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.
FibroGen (Nasdaq: FGEN) rebranded as Kyntra Bio and will begin trading under the new Nasdaq symbol KYNB at market open on January 8, 2026. The company said the change reflects a sharpened focus on oncology and rare disease, centered on three mid/late‑stage assets: FG-3246 (CD46 ADC), FG-3180 (CD46 PET imaging), and roxadustat (Phase 3‑ready). Recent corporate milestones cited include sale of FibroGen China, payoff of the senior secured term loan, and extension of cash runway into 2028. Upcoming catalysts: FG-3246 topline data at ASCO GU in Q1 2026, FG-3180/FG-3246 Phase 2 interim readout in H2 2026, and an FDA Orphan Drug Designation plus a submitted Phase 3 protocol for roxadustat in MDS.
FibroGen (NASDAQ: FGEN) announced that the U.S. FDA granted Orphan Drug Designation to roxadustat for the treatment of myelodysplastic syndromes (MDS) on Dec 15, 2025. The designation may provide fee exemptions, clinical development incentives, and 7 years of U.S. market exclusivity if approved. A post-hoc analysis from the Phase 3 MATTERHORN trial reported roxadustat benefit for transfusion independence in a subset of patients with high transfusion burden. FibroGen is finalizing a Phase 3 protocol for this MDS population and plans to submit it to the FDA in Q4 2025. The company noted ~58,000 LR-MDS patients in the U.S., with ~85% experiencing anemia and many facing transfusion dependence and related complications.
FibroGen (NASDAQ: FGEN) will present at the Oppenheimer Movers in Rare Disease Summit on December 11, 2025 in New York. Thane Wettig, Chief Executive Officer, will participate in a panel titled "Elevator Pitches from Rare Disease Companies with Key Near-Term, Potentially Stock-Moving Catalysts" on December 11 at 12:15 PM ET at the Sofitel New York. FibroGen management will be available for one-on-one investor meetings during the conference; investors should contact their Oppenheimer representative to arrange meetings.
FibroGen (NASDAQ: FGEN) reported third-quarter 2025 results and a business update highlighting a completed sale, clinical progress, and improved balance sheet.
Key facts: sale of FibroGen China for ~$220 million (including ~$135 million net cash in China); cash, cash equivalents, accounts receivable, and investments of $121.1 million with management saying this provides a runway into 2028; repaid term loan, simplifying capital structure. Clinical updates include initiation of the Phase 2 monotherapy trial of FG-3246 with companion diagnostic FG-3180 (interim analysis H2 2026) and FDA agreement on pivotal Phase 3 roxadustat design with final protocol submission anticipated in 4Q 2025. Q3 revenue was $1.1M and net loss from continuing operations was $13.1M.
FibroGen (NASDAQ: FGEN) will report its third quarter 2025 financial results on Monday, November 10, 2025 after market close. Management will host a conference call and live webcast the same day at 5:00 PM Eastern Time to discuss the results, provide a business update, and conduct a live Q&A session.
Investors can access a live audio webcast or register for phone dial-in details. A replay of the webcast will be available for a limited time on the company’s Events & Presentations page.
FibroGen (NASDAQ: FGEN) has launched a Phase 2 monotherapy trial for FG-3246, a first-in-class antibody-drug conjugate (ADC) targeting CD46-expressing cancer lesions in metastatic castration-resistant prostate cancer (mCRPC) patients.
The trial will enroll 75 patients randomized into three dosing groups (1.8, 2.4, or 2.7 mg/kg AJBW) and includes patients who have progressed after ARSI treatment but haven't received chemotherapy. The study will also evaluate FG-3180, a companion PET imaging agent, as a potential diagnostic and predictive biomarker.
An interim analysis is expected in 2H 2026, while topline results from a separate investigator-sponsored study of FG-3246 combined with enzalutamide are anticipated in Q4 2025. The company reports having cash runway extending into 2028.
FibroGen (NASDAQ: FGEN) has completed the sale of its China subsidiary to AstraZeneca for approximately $220 million, comprising $85 million in enterprise value and $135 million in net cash held in China. This amount represents a $60 million increase from initial guidance.
Following the transaction, FibroGen has repaid its term loan to Morgan Stanley Tactical Value for approximately $81 million and extended its cash runway into 2028. The company retains roxadustat rights in the U.S. and markets not licensed to Astellas (excluding China and South Korea).
The company plans to submit a Phase 3 protocol for roxadustat in anemia associated with lower-risk MDS in Q4 2025 and initiate a Phase 2 monotherapy trial of FG-3246 in metastatic castration-resistant prostate cancer in Q3 2025.
FibroGen (NASDAQ: FGEN) announced its participation in the H.C. Wainwright 27th Annual Global Investment Conference taking place from September 8-10, 2025, in New York. CEO Thane Wettig will present on Tuesday, September 9 at 12:00 PM ET at the Lotte New York Palace Hotel.
The presentation will be available via live webcast, and the management team will conduct one-on-one meetings with investors during the conference. A replay will be accessible on FibroGen's website in the Investors and Media section for 90 days following the event.
FibroGen (NASDAQ: FGEN) has received a crucial regulatory approval from the China State Administration for Market Regulation for the sale of FibroGen International (Hong Kong) Ltd. to AstraZeneca Treasury Limited. This approval marks a significant milestone in the transaction that was initially announced on February 20, 2025.
The deal remains subject to other contractual closing conditions and deliverables, with the transaction expected to close in the third quarter of 2025.
FibroGen (NASDAQ: FGEN) reported its Q2 2025 financial results and significant business updates. The company announced an increased total consideration of $210 million for the sale of FibroGen China to AstraZeneca, representing a $50 million increase from initial guidance. The transaction, expected to close in Q3 2025, includes an enterprise value of $85 million plus approximately $125 million in net cash.
Key financial results show Q2 2025 revenue of $1.3 million and a net loss of $13.7 million. The company reported $142.1 million in total consolidated cash and expects its cash runway to extend into 2028 post-China sale.
In clinical developments, FibroGen reached an agreement with the FDA on Phase 3 trial design for roxadustat in LR-MDS patients and plans to initiate a Phase 2 trial of FG-3246, their CD46-targeting ADC, in metastatic castration-resistant prostate cancer in Q3 2025.
[ "Sale of FibroGen China increased by $50 million to $210 million total consideration", "Cash runway expected to extend into 2028 after China sale closes", "FDA agreement reached on Phase 3 trial design for roxadustat in LR-MDS", "Net loss decreased significantly from $47.1M in Q2 2024 to $13.7M in Q2 2025", "Revenue increased 30% year-over-year to $1.3M in Q2 2025" ]FAQ
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