Bicara Therapeutics Announces Ficerafusp Alfa Granted Breakthrough Therapy Designation by U.S. FDA for 1L HPV-Negative R/M HNSCC
Bicara Therapeutics Inc. (BCAX)
Company Research
Source: GlobeNewswire
BOSTON, Oct. 13, 2025 (GLOBE NEWSWIRE) -- Bicara Therapeutics Inc. (Nasdaq: BCAX), a clinical-stage biopharmaceutical company committed to bringing transformative bifunctional therapies to patients with solid tumors, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) to ficerafusp alfa in combination with pembrolizumab for the first line (1L) treatment of patients with metastatic or with unresectable, recurrent (R/M) head and neck squamous cell carcinoma (HNSCC) whose tumors express programmed death-ligand 1 with combined positive score (CPS) =1, excluding human papillomavirus (HPV)-positive oropharyngeal squamous cell carcinoma. This designation from the FDA underscores the growing recognition of HPV-negative HNSCC as a distinct clinical indication within head and neck cancer – one with particularly poor outcomes, limited therapeutic options, and that represents the vast majority of patients. “This recognition highl
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News
- Bicara Therapeutics Announces Publication of an Abstract with Preliminary Phase 1b Expansion Cohort Data Evaluating 750mg of Ficerafusp Alfa Weekly Plus Pembrolizumab in 1L HPV-negative R/M HNSCC at ESMO Asia 2025GlobeNewswire
- Bicara Therapeutics (NASDAQ:BCAX) had its price target raised by analysts at Wells Fargo & Company from $8.00 to $11.00. They now have an "equal weight" rating on the stock.MarketBeat
- Bicara Therapeutics (NASDAQ:BCAX) had its "outperform" rating reaffirmed by analysts at Wedbush. They now have a $30.00 price target on the stock.MarketBeat
- Bicara Therapeutics GAAP EPS of -$0.67 [Seeking Alpha]Seeking Alpha
- Bicara Therapeutics Reports Third Quarter 2025 Financial Results and Provides Business Update [Yahoo! Finance]Yahoo! Finance
BCAX
Earnings
- 11/10/25 - Miss
BCAX
Sec Filings
- 11/28/25 - Form EFFECT
- 11/26/25 - Form 424B5
- 11/25/25 - Form 4
- BCAX's page on the SEC website