Roxadustat

FibroGen Presents Data from Phase 3 MATTERHORN Trial of Roxadustat in Patients with Anemia of Lower Risk Transfusion-Dependent Myelodysplastic Syndromes at American Society of Hematology Annual Meeting

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토요일, 12월 9, 2023
Roxadustat, Risk, Anemia, SAN, Society, MDS, ASH, TI, Patient, Safety, Pharmaceutical industry

SAN FRANCISCO, Dec. 09, 2023 (GLOBE NEWSWIRE) -- FibroGen, Inc. (NASDAQ: FGEN) announced today the presentation of efficacy and safety data from MATTERHORN, a Phase 3 clinical study of roxadustat for the treatment of anemia in patients with lower risk transfusion-dependent myelodysplastic syndromes (MDS) at the 65th American Society of Hematology (ASH) Annual Meeting and Exposition being held in San Diego, California December 9 - 12, 2023. The oral presentation was selected for the “2024 Highlights of ASH”.

Key Points: 
  • SAN FRANCISCO, Dec. 09, 2023 (GLOBE NEWSWIRE) -- FibroGen, Inc. (NASDAQ: FGEN) announced today the presentation of efficacy and safety data from MATTERHORN, a Phase 3 clinical study of roxadustat for the treatment of anemia in patients with lower risk transfusion-dependent myelodysplastic syndromes (MDS) at the 65th American Society of Hematology (ASH) Annual Meeting and Exposition being held in San Diego, California December 9 - 12, 2023.
  • “We are excited to have our data selected for presentation as part of the 2024 Highlights of ASH.
  • We believe that roxadustat could represent an important new therapy for patients with higher transfusion burden low-risk-MDS,” said Thane Wettig, Chief Executive Officer, FibroGen.
  • Additionally, in TI responders, more patients in the roxadustat arm vs. placebo had hemoglobin concentration increases of ≥1.5 g/dL: 45.5% vs 17.4% (p=0.004)ǂ.

FibroGen Reports Third Quarter 2023 Financial Results

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월요일, 11월 6, 2023
Sale, JDE, AstraZeneca, LAPC, Pancreatic Cancer Action Network, American Society of Nephrology, CD46, Poster, Society, Bank statement, Chronic kidney disease, Immunotherapy, Growth, ADC, Interest, ASN, Webcast, Abstract, Pamrevlumab, Pancreatic cancer, Oncology, Anemia, CKD, European Society of Gynaecological Oncology, Investment, Patient, CIA, SAN, Shanda, Pharmaceutical industry, Video game, Vaccine, Roxadustat

Total revenue for the third quarter of 2023 was $40.1 million, as compared to $15.7 million for the third quarter of 2022, an increase of 155% year over year.

Key Points: 
  • Total revenue for the third quarter of 2023 was $40.1 million, as compared to $15.7 million for the third quarter of 2022, an increase of 155% year over year.
  • Restructuring charge for the third quarter of 2023 was $12.6 million, or $0.13 impact to net loss per basic and diluted share, resulting from the reduction in U.S. workforce announced in July 2023.
  • The distribution entity jointly owned by AstraZeneca and FibroGen is not consolidated into FibroGen’s financial statements.
  • FibroGen will host a conference call and webcast today, Monday, November 6, 2023, at 5:00 PM Eastern Time to discuss financial results and provide a business update.

FibroGen Reports Second Quarter 2023 Financial Results

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월요일, 8월 7, 2023
Pancreatic cancer, Interim, Chronic kidney disease, Pancreatic Cancer Action Network, LAPC, Bank statement, Research, Second, AstraZeneca, Sale, Interest, JDE, Shanda, DMD, Patient, Investment, CD46, Anemia, SAN, Webcast, ADC, Growth, Pamrevlumab, MSTV, IPF, Therapy, Idiopathic pulmonary fibrosis, Pharmaceutical industry, Management, Video game, Vaccine, Life insurance, Roxadustat

Achieved second quarter net product revenue under U.S. GAAP from the sale of roxadustat in China of $23.9 million compared to $23.3 million in the second quarter of 2022.

Key Points: 
  • Achieved second quarter net product revenue under U.S. GAAP from the sale of roxadustat in China of $23.9 million compared to $23.3 million in the second quarter of 2022.
  • Achieved second quarter total roxadustat net sales in China1 by FibroGen and the distribution entity (JDE) jointly owned by FibroGen and AstraZeneca of $76.4 million, compared to $53.1 million in the second quarter of 2022, an increase of 44%, driven by over 40% growth in volume.
  • Total revenue for the second quarter of 2023 was $44.3 million, as compared to $29.8 million for the second quarter of 2022, an increase of 49%.
  • FibroGen will host a conference call and webcast today, Monday, August 7, 2023, at 5:00 PM Eastern Time to discuss financial results and provide a business update.

