Welcome to our dedicated page for Fibrogen news (Ticker: FGEN), a resource for investors and traders seeking the latest updates and insights on Fibrogen stock.
The news archive for FibroGen, Inc. (FGEN) captures the company’s transition to Kyntra Bio, Inc. and its focus on oncology, anemia, and rare disease programs. Company press releases document the formal name change to Kyntra Bio through a Certificate of Amendment filed in Delaware and the shift of its Nasdaq listing from the ticker FGEN to KYNB as of January 8, 2026.
News items highlight Kyntra Bio’s biopharmaceutical pipeline, including updates on roxadustat, an oral HIF-PH inhibitor approved in China, Europe, Japan, and numerous other countries for anemia of chronic kidney disease in adults on dialysis and not on dialysis. Releases also cover regulatory milestones such as FDA Orphan Drug Designation for roxadustat in myelodysplastic syndromes and plans for a pivotal Phase 3 trial in anemia associated with lower-risk MDS and high transfusion burden in the United States.
Investors can review announcements on FG-3246, a potential first-in-class CD46-targeting antibody-drug conjugate in development for metastatic castration-resistant prostate cancer, and FG-3180, a related CD46-targeted PET imaging agent being evaluated as a companion diagnostic. The news flow includes trial initiations, investigator-sponsored studies, and planned data readouts.
Additional coverage details corporate and financial developments, such as the completed sale of FibroGen China to AstraZeneca, repayment of a senior secured term loan, and commentary on the company’s cash runway. This page serves as a historical record of FGEN-labeled announcements, including the period before and during the company’s transformation into Kyntra Bio.
Astellas Pharma and FibroGen announced a positive opinion from the European Medicines Agency's CHMP for roxadustat, an oral treatment for anemia in adults with chronic kidney disease (CKD). This condition affects 1 in 10 globally, with many patients untreated. If approved by the European Commission, roxadustat will be the first HIF-PH inhibitor in Europe, providing a novel mechanism to increase hemoglobin levels. The positive opinion is based on a Phase 3 program involving 9,600 patients, showing efficacy and safety comparable to existing treatments.
Astellas Pharma and FibroGen announced a positive opinion from the European Medicines Agency's CHMP for roxadustat, aimed at treating symptomatic anemia in chronic kidney disease (CKD) patients. This potential approval would make roxadustat the first oral HIF-PH inhibitor in Europe. The CHMP's positive stance is based on a Phase 3 program involving 9,600 patients, demonstrating effectiveness in increasing hemoglobin levels and a safety profile comparable to existing treatments. The European Commission will review the opinion within 67 days for a final decision.
FibroGen has entered into a comprehensive partnership with HiFiBiO Therapeutics, which includes an exclusive license for HiFiBiO's Galectin-9 program and options for CXCR5 and CCR8 programs. This transformative deal involves a $25 million upfront payment and potential milestone payments totaling up to $1.1 billion across all three programs. FibroGen will develop the Galectin-9 program worldwide, with clinical development for its lead candidate expected in Q1 2023, while the CXCR5 and CCR8 candidates are anticipated to begin clinical trials by mid-2023.
FibroGen (NASDAQ: FGEN) announced the activation of an experimental arm in the Pancreatic Cancer Action Network's Precision Promise trial. This trial aims to expedite approval of therapies for metastatic pancreatic cancer by integrating multiple stakeholders. The new arm tests FibroGen's pamrevlumab with standard chemotherapy treatments. Patients may receive pamrevlumab as a first-line treatment in the trial, aiming to enhance patient outcomes. Currently, the trial is enrolling at 15 sites nationwide, with plans for additional sites in early 2022.
FibroGen, Inc. (NASDAQ: FGEN) announced that CEO Enrique Conterno will participate in two upcoming virtual healthcare conferences: the Jefferies Virtual Healthcare Conference on June 4, 2021, at 10:30 AM ET and the Goldman Sachs 42nd Annual Global Healthcare Conference on June 10, 2021, at 3:00 PM ET. A live audio webcast will be accessible on the FibroGen Investor webpage, with a replay available for about 30 days. FibroGen focuses on developing innovative therapeutics, including roxadustat for anemia related to chronic kidney disease and pamrevlumab for various conditions.
FibroGen reported Q1 2021 total revenue of $38.4 million, up from $24.4 million year-over-year. This includes $15.4 million in net product revenue from roxadustat in China, part of $43.5 million total roxadustat sales, a significant increase from $29.2 million last quarter. The company faces a net loss of $71.8 million, improving from $78.3 million last year. Upcoming FDA advisory meeting for roxadustat is scheduled for July 15, 2021, with a European approval decision expected mid-2021.
FibroGen, Inc. (NASDAQ: FGEN) will announce its Q1 2021 financial results on May 10, after market close. A conference call will follow at 5:00 p.m. ET to discuss the company's performance with investors. Interested parties can access the audio webcast via FibroGen's website and are encouraged to join 15 minutes early. The company is focused on innovative therapies, including the development of roxadustat for anemia related to chronic kidney disease and other conditions, as well as pamrevlumab for various serious diseases.
FibroGen, Inc. (NASDAQ: FGEN) announced CEO Enrique Conterno will participate in a fireside chat at the BofA Securities 2021 Virtual Health Care Conference on May 13, 2021, at 5:00 PM Eastern Time. A live audio webcast will be available on the company’s investor webpage.
FibroGen is a biopharmaceutical company focused on developing innovative therapeutics, including roxadustat for anemia related to chronic kidney disease and other conditions, and pamrevlumab for various cancers and diseases.
FibroGen has received Rare Pediatric Disease Designation from the FDA for its anti-CTGF antibody, pamrevlumab, aimed at treating Duchenne muscular dystrophy (DMD). The drug has also been granted Fast Track designation and is undergoing evaluation in two Phase 3 clinical trials. The FDA's designation highlights the unmet medical needs of pediatric patients with DMD, which affects roughly 1 in 5,000 newborn boys. If approved, pamrevlumab could qualify FibroGen for a Priority Review Voucher, enhancing its future drug approval processes.
FibroGen has received FDA Fast Track designation for its anti-CTGF antibody, pamrevlumab, aimed at treating Duchenne muscular dystrophy (DMD). This designation, based on Phase 2 clinical data from non-ambulatory patients, acknowledges the unmet medical need for DMD therapies. Pamrevlumab is also in Phase 3 trials for DMD and other conditions. Approximately 20,000 children worldwide are diagnosed with DMD annually, highlighting the potential impact of this treatment.