Isoquinolines

FibroGen Announces Outcome of FDA Advisory Committee Review of Roxadustat for Treatment of Anemia of Chronic Kidney Disease

Retrieved on: 
Thursday, July 15, 2021
Enzymes, Chemical compounds, Acetic acids, Organic compounds, Isoquinolines, Roxadustat, Hypoxia-inducible factor, Anemias, Myelodysplastic syndrome, HIF prolyl-hydroxylase inhibitor, Procollagen-proline dioxygenase, Chronic kidney disease

Roxadustat, an oral small molecule hypoxia-inducible factor prolyl hydroxylase (HIF-PH) inhibitor, is the first HIF-PH inhibitor accepted by the FDA for review for the treatment of anemia of CKD.

Key Points: 
  • Roxadustat, an oral small molecule hypoxia-inducible factor prolyl hydroxylase (HIF-PH) inhibitor, is the first HIF-PH inhibitor accepted by the FDA for review for the treatment of anemia of CKD.
  • Roxadustat is also in clinical development for anemia associated with myelodysplastic syndromes (MDS) and for chemotherapy-induced anemia (CIA).
  • The Company is currently developing and commercializing roxadustat, an oral small molecule inhibitor of HIF prolyl hydroxylase activity, for anemia of chronic kidney disease (CKD).
  • Roxadustat is also in clinical development for anemia associated with myelodysplastic syndromes (MDS) and for chemotherapy-induced anemia (CIA).

Astellas Receives Positive CHMP Opinion for EVRENZO™ (roxadustat) for Adult Patients with Symptomatic Anemia of Chronic Kidney Disease

Retrieved on: 
Friday, June 25, 2021
Enzymes, Chemical compounds, Acetic acids, Isoquinolines, Roxadustat, Anemias, Myelodysplastic syndrome, Chronic kidney disease, Procollagen-proline dioxygenase, HIF prolyl-hydroxylase inhibitor, Molidustat

Todays positive CHMP opinion marks a significant step in providing patients with a new and important treatment option for anemia associated with CKD, regardless of dialysis status, saidBernhardt G. Zeiher, M.D., Chief Medical Officer, Astellas.

Key Points: 
  • Todays positive CHMP opinion marks a significant step in providing patients with a new and important treatment option for anemia associated with CKD, regardless of dialysis status, saidBernhardt G. Zeiher, M.D., Chief Medical Officer, Astellas.
  • We look forward to the review and assessment by the European Commission which, if positive, would make roxadustat the first HIF-PH inhibitor approved in Europe to treat symptomatic anemia in adult patients with CKD.
  • Roxadustat is also in Phase 3 clinical development for anemia associated with myelodysplastic syndromes (MDS) and Phase 2 for chemotherapy-induced anemia (CIA).
  • The Company is currently developing and commercializing roxadustat, an oral small molecule inhibitor of HIF prolyl hydroxylase activity, for anemia associated with chronic kidney disease (CKD).

Astellas Receives Positive CHMP Opinion for EVRENZO™ (roxadustat) for Adult Patients with Symptomatic Anemia of Chronic Kidney Disease

Retrieved on: 
Friday, June 25, 2021
Chemical compounds, Acetic acids, Organic compounds, Isoquinolines, Roxadustat, Kidney diseases, Chronic kidney disease, Chronic condition, Anemia, HIF prolyl-hydroxylase inhibitor, Molidustat

The Company is currently developing and commercializing roxadustat, an oral small molecule inhibitor of HIF prolyl hydroxylase activity, for anemia associated with chronic kidney disease (CKD).

Key Points: 
  • The Company is currently developing and commercializing roxadustat, an oral small molecule inhibitor of HIF prolyl hydroxylase activity, for anemia associated with chronic kidney disease (CKD).
  • Association of anaemia in primary care patients with chronic kidney disease: cross sectional study of quality improvement in chronic kidney disease (QICKD) trial data.
  • Anemia and iron deficiency among chronic kidney disease Stages 3-5ND patients in the Chronic Kidney Disease Outcomes and Practice Patterns Study: often unmeasured, variably treated.
  • Anemia in Chronic Kidney Disease: National Institute of Diabetes and Digestive and Kidney Disease.

