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Investing.com - Bicara Therapeutics Inc (NASDAQ:BCAX), a $1 billion market cap biotech company, saw its stock climb to $18.51 after H.C. Wainwright reiterated its Buy rating and $40.00 price target following the FDA’s Breakthrough Therapy Designation for the company’s ficerafusp alfa. According to InvestingPro data, analysts maintain a bullish consensus with price targets ranging from $8 to $48.
The FDA granted the designation for ficerafusp alfa in combination with pembrolizumab for first-line treatment of patients with metastatic or unresectable, recurrent head and neck squamous cell carcinoma whose tumors express programmed death-ligand 1 with combined positive score ≥1, excluding HPV-positive oropharyngeal squamous cell carcinoma. The stock has shown strong momentum, gaining over 62% in the past six months.
H.C. Wainwright highlighted clinical results presented at ASCO 2025, where the combination therapy demonstrated a 54% confirmed objective response rate and 21% complete response rate in the evaluable study population.
The firm noted these results appear superior to pembrolizumab alone (19.1% ORR, 6.6% CR) and pembrolizumab plus chemotherapy (38.0% ORR, 7.9% CR) in similar patient populations from the Phase 3 KEYNOTE-048 trial.
From a survival perspective, the combination showed a median progression-free survival of 9.9 months and median overall survival of 21.3 months, which H.C. Wainwright called notable compared to real-world data showing median overall survival of nine to eleven months for similar patients treated with pembrolizumab alone. InvestingPro subscribers can access 10+ additional analyst insights and financial health metrics to better evaluate BCAX’s investment potential.
In other recent news, Bicara Therapeutics Inc. announced that its cancer treatment, ficerafusp alfa, has received Breakthrough Therapy Designation from the U.S. Food and Drug Administration. This designation applies to its use in combination with pembrolizumab for certain head and neck cancer patients, specifically those with metastatic or unresectable, recurrent head and neck squamous cell carcinoma. The treatment targets tumors expressing programmed death-ligand 1, excluding HPV-positive cases.
In addition to this regulatory milestone, Bicara Therapeutics has garnered attention from analysts. TD Cowen reiterated its Buy rating, highlighting the company’s involvement in the emerging field of EGFR bispecific antibodies. Jones Trading also initiated coverage with a Buy rating, setting a price target of $22.00, based on promising clinical data from Bicara’s bispecific antibody treatments. Meanwhile, H.C. Wainwright adjusted its price target to $40.00, citing anticipated higher long-term operating expenses, but maintained a Buy rating. These developments underscore the growing interest and confidence in Bicara’s potential within the biopharmaceutical sector.
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