FGEN News & Events

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)."

FibroGen is rebranding the company to Kyntra Bio, representing the next step of the transformation of the Company and its focus on oncology and rare disease assets. The Company's common stock will begin trading under the new Nasdaq symbol "KYNB" at stock market open on January 8. "2025 was a transformational year, highlighted by the sale of FibroGen China, the payoff of our senior secured term loan, and the extension of our cash runway into 2028. We begin this year as Kyntra Bio, a name that captures our company journey and evolution and reflects our purposeful move to a company obsessed with creating outsized impact for patients and shareholders," said Thane Wettig, CEO. "Today, with a sharpened direction, Kyntra Bio is laser-focused on our mid- and late-stage assets - specifically, FG-3246, our first-in-class, CD46 targeting antibody drug conjugate, and FG-3180, our companion PET imaging agent, currently in a Phase 2 monotherapy trial in prostate cancer, and roxadustat, our Phase 3 ready asset, for which we recently received Orphan Drug Designation in myelodysplastic syndromes. We are thrilled to move forward with renewed purpose into this bold era for our company and are excited for what is in front of us." In addition to the new name, the Company is refreshing its corporate website to better reflect the Company's strategy moving forward. The CUSIP number for the Company's common stock is not affected by the name change.

FibroGen announced that the Office of Orphan Products Development of the U.S. Food and Drug Administration has granted roxadustat Orphan Drug Designation for the treatment of myelodysplastic syndromes. "The Orphan Drug Designation granted to roxadustat for MDS underscores the significant treatment gap in this indication, and highlights patients' need for additional convenient treatments that can provide durable response," said Thane Wettig, Chief Executive Officer of FibroGen. "Roxadustat showed an improvement in transfusion-independence in a subset of patients with high transfusion burden in a post-hoc analysis from the Phase 3 MATTHERHORN trial, which along with its favorable tolerability profile and oral route of administration has the ability to set it apart from current second-line treatments. Our team is finalizing the Phase 3 protocol in this patient population for submission to the FDA in the fourth quarter of 2025."