FDA refuses to file Celgene's NDA for new MS drug candidate

Celgene’s (Nasdaq: CELG) shares were down 7.7% at $88.33 in extended trading on Tuesday, after the US biotech major revealed that it has received a Refusal to File letter from the US Food and Drug Administration regarding its New Drug Application 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 non-clinical 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.