Bicara Therapeutics Shares Sink Over 43% On Mixed Phase 1/1b Trial Results: What's Going On?

Bicara Therapeutics Inc. (NASDAQ:BCAX) shares are trading lower Friday following the release of updated interim data from its Phase 1/1b trial of ficerafusp alfa in combination with pembrolizumab for patients with recurrent or metastatic head and neck squamous cell carcinoma.

What To know: The results were posted ahead of the company's upcoming oral presentation at the 2025 ASCO Annual Meeting.

The data showed a 64% objective response rate in HPV-negative patients, with 21% achieving complete responses. While median overall survival has not yet been reached, the current estimate exceeds 20 months. Median progression-free survival was reported at 9.8 months and the 12-month overall survival rate stood at 61%.

Despite these signals, investor reaction was negative due to concerns about the lack of clarity around long-term durability and the relatively small sample size. The company reported that the trial remains ongoing and the full data will be discussed during a conference call on June 1.

Ficerafusp alfa, a bifunctional antibody targeting both EGFR and TGF-β, is intended to improve tumor penetration and response in solid tumors. While Bicara emphasized encouraging signals in HPV-negative patients, who generally face worse outcomes, the market appeared focused on the uncertainty tied to long-term efficacy and the need for more mature survival data.

BCAX Price Action: Bicara shares closed down Friday 40.80% at $9.27, according to Benzinga Pro.

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