Citius Shares Fall Premarket After FDA Rejects Cancer Treatment

By Colin Kellaher

Citius Pharmaceuticals shares fell sharply in premarket trading Monday after the U.S. Food and Drug Administration turned away the biopharmaceutical company proposed treatment for a group of rare blood cancers that affects the skin.

Citius had been seeking FDA approval of denileukin diftitox, also known as I/Ontak, for patients with relapsed or refractory cutaneous T-cell lymphoma after at least one prior systemic therapy, but the Cranford, N.J., company on Saturday said the FDA issued a so-called complete response letter, indicating the agency won't approve the application in its current form.

Citius said the FDA is requiring the company to incorporate enhanced product testing, along with additional controls agreed to with the agency during the application review.

The company noted that the FDA didn't raise any concerns relating to the application's safety and efficacy clinical data package, or with the proposed prescribing information.

Citius, which hopes to spin I/Ontak off into a standalone public company, said it plans to provide additional data and remain fully engaged with the FDA as it continues to work toward approval.

Citius shares, which closed Friday at $1.12, were recently down 13% to 97.4 cents in premarket trading.

Write to Colin Kellaher at colin.kellaher@wsj.com

(END) Dow Jones Newswires

July 31, 2023 06:23 ET (10:23 GMT)

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