Source: European Pharmaceutical Review
Celgene (CELG) gave the market some bad news earlier this week. The company announced it received a Refusal To File ("RTF") letter from the FDA regarding its New Drug Administration ("NDA") application for ozanimod, a treatment for relapsing multiple sclerosis:
Celgene Corporation [NASDAQ: CELG] today announced that it has received a Refusal to File letter from the United States Food and Drug Administration (FDA) regarding its New Drug Application (NDA) for ozanimod in development for the treatment of patients with relapsing forms of multiple sclerosis. Ozanimod is a novel, oral, selective sphingosine 1-phosphate 1 (S1PR1) and 5 (S1PR5) receptor modulator.
Upon its preliminary review, the FDA determined that the nonclinical and clinical pharmacology sections in the NDA were insufficient to permit a complete review. Celgene intends to seek immediate guidance, including requesting a Type A meeting with the FDA, to ascertain what additional information will be required to resubmit the NDA.
Celgene vowed to work with the FDA to "expeditiously address all outstanding items" in order to bring ozanimod to the market. Celgene's stock is off 9% since the announcement and hovers just above its 52-week low of $87.