Corcept Therapeutics Settles Patent Litigation with Sun Pharmaceutical

Retrieved on: 
Tuesday, June 15, 2021
Chemical compounds, Organic compounds, Chemistry, Isoquinolines, Ketones, Pyrazoles, Pyridines, Relacorilant, Sulfonamides

The settlement agreement is subject to entry by the Court of a stipulation and order of dismissal related to the litigation.

Key Points: 
  • The settlement agreement is subject to entry by the Court of a stipulation and order of dismissal related to the litigation.
  • As required by law, Corcept and Sun will submit the agreement to theUnited States Federal Trade Commission(FTC) and theUnited States Department of Justice(DOJ) for review.
  • Similar patent litigation brought byCorceptagainst two other companies that have filed ANDAs seeking approval to market generic Korlym remains pending.
  • Corcept has discovered a large portfolio of proprietary compounds, including relacorilant, that selectively modulate the effects of cortisol.

Glancy Prongay & Murray LLP Reminds Investors of Looming Deadline in the Class Action Lawsuit Against FibroGen Inc. (FGEN)

Retrieved on: 
Friday, May 14, 2021
Enzymes, Life sciences, Biotechnology, Acetic acids, Isoquinolines, Roxadustat, Hypoxia-inducible factor, Hydroxylation, Procollagen-proline dioxygenase, Biopharmaceutical

You can also contact Charles H. Linehan, of GPM at 310-201-9150, Toll-Free at 888-773-9224, or via email at [email protected] to learn more about your rights.\nFibroGen is a biopharmaceutical company that develops medicines for the treatment of anemia, fibrotic disease, and cancer.

Key Points: 
  • You can also contact Charles H. Linehan, of GPM at 310-201-9150, Toll-Free at 888-773-9224, or via email at [email protected] to learn more about your rights.\nFibroGen is a biopharmaceutical company that develops medicines for the treatment of anemia, fibrotic disease, and cancer.
  • Its most advanced product is roxadustat, an oral small molecule inhibitor of hypoxia-inducible factor-prolyl hydroxylase (\xe2\x80\x9cHIF-PH\xe2\x80\x9d) activity that acts by stimulating the body\xe2\x80\x99s natural pathway for red cell production.
  • To be a member of the class action you need not take any action at this time; you may retain counsel of your choice or take no action and remain an absent member of the class action.
  • If you inquire by email please include your mailing address, telephone number and number of shares purchased.\nThis press release may be considered Attorney Advertising in some jurisdictions under the applicable law and ethical rules.\nGlancy Prongay & Murray LLP, Los Angeles\n'

HAGENS BERMAN, NATIONAL TRIAL ATTORNEYS, Alerts FibroGen (FGEN) Investors to EXPANDED FRAUDULENT PERIOD in Securities Fraud Action: Investors Should Secure Counsel

Retrieved on: 
Saturday, May 8, 2021
Acetic acids, Branches of biology, Isoquinolines, Roxadustat, Growth factors, Erythropoietin, Stratification, Hazard ratio, Medicine, Medical specialties

To support this marketing edge, FibroGen presented data from phase 3 trials purportedly showing roxadustat was safer than EPO, among other at risk populations, in incident dialysis patients.\nBut after the market closed on Apr.

Key Points: 
  • To support this marketing edge, FibroGen presented data from phase 3 trials purportedly showing roxadustat was safer than EPO, among other at risk populations, in incident dialysis patients.\nBut after the market closed on Apr.
  • 6, 2021, FibroGen stunningly admitted to altering stratification factors to make roxadustat\xe2\x80\x99s hazard ratios indicate lower risk relative to EPO.
  • On this news, the Company\xe2\x80\x99s share price fell over 43%, to close at $19.74 per share on Apr.
  • For the latest news visit our newsroom or follow us on Twitter at @classactionlaw .\n'

FIBROGEN SHAREHOLDERS: June 11, 2021 Filing Deadline in Class Action – Contact Lieff Cabraser

Retrieved on: 
Friday, April 30, 2021
Legal, Professional services, Acetic acids, Isoquinolines, Roxadustat, Chronic kidney disease

A lead plaintiff is a representative party who acts on behalf of other class members in directing the litigation.

