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FibroGen Announces Clinical Trial Supply Agreement with Regeneron Pharmaceuticals to Evaluate FibroGen's Immuno-Oncology Assets, FG-3165 (anti-Galectin 9) and FG-3175 (anti-CCR8), in Combination with LIBTAYO® in Upcoming Clinical Trials
Newsfilter· 2024-06-03 20:05
FibroGen to evaluate FG-3165, an anti-galectin 9 (Gal9) monoclonal antibody (mAb), as monotherapy treatment as well as in combination with LIBTAYO® in patients with select solid tumors FibroGen to evaluate FG-3175, an anti-c-c motif chemokine receptor 8 (CCR8) mAb, as monotherapy treatment as well as in combination with LIBTAYO® in patients with select solid tumors Both FG-3165 and FG-3175 have demonstrated complementary mechanisms of action with PD-1 inhibitors in preclinical studies SAN FRANCISCO, June 03 ...
FibroGen Announces Clinical Trial Supply Agreement with Regeneron Pharmaceuticals to Evaluate FibroGen's Immuno-Oncology Assets, FG-3165 (anti-Galectin 9) and FG-3175 (anti-CCR8), in Combination with LIBTAYO® in Upcoming Clinical Trials
GlobeNewswire News Room· 2024-06-03 20:05
FibroGen to evaluate FG-3165, an anti-galectin 9 (Gal9) monoclonal antibody (mAb), as monotherapy treatment as well as in combination with LIBTAYO® in patients with select solid tumors FibroGen to evaluate FG-3175, an anti-c-c motif chemokine receptor 8 (CCR8) mAb, as monotherapy treatment as well as in combination with LIBTAYO® in patients with select solid tumors Both FG-3165 and FG-3175 have demonstrated complementary mechanisms of action with PD-1 inhibitors in preclinical studies SAN FRANCISCO, June 03 ...
FibroGen Announces FDA Clearance of Investigational New Drug Application for FG-3165, a Galectin-9 Targeting Monoclonal Antibody, for the Treatment of Patients with Solid Tumors
Newsfilter· 2024-06-03 20:02
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 ...
FibroGen Announces FDA Clearance of Investigational New Drug Application for FG-3165, a Galectin-9 Targeting Monoclonal Antibody, for the Treatment of Patients with Solid Tumors
GlobeNewswire News Room· 2024-06-03 20:02
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 ...
FibroGen(FGEN) - 2024 Q1 - Earnings Call Transcript
2024-05-07 02:31
FibroGen, Inc. (NASDAQ:FGEN) Q1 2024 Earnings Conference Call May 6, 2024 5:00 PM ET Company Participants David DeLucia - VP, Corporate FP&A and IR Thane Wettig - CEO Deyaa Adib - CMO Juan Graham - CFO Chris Chung - SVP, China Operations Conference Call Participants Andy Hsieh - William Blair Paul Choi - Goldman Sachs Operator Good day and thank you for standing by. Welcome to the FibroGen's First Quarter 2024 Earnings Conference Call. At this time, all participants are in a listen-only mode. After the spea ...
FibroGen(FGEN) - 2024 Q1 - Quarterly Report
2024-05-06 20:10
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 ...
FibroGen(FGEN) - 2024 Q1 - Quarterly Results
2024-05-06 20:05
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 ...
FibroGen Reports First Quarter 2024 Financial Results
Newsfilter· 2024-05-06 20:02
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 ...
FibroGen Announces Topline Results from Phase 1 Monotherapy Study of FG-3246 in Patients with Metastatic Castration-Resistant Prostate Cancer
Newsfilter· 2024-04-02 21:46
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 ...
3 Nightmare Nasdaq Stocks Not Worth Holding Another Day
InvestorPlace· 2024-03-20 19:45
Stocks are at the mercy of many factors, and often, prices are just a poor earnings report or a negative headline away from a significant drop. There are times when nobody has any way of preparing. In many instances, however, early signs of trouble creep in. Sensible investors can identify potential issues from declining financial reports, brewing service problems, poorly managed spending, or questionable business decisions. Unfortunately, these three companies all show these signs, which may mean things ar ...