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BOSTON - The U.S. Food and Drug Administration has granted Breakthrough Therapy Designation to Bicara Therapeutics Inc.’s (NASDAQ:BCAX) ficerafusp alfa in combination with pembrolizumab for certain head and neck cancer patients, the company announced Monday. The $971 million market cap company has seen its shares surge 65% over the past six months, according to InvestingPro data, though current analysis suggests the stock is trading near its Fair Value.
The designation applies to first-line treatment of patients with metastatic or unresectable, recurrent head and neck squamous cell carcinoma (HNSCC) whose tumors express programmed death-ligand 1 with combined positive score ≥1, excluding HPV-positive oropharyngeal squamous cell carcinoma.
The FDA’s decision was supported by results from multiple Phase 1/1b dose cohorts evaluating the drug combination in patients with first-line HPV-negative recurrent/metastatic HNSCC. Data presented at the 2025 American Society of Clinical Oncology Annual Meeting showed a median duration of response of 21.7 months and median overall survival of 21.3 months.
"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," said David Raben, Chief Medical Officer of Bicara Therapeutics, in the press release. InvestingPro data shows the company maintains strong financial health with a robust current ratio of 25.8 and more cash than debt on its balance sheet, providing runway for its clinical development programs.
Breakthrough Therapy Designation is intended to expedite development and review of potential new medicines that demonstrate substantial improvement over available therapies for serious conditions.
Bicara is currently evaluating ficerafusp alfa in FORTIFI-HN01, a pivotal Phase 2/3 clinical trial in patients with first-line recurrent/metastatic HNSCC. The company describes ficerafusp alfa as a first-in-class bifunctional antibody designed to drive tumor penetration by targeting EGFR and TGF-β.
Head and neck squamous cell carcinoma is one of the most common cancers globally, with incidence expected to reach one million new cases annually by 2030. Approximately 80% of patients with recurrent/metastatic HNSCC are HPV-negative. With Bicara’s next earnings report scheduled for November 18, investors tracking this development can access additional insights and 12 more exclusive ProTips through InvestingPro, including detailed analyst forecasts and financial health metrics.
In other recent news, Bicara Therapeutics has seen several developments that may interest investors. TD Cowen has reiterated its Buy rating for Bicara Therapeutics, citing the $8 billion acquisition of Merus by Genmab as a validation for the class of EGFR bispecific antibodies, a field in which Bicara is active. Jones Trading has initiated coverage with a Buy rating and a price target of $22.00, highlighting promising clinical data from Bicara’s bispecific antibody treatment for head and neck cancer. This treatment, when combined with Keytruda, showed more than double the clinical benefits compared to standard treatment, positioning Bicara competitively for potential drug approvals by 2027/2028.
H.C. Wainwright has lowered its price target for Bicara Therapeutics to $40.00 from $41.00, maintaining a Buy rating but citing higher projected long-term operating expenses. Piper Sandler has initiated coverage with an Overweight rating and a $36.00 price target, noting a "substantial disconnect" between market perceptions of Bicara’s ficera treatment and the views of key opinion leaders in the medical field. Meanwhile, Rice Biotech Launch Pad announced the appointment of Carolyn Ng from TPG Life Sciences to its advisory board, expanding its expertise in biotech investments. These developments reflect ongoing interest and activity around Bicara Therapeutics in the investment community.
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