Fibrogen Inc Stock Price, News & Analysis

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 announced a 1-for-25 reverse stock split effective June 16, 2025, with split-adjusted trading beginning June 17 under the same FGEN symbol. The split will reduce outstanding shares from 101.1 million to approximately 4.0 million. This strategic move aims to boost the stock's per-share price to regain compliance with Nasdaq's minimum bid price requirement. The reverse split was approved by stockholders on June 4, 2025. Proportional adjustments will be made to equity incentive plans and outstanding equity awards. Stockholders with fractional shares will receive cash payments, and those holding electronic shares need not take action. Equiniti Trust Company is serving as the exchange agent for this corporate action.

FibroGen (NASDAQ: FGEN) has appointed Dr. Michael Kauffman to its Board of Directors effective June 4, 2025. Dr. Kauffman brings 30 years of life sciences industry experience, particularly in oncology therapeutics, with expertise spanning preclinical research, clinical development, regulatory strategy, and global approvals. He currently serves as CEO, president, and board member of Nereid Therapeutics and holds board positions at several biotech companies. His notable achievements include co-founding Karyopharm and leading the global approval of XPOVIO®, serving as CMO at Onyx Pharma overseeing Kyprolis® development, and leading the Velcade® development program at Millennium Pharmaceuticals. Dr. Kauffman, who holds an MD and PhD from Johns Hopkins Medical School, joins FibroGen as the company positions itself for a potential turnaround with its pipeline of first-in-class assets.

FibroGen (NASDAQ: FGEN) reported its Q1 2025 financial results and business updates. The company announced an increased total consideration of $185 million for the sale of FibroGen China to AstraZeneca, up $25 million from initial guidance, with approximately $100 million in net cash held in China at closing. The transaction is expected to close in Q3 2025, extending the company's cash runway into 2H 2027. Key developments include the planned initiation of a Phase 2 monotherapy trial for FG-3246, their lead ADC targeting CD46 in metastatic castration-resistant prostate cancer, in Q3 2025. The company reported Q1 2025 revenue of $2.7 million, down from $25.4 million in Q1 2024, and a net loss of $16.8 million ($0.16 per share). FibroGen also filed a Type-C meeting request with the FDA regarding roxadustat for anemia associated with lower-risk myelodysplastic syndromes.

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