Fibrogen Inc Stock Price, News & Analysis

FibroGen Inc (NASDAQ: FGEN) has announced it will release its second quarter 2024 financial results on Tuesday, August 6, after the market closes. The company will host a conference call at 5:00 PM Eastern Time on the same day to discuss its corporate and financial performance with the investment community.

Investors can access the call via the following methods:

• Toll-free: 1-877-300-8521
• International: 1-412-317-6026
• Webcast: Available on FibroGen's website

FibroGen (NASDAQ: FGEN) announced disappointing results from two late-stage trials evaluating pamrevlumab in pancreatic cancer patients. The pamrevlumab arm in PanCAN's Precision Promise study for metastatic pancreatic cancer and the Phase 3 LAPIS trial for locally advanced, unresectable pancreatic cancer both failed to meet the primary endpoint of overall survival. In response, FibroGen plans to terminate the pamrevlumab development program and implement a significant cost reduction plan, including a 75% reduction in U.S. workforce. The company will focus on its collaboration with AstraZeneca for roxadustat in China and with Astellas in other territories. Despite the setback, pamrevlumab was generally safe and well-tolerated across both studies.

FibroGen will host the second part of its virtual Key Opinion Leader (KOL) investor event series on June 26, 2024, focusing on the FG-3246 development program for metastatic castration-resistant prostate cancer (mCRPC).

Dr. Rahul Aggarwal from the University of California, San Francisco, will discuss the unmet need and evolving treatment landscape for prostate cancer and the potential of FG-3246, a first-in-class CD46 targeting antibody-drug conjugate (ADC).

The event will also cover data from the Phase 1b/2 study evaluating FG-3246 in combination with enzalutamide, presented at the 2024 ASCO meeting. A Phase 2 monotherapy trial for FG-3246 in mCRPC is anticipated to begin in the second half of 2024. A live Q&A session will follow the presentation.

FibroGen has entered a clinical trial supply agreement with Regeneron Pharmaceuticals to test its immuno-oncology assets, FG-3165 and FG-3175, in combination with Regeneron's anti-PD-1 therapy, LIBTAYO®, for treating solid tumors. 

FG-3165 targets Gal9, which suppresses T and NK cell activation. FG-3175 targets CCR8, over-expressed on T regulatory cells in tumors. Both showed complementary mechanisms with PD-1 inhibitors in preclinical studies.

FibroGen will sponsor Phase 1 trials, while Regeneron will supply the drugs. FibroGen retains rights to its compounds. The FDA has cleared the IND application for FG-3165, with an IND for FG-3175 expected in 2025.

FibroGen (NASDAQ: FGEN) announced FDA clearance for its Investigational New Drug (IND) application for FG-3165, a monoclonal antibody targeting galectin-9 (Gal9) for treating solid tumors. FG-3165 has shown anti-tumor activity and improved survival in preclinical models and exhibited excellent tolerability in nonclinical safety studies. The company plans to start enrollment for a Phase 1 clinical trial in the second half of 2024 to evaluate the safety and efficacy of FG-3165 in patients with solid tumors characterized by high Gal9 expression. CEO Thane Wettig stated that this marks a significant milestone for FibroGen's oncology pipeline.

FibroGen (NASDAQ: FGEN) announced that CEO Thane Wettig will participate in a Fireside Chat at the Goldman Sachs 45th Annual Global Healthcare Conference in Miami, Florida, on June 10, 2024, from 10:00-10:35 AM ET.

The company will also have one-on-one meetings with investors during the event. A live audio webcast will be accessible through the FibroGen Investor webpage, with a replay available for 90 days.

FibroGen announced positive interim data from a Phase 1b study of FG-3246 (FOR46) in combination with enzalutamide in metastatic castration-resistant prostate cancer (mCRPC) patients. Presented at the 2024 ASCO Annual Meeting, the study revealed a median radiographic progression-free survival (rPFS) of 10.2 months in biomarker-unselected patients. FG-3246, an anti-CD46 antibody-drug conjugate, showed an acceptable safety profile with adverse events similar to other MMAE-based therapies. The recommended Phase 2 dose for FG-3246 is set at 2.1 mg/kg every three weeks alongside enzalutamide at 160 mg daily.

The trial involved 17 patients, most of whom had received at least two prior androgen receptor signaling inhibitors. The study explored dose escalation with and without granulocyte colony-stimulating factor (G-CSF) support. The primary endpoint was to determine the maximally tolerated dose (MTD) of FG-3246, established at 2.1 mg/kg ABW with primary G-CSF prophylaxis in combination with enzalutamide.

FibroGen, Inc. (NASDAQ: FGEN) will participate in upcoming investor conferences such as Bank of America Health Care Conference and H.C. Wainwright Bioconnect Investor Conference. The company's management will engage in 1x1 investor meetings and a Fireside Chat on specific dates in May 2024.

FibroGen, Inc. (NASDAQ: FGEN) reported strong financial results for Q1 2024, showing a 55% year-over-year net revenue growth driven by roxadustat sales in China and one-time revenue from the termination of the US/RoW AstraZeneca agreement. The company has a healthy cash balance of $214.7 million, ensuring financial stability till 2026.