Kyntra Bio to Present FG-3246 Data at ASCO GU Conference
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Feb 23 2026
0mins
Should l Buy KYNB?
The company states: "Kyntra Bio (KYNB), formerly FibroGen (FGEN), announced that the data on anti-tumor activity of FG-3246 in combination with enzalutamide in patients with metastatic castration-resistant prostate cancer (mCRPC) from the investigator-sponsored Phase 1b/2 study will be presented at the 2026 American Society of Clinical Oncology Genitourinary Cancers Symposium (ASCO GU), taking place February 26-28, 2026 in San Francisco, CA. The presentation includes data from 44 biomarker unselected patients with progressive metastatic castration-resistant prostate cancer, 17 of which were enrolled in the Phase 1b dose escalation portion of the study. Eligibility criteria for the trial included patients who progressed on at least one prior ARPI while patients who were treated with prior chemotherapy in the castration-resistant setting were excluded. Over 60% of the patients progressed on two or more prior ARPIs, which included prior enzalutamide treatment. The primary endpoint of the escalation phase was assessment of dose-limiting toxicities and determination of the maximum tolerated dose and recommended dose for the Phase 2 portion of the study - which was determined to be 2.1 mg/kg of FG-3246 and 160 mg/day of enzalutamide. The primary endpoint of the Phase 2 expansion portion of the study was composite response rate (PSA50 response and/or objective response per RECIST v1.1). Secondary endpoints were PSA50 response rate, objective response rate, radiographic progression free survival (rPFS), overall survival, and treatment-related adverse events (TRAEs)."
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Analyst Views on KYNB
Wall Street analysts forecast KYNB stock price to rise
2 Analyst Rating
1 Buy
1 Hold
0 Sell
Moderate Buy
Current: 6.920
Low
43.00
Averages
43.00
High
43.00
Current: 6.920
Low
43.00
Averages
43.00
High
43.00
No data
About KYNB
Kyntra Bio, Inc., formerly FibroGen, Inc., is a biopharmaceutical company. The Company is focused on development of novel therapies in oncology and rare disease. The Company continues to evaluate the development plan for the Phase III trial of roxadustat in anemia associated with lower-risk myelodysplastic syndrome (LR-MDS) in the U.S. FG-3246 (also known as FOR46), a first-in-class antibody-drug conjugate (ADC) targeting CD46, is in Phase II development for the treatment of metastatic castration-resistant prostate cancer. This program also includes the development of FG-3180, an associated CD46-targeted PET biomarker. Roxadustat (EVRENZO) is approved in Europe, Japan, and numerous other countries for the treatment of anemia in chronic kidney disease (CKD) patients on dialysis and not on dialysis.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
Kyntra Bio Reports Q4 and Full Year 2025 Financial Results with Losses
- Financial Decline: Kyntra Bio reported a net loss of $14.22 million in Q4 2025, translating to a loss of $3.51 per share, compared to a net profit of $17.98 million or $4.46 per share in the same quarter last year, indicating a significant decline in profitability.
- Annual Performance Shift: For the full year 2025, the company achieved a net profit of $183.45 million, or $45.37 per share, a substantial recovery from a net loss of $47.58 million in the previous year, although it still faced ongoing operational losses.
- Revenue Drop: Total revenue for Q4 decreased to $1.28 million from $3.14 million year-over-year, while annual revenue fell from $29.62 million to $6.44 million, reflecting competitive pressures and challenges in product sales.
- Pipeline Developments: Kyntra Bio is advancing several investigational products, including Roxadustat for anemia in chronic kidney disease, FG-3246 for metastatic castration-resistant prostate cancer, and FG-3180 as a diagnostic PET imaging agent, demonstrating the company's commitment to innovation in drug development.
See More
FibroGen Q4 Earnings Report Analysis
- Earnings Performance: FibroGen reported a Q4 GAAP EPS of -$3.51, beating expectations by $0.37, but revenue of $1.27 million fell 59% year-over-year, indicating significant challenges in revenue growth.
- Annual Revenue Comparison: Total revenue from continuing operations for 2025 was $6.4 million, a sharp decline from $29.6 million in 2024, reflecting substantial difficulties in market competition and product sales.
