is still reviewing the information submitted at the end of Phase 1 in preparation for an ALLO-501A pivotal Phase 2 study.
Moreover, the clinical hold comes after the company informed the FDA of a chromosomal aberration. The chromosomal aberration was discovered in an ALPHA2 trial patient during a bone marrow biopsy to test pancytopenia. An inquiry is underway to determine the clinical significance of the discovered anomaly.
New Appointment to Scientific Advisory Board
On 20th September 2021, ALLO announced the appointment of Jae Park, M.D. to the scientific advisory board. Dr. Park is the main investigator for many clinical trials in patients with non-Hodgkin lymphoma, chronic lymphocytic leukemia, and acute lymphoblastic leukemia. He is one of the world’s leading specialists in cell treatments.
The company welcomes Dr. Park to join their Scientific Advisory Board. Dr. Park has breakthrough research and expertise in treating patients with CAR T and other new immunotherapies. This will aid ALLO in maintaining its leading position as it expands the platform for patients.
FDA Orphan Drug Designation
On 12th August 2021, ALLO-715 has been given orphan-drug designation by the US Food and Drug Administration for the treatment of multiple myeloma. The US Food and Drug Administration designated ALLO-715 as a Regenerative Medicine Advanced Therapy (RMAT) in April 2021. The FDA grants orphan-drug certification to a drug that treats a rare disease or condition that affects fewer than 200,000 people in the United States. ODD, granted treatments entitle businesses to career possibilities such as tax credits for clinical testing, prescription drug user fee exemptions, and a seven-year marketing exclusivity period.