FibroGen Announces Leadership Transition

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화요일, 7월 25, 2023
Interim, Culture, Intarcia Therapeutics, Conterno, Intarsia, Washington University in St. Louis, Science, Lilly, Patient, SAN, Biology, Growth, Therapy, Global marketing, Eli Lilly and Company, Management, Nursing, Pharmaceutical industry, Roxadustat

SAN FRANCISCO, July 25, 2023 (GLOBE NEWSWIRE) -- FibroGen, Inc. (NASDAQ: FGEN), today announced the appointment of Thane Wettig as the Company’s interim Chief Executive Officer effective as of July 23, 2023. Mr. Wettig has served as FibroGen’s Chief Commercial Officer and a key member of the senior leadership team since June 2020. Mr. Wettig succeeds Chief Executive Officer Enrique Conterno, who resigned due to personal reasons. To support Mr. Wettig, Mr. Conterno will serve as a Special Advisor to the CEO during a transition period.

Key Points: 
  • Mr. Wettig has served as FibroGen’s Chief Commercial Officer and a key member of the senior leadership team since June 2020.
  • To support Mr. Wettig, Mr. Conterno will serve as a Special Advisor to the CEO during a transition period.
  • “We have a strong cash position, and have built a great team at FibroGen, including a highly experienced and collaborative leadership team.
  • Mr. Wettig began his career at Lilly in 1990 and served in multiple leadership roles of increasing responsibility during his Lilly tenure.

Akebia’s Vafseo (vadadustat) Poised to Make Waves for GSK’s Jesduvroq and FibroGen/Astellas’ Evrenzo

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목요일, 7월 20, 2023
Anemia, GSK, Chronic kidney disease, Civil service commission, Myocardial infarction, ESA, Vadadustat, Stroke, NDA, Nephrology, Launch, Dialysis, Thrombosis, Coronary thrombosis, Patient, Physician, FDA, EC, CKD, Death, RealTime, European Commission, Daprodustat, Pharmaceutical industry, Medical device, EU, Roxadustat

While several agents within the class have found success globally, the U.S. struggled to get even just one approval across the finish line.

Key Points: 
  • While several agents within the class have found success globally, the U.S. struggled to get even just one approval across the finish line.
  • However, Jesduvroq’s approval did come with a black box warning for increased risk of death, myocardial infarction, stroke, venous thromboembolism, and thrombosis of vascular access.
  • At the same time, their perceptions of ESAs as a treatment for renal anemia in dialysis patients have become increasingly favorable.
  • Assuming approval, Akebia’s launch of vadadustat will also be covered once commercially available and benchmarked against Jesduvroq at a similar time post-launch​.

FIBROGEN INVESTIGATION CONTINUED BY FORMER LOUISIANA ATTORNEY GENERAL: Kahn Swick & Foti, LLC Continues its Investigation of the Officers and Directors of FibroGen, Inc. - FGEN

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토요일, 7월 1, 2023
Epoetin alfa, Certification, Committee, KSF, Death, Food, Roxadustat

NEW ORLEANS, June 30, 2023 (GLOBE NEWSWIRE) -- Former Attorney General of Louisiana, Charles C. Foti, Jr., Esq., a partner at the law firm of Kahn Swick & Foti, LLC (“KSF”), announces that KSF continues its investigation into FibroGen, Inc. (NasdaqGS: FGEN).

Key Points: 
  • NEW ORLEANS, June 30, 2023 (GLOBE NEWSWIRE) -- Former Attorney General of Louisiana, Charles C. Foti, Jr., Esq., a partner at the law firm of Kahn Swick & Foti, LLC (“KSF”), announces that KSF continues its investigation into FibroGen, Inc. (NasdaqGS: FGEN).
  • The Company was subsequently sued in a securities class action lawsuit for failing to disclose material information, violating federal securities laws.
  • Recently, the Lead Plaintiffs in the case moved for certification of the class as the case continues to move forward.
  • KSF’s investigation is focusing on whether FibroGen’s officers and/or directors breached their fiduciary duties to the Company’s shareholders or otherwise violated state or federal laws.

FIBROGEN INVESTIGATION CONTINUED BY FORMER LOUISIANA ATTORNEY GENERAL: Kahn Swick & Foti, LLC Continues its Investigation of the Officers and Directors of FibroGen, Inc. - FGEN

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토요일, 6월 17, 2023
Epoetin alfa, Certification, Committee, KSF, Death, Food, Roxadustat

NEW ORLEANS, June 16, 2023 (GLOBE NEWSWIRE) -- Former Attorney General of Louisiana, Charles C. Foti, Jr., Esq., a partner at the law firm of Kahn Swick & Foti, LLC (“KSF”), announces that KSF continues its investigation into FibroGen, Inc. (NasdaqGS: FGEN).

Key Points: 
  • NEW ORLEANS, June 16, 2023 (GLOBE NEWSWIRE) -- Former Attorney General of Louisiana, Charles C. Foti, Jr., Esq., a partner at the law firm of Kahn Swick & Foti, LLC (“KSF”), announces that KSF continues its investigation into FibroGen, Inc. (NasdaqGS: FGEN).
  • The Company was subsequently sued in a securities class action lawsuit for failing to disclose material information, violating federal securities laws.
  • Recently, the Lead Plaintiffs in the case moved for certification of the class as the case continues to move forward.
  • KSF’s investigation is focusing on whether FibroGen’s officers and/or directors breached their fiduciary duties to the Company’s shareholders or otherwise violated state or federal laws.

