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.