- Net Loss Situation: The net loss for Q4 2025 was $14.6 million, or $3.61 per share, which is a significant increase from a net loss of $8.7 million and $2.15 per share in the same quarter last year, indicating a deterioration in the company's financial health.
- Cash Flow Status: As of December 31, 2025, FibroGen reported $109.4 million in cash, cash equivalents, investments, and accounts receivable, with expectations that these funds will be sufficient to support operating plans into 2028, despite ongoing losses.
See More
FibroGen to Announce Q4 Earnings on March 16
- Earnings Announcement Schedule: FibroGen is set to release its Q4 earnings on March 16 after market close, drawing significant attention from investors regarding its performance.
- EPS Expectations: The consensus EPS estimate stands at -$3.88, reflecting a staggering year-over-year decline of 2255.6%, indicating severe profitability challenges for the company.
- Revenue Forecast Decline: The anticipated revenue for Q4 is $1.67 million, representing a 46.1% year-over-year decrease, highlighting the company's struggles in market competition and product sales.
- Market Reaction Anticipation: Given the poor earnings outlook, investors may react negatively to FibroGen's stock price, potentially impacting market confidence and the company's investment appeal.
See More
Kyntra Bio Reports Phase 1b/2 Data for Prostate Cancer Treatment
- Clinical Trial Results: Kyntra Bio's Phase 1b/2 study of FG-3246 in combination with enzalutamide for metastatic castration-resistant prostate cancer showed a 21% overall response rate among 44 patients, with a notable 40% response rate in those previously treated with only one androgen receptor pathway inhibitor, indicating the potential of this combination therapy.
- Survival Data: The study reported a median radiographic progression-free survival (rPFS) of 10.1 months for patients, while the overall cohort had a median rPFS of 7.0 months, suggesting FG-3246 may positively impact patient survival and provide new treatment options.
- Safety Analysis: The combination therapy demonstrated a safety profile similar to that of previous monotherapy trials, with the use of G-CSF prophylaxis mitigating the risk of neutropenia, indicating the clinical feasibility of this treatment approach.
- Market Outlook: While William Blair analysts expressed encouragement regarding the initial results of FG-3246, they also noted the need for additional data to assess its long-term potential in the highly competitive prostate cancer market, thus maintaining a Market Perform rating on Kyntra shares.
See More
FG-3246 and Enzalutamide Combination Therapy Shows Promising Results
- Clinical Trial Results: The combination therapy of FG-3246 and enzalutamide demonstrated a median radiographic progression-free survival (rPFS) of 7.0 months in biomarker-unselected metastatic castration-resistant prostate cancer patients, with a notable 10.1 months rPFS in patients who progressed after only one prior ARPI, indicating its potential in earlier lines of therapy.
- Biomarker Potential: Higher tumor uptake of FG-3180 showed a trend towards a higher probability of PSA50 response (p=0.053), highlighting FG-3180's potential as a patient selection biomarker, which may play a crucial role in future clinical trials.
- Safety Analysis: The safety profile of the combination therapy was similar to that observed in the previous FG-3246 monotherapy trial, with the risk of neutropenia effectively mitigated through G-CSF prophylaxis, while common treatment-related adverse events included fatigue, peripheral neuropathy, and anorexia.
- Future Outlook: The Phase 2 monotherapy trial of FG-3246 is on track for interim analysis in the second half of 2026, further validating its application potential in metastatic castration-resistant prostate cancer and exploring the efficacy of FG-3180 as a biomarker.
See More
Kyntra Bio Reports Q4 and Full Year 2025 Financial Results with Losses
- Financial Decline: Kyntra Bio reported a net loss of $14.22 million in Q4 2025, translating to a loss of $3.51 per share, compared to a net profit of $17.98 million or $4.46 per share in the same quarter last year, indicating a significant decline in profitability.
- Annual Performance Shift: For the full year 2025, the company achieved a net profit of $183.45 million, or $45.37 per share, a substantial recovery from a net loss of $47.58 million in the previous year, although it still faced ongoing operational losses.
- Revenue Drop: Total revenue for Q4 decreased to $1.28 million from $3.14 million year-over-year, while annual revenue fell from $29.62 million to $6.44 million, reflecting competitive pressures and challenges in product sales.
