On May 9, 2017 FibroGen, Inc. (NASDAQ:FGEN), a science-based biopharmaceutical company, reported financial results for the first quarter of 2017 and provided an update on the company’s recent developments (Press release, FibroGen, MAY 9, 2017, View Source [SID1234518945]). Schedule your 30 min Free 1stOncology Demo! "This is an exciting time for FibroGen, as we prepare for an eventful second half of the year across our pipeline. In the third quarter of 2017, we anticipate reporting topline Phase 2 clinical trial results for pamrevlumab in idiopathic pulmonary fibrosis patients, and we are preparing to complete submission of the roxadustat China NDA for the treatment of anemia in non-dialysis and dialysis CKD patients," said Thomas B. Neff, FibroGen’s Chief Executive Officer. "We are gratified by the support we received from new and current investors in our recent equity offering, which raised $115.1 million in net proceeds. This financing will support our plans to increase the number of studies and accelerate development in other anemia categories in China, including for roxadustat in anemias in certain oncology settings."
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Recent Developments AND HIGHLIGHTS
U.S. Roxadustat for Anemia in Chronic Kidney Disease (CKD)
The independent data safety monitoring board (DSMB) recommended in April that all trials continue with no modifications to current protocols.
On track to submit the NDA for roxadustat in the U.S. in 2018.
U.S. Roxadustat for Anemia in Myelodysplastic Syndromes (MDS)
Received approval from FDA to conduct Phase 3 study for the treatment of anemia in MDS. This study is planned to start in the third quarter of 2017.
China Roxadustat Anemia in CKD: Dialysis and Non-Dialysis
Positive Phase 3 results from two pivotal trials in China were announced on January 30, 2017.
On target for NDA submission in China in the third quarter of 2017.
China Roxadustat for Myelodysplastic Syndromes (MDS)
Received approval from the CFDA to undertake a Phase 2/3 study for the treatment of anemia in MDS. We plan to start this study in the fourth quarter of 2017.
Pamrevlumab in Idiopathic Pulmonary Fibrosis (IPF)
On track to report topline Phase 2 study results from a double-blind, placebo-controlled study, and a double-blind, active-controlled sub-study for the treatment of IPF in the third quarter of 2017.
Pamrevlumab in Pancreatic Cancer
Positive findings from an ongoing open-label, randomized Phase 1/2 study in locally advanced pancreatic cancer were presented at the 2017 Gastrointestinal Cancers Symposium in January.
Positive results from a prior Phase 1/2 trial were published online in January 2017 in the Journal of Cancer Clinical Trials.
Corporate and Financial Highlights
Net loss per basic and diluted share for the quarter ended March 31, 2017 was $0.52, as compared to $0.45 a year ago.
At March 31, 2017, FibroGen had $314.2 million of cash, restricted time deposits, cash equivalents, investments, and receivables.
In addition, we completed an equity financing on April 11, 2017 that generated $115.1 million in net proceeds.