Kymera Therapeutics Gets Orphan Drug Designation for KT-333 Lymphoma Treatment

By Chris Wack

The U.S. Food and Drug Administration has granted orphan drug designation to Kymera Therapeutics Inc.'s KT-333 for the treatment of peripheral T-cell lymphoma, or PTCL, the company said Wednesday.

KT-333 is a first-in-class degrader of the transcriptional regulator STAT3, which has been shown to be a key modulator of disease in PTCL, Kymera said.

The FDA's Orphan Drug Designation program provides orphan status to drugs defined as those intended for the treatment, diagnosis or prevention of rare diseases that affect fewer than 200,000 people in the U.S. Orphan drug designation qualifies the sponsor of the drug for certain development incentives, including tax credits for qualified clinical testing, prescription drug user fee exemptions and seven-year marketing exclusivity upon FDA approval.

KT-333 is currently being evaluated in a continuing Phase 1 trial in adult patients with relapsed/refractory liquid and solid tumors, including aggressive lymphomas.

Earlier Wednesday, Wells Fargo cut its price target for Kymera shares to $35 from $62 a share, while maintaining its "Overweight" rating.

Kymera shares were up 7%, to $15.21, in premarket trading.

Write to Chris Wack at [e-mail]

(END) Dow Jones Newswires

June 01, 2022 09:20 ET (13:20 GMT)

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