Why the Celgene Damage May Be an Overreaction

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Celgene Corp. (NASDAQ: CELG) watched its shares drop on Wednesday after the company announced that it received a Refusal to File letter from the U.S. Food and Drug Administration (FDA). Specifically, this is concerning the firm’s New Drug Application (NDA) for ozanimod in development for the treatment of patients with relapsing forms of multiple sclerosis. While Investors let the shares sell off, analysts adjusted their targets accordingly.

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.

Jay Backstrom, M.D., chief medical officer and head of Global Regulatory Affairs for Celgene, commented:

We remain confident in ozanimod’s clinical profile demonstrated in the pivotal program in relapsing forms of multiple sclerosis. We will work with the FDA to expeditiously address all outstanding items and bring this important medicine to patients.

Here’s what analysts had to say after the fact:

  • Credit Suisse maintained its Outperform rating but lowered its target price to $129 from $130.
  • SunTrust Robinson Humphrey downgraded it to Hold from Buy with a new $106 price target, down from $139.
  • Stifel maintained its Buy rating but trimmed its target to $128 from $130.
  • Robert W. Baird cut its price target to $92 from $101.
  • BMO Capital markets cut the price target to $139 from $144.
  • Guggenheim Securities cut its price target to $124 from $144.
  • Leerink cut its price target to $123 from $135.
  • Piper Jaffray cut its price target to $95 from $105.
  • RBC Capital Markets cut its price target to $131 from $140.

Shares of Celgene were last seen down about 8% at $88.27 on Wednesday, with a consensus analyst price target of $124.62 and a 52-week range of $87.11 to $147.17.