Key Points: 
  • A lead plaintiff is a representative party who acts on behalf of other class members in directing the litigation.
  • Your share of any recovery in the actions will not be affected by your decision of whether to seek appointment as lead plaintiff.
  • One of its flagship products is roxadustat, a drug used to treat anemia caused by chronic kidney disease (\xe2\x80\x9cCKD\xe2\x80\x9d).
  • In 2019, FibroGen filed its New Drug Application (\xe2\x80\x9cNDA\xe2\x80\x9d) with the U.S. Food and Drug Administration (\xe2\x80\x9cFDA\xe2\x80\x9d) for the approval of roxadustat.

FibroGen to Present at Upcoming Investor Conference

Retrieved on: 
Wednesday, April 28, 2021
Enzymes, Chemical compounds, Acetic acids, Branches of biology, Transcription factors, Isoquinolines, Roxadustat, Hypoxia-inducible factor, Myelodysplastic syndrome, HIF prolyl-hydroxylase inhibitor, Procollagen-proline dioxygenase, CTGF

A replay will be available for approximately 30 days.\nFibroGen, Inc. is a biopharmaceutical company committed to discovering, developing, and commercializing a pipeline of first-in-class therapeutics.

Key Points: 
  • A replay will be available for approximately 30 days.\nFibroGen, Inc. is a biopharmaceutical company committed to discovering, developing, and commercializing a pipeline of first-in-class therapeutics.
  • The Company applies its pioneering expertise in hypoxia-inducible factor (HIF) and connective tissue growth factor (CTGF) biology to advance innovative medicines for the treatment of unmet needs.
  • The Company is currently developing and commercializing roxadustat, an oral small molecule inhibitor of HIF prolyl hydroxylase activity, for anemia associated with chronic kidney disease (CKD).
  • Roxadustat is also in clinical development for anemia associated with myelodysplastic syndromes (MDS) and for chemotherapy-induced anemia (CIA).

FIBROGEN INVESTORS: June 11, 2021 Filing Deadline in Class Action – Contact Lieff Cabraser

Retrieved on: 
Monday, April 26, 2021
Legal, Professional services, Acetic acids, Isoquinolines, Roxadustat, Chronic kidney disease

A lead plaintiff is a representative party who acts on behalf of other class members in directing the litigation.

Key Points: 
  • A lead plaintiff is a representative party who acts on behalf of other class members in directing the litigation.
  • Your share of any recovery in the actions will not be affected by your decision of whether to seek appointment as lead plaintiff.
  • One of its flagship products is roxadustat, a drug used to treat of anemia caused by chronic kidney disease (\xe2\x80\x9cCKD\xe2\x80\x9d).
  • In 2019, FibroGen filed its New Drug Application (\xe2\x80\x9cNDA\xe2\x80\x9d) with the U.S. Food and Drug Administration (\xe2\x80\x9cFDA\xe2\x80\x9d) for the approval of roxadustat.

Kessler Topaz Meltzer & Check, LLP: Securities Fraud Class Action Lawsuit Filed Against FibroGen, Inc.

Retrieved on: 
Sunday, April 25, 2021
Minerals, Acetic acids, Chemical compounds, Isoquinolines, Roxadustat, Kidney diseases, XC2, Chronic kidney disease, Topaz

