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, now Kyntra Bio, reports biopharmaceutical developments centered on oncology, rare disease and anemia assets. Recurring updates cover FG-3246, a CD46-targeting antibody-drug conjugate in development for metastatic castration-resistant prostate cancer, and FG-3180, an associated CD46-targeted PET imaging agent. News also covers roxadustat, including its approvals for anemia in chronic kidney disease in multiple non-U.S. markets and its U.S. orphan drug designation for myelodysplastic syndromes.
Company updates also include financial results, conference presentations, regulatory communications, shareholder and governance matters, and corporate-status changes. Completed corporate actions include the sale of FibroGen China operations and the 2026 name and ticker transition from FibroGen and FGEN to Kyntra Bio and KYNB.
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.
FibroGen (NASDAQ: FGEN) has scheduled its first quarter 2025 financial results announcement for Monday, May 12, 2025, after market close. The company will host a conference call and webcast presentation at 5:00 PM Eastern Time on the same day, where management will discuss financial performance and provide a business update. The event will include a live Q&A session following the presentation. Interested participants can access the audio webcast through the company's website, and phone dial-in details will be provided upon registration. A replay of the webcast will be available for a limited time on FibroGen's Events & Presentations webpage.
FibroGen (NASDAQ: FGEN) has announced its participation in the upcoming 24th Annual Needham Virtual Healthcare Conference, scheduled for April 7-10, 2025. The company's management team will be conducting one-on-one meetings with investors on Wednesday, April 9th, 2025. Interested investors are advised to reach out to their Needham representatives to schedule meetings.
FibroGen (NASDAQ: FGEN) announced the publication of Phase 1 trial results for FG-3246, a first-in-class anti-CD46 antibody drug conjugate, in treating metastatic castration-resistant prostate cancer (mCRPC). The study, involving 56 heavily pre-treated patients, demonstrated promising results:
Key findings include:
- Maximally tolerated dose: 2.7 mg/kg every 3 weeks
- 20% confirmed objective response rate with 7.5-month median duration
- 80% disease control rate
- 36% PSA50 response rate in 39 evaluable patients
- 8.7-month median radiographic progression-free survival
The company plans to initiate a Phase 2 monotherapy dose optimization study by mid-2025, with topline results from a combination trial with enzalutamide expected in the second half of 2025.
FibroGen (NASDAQ: FGEN) has announced the sale of FibroGen China to AstraZeneca for approximately $160 million, comprising an $85 million enterprise value plus estimated $75 million net cash at closing. The transaction, expected to close by mid-2025, will extend the company's cash runway into 2027.
Key financial results for 2024 show total revenue from continuing operations at $29.6 million, down from $46.8 million in 2023. The company reported a net loss of $153.1 million ($1.53 per share) for 2024, improved from a $323.0 million loss ($3.32 per share) in 2023.
Notable upcoming milestones include:
- Initiation of Phase 2 monotherapy trial for FG-3246 in metastatic castration-resistant prostate cancer by mid-2025
- Expected topline results from Phase 2 combination study with enzalutamide in 2H 2025
- Planned FDA meeting in Q2 2025 regarding roxadustat development for anemia in lower-risk myelodysplastic syndrome
FibroGen (NASDAQ: FGEN) has scheduled the release of its fourth quarter and full year 2024 financial results for Monday, March 17, 2025, after market close. The company will host a conference call at 5:00 PM Eastern Time on the same day, featuring a presentation by the management team followed by a live Q&A session to discuss corporate and financial performance.