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.
FibroGen Inc (NASDAQ: FGEN) is a clinical-stage biopharmaceutical company pioneering novel therapies for oncology and anemia through innovative HIF biology and antibody-drug conjugate research. This page serves as the definitive source for verified FibroGen news and official communications, providing stakeholders with timely updates on clinical developments and corporate milestones.
Investors and industry observers will find essential information including clinical trial results, regulatory submissions, and strategic partnership announcements. Our curated feed includes earnings reports, research publications, and manufacturing updates directly impacting FibroGen's progress in bringing targeted therapies to market.
Key content categories cover advancements in the company's HIF-PH inhibitor programs for anemia management, ADC oncology candidates, and updates from global collaborations. All materials are sourced from primary corporate disclosures to ensure accuracy and compliance with financial reporting standards.
Bookmark this page for streamlined access to FibroGen's latest developments. Check regularly for critical updates on pipeline progress, peer-reviewed study data, and market-moving announcements relevant to FGEN shareholders and industry analysts.
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" ]FibroGen (NASDAQ: FGEN) has received positive feedback from the FDA during a Type C meeting regarding roxadustat for treating anemia in patients with lower-risk myelodysplastic syndromes (LR-MDS) and high red blood cell transfusion burden.
The feedback was based on promising post-hoc analysis data from the MATTERHORN Phase 3 trial, where roxadustat showed significant efficacy: 36% (8/22) of patients achieved transfusion independence versus 7% (1/15) in the placebo group. The company plans to initiate a new Phase 3 trial with approximately 200 patients, with the protocol submission expected in Q4 2025.
The planned study will be randomized, double-blind, and placebo-controlled, targeting patients requiring ≥4 pRBC units in consecutive 8-week periods who are refractory to, intolerant to, or ineligible for prior ESA therapy.
FibroGen (NASDAQ: FGEN) has scheduled its second quarter 2025 financial results announcement for Monday, August 11, 2025, after market close. The company will host a conference call and webcast presentation at 5:00 PM Eastern Time on the same day.
The event will feature the FibroGen management team presenting financial results and providing a business update, followed by a live Q&A session. Investors can access the audio webcast through the company's website, and dial-in details will be provided upon registration.