FIBROGEN WKN: A12EZ0 ISIN: US31572Q8087 Kürzel: 1FG Forum: Aktien Thema: Hauptdiskussion

Super!!!!!

$FGEN Astellas Receives European Commission Approval for First-in-Class EVRENZO™ (roxadustat) for Adult Patients with Symptomatic Anemia of Chronic Kidney Disease

FibroGen (FGEN) Receives CRL from FDA for Roxadustat for Anemia of Chronic Kidney Disease https://www.streetinsider.com/dr/news.php?id=18800521&gfv=1 ... The letter indicates the FDA will not approve the roxadustat NDA in its present form and has requested additional clinical study of roxadustat be conducted, prior to resubmission. ...

FibroGen Reports Second Quarter 2021 Financial Results https://www.globenewswire.com/news-release/2021/08/09/2277395/33525/en/FibroGen-Reports-Second-Quarter-2021-Financial-Results.html • Roxadustat net product revenue in China of $13.4 million, on a US GAAP basis. • Total roxadustat net sales in China of $52.8 million1 by FibroGen and the distribution entity jointly owned by FibroGen and AstraZeneca • Roxadustat Receives Positive Opinion from the CHMP of EMA for Patients with Anemia of CKD • Roxadustat Receives Negative Vote from FDA Advisory Committee for Patients with Anemia of CKD ...

Guter Zeitpunkt um einzusteigen. Kursziele hier: https://ch.marketscreener.com/kurs/aktie/FIBROGEN-INC-18537026/analystenerwartungen/

Eluminex Biosciences Licenses Investigational Biosynthetic Cornea from FibroGen https://www.marketwatch.com/story/eluminex-biosciences-licenses-investigational-biosynthetic-cornea-from-fibrogen-271626695741

Ich warte noch.....

Sie tut gerade alles dafür 📉

Fibrogen hat Potenzial ohne Ende

Noch bisschen tiefer, dann bin ich sofort wieder dabei

AstraZeneca, FibroGen hit another roxadustat setback as FDA panel calls for more safety data https://www.fiercepharma.com/pharma/astrazeneca-fibrogen-hit-another-roxadustat-setback-as-fda-panel-calls-for-more-safety-data

Wegen AdComm Meeting vom Handel ausgesetzt: FibroGen (FGEN) Halted, News Pending https://www.streetinsider.com/dr/news.php?id=18680186

FibroGen slides after FDA posted documents ahead of AdCom meeting on Roxadustat https://seekingalpha.com/news/3714766-fibrogen-slides-after-fda-posted-documents-ahead-of-adcom-meeting-on-roxadustat FibroGen (FGEN -6.3%) is trading lower after the FDA posted a report on Roxadustat ahead of a decision by its advisory committee this week. Roxadustat, an oral agent developed by the company in partnership with AstraZeneca (AZN -0.1%) for anemia of chronic kidney disease is set to undergo the review of FDA’s Cardiovascular and Renal Drugs Advisory Committee (CRDAC) on Thursday. The treatment that belongs to the category of Erythropoiesis Stimulating Agents (ESA) could face safety risks, the briefing documents filed by the FDA indicated. “You will discover that roxadustat’s efficacy is comparable to that of ESAs; however, there are important risks of serious thromboembolic events, as well as other risks, with Roxadustat,” the staff mentioned in the report. “The principal issue before the Committee is the drug’s safety, and safety with respect to the specific CKD patient populations,” they added. Last month, Fibrogen shares surged after the company announced that the European Medicines Agency (EMA) endorsed the therapy for the treatment of anemia symptoms in patients with chronic kidney disease.

https://www.reuters.com/article/brief-eu-drug-regulator-posts-human-medi-idUSFWN2O70C0 EMA-EVRENZO (ROXADUSTAT) ERHÄLT EINE POSITIVE STELLUNGNAHME ZUR BEHANDLUNG VON ANÄMIE-SYMPTOMEN BEI PATIENTEN MIT CHRONISCHER NIERENKRANKHEIT On 24 June 2021, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Evrenzo, intended for the treatment of anaemia symptoms in patients with chronic kidney disease. ... https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-evrenzo_en.pdf

FibroGen is facing a milestone this week: Mizuho https://seekingalpha.com/news/3708878-fibrogen-is-facing-a-milestone-this-week-mizuho • Fibrogen (FGEN -0.5%) is awaiting a key decision on its oral small molecule inhibitor Roxadustat as the European Medicines Agency (EMA) is set to decide on its approval for the treatment of anemia in adults with chronic kidney disease. • The decision expected this week will lead Fibrogen shares to move, Mizuho analysts led by Difei Yang note adding that the investors will consider the opinion of EMA’s Committee for Medicinal Products for Human Use ("CHMP") as a read through to an upcoming FDA Adcom meeting. • “A positive CHMP opinion in both the dialysis-dependent and non-dialysis-dependent settings would help de-risk next month's AdCom, in our opinion,” the analysts wrote. • In connection with the company’s New Drug Application (NDA) for roxadustat, the FDA has tentatively scheduled a meeting of its expert panel on July 15, Fibrogen announced last month.