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FibroGen, Inc. (FGEN): A Turnaround Story Focused on a New Oncology Pipeline
San Francisco, CA, July 2, 2025 – FibroGen, Inc. (NASDAQ: FGEN) is a biopharmaceutical company in the midst of a significant strategic turnaround. Following major clinical and regulatory setbacks, the company is now leveraging its stable, international commercial revenue stream to fund the development of a new, early-stage oncology pipeline, representing a complete pivot in its R&D focus.

Reflecting its challenges, the company's stock has been under pressure, leading to a 1-for-25 reverse stock split in mid-June 2025 to regain compliance with NASDAQ listing requirements. Analyst sentiment is currently mixed, with a consensus "Hold" rating as the market awaits tangible progress from the company's new strategy.

The Commercial Foundation: Roxadustat (Evrenzo®)
FibroGen's primary source of funding is roxadustat (marketed as Evrenzo®), a first-in-class oral therapy for the treatment of anemia associated with chronic kidney disease (CKD).

International Success: The drug is approved and commercialized in numerous major markets, including Europe, Japan, and China. FibroGen has lucrative partnerships with Astellas and AstraZeneca for these regions, which provide the company with a stable and significant stream of collaboration revenue. For the first quarter of 2025, this revenue totaled $55.7 million.

U.S. Regulatory Failure: In a crucial setback, roxadustat is not approved in the United States. The U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) in 2021, citing safety concerns. There is currently no clear path forward for the drug in the U.S. market.

The Pipeline Reset
The company's strategic pivot was necessitated by the complete failure of its other late-stage asset, pamrevlumab, which failed four separate Phase 3 clinical trials in 2023 for various fibrotic diseases. This led to the discontinuation of the entire pamrevlumab program and a major corporate restructuring to conserve cash and refocus R&D efforts.

The new pipeline is now centered on oncology:

FG-3246 (ADC): This is the company's new lead clinical candidate. It is a CD46-targeted antibody-drug conjugate (ADC) being investigated in a Phase 1 trial for patients with metastatic castration-resistant prostate cancer (mCRPC) and other solid tumors. The company has presented early data from this trial and is continuing to enroll patients in dose-escalation cohorts. This program represents the most significant asset in FibroGen's rebuilt pipeline.

Other Early-Stage Assets: The company is also advancing other preclinical and early-clinical assets in immuno-oncology.

Financial Health and Outlook
The restructuring has placed FibroGen on more stable financial footing, allowing it to fund its new strategy. As of March 31, 2025, the company reported:

Cash Position: A strong cash, cash equivalents, and investments balance of $344.3 million.

Net Loss: A net loss of $36.2 million for the first quarter of 2025.

Cash Runway: The company has guided that its current cash reserves are sufficient to fund its operations through 2026.

FibroGen's investment thesis has fundamentally shifted. It is now an early-stage oncology company funded by a commercial-stage ex-U.S. asset. Its future success is entirely dependent on its ability to successfully advance its new, high-risk pipeline, particularly the ADC candidate FG-3246. The path forward is long, and the company must execute flawlessly to demonstrate the value of its new strategy and regain broader investor confidence.