Celgene receives Refusal to File letter from FDA regarding ozanimod NDA
Celgene Corporation (CELG) announced that it has received a Refusal to File letter from the United States 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 and 5 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.
UBS analyst Carter Gould noted Celgene disclosed the FDA issued a Refusal to File regarding the NDA for ozanimod in multiple sclerosis.
He believes this will likely delay its approval until at least 2019 and raise another round of questions on Celgene’s execution as the last six months have brought clinical, regulatory, and commercial setbacks. Gould maintained his Buy rating, but lowered his price target to $106 from $120.
SunTrust analyst Yatin Suneja downgraded Celgene to Hold from Buy and lowered his price target to $106 from $139. Suneja cites the FDA refusal letter on ozanimod for relapsing forms of multiple sclerosis after its determination that the nonclinical and clinical pharmacology sections in the NDA were “insufficient” to permit a complete review.
The analyst says ozanimod was “central to our bull thesis to re-accelerate growth in the I&I franchise”, lowering his projected peak sales estimate for the treatment to $3.5B from $5.0B following this latest setback.
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