FDA grants fast track nod to Kinnate Biopharma's skin cancer inhibitor

Sep. 21, 2022 4:20 PM ETKinnate Biopharma Inc. (KNTE)By: Anuron Mitra, SA News Editor1 Comment

On a blue background, a stethoscope, a syringe and pills and a wooden block with the word MELANOMA.

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  • Clinical-stage oncology company Kinnate Biopharma (NASDAQ:KNTE) on Wednesday said it had got a fast track designation from the U.S. FDA for its inhibitor KIN-2787 for the treatment of patients with melanoma, the most serious type of skin cancer.
  • The exact indication for KIN-2787 is for the treatment of patients with BRAF Class II or III alteration-positive and/or NRAS mutation-positive stage IIb to IV malignant melanoma that is metastatic or unresectable.
  • The FDA's Fast Track approval is a process designed to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need.
  • KIN-2787 is being evaluated in an ongoing phase 1 clinical trial in patients with solid tumors harboring BRAF alterations or who have NRAS mutant melanoma, KNTE said in a statement.
  • The fast track nod for KIN-2787 follows an earlier orphan drug designation granted by the FDA for the treatment of stage IIb-IV melanoma.
  • KNTE stock +4.8% to $12.65 after hours.

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