Bicara Shares Rise Premarket on FDA Breakthrough Designation

Dow Jones

Yesterday

By Colin Kellaher

Shares of Bicara Therapeutics rose sharply in premarket trading Monday after the clinical-stage biopharmaceutical company won U.S. Food and Drug Administration breakthrough-therapy designation for its lead program, ficerafusp alfa, in certain head and neck cancers.

Bicara on Monday said the designation covers ficerafusp alfa in combination with Merck's blockbuster cancer drug Keytruda for first-line treatment of patients with metastatic or with unresectable, recurrent head and neck squamous cell carcinoma that is human papillomavirus-negative.

The Boston company said HPV-negative head-and-neck squamous cell carcinoma has particularly poor outcomes and limited therapeutic options.

The FDA's breakthrough-therapy designation aims to expedite the development and review of a drug for serious conditions when preliminary clinical evidence shows the drug might offer substantial improvement over available therapies.

Bicara shares, which closed Friday at $17.78, were recently up 40% to $24.98 in premarket trading.

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

(END) Dow Jones Newswires

October 13, 2025 08:04 ET (12:04 GMT)

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