Company Description
FibroGen, Inc. (historically trading on Nasdaq under the symbol FGEN) is a biopharmaceutical company that has undergone a corporate name change to Kyntra Bio, Inc. According to a Form 8-K filed with the U.S. Securities and Exchange Commission, the company amended its certificate of incorporation to change its name from FibroGen, Inc. to Kyntra Bio, Inc., effective January 7, 2026. The company’s common stock, formerly listed as FGEN, began trading on Nasdaq under the new ticker symbol KYNB on January 8, 2026. The CUSIP number for the common stock remained unchanged.
As described in multiple company press releases, Kyntra Bio (formerly FibroGen) is a biopharmaceutical company focused on the development of novel therapies in oncology and anemia, including rare disease indications. The company’s work centers on developing drug candidates that address serious medical needs in cancer biology and blood disorders.
Therapeutic Focus and Key Programs
The company highlights three principal programs in its public disclosures:
- Roxadustat: An oral medication described as the first in a new class of medicines known as HIF-PH inhibitors, which promote erythropoiesis (red blood cell production) through increased endogenous erythropoietin production, improved iron absorption and mobilization, and downregulation of hepcidin. Roxadustat is approved in China, Europe, Japan, and numerous other countries for the treatment of anemia of chronic kidney disease (CKD) in adult patients on dialysis and not on dialysis. The company retains rights to roxadustat in the United States, Canada, Mexico, and in markets not held by AstraZeneca or licensed to Astellas.
- FG-3246 (FOR46): A potential first-in-class fully human antibody-drug conjugate (ADC) targeting CD46. Public statements describe FG-3246 as being developed for metastatic castration-resistant prostate cancer (mCRPC) and potentially other tumor types. FG-3246 binds to an epitope of CD46, a cell receptor target that induces internalization upon antibody binding, is present at high levels in prostate cancer and other tumor types, and shows very limited expression in most normal tissues. FG-3246 is composed of an anti-CD46 antibody (YS5) linked to the anti-mitotic agent MMAE. The company reports that FG-3246 has demonstrated anti-tumor activity in preclinical and clinical studies and is in Phase 2 development in mCRPC, including a monotherapy dose-optimization trial and an investigator-sponsored Phase 1b/2 combination study with enzalutamide.
- FG-3180: A CD46-targeted PET imaging agent described as a companion biomarker program to FG-3246. Company disclosures indicate that FG-3180 is being evaluated as a diagnostic radiopharmaceutical and potential predictive patient selection biomarker, including in a Phase 2 trial designed to assess its diagnostic performance and the potential correlation between CD46 expression and response to FG-3246.
Oncology and Rare Disease Orientation
In a January 2026 press release, the company stated that the rebranding to Kyntra Bio reflects a sharpened focus on novel therapies with potential for significant impact in oncology and rare disease. It emphasized a concentration on mid- and late-stage assets, specifically FG-3246, FG-3180, and roxadustat, and described itself as focusing on development of novel therapies in oncology and rare disease.
The company has also disclosed that roxadustat received Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) for the treatment of myelodysplastic syndromes (MDS). Public communications describe ongoing work on a pivotal Phase 3 clinical trial protocol for roxadustat for the treatment of anemia in patients with lower-risk MDS and high transfusion burden in the United States.
Geographic and Collaboration Context
Press releases identify the company as being based in San Francisco, California. Historically, FibroGen operated a China-focused subsidiary (FibroGen China) related to roxadustat. In 2025, the company completed the sale of FibroGen International (Hong Kong) Ltd. (including its subsidiaries, referred to as FibroGen China) to AstraZeneca Treasury Limited. SEC filings and company announcements state that the total consideration for this transaction was approximately $220 million, comprised of enterprise value and net cash held in China, and that the sale included all roxadustat assets in China.
Following this transaction, the company reported that it maintained rights to roxadustat in the United States, Canada, Mexico, and in markets not held by AstraZeneca or licensed to Astellas Pharma Inc. Public disclosures also note that Astellas and the company are collaborating on the commercialization of roxadustat for the treatment of anemia in territories including Japan, Europe, Turkey, Russia, the Commonwealth of Independent States, the Middle East, and South Africa.
Development Stage and Regulatory Interactions
Company communications describe Kyntra Bio (formerly FibroGen) as focusing on clinical-stage assets. FG-3246 is reported to be in Phase 2 development for metastatic castration-resistant prostate cancer, with an ongoing monotherapy dose-optimization trial and an investigator-sponsored Phase 1b/2 combination study. FG-3180 is being evaluated as a companion PET imaging agent within these clinical programs.
Roxadustat is described as approved in multiple territories for anemia of CKD, while in the United States the company has communicated plans and regulatory interactions related to a pivotal Phase 3 trial in anemia associated with lower-risk myelodysplastic syndromes. Public statements reference discussions with the FDA regarding key design elements of this planned Phase 3 trial.
Corporate Transformation and Capital Structure Actions
In its public updates, the company has characterized recent years as transformational. It reported the completion of the sale of FibroGen China to AstraZeneca, repayment of a senior secured term loan to investment funds managed by Morgan Stanley Tactical Value, and an extension of its cash runway into 2028. SEC filings document amendments to a financing agreement that, among other things, adjusted minimum qualified cash balance requirements, and later filings and press releases note the repayment of the term loan following the China transaction.
The name change from FibroGen, Inc. to Kyntra Bio, Inc., formalized through a Certificate of Amendment filed in Delaware and disclosed in a Form 8-K, is presented by the company as part of this broader transformation and renewed focus on oncology and rare disease assets.
Historical Context for FGEN Ticker
For investors and researchers reviewing the historical ticker FGEN, it is important to note that this symbol represents the period when the company operated under the name FibroGen, Inc. As disclosed in the January 2026 Form 8-K and accompanying press release, the company’s common stock transitioned to trade under the symbol KYNB on Nasdaq as of January 8, 2026. The underlying corporate entity continues as Kyntra Bio, Inc., and the FGEN symbol serves as a historical reference for prior trading and filings.