FIBROGEN INVESTIGATION CONTINUED BY FORMER LOUISIANA ATTORNEY GENERAL: Kahn Swick & Foti, LLC Continues its Investigation of the Officers and Directors of FibroGen, Inc. - FGEN

Retrieved on: 
화요일, 6월 6, 2023
Epoetin alfa, Certification, Committee, KSF, Death, Food, Roxadustat

NEW ORLEANS, June 06, 2023 (GLOBE NEWSWIRE) -- Former Attorney General of Louisiana, Charles C. Foti, Jr., Esq., a partner at the law firm of Kahn Swick & Foti, LLC (“KSF”), announces that KSF continues its investigation into FibroGen, Inc. (NasdaqGS: FGEN).

Key Points: 
  • NEW ORLEANS, June 06, 2023 (GLOBE NEWSWIRE) -- Former Attorney General of Louisiana, Charles C. Foti, Jr., Esq., a partner at the law firm of Kahn Swick & Foti, LLC (“KSF”), announces that KSF continues its investigation into FibroGen, Inc. (NasdaqGS: FGEN).
  • The Company was subsequently sued in a securities class action lawsuit for failing to disclose material information, violating federal securities laws.
  • Recently, the Lead Plaintiffs in the case moved for certification of the class as the case continues to move forward.
  • KSF’s investigation is focusing on whether FibroGen’s officers and/or directors breached their fiduciary duties to the Company’s shareholders or otherwise violated state or federal laws.

FibroGen Announces Positive Topline Results from China Pivotal Phase 3 Clinical Trial of Roxadustat for the Treatment of Chemotherapy Induced Anemia

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목요일, 5월 18, 2023
TIW, Alfa, New Drug Application, Cancer, AstraZeneca, HB, CIA, Patient, Anemia, Erythropoietin, SAN, MPH, Safety, Pharmaceutical industry, Dietary supplement, Roxadustat, MD

SAN FRANCISCO and BEIJING, May 18, 2023 (GLOBE NEWSWIRE) -- FibroGen, Inc. (NASDAQ: FGEN) and its subsidiary, FibroGen (China) Medical Technology Development Co., Ltd. today announced positive topline data from Company’s Phase 3 clinical study of roxadustat for treatment of anemia in patients receiving concurrent chemotherapy treatment for non-myeloid malignancies in China.

Key Points: 
  • SAN FRANCISCO and BEIJING, May 18, 2023 (GLOBE NEWSWIRE) -- FibroGen, Inc. (NASDAQ: FGEN) and its subsidiary, FibroGen (China) Medical Technology Development Co., Ltd. today announced positive topline data from Company’s Phase 3 clinical study of roxadustat for treatment of anemia in patients receiving concurrent chemotherapy treatment for non-myeloid malignancies in China.
  • In the preliminary safety analysis, the adverse event profile of roxadustat was generally consistent with previous findings and supportive of a positive benefit risk in this patient population.
  • “Roxadustat is a promising potential new oral drug for treating chemotherapy-induced anemia, which complicates the treatment of many cancer patients,” said Mark D. Eisner, MD, MPH, Chief Medical Officer, FibroGen.
  • FibroGen will work with AstraZeneca and the China Health Authority to file the supplemental New Drug Application.

FibroGen Reports First Quarter 2023 Financial Results

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월요일, 5월 8, 2023
Roxadustat, Pancreatic cancer, Cornea, LAPC, Bank statement, AstraZeneca, Sale, First, Interest, JDE, DMD, Patient, Syndrome, Anemia, Investment, SAN, Webcast, Pamrevlumab, IPF, Therapy, CKD, Idiopathic pulmonary fibrosis, Pharmaceutical industry, Video game, Nursing, Life insurance

SAN FRANCISCO, May 08, 2023 (GLOBE NEWSWIRE) -- FibroGen, Inc. (NASDAQ: FGEN) today reported financial results for the first quarter 2023 and provided an update on the company’s recent developments.

Key Points: 
  • SAN FRANCISCO, May 08, 2023 (GLOBE NEWSWIRE) -- FibroGen, Inc. (NASDAQ: FGEN) today reported financial results for the first quarter 2023 and provided an update on the company’s recent developments.
  • First quarter total roxadustat net sales in China1 by FibroGen and the distribution entity (JDE) jointly owned by FibroGen and AstraZeneca was $64.1 million, compared to $43.5 million in the first quarter of 2022, an increase of 47%.
  • Total revenue for the first quarter of 2023 was $36.2 million, as compared to $60.8 million for the first quarter of 2022, which included a $25 million milestone payment.
  • FibroGen will host a conference call and webcast today, Monday, May 8, 2023, at 5:00 PM Eastern Time to discuss financial results and provide a business update.