The safety and efficacy of FG-3165 will be evaluated in a Phase 1 trial in select solid tumors Plan to begin enrollment in 2H 2024 SAN FRANCISCO, June 03, 2024 (GLOBE NEWSWIRE) -- FibroGen, Inc. (NASDAQ: FGEN) today announced that the U.S. Food and Drug Administration (FDA) has cleared the Company's Investigational New Drug (IND) of FG-3165, a galectin-9 (Gal9) targeted monoclonal antibody under development for treatment of solid tumors characterized by high Gal9 levels of expression. "The FDA's IND clearan ...

The safety and efficacy of FG-3165 will be evaluated in a Phase 1 trial in select solid tumors Plan to begin enrollment in 2H 2024 SAN FRANCISCO, June 03, 2024 (GLOBE NEWSWIRE) -- FibroGen, Inc. (NASDAQ: FGEN) today announced that the U.S. Food and Drug Administration (FDA) has cleared the Company's Investigational New Drug (IND) of FG-3165, a galectin-9 (Gal9) targeted monoclonal antibody under development for treatment of solid tumors characterized by high Gal9 levels of expression. "The FDA's IND clearan ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Form 10-Q (Mark One) ☑ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number: 001-36740 FIBROGEN, INC. (Exact name of registrant as specified in its charter) For the quarterly period ended March 31, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 San Francisco, CA 94158 (Address of Principal Execu ...

Exhibit 99.1 FibroGen Reports First Quarter 2024 Financial Results SAN FRANCISCO, May 6, 2024 (GLOBE NEWSWIRE) -- FibroGen, Inc. (NASDAQ: FGEN) today reported financial results for the first quarter 2024 and provided an update on the company's recent developments. "We are off to a strong start in 2024 marked by the recent release of compelling Phase 1 data on FG-3246, our CD46 targeted antibody drug conjugate, in metastatic castration-resistant prostate cancer and continued robust growth of our roxadustat b ...

Topline data from the Pancreatic Cancer Action Network (PanCAN) Precision PromiseSM Phase 2/3 study in metastatic pancreatic cancer anticipated in mid-2024Topline data from LAPIS Phase 3 study in locally advanced unresectable pancreatic cancer anticipated in 3Q 2024Reported compelling data from Phase 1 monotherapy study of FG-3246, a CD46 targeted antibody drug conjugate, in metastatic castration-resistant prostate cancer First quarter net revenue growth of 55% year over year, driven by roxadustat China per ...

FG-3246 demonstrated efficacy in adenocarcinoma selected cohorts receiving biologically active doses of FG-3246 at ≥ 1.2 mg/kg in heavily pre-treated, biomarker unselected patients: Median radiographic progression free survival of 8.7 months PSA50 response in 36% of patients Confirmed radiographic objective response rate of 20%, with a median duration of response of 7.5 months FG-3246 demonstrated an acceptable safety profile; adverse events consistent with those observed in other antibody drug conjugate th ...

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SAN FRANCISCO, March 11, 2024 (GLOBE NEWSWIRE) -- FibroGen, Inc. (NASDAQ:FGEN) today announced the appointment of Deyaa Adib, M.D., an executive leader with almost three decades of oncology development experience, as Senior Vice President & Chief Medical Officer to oversee all global clinical development activities. The appointment is effective March 11, 2024. "Deyaa's leadership and expertise in oncology research and clinical development, particularly in bringing oncology therapeutics to market, will be ke ...

Pamrevlumab in Pancreatic Cancer - Pamrevlumab promotes tumor cell apoptosis and reduces cell proliferation in pancreatic cancer preclinical models[1] - A Phase 1/2 study showed a positive exposure response relationship with pamrevlumab plasma level Cmin ≥150 µg/mL, resulting in a 2x increase in median survival (9.4 vs 4.8 months) (p=0.025) and a >3x increase in one-year survival (37% vs 11%) (p=0.01) [3] - Pamrevlumab is currently in two late-stage studies addressing approximately 90% of diagnosed pancreatic cancer patients [8, 39] - FibroGen has established a standard research agreement with PanCAN for the Pamrevlumab Precision Promise Phase 2/3 study [15] - Topline data from the Precision Promise Phase 2/3 study and the LAPIS Phase 3 study are expected in 2Q 2024 [16, 38] - In the U S, pancreatic cancer represents a multi-billion-dollar commercial opportunity for pamrevlumab [27, 44] Roxadustat - Roxadustat net sales to distributors in China reached $284.1 million in full year 2023, a 36% increase compared to $208.8 million a year ago [49] - Roxadustat maintains category leadership based on dollar sales in the ESA + HIF market [54] - A sNDA for Roxadustat has been accepted in China for Anemia associated with CIA, with an approval decision expected in mid-2024 [61, 88] - In MATTERHORN Phase III Trial, 44.4% of Roxadustat arm achieved TI for ≥56 days by EOT, compared to 19.2% in the placebo arm (p=0.048) [65] FG-3246 - Interim data from a Phase 1 study of FG-3246 in heavily pretreated mCRPC patients showed a 19% ORR and a median duration of response ≥ 16 weeks [74, 79]

Product Dependence - The company is heavily reliant on the success of its lead products, pamrevlumab and roxadustat, for future growth[22] - The company faces substantial competition in the discovery, development, and commercialization of product candidates[22] Regulatory Environment - The regulatory approval process for product candidates is highly uncertain, and the company may not obtain necessary approvals in various jurisdictions[26] - The pharmaceutical industry in China is highly regulated, and changes in regulations could materially affect the company's operations[26] International Operations - The company operates in China through FibroGen Beijing, which holds regulatory licenses for roxadustat and has a drug product manufacturing facility[25] - The company has established operations in China and is seeking to commercialize product candidates outside the U.S., facing various international operational risks[26] Financial Management - As of December 31, 2023, the company reported no material financial assets and liabilities denominated in foreign currencies, indicating low foreign currency risk[596] - The company aims to preserve capital while maximizing income from cash and cash equivalents, primarily investing in commercial paper and money market funds[597] - The company has not entered into any hedging arrangements regarding foreign currency risk or other derivative financial instruments[598] - The company’s future financial condition and results of operations may be adversely affected by fluctuations in foreign currency exchange rates[595]