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