- Pipeline Developments: Kyntra Bio is advancing several investigational products, including Roxadustat for anemia in chronic kidney disease, FG-3246 for metastatic castration-resistant prostate cancer, and FG-3180 as a diagnostic PET imaging agent, demonstrating the company's commitment to innovation in drug development.
See More
FibroGen Q4 Earnings Report Analysis
- Earnings Performance: FibroGen reported a Q4 GAAP EPS of -$3.51, beating expectations by $0.37, but revenue of $1.27 million fell 59% year-over-year, indicating significant challenges in revenue growth.
- Annual Revenue Comparison: Total revenue from continuing operations for 2025 was $6.4 million, a sharp decline from $29.6 million in 2024, reflecting substantial difficulties in market competition and product sales.
- Net Loss Situation: The net loss for Q4 2025 was $14.6 million, or $3.61 per share, which is a significant increase from a net loss of $8.7 million and $2.15 per share in the same quarter last year, indicating a deterioration in the company's financial health.
- Cash Flow Status: As of December 31, 2025, FibroGen reported $109.4 million in cash, cash equivalents, investments, and accounts receivable, with expectations that these funds will be sufficient to support operating plans into 2028, despite ongoing losses.
See More
FibroGen to Announce Q4 Earnings on March 16
- Earnings Announcement Schedule: FibroGen is set to release its Q4 earnings on March 16 after market close, drawing significant attention from investors regarding its performance.
- EPS Expectations: The consensus EPS estimate stands at -$3.88, reflecting a staggering year-over-year decline of 2255.6%, indicating severe profitability challenges for the company.
- Revenue Forecast Decline: The anticipated revenue for Q4 is $1.67 million, representing a 46.1% year-over-year decrease, highlighting the company's struggles in market competition and product sales.
- Market Reaction Anticipation: Given the poor earnings outlook, investors may react negatively to FibroGen's stock price, potentially impacting market confidence and the company's investment appeal.
See More
Kyntra Bio Reports Phase 1b/2 Data for Prostate Cancer Treatment
- Clinical Trial Results: Kyntra Bio's Phase 1b/2 study of FG-3246 in combination with enzalutamide for metastatic castration-resistant prostate cancer showed a 21% overall response rate among 44 patients, with a notable 40% response rate in those previously treated with only one androgen receptor pathway inhibitor, indicating the potential of this combination therapy.
- Survival Data: The study reported a median radiographic progression-free survival (rPFS) of 10.1 months for patients, while the overall cohort had a median rPFS of 7.0 months, suggesting FG-3246 may positively impact patient survival and provide new treatment options.
- Safety Analysis: The combination therapy demonstrated a safety profile similar to that of previous monotherapy trials, with the use of G-CSF prophylaxis mitigating the risk of neutropenia, indicating the clinical feasibility of this treatment approach.
- Market Outlook: While William Blair analysts expressed encouragement regarding the initial results of FG-3246, they also noted the need for additional data to assess its long-term potential in the highly competitive prostate cancer market, thus maintaining a Market Perform rating on Kyntra shares.
See More
FG-3246 and Enzalutamide Combination Therapy Shows Promising Results
- Clinical Trial Results: The combination therapy of FG-3246 and enzalutamide demonstrated a median radiographic progression-free survival (rPFS) of 7.0 months in biomarker-unselected metastatic castration-resistant prostate cancer patients, with a notable 10.1 months rPFS in patients who progressed after only one prior ARPI, indicating its potential in earlier lines of therapy.
- Biomarker Potential: Higher tumor uptake of FG-3180 showed a trend towards a higher probability of PSA50 response (p=0.053), highlighting FG-3180's potential as a patient selection biomarker, which may play a crucial role in future clinical trials.
- Safety Analysis: The safety profile of the combination therapy was similar to that observed in the previous FG-3246 monotherapy trial, with the risk of neutropenia effectively mitigated through G-CSF prophylaxis, while common treatment-related adverse events included fatigue, peripheral neuropathy, and anorexia.
- Future Outlook: The Phase 2 monotherapy trial of FG-3246 is on track for interim analysis in the second half of 2026, further validating its application potential in metastatic castration-resistant prostate cancer and exploring the efficacy of FG-3180 as a biomarker.
See More