b'FibroGen is a biopharmaceutical company that develops medicines for the treatment of anemia, fibrotic disease, and cancer.\nThe complaint alleges that throughout the Class Period, the defendants failed to disclose to investors that: (1) FibroGen\xe2\x80\x99s prior disclosures of U.S. primary cardiovascular safety analyses from the roxadustat Phase 3 program for the treatment of anemia and certain safety analyses submitted in connection with chronic kidney disease included post-hoc changes to the stratification factors; (2) FibroGen\xe2\x80\x99s analyses with the pre-specified stratification factors result in higher hazard ratios (point estimates of relative risk) and 95% confidence intervals; (3) based on these analyses FibroGen could not conclude that roxadustat reduces the risk of (or is superior to) MACE+ in dialysis, and MACE and MACE+ in incident dialysis compared to epoetin-alfa; (4) as a result, FibroGen faced significant uncertainty that its New Drug Application for roxadustat as a treatment for anemia of chronic kidney disease would be approved by the U.S. Food and Drug Administration; and (5) as a result of the foregoing, the defendants\xe2\x80\x99 statements about FibroGen\xe2\x80\x99s business, operations, and prospects were materially misleading and/or lacked a reasonable basis.\nFibroGen investors may, no later than June 11, 2021, seek to be appointed as a lead plaintiff representative of the class through Kessler Topaz Meltzer & Check, LLP, or other counsel, or may choose to do nothing and remain an absent class member.\xc2\xa0 A lead plaintiff is a representative party who acts on behalf of all class members in directing the litigation.\xc2\xa0 In order to be appointed as a lead plaintiff, the Court must determine that the class member\xe2\x80\x99s claim is typical of the claims of other class members, and that the class member will adequately represent the class.\xc2\xa0 Your ability to share in any recovery is not affected by the decision of whether or not to serve as a lead plaintiff.\nKessler Topaz Meltzer & Check, LLP prosecutes class actions in state and federal courts throughout the country involving securities fraud, breaches of fiduciary duties and other violations of state and federal law.

Key Points: 
  • b'FibroGen is a biopharmaceutical company that develops medicines for the treatment of anemia, fibrotic disease, and cancer.\nThe complaint alleges that throughout the Class Period, the defendants failed to disclose to investors that: (1) FibroGen\xe2\x80\x99s prior disclosures of U.S. primary cardiovascular safety analyses from the roxadustat Phase 3 program for the treatment of anemia and certain safety analyses submitted in connection with chronic kidney disease included post-hoc changes to the stratification factors; (2) FibroGen\xe2\x80\x99s analyses with the pre-specified stratification factors result in higher hazard ratios (point estimates of relative risk) and 95% confidence intervals; (3) based on these analyses FibroGen could not conclude that roxadustat reduces the risk of (or is superior to) MACE+ in dialysis, and MACE and MACE+ in incident dialysis compared to epoetin-alfa; (4) as a result, FibroGen faced significant uncertainty that its New Drug Application for roxadustat as a treatment for anemia of chronic kidney disease would be approved by the U.S. Food and Drug Administration; and (5) as a result of the foregoing, the defendants\xe2\x80\x99 statements about FibroGen\xe2\x80\x99s business, operations, and prospects were materially misleading and/or lacked a reasonable basis.\nFibroGen investors may, no later than June 11, 2021, seek to be appointed as a lead plaintiff representative of the class through Kessler Topaz Meltzer & Check, LLP, or other counsel, or may choose to do nothing and remain an absent class member.\xc2\xa0 A lead plaintiff is a representative party who acts on behalf of all class members in directing the litigation.\xc2\xa0 In order to be appointed as a lead plaintiff, the Court must determine that the class member\xe2\x80\x99s claim is typical of the claims of other class members, and that the class member will adequately represent the class.\xc2\xa0 Your ability to share in any recovery is not affected by the decision of whether or not to serve as a lead plaintiff.\nKessler Topaz Meltzer & Check, LLP prosecutes class actions in state and federal courts throughout the country involving securities fraud, breaches of fiduciary duties and other violations of state and federal law.
  • Kessler Topaz Meltzer & Check, LLP is a driving force behind corporate governance reform, and has recovered billions of dollars on behalf of institutional and individual investors from the United States and around the world.
  • \xc2\xa0The firm represents investors, consumers and whistleblowers (private citizens who report fraudulent practices against the government and share in the recovery of government dollars).\xc2\xa0 The complaint in this action was not filed by Kessler Topaz Meltzer & Check, LLP.
  • For more information about Kessler Topaz Meltzer & Check, LLP please visit www.ktmc.com .\nKessler Topaz Meltzer & Check, LLP\n'